1. Efficacy and safety of tofacitinib for the treatment of rheumatoid arthritis in patients from the Asia-Pacific region: Post-hoc analyses of pooled clinical study data.
- Author
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Lee EB, Yamanaka H, Liu Y, Tsai WC, Chen C, Kwok K, Yoo HJ, Llamado LJ, Wang L, Luo Y, Sugiyama N, and Tanaka Y
- Subjects
- Adult, Arthritis, Rheumatoid diagnosis, Arthritis, Rheumatoid epidemiology, Arthritis, Rheumatoid physiopathology, Asia epidemiology, Clinical Trials as Topic, Evidence-Based Medicine, Female, Humans, Janus Kinase Inhibitors adverse effects, Male, Middle Aged, Neoplasms epidemiology, Opportunistic Infections epidemiology, Piperidines adverse effects, Pyrimidines adverse effects, Pyrroles adverse effects, Recovery of Function, Remission Induction, Risk Factors, Time Factors, Treatment Outcome, Arthritis, Rheumatoid drug therapy, Janus Kinase Inhibitors therapeutic use, Piperidines therapeutic use, Pyrimidines therapeutic use, Pyrroles therapeutic use
- Abstract
Aim: We report tofacitinib efficacy and safety in Asia-Pacific patients who participated in the rheumatoid arthritis (RA) clinical development program., Method: This post-hoc analysis included pooled data from patients with RA in the Asia-Pacific region treated with tofacitinib with/without conventional synthetic disease-modifying antirheumatic drugs in Phase (P)1, 2, 3, and long-term extension (LTE) studies (one LTE ongoing; January 2016 data-cut). Efficacy was assessed over 24 months in patients who received tofacitinib 5 (N = 397) or 10 (N = 382) mg twice daily or placebo (N = 243) in three P2 and five P3 studies. Endpoints included American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4[ESR]) and Clinical Disease Activity Index (CDAI) remission rates, and change from baseline in Health Assessment Questionnaire-Disability Index (∆HAQ-DI). Safety data pooled over 92 months from one P1, four P2, six P3, and two LTE studies for all tofacitinib doses (N = 1464) included incidence rates (IRs) (patients with events/100 patient-years) for adverse events (AEs) of special interest., Results: At month 3, patients receiving tofacitinib 5/10 mg twice daily improved vs placebo in ACR20 (69.2%/77.9% vs 27.5%), ACR50 (36.9%/44.4% vs 9.5%), and ACR70 (15.1%/22.4% vs 2.7%) responses, remission rates for DAS28-4(ESR) (8.5%/18.5% vs 2.6%) and CDAI (6.1%/12.3% vs 0.5%), and ∆HAQ-DI (-0.5/-0.6 vs -0.1); improvements were sustained through 24 months. IRs (95% CI) were 9.4 (8.5, 10.3) for serious AEs, 9.1 (8.3, 10.1) for discontinuations due to AEs, 3.7 (3.2, 4.3) for serious infections, 5.9 (5.2, 6.7) for herpes zoster, and 0.8 (0.6, 1.1) for malignancies (excluding non-melanoma skin cancer)., Conclusion: In Asia-Pacific patients, tofacitinib improved signs/symptoms over 24 months. Safety over 92 months was generally consistent with global tofacitinib studies; however, infection IRs were higher in Asia-Pacific patients., (© 2019 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)
- Published
- 2019
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