Trial Outcomes & Findings for Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX (NCT NCT03975790)

NCT ID: NCT03975790

Last Updated: 2023-06-09

Results Overview

Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.

Recruitment status

COMPLETED

Target enrollment

479 participants

Primary outcome timeframe

During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Results posted on

2023-06-09

Participant Flow

The study was a retrospective population-based register study. Detailed data on each participant was retrieved from the Truven Health MarketScan Research Database and assessed in this study.

Participant milestones

Participant milestones
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
Rheumatoid arthritis (RA) diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of more than (\>)60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Overall Study
STARTED
337
94
48
Overall Study
COMPLETED
337
94
48
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Total
n=479 Participants
Total of all reporting groups
Age, Continuous
56.10 years
STANDARD_DEVIATION 10.37 • n=337 Participants
55.02 years
STANDARD_DEVIATION 9.81 • n=94 Participants
58.08 years
STANDARD_DEVIATION 9.43 • n=48 Participants
56.09 years
STANDARD_DEVIATION 10.18 • n=479 Participants
Sex: Female, Male
Female
269 Participants
n=337 Participants
82 Participants
n=94 Participants
35 Participants
n=48 Participants
386 Participants
n=479 Participants
Sex: Female, Male
Male
68 Participants
n=337 Participants
12 Participants
n=94 Participants
13 Participants
n=48 Participants
93 Participants
n=479 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants as Per Type of Insurance Plan
Private insurance plan
36 Participants
13 Participants
9 Participants
Number of Participants as Per Type of Insurance Plan
Insurance plan from employer
301 Participants
81 Participants
39 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants enrolled in the study per geographic region of the United States (northeast; north central; south; west; unknown) is reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants in Each Geographic Region
Northeast Region
81 Participants
25 Participants
10 Participants
Number of Participants in Each Geographic Region
North Central Region
76 Participants
17 Participants
14 Participants
Number of Participants in Each Geographic Region
South Region
150 Participants
47 Participants
21 Participants
Number of Participants in Each Geographic Region
West Region
29 Participants
5 Participants
3 Participants
Number of Participants in Each Geographic Region
Unknown Region
1 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of Participants with use of at least one bDMARD during pre-index period is reported. The bDMARD could have been any tumor-necrosis factor-alpha inhibitors (TNFi), any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period
225 Participants
59 Participants
31 Participants

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study.

Number of Participants with use of at least one bDMARD during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant, could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period
247 Participants
69 Participants
36 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Mean number of bDMARD received during pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=225 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=59 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=31 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period
1.38 bDMARD
Standard Deviation 0.59
1.31 bDMARD
Standard Deviation 0.46
1.23 bDMARD
Standard Deviation 0.50

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Mean number of bDMARD received during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=247 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=69 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=36 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period
1.81 bDMARD
Standard Deviation 0.87
1.55 bDMARD
Standard Deviation 0.76
1.50 bDMARD
Standard Deviation 0.61

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of Participants with NB-DMARD use during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period
333 Participants
93 Participants
47 Participants

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study. p-value could not be calculated for reporting groups with 100% response.

Number of Participants with NB-MARD use during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period
334 Participants
94 Participants
48 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Mean number of NB-DMARD received during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=333 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=93 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=47 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period
1.46 NB-DMARD
Standard Deviation 0.67
1.41 NB-DMARD
Standard Deviation 0.63
1.40 NB-DMARD
Standard Deviation 0.65

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Mean number of NB-DMARD received during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=334 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period
1.62 NB-DMARD
Standard Deviation 0.77
1.52 NB-DMARD
Standard Deviation 0.70
1.63 NB-DMARD
Standard Deviation 0.82

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

The mean Quan-Charlson Comorbidity Score during the Pre-Index Period is reported. Quan-Charlson Comorbidity Score predicts the probability of death within one year in participants and was based on the presence of any diagnosis codes on medical claims at any time during the 12-month pre-index period, based on the International Classification of Diseases (ICD) diagnosis codes. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality or higher healthcare resource utilization.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Quan-Charlson Comorbidity Score of Participants
1.69 score on a scale
Standard Deviation 1.08
1.76 score on a scale
Standard Deviation 1.18
1.90 score on a scale
Standard Deviation 1.46

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. p-value could not be calculated between reporting groups for specified rows with 100% response.

Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)genitourinary symptoms/ill-defined conditions. A participant could have had \>=1 comorbidity.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Thyroid disorders
95 Participants
24 Participants
9 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Rheumatoid arthritis/related disease
337 Participants
94 Participants
48 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other aftercare
277 Participants
68 Participants
36 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other connective tissue disease
203 Participants
66 Participants
26 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other non-traumatic joint disorders
200 Participants
56 Participants
29 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Medical examination/evaluation
195 Participants
56 Participants
24 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other suspected conditions
179 Participants
49 Participants
21 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Immunizations/screening for infectious disease
176 Participants
44 Participants
19 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Osteoarthritis
154 Participants
37 Participants
28 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Essential hypertension
144 Participants
44 Participants
27 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Residual codes; unclassified
144 Participants
42 Participants
23 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Disorders of lipid metabolism
147 Participants
36 Participants
22 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Back problems
128 Participants
48 Participants
21 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other upper respiratory infections
114 Participants
31 Participants
13 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other lower respiratory disease
101 Participants
30 Participants
18 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other nervous system disorders
98 Participants
33 Participants
14 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other skin disorders
97 Participants
16 Participants
16 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other bone disease/musculoskeletal deformities
88 Participants
26 Participants
12 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Malaise/fatigue
81 Participants
21 Participants
9 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Esophageal disorders
74 Participants
23 Participants
12 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Nutritional deficiencies
75 Participants
22 Participants
12 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other nutritional: endocrine, metabolic disorders
74 Participants
17 Participants
12 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Diabetes mellitus without complication
72 Participants
18 Participants
11 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Other/unspecified benign neoplasm
65 Participants
18 Participants
5 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
Genitourinary symptoms/ill-defined conditions
59 Participants
12 Participants
9 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)Other upper respiratory disease. A participant could have had \>=1 comorbidity.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other upper respiratory disease
67 Participants
18 Participants
7 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Rheumatoid arthritis/related disease
336 Participants
92 Participants
48 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other aftercare
290 Participants
69 Participants
39 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other connective tissue disease
187 Participants
54 Participants
32 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other suspected conditions
186 Participants
57 Participants
29 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Medical examination/evaluation
186 Participants
51 Participants
22 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other non-traumatic joint disorders
169 Participants
53 Participants
29 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Essential hypertension
156 Participants
51 Participants
26 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Residual codes; unclassified
165 Participants
42 Participants
23 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Disorders of lipid metabolism
155 Participants
42 Participants
20 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Osteoarthritis
141 Participants
41 Participants
21 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Immunizations/screening for infectious disease
142 Participants
44 Participants
15 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Back problems
138 Participants
38 Participants
25 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other upper respiratory infections
123 Participants
29 Participants
21 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other nervous system disorders
100 Participants
37 Participants
20 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other lower respiratory disease
106 Participants
28 Participants
20 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other skin disorders
100 Participants
30 Participants
17 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other nutritional, endocrine, metabolic disorders
104 Participants
25 Participants
14 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Thyroid disorders
90 Participants
23 Participants
11 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other bone disease/musculoskeletal deformities
90 Participants
20 Participants
13 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Nutritional deficiencies
74 Participants
25 Participants
16 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Diabetes mellitus without complication
71 Participants
24 Participants
11 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Esophageal disorders
71 Participants
19 Participants
11 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Malaise/fatigue
69 Participants
17 Participants
7 Participants
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
Other/unspecified benign neoplasm
60 Participants
19 Participants
11 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

The mean of the CIRAS score during pre-index period is reported. The CIRAS is based on claims at any time during the 12-month pre-index period, used to measure RA disease severity using 9 measures (age at index, gender, inflammatory marker test ordered, rehabilitation visit, rheumatoid factor test, Felty's syndrome, number of platelet counts ordered, number of chemistry panels ordered, rheumatologist visit). Value of all 9 measure was used to derive the overall CIRAS score which ranges from 0-7.9 with higher value indicating greater severity of RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period
4.57 score on a scale
Standard Deviation 1.37
4.76 score on a scale
Standard Deviation 1.50
4.31 score on a scale
Standard Deviation 1.20

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with 25 most common medications use during the pre-index period are reported. The 25 most medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) diclofenac sodium, 25) levofloxacin. A participant could have received \>=1 most common medication.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
MTX Sodium
330 Participants
92 Participants
47 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Folic Acid
243 Participants
65 Participants
34 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Prednisone
214 Participants
70 Participants
38 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Acetaminophen/Hydrocodone Bitartrate
111 Participants
33 Participants
14 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Azithromycin
80 Participants
28 Participants
15 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Adalimumab
84 Participants
26 Participants
6 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Hydroxychloroquine Sulfate
83 Participants
21 Participants
10 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Etanercept
76 Participants
21 Participants
16 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Levothyroxine Sodium
80 Participants
16 Participants
10 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Methylprednisolone
66 Participants
22 Participants
15 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Omeprazole
69 Participants
16 Participants
10 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Tramadol Hydrochloride
59 Participants
22 Participants
11 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Meloxicam
58 Participants
20 Participants
8 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Amoxicillin
54 Participants
17 Participants
9 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Albuterol Sulfate
58 Participants
17 Participants
4 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Gabapentin
52 Participants
15 Participants
7 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Acetaminophen/Oxycodone Hydrochloride
46 Participants
20 Participants
7 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Amoxicillin/Clavulanate Potassium
53 Participants
11 Participants
6 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Cyclobenzaprine Hydrochloride
45 Participants
16 Participants
7 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Fluticasone Propionate
47 Participants
13 Participants
5 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Ciprofloxacin Hydrochloride
46 Participants
10 Participants
8 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Duloxetine Hydrochloride
42 Participants
17 Participants
4 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Atorvastatin Calcium
44 Participants
11 Participants
7 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Diclofenac Sodium
39 Participants
16 Participants
4 Participants
Number of Participants With 25 Most Common Medications Use During Pre-Index Period
Levofloxacin
40 Participants
13 Participants
4 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. p-value could not be calculated between reporting groups for specified rows with 100% response.

Number of participants with 26 most common medications use during the post-index period are reported. The 26 most common medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) diclofenac Sodium, 24) levofloxacin, 25) cephalexin, 26) ibuprofen. A participant could have received \>=1 most common medication.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Meloxicam
96 Participants
25 Participants
10 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Amoxicillin
105 Participants
28 Participants
15 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Omeprazole
89 Participants
20 Participants
13 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Tramadol Hydrochloride
96 Participants
39 Participants
17 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
MTX Sodium
332 Participants
94 Participants
48 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Folic Acid
254 Participants
68 Participants
35 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Prednisone
260 Participants
81 Participants
43 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Acetaminophen/Hydrocodone Bitartrate
184 Participants
58 Participants
23 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Azithromycin
153 Participants
47 Participants
25 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Adalimumab
126 Participants
37 Participants
11 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Hydroxychloroquine Sulfate
108 Participants
25 Participants
13 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Etanercept
112 Participants
27 Participants
17 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Levothyroxine Sodium
82 Participants
16 Participants
10 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Methylprednisolone
123 Participants
43 Participants
22 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Albuterol Sulfate
91 Participants
25 Participants
8 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Gabapentin
78 Participants
21 Participants
11 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Acetaminophen/Oxycodone Hydrochloride
80 Participants
30 Participants
15 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Amoxicillin/Clavulanate Potassium
94 Participants
20 Participants
14 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Cyclobenzaprine Hydrochloride
83 Participants
31 Participants
11 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Fluticasone Propionate
83 Participants
24 Participants
13 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Ciprofloxacin Hydrochloride
88 Participants
26 Participants
11 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Duloxetine Hydrochloride
52 Participants
23 Participants
8 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Diclofenac Sodium
71 Participants
27 Participants
10 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Levofloxacin
79 Participants
24 Participants
12 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Cephalexin
76 Participants
15 Participants
11 Participants
Number of Participants With 26 Most Common Medications Use During Post-Index Period
Ibuprofen
50 Participants
22 Participants
11 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used at least one opioid during pre-index period are reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Opioids During Pre-Index Period
173 Participants
55 Participants
27 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used at least one NSAID during pre-index period are reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period
160 Participants
44 Participants
21 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used at least one opioid during the post-index period are reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Opioids During Post-Index Period
170 Participants
47 Participants
28 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used at least one NSAID during the post-index period are reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used NSAIDs During Post-Index Period
152 Participants
41 Participants
24 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

The mean number of pharmacy claims for opioids during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=173 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=55 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=27 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Pharmacy Claims for Opioids During Pre-Index Period
5.21 pharmacy claims
Standard Deviation 5.48
6.83 pharmacy claims
Standard Deviation 7.33
9.00 pharmacy claims
Standard Deviation 12.29

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

The mean number of pharmacy claims for NSAIDs during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=160 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=44 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=21 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period
3.81 pharmacy claims
Standard Deviation 3.05
4.29 pharmacy claims
Standard Deviation 3.68
3.48 pharmacy claims
Standard Deviation 2.91

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

The mean number of pharmacy claims for opioids during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=170 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=47 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=28 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Pharmacy Claims for Opioids During Post-Index Period
5.35 pharmacy claims
Standard Deviation 5.28
6.51 pharmacy claims
Standard Deviation 7.57
7.29 pharmacy claims
Standard Deviation 9.37

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

The mean number of pharmacy claims for NSAIDs during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=152 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=41 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=24 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period
4.40 pharmacy claims
Standard Deviation 3.83
4.57 pharmacy claims
Standard Deviation 3.77
3.00 pharmacy claims
Standard Deviation 1.80

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Mean number of days from the index date to the first opioid claim during post index period are reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=170 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=47 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=28 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period
106.71 days
Standard Deviation 96.40
109.93 days
Standard Deviation 108.35
92.85 days
Standard Deviation 81.74

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Mean number of days from the index date to the first NSAIDs claim during post index period are reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=152 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=41 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=24 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period
100.25 days
Standard Deviation 91.68
117.00 days
Standard Deviation 93.12
124.08 days
Standard Deviation 108.34

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used opioids during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency
During Persistency
159 Participants
40 Participants
25 Participants
Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency
Post Persistency
49 Participants
20 Participants
11 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time \>60 days before restarting.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency
During Persistency
138 Participants
37 Participants
21 Participants
Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency
Post Persistency
51 Participants
17 Participants
8 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

The number of participants who used at least one oral corticosteroid during the pre-index period is reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Oral Corticosteroids During Pre-Index Period
243 Participants
75 Participants
43 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

The number of participants who used at least one oral corticosteroid during the post-index period is reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Oral Corticosteroids During Post-Index Period
213 Participants
59 Participants
34 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Mean total dose of oral corticosteroids during pre-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=243 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=75 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=43 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total Dose of Oral Corticosteroids During Pre-Index Period
1617.82 milligram(mg)
Standard Deviation 2148.87
1572.15 milligram(mg)
Standard Deviation 1266.59
1209.77 milligram(mg)
Standard Deviation 978.90

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Mean total dose of oral corticosteroids during post-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=213 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=59 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=34 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total Dose of Oral Corticosteroid During Post-Index Period
1792.20 mg
Standard Deviation 3855.57
1871.85 mg
Standard Deviation 4092.22
1593.97 mg
Standard Deviation 1724.89

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Mean number of visits to a rheumatologist during pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=259 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=74 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=34 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Visits to Rheumatologist During Pre-Index Period
5.43 visits
Standard Deviation 3.27
5.14 visits
Standard Deviation 3.50
4.74 visits
Standard Deviation 2.74

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Mean number of visits to rheumatologist during the variable-length pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=276 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=76 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=37 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period
12.20 visits
Standard Deviation 9.28
11.72 visits
Standard Deviation 8.68
10.16 visits
Standard Deviation 6.22

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study.

Mean Disease Duration of RA based upon the variable length pre-index period is reported. Disease duration (in days) defined as the number of days from the earliest claim with a diagnosis of RA in the variable length pre-index period until the index date. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Disease Duration
852.13 days
Standard Deviation 431.04
786.30 days
Standard Deviation 428.83
862.75 days
Standard Deviation 462.33

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Mean out of pocket health care costs for healthcare services during pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies money spent by participants on health care services for RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period
All cause
2471.36 dollars
Standard Deviation 1952.53
3296.62 dollars
Standard Deviation 2643.12
2233.31 dollars
Standard Deviation 1674.19
Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period
RA related
1261.49 dollars
Standard Deviation 1578.25
1484.58 dollars
Standard Deviation 1600.74
1002.81 dollars
Standard Deviation 1364.90

PRIMARY outcome

Timeframe: During variable length pre-index period (1 year before the index date up to 5.2 years)

Population: Analysis was performed on all participants included in the study.

Mean out of pocket health care costs for healthcare services during variable length pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical \[ambulatory, emergency department and inpatient admission\]). RA related signifies one spent by participants on health care services for RA. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period
All cause
7031.96 dollars
Standard Deviation 6241.15
7779.41 dollars
Standard Deviation 5492.89
6451.08 dollars
Standard Deviation 4604.24
Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period
RA related
3023.26 dollars
Standard Deviation 4459.08
3049.87 dollars
Standard Deviation 2804.35
2684.47 dollars
Standard Deviation 2577.28

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one of comorbidity of interest during pre-index period is reported. The comorbidities of interest included cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), asthma, kidney disease, diabetes, depression, anxiety, liver disease, sleep disorders. A participant could have \>1 comorbidity of interest.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Comorbidities of Interest During Pre-Index Period
Sleep disorders
43 Participants
13 Participants
10 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Cardiovascular Disease
90 Participants
25 Participants
12 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
COPD
20 Participants
7 Participants
4 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Asthma
33 Participants
8 Participants
4 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Kidney disease
17 Participants
5 Participants
3 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Diabetes
58 Participants
16 Participants
8 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Depression
44 Participants
12 Participants
6 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Anxiety
36 Participants
14 Participants
8 Participants
Number of Participants With Comorbidities of Interest During Pre-Index Period
Liver disease
13 Participants
2 Participants
3 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Non-persistence was defined as the gap of at least 60 days in treatment with the index medication (tofacitinib) or switching to other biologic.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Non-persistence to Index Medication (Tofacitinib)
110 Participants
37 Participants
27 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with post-persistence treatment patterns is reported. Post-persistence was categorized as: 1) switch immediately (if participants initiated a non-index biologic before a 60-day gap in treatment is observed for the index medication); 2) discontinue then restart (if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is the index medication); 3) discontinue then switch ( if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is a biologic \[including Tofacitinib\] different from index medication), 4) discontinue without switch or restart (if participant's had a gap in therapy of at least 60 days and there are no claims for either the index medication or a different biologic for the remaining observation period).

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With Post-Persistence Treatment Patterns
Switch immediately
58 Participants
14 Participants
8 Participants
Number of Participants With Post-Persistence Treatment Patterns
Discontinue then switch
6 Participants
3 Participants
3 Participants
Number of Participants With Post-Persistence Treatment Patterns
Discontinue then restart
17 Participants
8 Participants
5 Participants
Number of Participants With Post-Persistence Treatment Patterns
Discontinue without switch or restart
29 Participants
12 Participants
11 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who switched from index medication (tofacitinib) to a biologic at any time during post-index period is reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period
64 Participants
17 Participants
12 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Here, "overall number of participants analyzed" signifies the participants evaluable for this outcome measure.

Number of participants who re-started tofacitinib (after considered as non-persistence with the tofacitinib) after discontinuation at any time during post-index period is reported.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=110 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=37 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=27 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period
17 Participants
8 Participants
5 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. Analysis was performed on "MTX persistent" participants only and the data for this OM was not planned to be collected and analyzed for "MTX Discontinued" and "MTX Interrupted".

Mean MPR for Methotrexate is reported. MPR was calculated as the total days supply of MTX between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Medication Possession Ratio (MPR) for Methotrexate (MTX)
0.93 ratio
Standard Deviation 0.11

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Mean adherence for methotrexate is reported. Adherence was calculated as the total number of days supplied for MTX during the post-index period divided by the number of days from the first claim during the post-index period to the end of the post-index period

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Adherence To Methotrexate (MTX)
0.89 ratio
Standard Deviation 0.11
0.43 ratio
Standard Deviation 0.19
0.58 ratio
Standard Deviation 0.15

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants who used additional NB-DMARD during post index period is reported. Additional NB-DMARD use could have been leflunomide, sulfasalazine and hydroxychloroquine.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Used Additional NB-DMARD During Post Index Period
Leflunomide
7 Participants
6 Participants
1 Participants
Number of Participants Who Used Additional NB-DMARD During Post Index Period
Sulfasalazine
3 Participants
4 Participants
1 Participants
Number of Participants Who Used Additional NB-DMARD During Post Index Period
Hydroxychloroquine
10 Participants
2 Participants
1 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Adherence to index medication was defined as at least 30 days continuous supply of tofacitinib during post-index period.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib)
212 Participants
50 Participants
14 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No dose escalation for index medication was defined as no increase in dose for index medication compared to the starting dose during post-index period.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib)
321 Participants
91 Participants
48 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No switch from index medication was defined as no switching from the index medication to a (different) biologic agent during post-index period.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib)
273 Participants
77 Participants
36 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No addition of NB-DMARD was defined as no addition of new NB-DMARD to index therapy during post-index period.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD
319 Participants
84 Participants
46 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Medication effectiveness criteria for oral glucocorticoids was defined as either of the following: 1) Participants cannot receive oral glucocorticoids for \> 30 days between (index date +91 days) to (index date + 359 days); 2) No increase in oral glucocorticoid dose during months 6-12 after index date.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids
281 Participants
81 Participants
39 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Use of Injectable glucocorticoids was defined as maximum one parenteral or intra-articular glucocorticoid joint injection use after the participant had been on biologic treatment for \>3 months post index date (\[index date +91 days\] to \[index date +359 days\]).

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids
278 Participants
77 Participants
36 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one ambulatory visit that was due to all cause during the pre-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With All Cause Ambulatory Visits During Pre-Index Period
337 Participants
94 Participants
48 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one emergency department visits that was due to all cause during the pre-index period is reported. All cause refers to emergency visits due to all comorbidities, including RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With All Cause Emergency Department Visits During Pre-Index Period
88 Participants
29 Participants
15 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one inpatient admissions that was due to all cause during the pre-index period is reported. All cause refers to inpatient admission due to all comorbidities, including RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With All Cause Inpatient Admissions During Pre-Index Period
40 Participants
12 Participants
7 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study. p-value could not be calculated for reporting groups with 100% response.

Number of participants with at least one ambulatory visit that was due to RA during the pre-index period is reported. RA related refers to ambulatory visits due to RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With RA Related Ambulatory Visits During Pre-Index Period
336 Participants
94 Participants
48 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one emergency department visits that was due to RA during the pre-index period is reported. RA related refers to emergency department visits due to RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With RA Related Emergency Department Visits During Pre-Index Period
29 Participants
10 Participants
5 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one inpatient admissions that was due to RA during the pre-index period is reported. RA related refers to inpatient admission due to RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With RA Related Inpatient Admissions During Pre-Index Period
24 Participants
6 Participants
5 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one ambulatory visit that was due to all cause during the post-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With All Cause Ambulatory Visits During Post-Index Period
337 Participants
94 Participants
48 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one emergency department visits that was due to all cause during the post-index period is reported. All cause refers to emergency department visits due to all comorbidities, including RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With All Cause Emergency Department Visits During Post-Index Period
85 Participants
25 Participants
18 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Number of participants with at least one inpatient admissions that was due to all cause during the post-index period is reported. All cause refers to inpatient admissions due to all comorbidities, including RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With All Cause Inpatient Admissions During Post-Index Period
41 Participants
7 Participants
9 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study

Number of participants with at least one of the RA-related ambulatory visits during the post-index period is reported. RA related refers to ambulatory visits due to RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With RA Related Ambulatory Visits During Post Index Period
335 Participants
92 Participants
48 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study

Number of participants with at least one of the RA-related emergency department visit during the post-index period is reported. RA related refers to emergency department visits due to RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With RA Related Emergency Department Visits During Post Index Period
24 Participants
7 Participants
4 Participants

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study

Number of participants with at least one of an RA-related inpatient admission during the post-index period is reported. RA related refers to inpatient admissions due to RA.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Number of Participants With RA Related Inpatient Admissions During Post Index Period
31 Participants
4 Participants
9 Participants

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Mean total health care cost all cause during pre-index period is reported. All cause refers to cost spent due to all comorbidities including RA and calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total Health Care Cost All Cause During Pre-Index Period
38294.06 dollars
Standard Deviation 29855.01
37703.67 dollars
Standard Deviation 34291.57
40845.52 dollars
Standard Deviation 51582.10

PRIMARY outcome

Timeframe: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of intravenous (IV) biologics) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total Health Care Cost RA Related During Pre-Index Period
26310.56 dollars
Standard Deviation 23044.42
21927.28 dollars
Standard Deviation 18179.77
25941.25 dollars
Standard Deviation 28226.04

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Mean total health care cost due to all cause during post-index period is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total Health Care Cost Due to All Cause During Post-Index Period
54792.79 dollars
Standard Deviation 29936.57
52877.64 dollars
Standard Deviation 44741.22
54617.88 dollars
Standard Deviation 51150.03

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total Health Care Cost RA Related During Post-Index Period
42402.93 dollars
Standard Deviation 20786.01
35768.64 dollars
Standard Deviation 13706.47
41984.33 dollars
Standard Deviation 39638.80

PRIMARY outcome

Timeframe: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])

Population: Analysis was performed on all participants included in the study.

Treatment persistence with tofacitinib was defined as not having a gap in therapy of at least 60 days between prescription re-fills of tofacitinib.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib)
297.61 days
Standard Deviation 99.42
284.48 days
Standard Deviation 102.42
246.94 days
Standard Deviation 120.12

SECONDARY outcome

Timeframe: During pre-index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month post index date)

Population: Analysis was performed on all participants included in the study.

Mean total monthly health care cost due to all cause is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). Total all cause monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total All Cause Monthly Health Care Cost
2 months before index date
2961.52 dollars
Standard Deviation 6134.21
2859.41 dollars
Standard Deviation 4782.43
2007.33 dollars
Standard Deviation 2279.76
Mean Total All Cause Monthly Health Care Cost
12 months before index date
3504.01 dollars
Standard Deviation 7280.54
3348.60 dollars
Standard Deviation 7074.21
3447.74 dollars
Standard Deviation 7167.30
Mean Total All Cause Monthly Health Care Cost
7 months after index date
4335.90 dollars
Standard Deviation 5099.96
4876.01 dollars
Standard Deviation 5517.19
6839.45 dollars
Standard Deviation 24302.54
Mean Total All Cause Monthly Health Care Cost
8 months after index date
3998.48 dollars
Standard Deviation 5427.41
3232.79 dollars
Standard Deviation 3365.36
3870.33 dollars
Standard Deviation 5967.14
Mean Total All Cause Monthly Health Care Cost
9 months after index date
4562.22 dollars
Standard Deviation 7188.96
4250.44 dollars
Standard Deviation 5153.79
3033.80 dollars
Standard Deviation 4573.15
Mean Total All Cause Monthly Health Care Cost
10 months after index date
4680.99 dollars
Standard Deviation 6427.93
4507.04 dollars
Standard Deviation 4474.32
4208.68 dollars
Standard Deviation 6898.73
Mean Total All Cause Monthly Health Care Cost
11 months after index date
4297.17 dollars
Standard Deviation 5507.21
3527.33 dollars
Standard Deviation 5467.69
3958.85 dollars
Standard Deviation 6181.37
Mean Total All Cause Monthly Health Care Cost
12 months after index date
4419.74 dollars
Standard Deviation 6361.66
8174.95 dollars
Standard Deviation 40068.17
4932.28 dollars
Standard Deviation 13927.49
Mean Total All Cause Monthly Health Care Cost
1 month after index date
6493.14 dollars
Standard Deviation 5621.42
6219.90 dollars
Standard Deviation 4771.10
5613.83 dollars
Standard Deviation 2685.11
Mean Total All Cause Monthly Health Care Cost
2 months after index date
3401.05 dollars
Standard Deviation 3629.35
3335.68 dollars
Standard Deviation 2638.48
3534.10 dollars
Standard Deviation 3435.08
Mean Total All Cause Monthly Health Care Cost
1 month before index date
1982.85 dollars
Standard Deviation 3160.93
1298.00 dollars
Standard Deviation 1660.83
1590.23 dollars
Standard Deviation 2342.22
Mean Total All Cause Monthly Health Care Cost
3 months before index date
2920.21 dollars
Standard Deviation 3787.33
3160.66 dollars
Standard Deviation 5286.29
2283.86 dollars
Standard Deviation 2405.21
Mean Total All Cause Monthly Health Care Cost
4 months before index date
3218.67 dollars
Standard Deviation 4385.35
3481.17 dollars
Standard Deviation 4512.71
3255.21 dollars
Standard Deviation 3927.64
Mean Total All Cause Monthly Health Care Cost
5 months before index date
3085.10 dollars
Standard Deviation 4078.22
2821.69 dollars
Standard Deviation 3482.77
4322.60 dollars
Standard Deviation 12892.15
Mean Total All Cause Monthly Health Care Cost
6 months before index date
3708.45 dollars
Standard Deviation 6412.35
3469.21 dollars
Standard Deviation 7966.20
6210.48 dollars
Standard Deviation 15934.47
Mean Total All Cause Monthly Health Care Cost
7 months before index date
3004.67 dollars
Standard Deviation 3751.57
5219.03 dollars
Standard Deviation 20901.31
3332.57 dollars
Standard Deviation 4279.40
Mean Total All Cause Monthly Health Care Cost
8 months before index date
3650.97 dollars
Standard Deviation 7165.39
3407.89 dollars
Standard Deviation 6513.74
4578.01 dollars
Standard Deviation 16218.40
Mean Total All Cause Monthly Health Care Cost
9 months before index date
3902.43 dollars
Standard Deviation 7411.23
2798.05 dollars
Standard Deviation 3916.34
4698.18 dollars
Standard Deviation 13942.52
Mean Total All Cause Monthly Health Care Cost
10 months before index date
3128.19 dollars
Standard Deviation 4655.37
3074.57 dollars
Standard Deviation 5981.65
2850.71 dollars
Standard Deviation 3512.63
Mean Total All Cause Monthly Health Care Cost
11 months before index date
3226.98 dollars
Standard Deviation 6905.09
2765.39 dollars
Standard Deviation 3795.95
2268.61 dollars
Standard Deviation 2941.55
Mean Total All Cause Monthly Health Care Cost
3 months after index date
5192.25 dollars
Standard Deviation 12424.70
4274.36 dollars
Standard Deviation 3929.19
7069.72 dollars
Standard Deviation 23449.05
Mean Total All Cause Monthly Health Care Cost
4 months after index date
5542.45 dollars
Standard Deviation 12928.65
3884.67 dollars
Standard Deviation 2886.54
3936.05 dollars
Standard Deviation 5042.01
Mean Total All Cause Monthly Health Care Cost
5 months after index date
3502.04 dollars
Standard Deviation 5264.36
3164.43 dollars
Standard Deviation 3257.78
3558.20 dollars
Standard Deviation 4942.20
Mean Total All Cause Monthly Health Care Cost
6 months after index date
4367.35 dollars
Standard Deviation 5250.44
3430.03 dollars
Standard Deviation 4363.37
4062.60 dollars
Standard Deviation 4741.14

SECONDARY outcome

Timeframe: During pre-index period (at1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month after index date)

Population: Analysis was performed on all participants included in the study.

Mean total monthly health care cost due to RA is reported. RA related refers to cost spent by participants due to RA on health care services. This is calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost). RA related monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.

Outcome measures

Outcome measures
Measure
Methotrexate (MTX) + Tofacitinib: MTX Persistent
n=337 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with no gap of \>60 days in MTX therapy (persistent) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Discontinued
n=94 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days in MTX therapy (discontinued) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Methotrexate (MTX) + Tofacitinib: MTX Interrupted
n=48 Participants
RA diagnosed participants who were privately insured or under Medicare Supplemental insurance (from their employer), initiated tofacitinib in combination with MTX, orally, between 01 January 2014 to 31 January 2017 (identification period) with a gap of \>60 days with 1 or more subsequent prescription re-fills in MTX therapy (interrupted) within 12 months post-index date, were included in the study and their information as per Truven Health MarketScan Research Database (from January 1, 2012 to January 2018) was assessed in this study. Index date defined as the date of first claim for tofacitinib by participants to their insurance provider during identification period.
Mean Total RA Related Monthly Health Care Cost
1 month before index date
1195.04 dollars
Standard Deviation 2637.68
671.18 dollars
Standard Deviation 1213.40
636.05 dollars
Standard Deviation 1238.09
Mean Total RA Related Monthly Health Care Cost
2 months before index date
1903.16 dollars
Standard Deviation 3155.45
1577.52 dollars
Standard Deviation 2390.24
1141.74 dollars
Standard Deviation 1700.28
Mean Total RA Related Monthly Health Care Cost
3 months before index date
2152.29 dollars
Standard Deviation 3413.71
2361.03 dollars
Standard Deviation 4927.73
1581.22 dollars
Standard Deviation 2378.86
Mean Total RA Related Monthly Health Care Cost
4 months before index date
2168.50 dollars
Standard Deviation 3489.71
2614.99 dollars
Standard Deviation 4041.35
2285.37 dollars
Standard Deviation 3322.71
Mean Total RA Related Monthly Health Care Cost
2 months after index date
2475.97 dollars
Standard Deviation 2565.47
2562.85 dollars
Standard Deviation 1762.39
2467.49 dollars
Standard Deviation 1841.74
Mean Total RA Related Monthly Health Care Cost
5 months before index date
2254.93 dollars
Standard Deviation 3480.55
1917.28 dollars
Standard Deviation 2766.38
3312.04 dollars
Standard Deviation 12509.62
Mean Total RA Related Monthly Health Care Cost
6 months before index date
2422.23 dollars
Standard Deviation 4000.01
1931.47 dollars
Standard Deviation 3046.55
4535.86 dollars
Standard Deviation 13927.05
Mean Total RA Related Monthly Health Care Cost
7 months before index date
2183.57 dollars
Standard Deviation 3240.88
2403.88 dollars
Standard Deviation 3808.44
1776.81 dollars
Standard Deviation 2692.28
Mean Total RA Related Monthly Health Care Cost
8 months before index date
2697.28 dollars
Standard Deviation 6295.30
1756.79 dollars
Standard Deviation 2719.69
3511.39 dollars
Standard Deviation 15412.06
Mean Total RA Related Monthly Health Care Cost
9 months before index date
2516.49 dollars
Standard Deviation 4380.11
1700.46 dollars
Standard Deviation 2463.15
1755.33 dollars
Standard Deviation 2741.92
Mean Total RA Related Monthly Health Care Cost
10 months before index date
2420.82 dollars
Standard Deviation 4487.55
1640.42 dollars
Standard Deviation 2578.03
2197.70 dollars
Standard Deviation 3256.25
Mean Total RA Related Monthly Health Care Cost
11 months before index date
1932.94 dollars
Standard Deviation 3480.59
1664.42 dollars
Standard Deviation 3182.62
1534.64 dollars
Standard Deviation 2442.49
Mean Total RA Related Monthly Health Care Cost
12 months before index date
2463.30 dollars
Standard Deviation 6488.79
1687.84 dollars
Standard Deviation 2743.46
1673.11 dollars
Standard Deviation 2538.14
Mean Total RA Related Monthly Health Care Cost
1 month after index date
5520.12 dollars
Standard Deviation 3236.09
4864.96 dollars
Standard Deviation 2427.19
5078.09 dollars
Standard Deviation 2374.78
Mean Total RA Related Monthly Health Care Cost
3 months after index date
4264.21 dollars
Standard Deviation 11021.43
3525.69 dollars
Standard Deviation 3579.91
5901.33 dollars
Standard Deviation 22733.73
Mean Total RA Related Monthly Health Care Cost
4 months after index date
4513.18 dollars
Standard Deviation 11997.33
3312.81 dollars
Standard Deviation 2744.19
2193.74 dollars
Standard Deviation 1997.44
Mean Total RA Related Monthly Health Care Cost
5 months after index date
2525.72 dollars
Standard Deviation 3219.78
2171.23 dollars
Standard Deviation 2225.60
2550.85 dollars
Standard Deviation 4254.36
Mean Total RA Related Monthly Health Care Cost
6 months after index date
3448.44 dollars
Standard Deviation 4479.50
2290.80 dollars
Standard Deviation 2770.10
2715.92 dollars
Standard Deviation 2695.20
Mean Total RA Related Monthly Health Care Cost
7 months after index date
3214.12 dollars
Standard Deviation 3146.04
3172.63 dollars
Standard Deviation 3093.67
6205.73 dollars
Standard Deviation 23782.75
Mean Total RA Related Monthly Health Care Cost
8 months after index date
2792.29 dollars
Standard Deviation 3675.52
2441.75 dollars
Standard Deviation 2695.77
2888.44 dollars
Standard Deviation 5532.83
Mean Total RA Related Monthly Health Care Cost
9 months after index date
3596.05 dollars
Standard Deviation 6104.08
2667.32 dollars
Standard Deviation 3922.25
2532.87 dollars
Standard Deviation 4559.72
Mean Total RA Related Monthly Health Care Cost
10 months after index date
3536.10 dollars
Standard Deviation 4403.21
3295.99 dollars
Standard Deviation 3718.43
2521.96 dollars
Standard Deviation 3201.05
Mean Total RA Related Monthly Health Care Cost
11 months after index date
3292.62 dollars
Standard Deviation 4725.06
2574.32 dollars
Standard Deviation 4803.21
2966.58 dollars
Standard Deviation 5539.05
Mean Total RA Related Monthly Health Care Cost
12 months after index date
3224.11 dollars
Standard Deviation 5151.51
2888.29 dollars
Standard Deviation 4727.03
3961.34 dollars
Standard Deviation 13543.17

Adverse Events

Methotrexate (MTX) + Tofacitinib: MTX Persistent

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Methotrexate (MTX) + Tofacitinib: MTX Discontinued

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Methotrexate (MTX) + Tofacitinib: MTX Interrupted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER