Real-world effectiveness, safety and patient-reported outcomes of sarilumab in patients with rheumatoid arthritis: a 52-week, prospective, open-label, non-interventional, observational, nationwide, large-cohort study in Japan (PROFILE-J)

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OBJECTIVES: To assess the patient characteristics and treatment patterns, effectiveness, safety and patient-reported outcomes (PROs) of sarilumab in routine clinical practice, used as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) in Japan. METHODS: Prospective Sarilumab (Prefilled Syringe/Pen) Observational Study-Japan (PROFILE-J) was a 52-week, prospective, non-interventional, observational study conducted across Japan. Adult patients with RA initiating sarilumab were enrolled. Effectiveness endpoints included Clinical Disease Activity Index (CDAI) scores, disease activity and PROs. Safety endpoints included treatment-emergent adverse events (TEAEs) and other clinically relevant safety outcomes. RESULTS: Among 1998 patients (monotherapy, n=567; combination, n=1431), the mean age was 66.6 years, with 63.2% aged ≥65 years and 67.9% naïve to biologic DMARDs. Sarilumab retention at week 52 was 67.5%. Effectiveness analysis population included 1715 patients (monotherapy, n=461; combination, n=1254). Baseline mean CDAI scores (21.2) decreased to low disease activity range (9.7) at week 12; mean changes from baseline were -13.6 and -13.1 at week 24 and -14.2 and -14.9 at week 52 for monotherapy and combination therapy respectively. Other measures, including PROs, showed similar improvements in both groups. In the safety population, TEAEs occurred in 44.6% of patients, with a slightly lower rate observed in monotherapy (40.2%) than in combination therapy (46.3%). CONCLUSIONS: This study described real-world treatment patterns of sarilumab, highlighting frequent initiation in biologic DMARD-naïve patients, particularly among older adults. Sarilumab demonstrated sustained effectiveness and a consistent safety profile with no new safety signals, supporting its use as monotherapy or combination therapy. TRIAL REGISTRATION NUMBER: jRCT1071190016.

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