We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention.
- Authors
Pope, Janet; Finckh, Axel; Silva-Fernández, Lucia; Mandl, Peter; Fan, Haiyun; Rivas, Jose L; Valderrama, Monica; Montoro, Maria
- Abstract
Abstracts (2012– 2022). Results: RCT/LTE analyses included 1000/498 patients receiving tofacitinib 5 mg BID monotherapy. Baseline disease activity was high; patients tended to receive concomitant glucocorticoids; most were biologic DMARD-naïve. CDAI LDA rates were 32.2– 62.2% for Groups 1/2 (months 3– 12) and 64.0– 70.7% for Group 3 (months 12– 72). In Groups 1, 2, and 3, 4.0%, 15.6%, and 27.7% of patients, respectively, discontinued tofacitinib monotherapy due to lack of efficacy/adverse events. From 11 RWD publications, 16.6– 66.1% received tofacitinib monotherapy. Consistent with clinical data, tofacitinib monotherapy effectiveness (month 6 CDAI LDA, 30.2%; month 3 DAS28-4[CRP] remission, 53.4%) and persistence were observed in RWD, with retention comparable to tofacitinib combination therapy. Conclusion: Tofacitinib monotherapy demonstrated clinically significant responses/persistence in RCT/LTE analyses, with effectiveness observed and persistence comparable to combination therapy in RWD. Trial Registration: NCT00814307, NCT02187055, NCT01039688, NCT00413699, NCT00661661 (ClinicalTrials.gov).
- Subjects
RHEUMATOID arthritis; CLINICAL trials; C-reactive protein; GLUCOCORTICOIDS; RECORDING &; registration
- Publication
Open Access Rheumatology: Research & Reviews, 2024, Vol 16, p115
- ISSN
1179-156X
- Publication type
Article
- DOI
10.2147/OARRR.S446431