Trial Outcomes & Findings for Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR) (NCT NCT04018001)

NCT ID: NCT04018001

Last Updated: 2024-04-03

Results Overview

Effectiveness criteria: 1) High adherence with proportion of days covered greater than or equal to \[\>=\] 0.8; 2) No increase in index medication dose; 3) No use of an advanced therapy other than index therapy 4) No addition/claims of conventional synthetic disease-modifying antirheumatic drug; 5) If no oral glucocorticoid prescriptions in the 6 months prior to index date, then no more than 30 total days supply of oral glucocorticoids between 3-12 months post index or if at least 1 claim for oral glucocorticoids during 6 months pre-index, then oral glucocorticoid not increased by \>=20% between 6-12 months post-index compared to 6 months before index date (6) Participants have one or fewer glucocorticoid injections during 3-12 months after index date. Adherence was defined as percentage of time with medication on hand. Participants who met all 6 effectiveness criteria considered as treated effectively.

Recruitment status

COMPLETED

Target enrollment

1057 participants

Primary outcome timeframe

Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

Results posted on

2024-04-03

Participant Flow

The study was a retrospective follow-up study of participants treated with index medication (tofacitinib) and enrolled in a health insurance plan for a minimum of 24 months.

Participant milestones

Participant milestones
Measure
Tofacitinib Modified Release (MR)
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Overall Study
STARTED
678
379
Overall Study
COMPLETED
678
379
Overall Study
NOT COMPLETED
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
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Total
n=1057 Participants
Total of all reporting groups
Age, Continuous
54.35 years
STANDARD_DEVIATION 10.20 • n=678 Participants
53.97 years
STANDARD_DEVIATION 10.91 • n=379 Participants
54.22 years
STANDARD_DEVIATION 10.46 • n=1057 Participants
Sex: Female, Male
Female
556 Participants
n=678 Participants
311 Participants
n=379 Participants
867 Participants
n=1057 Participants
Sex: Female, Male
Male
122 Participants
n=678 Participants
68 Participants
n=379 Participants
190 Participants
n=1057 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Combination Therapy
370 participants
n=678 Participants
214 participants
n=379 Participants
584 participants
n=1057 Participants
Use of non-steroidal antiinflammatory drug (NSAID)s Pre-Index
297 participants
n=678 Participants
190 participants
n=379 Participants
487 participants
n=1057 Participants
Number of Advanced Therapies At Index
0
142 advanced therapies
n=678 Participants
93 advanced therapies
n=379 Participants
235 advanced therapies
n=1057 Participants
Number of Advanced Therapies At Index
1
240 advanced therapies
n=678 Participants
128 advanced therapies
n=379 Participants
368 advanced therapies
n=1057 Participants
Number of Advanced Therapies At Index
2
192 advanced therapies
n=678 Participants
97 advanced therapies
n=379 Participants
289 advanced therapies
n=1057 Participants
Number of Advanced Therapies At Index
>=3
104 advanced therapies
n=678 Participants
61 advanced therapies
n=379 Participants
165 advanced therapies
n=1057 Participants
Insurance type
Commercial Claims and Encounters (CCAE)
596 participants
n=678 Participants
327 participants
n=379 Participants
923 participants
n=1057 Participants
Insurance type
Medicare (MDCR)
82 participants
n=678 Participants
52 participants
n=379 Participants
134 participants
n=1057 Participants
Region
North Central Region
110 participants
n=678 Participants
65 participants
n=379 Participants
175 participants
n=1057 Participants
Region
Northeast Region
125 participants
n=678 Participants
74 participants
n=379 Participants
199 participants
n=1057 Participants
Region
South Region
371 participants
n=678 Participants
191 participants
n=379 Participants
562 participants
n=1057 Participants
Region
Unknown Region
2 participants
n=678 Participants
0 participants
n=379 Participants
2 participants
n=1057 Participants
Region
West Region
70 participants
n=678 Participants
49 participants
n=379 Participants
119 participants
n=1057 Participants
Year and month of the participant's index date
2016-03
1 participants
n=678 Participants
45 participants
n=379 Participants
46 participants
n=1057 Participants
Year and month of the participant's index date
2016-04
5 participants
n=678 Participants
45 participants
n=379 Participants
50 participants
n=1057 Participants
Year and month of the participant's index date
2016-05
22 participants
n=678 Participants
31 participants
n=379 Participants
53 participants
n=1057 Participants
Year and month of the participant's index date
2016-06
25 participants
n=678 Participants
17 participants
n=379 Participants
42 participants
n=1057 Participants
Year and month of the participant's index date
2016-07
17 participants
n=678 Participants
15 participants
n=379 Participants
32 participants
n=1057 Participants
Year and month of the participant's index date
2016-08
40 participants
n=678 Participants
21 participants
n=379 Participants
61 participants
n=1057 Participants
Year and month of the participant's index date
2016-09
32 participants
n=678 Participants
20 participants
n=379 Participants
52 participants
n=1057 Participants
Year and month of the participant's index date
2016-10
33 participants
n=678 Participants
13 participants
n=379 Participants
46 participants
n=1057 Participants
Year and month of the participant's index date
2016-11
50 participants
n=678 Participants
15 participants
n=379 Participants
65 participants
n=1057 Participants
Year and month of the participant's index date
2016-12
38 participants
n=678 Participants
20 participants
n=379 Participants
58 participants
n=1057 Participants
Year and month of the participant's index date
2017-01
33 participants
n=678 Participants
18 participants
n=379 Participants
51 participants
n=1057 Participants
Year and month of the participant's index date
2017-02
48 participants
n=678 Participants
19 participants
n=379 Participants
67 participants
n=1057 Participants
Year and month of the participant's index date
2017-03
44 participants
n=678 Participants
14 participants
n=379 Participants
58 participants
n=1057 Participants
Year and month of the participant's index date
2017-04
36 participants
n=678 Participants
12 participants
n=379 Participants
48 participants
n=1057 Participants
Year and month of the participant's index date
2017-05
49 participants
n=678 Participants
19 participants
n=379 Participants
68 participants
n=1057 Participants
Year and month of the participant's index date
2017-06
34 participants
n=678 Participants
11 participants
n=379 Participants
45 participants
n=1057 Participants
Year and month of the participant's index date
2017-07
43 participants
n=678 Participants
13 participants
n=379 Participants
56 participants
n=1057 Participants
Year and month of the participant's index date
2017-08
51 participants
n=678 Participants
13 participants
n=379 Participants
64 participants
n=1057 Participants
Year and month of the participant's index date
2017-09
30 participants
n=678 Participants
10 participants
n=379 Participants
40 participants
n=1057 Participants
Year and month of the participant's index date
2017-10
39 participants
n=678 Participants
8 participants
n=379 Participants
47 participants
n=1057 Participants
Year and month of the participant's index date
2017-11
8 participants
n=678 Participants
0 participants
n=379 Participants
8 participants
n=1057 Participants
Index Medication
678 participants
n=678 Participants
379 participants
n=379 Participants
1057 participants
n=1057 Participants

PRIMARY outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

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

Effectiveness criteria: 1) High adherence with proportion of days covered greater than or equal to \[\>=\] 0.8; 2) No increase in index medication dose; 3) No use of an advanced therapy other than index therapy 4) No addition/claims of conventional synthetic disease-modifying antirheumatic drug; 5) If no oral glucocorticoid prescriptions in the 6 months prior to index date, then no more than 30 total days supply of oral glucocorticoids between 3-12 months post index or if at least 1 claim for oral glucocorticoids during 6 months pre-index, then oral glucocorticoid not increased by \>=20% between 6-12 months post-index compared to 6 months before index date (6) Participants have one or fewer glucocorticoid injections during 3-12 months after index date. Adherence was defined as percentage of time with medication on hand. Participants who met all 6 effectiveness criteria considered as treated effectively.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date
33.33 percentage of participants
25.86 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

Population: Analysis was performed on all participants included in the study. Here "Overall number of participants analyzed" signifies only those participants who had data available.

Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=142 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=93 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date
243.4 days
Standard Deviation 135.1
235.7 days
Standard Deviation 129.6

PRIMARY outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

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

Adherence was defined as percentage of time with medication on hand. Participants with MPR \>=0.8 were considered to show high adherence and participants with MPR less than (\<) 0.8 were considered as low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date
0.89 ratio
Standard Deviation 0.15
0.86 ratio
Standard Deviation 0.18

PRIMARY outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

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

Adherence is defined as percentage of time with medication on hand. Participants with MPR \>=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 12 Months From the Index Date
80.09 percentage of participants
69.92 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

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

Adherence was defined as percentage of time with medication on hand. Participants with PDC \>= 0.8 were considered to show high adherence and participants with PDC \<0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date
0.63 ratio
Standard Deviation 0.33
0.62 ratio
Standard Deviation 0.30

PRIMARY outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

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

Adherence was defined as percentage of time with medication on hand. Participants with PDC \>=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Primary: Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date
48.23 percentage of participants
37.73 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

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

Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date
143.7 days
Standard Deviation 57.7576
146.3 days
Standard Deviation 55.6362

SECONDARY outcome

Timeframe: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

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

Adherence was defined as percentage of time with medication on hand. Participants with MPR \>=0.8 were considered to show high adherence and participants with MPR \<0.8 were considered to show low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date
0.90 ratio
Standard Deviation 0.14
0.88 ratio
Standard Deviation 0.16

SECONDARY outcome

Timeframe: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

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

Adherence is defined as percentage of time with medication on hand. Participants with MPR \>=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 6 Months From the Index Date
82.45 percentage of participants
76.52 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

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

Adherence was defined as percentage of time with medication on hand. Participants with PDC \>= 0.8 were considered to show high adherence and participants with PDC \<0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 180 days post-index.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date
0.71 ratio
Standard Deviation 0.28
0.71 ratio
Standard Deviation 0.27

SECONDARY outcome

Timeframe: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

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

Adherence was defined as percentage of time with medication on hand. Participants with PDC \>=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 180 days post-index.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date
56.49 percentage of participants
53.56 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)

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

Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date
51.62 percentage of participants
45.65 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)

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

Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.

Outcome measures

Outcome measures
Measure
Tofacitinib Modified Release (MR)
n=678 Participants
Participants with Rheumatoid Arthritis (RA) who were treated with Tofacitinib 11 milligram (mg) MR tablet, orally, once daily, between 01 March 2016 and 31 October 2018 (identification period) and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Tofacitinib Immediate Release (IR)
n=379 Participants
Participants with RA who were treated with Tofacitinib 5 mg IR tablet orally, twice daily, between 01 March 2016 and 31 October 2018 and enrolled in a commercial or Medicare insurance plan for 1 year before the index date to at least 1 year after the index date, were included in this study. Index date was the date of first claim for 30-day supply of tofacitinib by participants to their insurance provider during identification period. Data collected retrospectively for participants included in this study.
Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date
68.14 percentage of participants
70.18 percentage of participants

Adverse Events

Tofacitinib Modified Release (MR)

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

Tofacitinib Immediate Release (IR)

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