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.
COMPLETED
1057 participants
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)
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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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)
Tofacitinib Immediate Release (IR)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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