Efficacy and Safety of Tocilizumab in Polymyalgia Rheumatica: A Systematic Review and Meta-Analysis.
Objective: No meta-analysis has holistically analyzed and summarized the efficacy and safety of tocilizumab in polymyalgia rheumatica (PMR). We undertook this meta-analysis to address this knowledge-gap.
Methods: Electronic databases were searched for RCTs involving patients living with PMR receiving tocilizumab in intervention arm, and placebo/active comparator in control arm. Primary outcome was to evaluate percentage of patients able to achieve C-reactive protein PMR assessment score (CRP-PMR-AS) < 10 or prednisolone dose < 5 mg/day or > 10 mg/dL decline in prednisolone from baseline. Secondary outcomes were to determine percentage of patients able to totally stop prednisolone and adverse-events.
Results: From initially screened 115 articles, data from 2 RCTs (136 patients) was analyzed. In addition, a descriptive analysis of 8 observational studies (356 patients) was also done. After 24-weeks of clinical use, patients with PMR receiving tocilizumab had significantly higher chances of achieving composite primary end-point defined as CRP-PMR-AS < 10 and either prednisone dosage < 5 mg/day or decrease in prednisolone dosage by > 10 mg/day compared to baseline [odds ratio (OR) 4.89 (95% CI: 2.34-10.23); p < 0.001; I2 = 0%], compared to placebo. Patients with PMR receiving tocilizumab also had significantly higher chances of being able to stop prednisolone compared to placebo [OR 4.45 (95% CI: 2.06-9.61); p < 0.001; I2 = 0%]. Occurrence of total adverse-events [risk ratio (RR) 1.24 (95% CI: 0.50-3.12); p = 0.64; I2 = 0%], adverse-events leading to treatment discontinuation [RR 0.45 (95% CI: 0.10-2.02); p = 0.29; I2 = 17%], and infections [RR 1.71 (95% CI: 0.83-3.52); p = 0.14; I2 = 6%] were comparable in patients receiving tocilizumab as compared to placebo. Observational studies have noted lung infections, neutropenia and increased cholesterol with tocilizumab use.
Conclusions: Tocilizumab is well tolerated and is effective for managing PMR. Tocilizumab is an effective glucocorticoid sparing agent in PMR.