N/A
Completed N=1,057
Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)
Source: ClinicalTrials.gov NCT04018001 ↗Enrolled (actual)
1,057
Serious AEs
—
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date — 33.33; 25.86 percentage of participants — p=0.0115
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date |
33.33; 25.86 | 0.0115 sig |
| PRIMARY Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date |
243.4; 235.7 | 0.3564 |
| PRIMARY Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date |
0.89; 0.86 | 0.0123 sig |
| 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 |
80.09; 69.92 | 0.0002 sig |
| PRIMARY Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date |
0.63; 0.62 | 0.4071 |
| 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 |
48.23; 37.73 | 0.0010 sig |
| SECONDARY Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date |
143.7; 146.3 | 0.4595 |
| SECONDARY Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date |
0.90; 0.88 | 0.1130 |
| 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 |
82.45; 76.52 | 0.0200 sig |
| SECONDARY Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date |
0.71; 0.71 | 0.9031 |
| 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 |
56.49; 53.56 | 0.3584 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04018001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.