Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

Abstract

Objective To assess the long-term safety, tolerability, and effectiveness of tocilizumab (TCZ) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in clinical practice in patients with moderate to severe rheumatoid arthritis (RA). Methods Patients in the 24-week, open-label ACT-SURE study who had at least a moderate EULAR response by week 24 and were from a participating country were eligible for this long-term extension (LTE); the patients continued to receive TCZ 8 mg/kg intravenously every 4 weeks as monotherapy or in combination with ≥ 1 csDMARD for up to an additional 108 weeks. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Effectiveness endpoints included Disease Activity Score in 28 joints (DAS28) responses, American College of Rheumatology (ACR) responses, and patient-reported outcomes (PROs). Results Of the 1102 patients who completed the core 24-week study, 934 participated in the LTE; the median exposure to TCZ was 64.3 weeks. From baseline to the end of the LTE, AEs and SAEs occurred in 90% and 9% of patients, respectively. The overall event rates (95% CI) of AEs and SAEs were 406.5 per 100 patient-years (PY) (395.5, 417.8) and 8.8 per 100 PY (7.3, 10.6), respectively. Mean (SD) improvement in DAS28 was 4.12 (1.18), P < 0.0001. The DAS28 remission rates, ACR response rates, and PRO scores were maintained during the LTE study. Conclusion In clinical practice, TCZ as monotherapy or in combination with csDMARDs was safe, well tolerated, and efficacious in patients with moderate to severe RA.

Efficacy and safety of tocilizumab in patients with refractory generalized myasthenia gravis

“…The reported AEs associated with tocilizumab in our study were consistent with its known safety profile in RA 36–38 . The long‐term safety profile of tocilizumab (mean treatment duration, 2.4 years) from several phase III trials and open‐label extensions did not demonstrate an increase in serious or treatment‐related AEs, and the data were overall consistent with those of post‐marketing trials and clinical experience 39 .…”

“…The reported AEs associated with tocilizumab in our study were consistent with its known safety profile in RA. [36][37][38] The long-term safety profile of tocilizumab (mean treatment duration,…”

Safety and efficacy of tocilizumab for rheumatoid arthritis: a systematic review and metaanalysis of clinical trial studies

“…Moreover, a significantly higher proportion of patients achieved clinical remission at 24-week follow-up. Other prospective studies also reported that patients with RA showed a better clinical response at 24-week follow-up [49][50][51].…”

Short-Term Efficacy and Safety of Subcutaneous Tocilizumab in Rheumatoid Arthritis Patients in Pakistan: A Real-World Experience

“…It is characterized by inflammation of the synovium, which often results in irreversible joint damage if left untreated. 1,2 Pro-inflammatory cytokines like tumour necrosis factor (TNF), Interleukin 6 (IL-6) and Interleukin 1(IL-1) have been implicated in pathogenesis. 3,4 TNF inhibitors have a high risk of tuberculosis (TB) reactivation, which is especially relevant in TB-endemic areas like ours.…”