Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Final analysis of an all-case postmarketing surveillance study.
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引用次数: 0
Abstract
Objective: To evaluate tofacitinib real-world safety/effectiveness in patients with rheumatoid arthritis (RA) in Japan in a 3-year all-case postmarketing surveillance study.
Methods: All patients with RA who initiated tofacitinib (30 July 2013-03 December 2017) were registered in Japan. Serious infections/malignancy/mortality incidences were compared in patients with active RA after >8 mg methotrexate/week for ≥3 months who received tofacitinib or other drugs (control: methotrexate/other disease-modifying antirheumatic drugs/immunosuppressants). Disease activity was assessed over 3 years.
Results: The adherent comparative safety analysis set included 3731/2419 (tofacitinib/control) patients. Baseline (tofacitinib/control) biologic disease-modifying antirheumatic drug history (53.3%/12.2%), methotrexate history (81.4%/98.6%), and RA stage (I-II: 45.3%/67.1%) and class (1-2: 76.5%/90.8%) varied between groups. For tofacitinib vs control, incidence rates [patients with event/100 patient-years (95% confidence interval)] were 6.86 (5.96-7.86) vs 1.42 (0.97-2.00) for serious infections (adjusted hazard ratios 3.25-3.80); 1.40 (1.18-1.66) vs 0.88 (0.66-1.15) for malignancies (adjusted hazard ratios 1.37-1.53); 0.89 (0.72-1.10) vs 0.26 (0.15-0.43) for mortality (unadjusted hazard ratio 3.29). Remission/low disease activity rates with tofacitinib increased over 3 years.
Conclusions: Serious infection rates were higher, and malignancy rates were numerically higher with tofacitinib vs control. Results should be interpreted cautiously due to imbalanced groups and unmeasured confounders.
期刊介绍:
Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery.
Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered.
Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions