Efficacy and Safety of Tocilizumab in Polymyalgia Rheumatica: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Abstract

Introduction: The efficacy and safety of tocilizumab in patients with polymyalgia rheumatica (PMR) is not well established.

Methods: We systematically searched PubMed, Cochrane, and Scopus to identify randomized controlled trials (RCTs) evaluating the efficacy and safety of tocilizumab compared with placebo in patients with PMR. The endpoints of interest were glucocorticoid-free remission at week 24, cumulative prednisolone dose at week 24, and adverse effects like risk of infection, gastrointestinal disorders, musculoskeletal and connective tissue disorders. We analyzed binary outcomes using risk ratios (RR) and continuous outcomes using mean difference (MD) with 95% confidence intervals (CI). Statistical analysis was performed using Review Manager 8.13 (Cochrane Collaboration).

Results: Three RCTs with 188 patients were included, of whom 99 (53%) received tocilizumab and 89 (47%) received a placebo. The three RCTs varied significantly regarding patient populations and clinical settings: Bonelli et al. (2022) studied patients with early PMR receiving short-term glucocorticoids (GCs), Devauchelle-Pensec et al. (2022) included patients with GC-dependent PMR and a prespecified GC tapering strategy, and Spiera et al. (2021) analyzed patients with PMR associated with giant cell arteritis (GCA). Tocilizumab was associated with higher glucocorticoid-free remission at week 24 (RR 2.64; 95% CI 1.38 to 5.06; p= 0.003) and a lower cumulative prednisolone dose at week 24 (MD -2.52mg; CI -4.00 to -1.03; p= 0.0009) compared to placebo. However, there were no significant differences between the groups regarding safety outcomes, including the risk of infections (RR 1.19; 95% CI 0.92 to 1.52, p = 0.18), gastrointestinal disorders (RR 1.17; 95% CI 0.72 to 1.89, p = 0.52), and musculoskeletal and connective tissue disorders (RR 1.13; 95% CI 0.53 to 2.42, p = 0.75).

Conclusion: Our findings indicate that tocilizumab significantly improved glucocorticoid-free remission rates and reduced the cumulative prednisolone dose at week 24. Notably, safety outcomes between tocilizumab and placebo groups were comparable. These findings support the efficacy of tocilizumab in treatment of PMR.