Real-world Effectiveness of Sarilumab in RA: Results from the Open-label, Prospective, Single-arm Observational PROFILE Study.

Introduction: The 1-year PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational (PROFILE) study evaluated the real-world effectiveness and safety of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA).

Methods: Safety endpoints included adverse events (AEs) and lab abnormalities. Effectiveness endpoints included the ACR core set.

The effects of sarilumab as monotherapy and in combination with non-methotrexate disease-modifying anti-rheumatic drugs on unacceptable pain in patients with rheumatoid arthritis: A post-hoc analysis of the HARUKA phase 3 study.

Objectives: To investigate unacceptable pain [UP; visual analogue scale (VAS) >40 mm] and uncontrolled inflammation [C-reactive protein (CRP) ≥1.0 mg/dL] in patients with active rheumatoid arthritis (RA) receiving sarilumab (SAR) as monotherapy or in combination with non-methotrexate conventional synthetic disease-modifying antirheumatic drugs (SAR + csDMARDs).

Methods: In the HARUKA Phase 3 study (NCT02373202), Japanese patients received either SAR monotherapy (n = 61) or SAR + csDMARDs (n = 30).

Efficacy and safety of sarilumab in patients with rheumatoid arthritis stratified by age (<65 and ≥65 years): A post hoc analysis of Japanese Phase 3 clinical trials.

Objectives: This study aimed to assess the efficacy and safety of sarilumab in older patients with active rheumatoid arthritis (RA).

Methods: This is a post hoc analysis of KAKEHASI (NCT02293902) and HARUKA (NCT02373202) trials with stratification by age (<65 and ≥65 years). Patients with moderately to severely active RA were treated with sarilumab in combination with methotrexate or with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or as monotherapy.

Safety of sarilumab in a Japanese population with rheumatoid arthritis by age group: Data from an interim analysis of a postmarketing surveillance study.

Objectives: Using data from a postmarketing surveillance, this interim subgroup analysis investigated the safety of sarilumab in younger (<65 years) and older patients (≥65 and ≥75 years) with rheumatoid arthritis.

Methods: During this interim analysis, patients who were treated with sarilumab in Japan were enrolled between June 2018 and 2021. Data collected by 12 January 2022 were analysed, with adverse drug events monitored over 52 weeks.