Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to compare adherence, persistence, and effectiveness among patients initiating tofacitinib Modified Release (MR) with tofacitinib Immediate Release (IR).
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period). * Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x & 714.81 or ICD10 = M05.\* & M06.0\*-M06.3\* or M06.8\*-M06.9\*. * At least 18 years old as of the index date.
Exclusion criteria
* Patients with claims for other conditions for which biologics are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study. * Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with other biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) \[adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)\] and non-TNFi's with alternative mechanisms of action \[abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)\]) during the one-year pre-index period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date | 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) | 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. |
| Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date | 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) | 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. |
| Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date | 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) | 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. |
| Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date | 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) | 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. |
| 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 | 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) | 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. |
| 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 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. |
| Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date | 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) | 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. |
| Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date | 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) | 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. |
| 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 | 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) | 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. |
| Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date | 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date | 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) | 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. |
| Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date | 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 678 |
| 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. | 379 |
| Total | 1,057 |
Baseline characteristics
| Characteristic | Tofacitinib Immediate Release (IR) | Tofacitinib Modified Release (MR) | Total |
|---|---|---|---|
| Age, Continuous | 53.97 years STANDARD_DEVIATION 10.91 | 54.35 years STANDARD_DEVIATION 10.2 | 54.22 years STANDARD_DEVIATION 10.46 |
| Combination Therapy | 214 participants | 370 participants | 584 participants |
| Index Medication | 379 participants | 678 participants | 1057 participants |
| Insurance type Commercial Claims and Encounters (CCAE) | 327 participants | 596 participants | 923 participants |
| Insurance type Medicare (MDCR) | 52 participants | 82 participants | 134 participants |
| Number of Advanced Therapies At Index 0 | 93 advanced therapies | 142 advanced therapies | 235 advanced therapies |
| Number of Advanced Therapies At Index 1 | 128 advanced therapies | 240 advanced therapies | 368 advanced therapies |
| Number of Advanced Therapies At Index 2 | 97 advanced therapies | 192 advanced therapies | 289 advanced therapies |
| Number of Advanced Therapies At Index >=3 | 61 advanced therapies | 104 advanced therapies | 165 advanced therapies |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region North Central Region | 65 participants | 110 participants | 175 participants |
| Region Northeast Region | 74 participants | 125 participants | 199 participants |
| Region South Region | 191 participants | 371 participants | 562 participants |
| Region Unknown Region | 0 participants | 2 participants | 2 participants |
| Region West Region | 49 participants | 70 participants | 119 participants |
| Sex: Female, Male Female | 311 Participants | 556 Participants | 867 Participants |
| Sex: Female, Male Male | 68 Participants | 122 Participants | 190 Participants |
| Use of non-steroidal antiinflammatory drug (NSAID)s Pre-Index | 190 participants | 297 participants | 487 participants |
| Year and month of the participant's index date 2016-03 | 45 participants | 1 participants | 46 participants |
| Year and month of the participant's index date 2016-04 | 45 participants | 5 participants | 50 participants |
| Year and month of the participant's index date 2016-05 | 31 participants | 22 participants | 53 participants |
| Year and month of the participant's index date 2016-06 | 17 participants | 25 participants | 42 participants |
| Year and month of the participant's index date 2016-07 | 15 participants | 17 participants | 32 participants |
| Year and month of the participant's index date 2016-08 | 21 participants | 40 participants | 61 participants |
| Year and month of the participant's index date 2016-09 | 20 participants | 32 participants | 52 participants |
| Year and month of the participant's index date 2016-10 | 13 participants | 33 participants | 46 participants |
| Year and month of the participant's index date 2016-11 | 15 participants | 50 participants | 65 participants |
| Year and month of the participant's index date 2016-12 | 20 participants | 38 participants | 58 participants |
| Year and month of the participant's index date 2017-01 | 18 participants | 33 participants | 51 participants |
| Year and month of the participant's index date 2017-02 | 19 participants | 48 participants | 67 participants |
| Year and month of the participant's index date 2017-03 | 14 participants | 44 participants | 58 participants |
| Year and month of the participant's index date 2017-04 | 12 participants | 36 participants | 48 participants |
| Year and month of the participant's index date 2017-05 | 19 participants | 49 participants | 68 participants |
| Year and month of the participant's index date 2017-06 | 11 participants | 34 participants | 45 participants |
| Year and month of the participant's index date 2017-07 | 13 participants | 43 participants | 56 participants |
| Year and month of the participant's index date 2017-08 | 13 participants | 51 participants | 64 participants |
| Year and month of the participant's index date 2017-09 | 10 participants | 30 participants | 40 participants |
| Year and month of the participant's index date 2017-10 | 8 participants | 39 participants | 47 participants |
| Year and month of the participant's index date 2017-11 | 0 participants | 8 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date | 0.89 ratio | Standard Deviation 0.15 |
| Tofacitinib Immediate Release (IR) | Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date | 0.86 ratio | Standard Deviation 0.18 |
p-value: 0.0123t-test, 2 sided
p-value: 0.004795% CI: [0.0092322, 0.0509385]Generalized linear model
Primary
Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | 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 |
| Tofacitinib Immediate Release (IR) | Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date | 0.62 ratio | Standard Deviation 0.3 |
p-value: 0.4071t-test, 2 sided
p-value: 0.614395% CI: [-0.030062, 0.0508746]Generalized linear model
Primary
Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date | 243.4 days | Standard Deviation 135.1 |
| Tofacitinib Immediate Release (IR) | Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date | 235.7 days | Standard Deviation 129.6 |
p-value: 0.3564t-test, 2 sided
p-value: 0.262995% CI: [0.7534, 1.0803]Regression, Cox
Primary
Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date | 33.33 percentage of participants |
| Tofacitinib Immediate Release (IR) | Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date | 25.86 percentage of participants |
p-value: 0.0115Chi-squared
p-value: 0.022795% CI: [1.0492535, 1.8953079]Regression, Logistic
Primary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | 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 |
| Tofacitinib Immediate Release (IR) | 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 | 69.92 percentage of participants |
p-value: 0.0002Chi-squared
p-value: 0.000295% CI: [1.3167136, 2.4362554]Regression, Logistic
Primary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | 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 |
| Tofacitinib Immediate Release (IR) | 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 | 37.73 percentage of participants |
p-value: 0.001Chi-squared
p-value: 0.002595% CI: [1.1594614, 1.9956882]Regression, Logistic
Secondary
Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date | 0.90 ratio | Standard Deviation 0.14 |
| Tofacitinib Immediate Release (IR) | Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date | 0.88 ratio | Standard Deviation 0.16 |
p-value: 0.113t-test, 2 sided
p-value: 0.119495% CI: [-0.003908, 0.0341568]Generalized linear model
Secondary
Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | 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 |
| Tofacitinib Immediate Release (IR) | Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date | 0.71 ratio | Standard Deviation 0.27 |
p-value: 0.9031t-test, 2 sided
p-value: 0.637695% CI: [-0.044317, 0.0271416]Generalized linear model
Secondary
Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date | 143.7 days | Standard Deviation 57.7576 |
| Tofacitinib Immediate Release (IR) | Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date | 146.3 days | Standard Deviation 55.6362 |
p-value: 0.4595t-test, 2 sided
p-value: 0.335495% CI: [0.8873, 1.4201]Regression, Cox
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | 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 |
| Tofacitinib Immediate Release (IR) | 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 | 76.52 percentage of participants |
p-value: 0.02Chi-squared
p-value: 0.036495% CI: [1.0221455, 1.9571335]Regression, Logistic
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | 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 |
| Tofacitinib Immediate Release (IR) | 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 | 53.56 percentage of participants |
p-value: 0.3584Chi-squared
p-value: 0.45195% CI: [0.8489444, 1.4454238]Regression, Logistic
Other Pre-specified
Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date | 51.62 percentage of participants |
| Tofacitinib Immediate Release (IR) | Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date | 45.65 percentage of participants |
p-value: 0.0624Chi-squared
Other Pre-specified
Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date | 68.14 percentage of participants |
| Tofacitinib Immediate Release (IR) | Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date | 70.18 percentage of participants |
p-value: 0.4914Chi-squared