Romatoid Artrit Tanılı Yaşlı ve Genç Hastalarda Tofasitinib Ekinlik ve Güvenliliği
In this analysis of patients with moderate to severe RA treated with tofacitinib (TOF) in Phase 3 and long-term extension (LTE) studies, patients aged 65 years had similar efficacy and a numerically higher risk of SAEs and discontinuations due to AEs compared with younger patients.
The Phase 3 population included patients from five trials (n=3111) of TOF 5 mg or 10 mg BID or placebo. The LTE population (n=4102) included patients from two studies who had participated in Phase 1, 2 or 3 TOF studies. Data were pooled from the Phase 3 trials and, separately, from the LTE studies.
Probability ratios for ACR responses and HAQ-DI improvement from baseline ≥0.22 (Month 3) favoured tofacitinib and were similar in older and younger patients. Incidence rates for SAEs and discontinuations due to AEs (pooled Phase 3 studies, at Month 12; pooled LTE data, at Month 24) were generally numerically higher in older versus younger patients, irrespective of treatment.
The overall efficacy of TOF appeared to be similar in patients aged 65 years compared with younger patients. The higher incidence rates of SAEs and discontinuations due to AEs in older patients are consistent with observations from studies of conventional synthetic and biological DMARDs, including TNF inhibitors, in patients with RA.