Efficacy and safety of mirikizumab in psoriasis: a systematic review and meta-analysis of randomized controlled trials

Abstract

Introduction: Mirikizumab, an interleukin-23 (IL-23) p19 subunit inhibitor, has emerged as a promising treatment for moderate-to-severe plaque psoriasis. Despite its promising results, a comprehensive synthesis of clinical data is essential to assess its overall efficacy and safety profile.

Methods: We searched PubMed, Embase, and Cochrane for studies assessing mirikizumab in moderate-to-severe psoriasis. A random-effects model using Inverse Variance (IV) computed mean differences (MD) for continuous outcomes and risk ratios (RR) for binary endpoints. Risk Difference (RD) studies were analysed using generic inverse variance (GIV) in Review Manager. Statistical analyses were conducted using R software version 4.2.1, following PRISMA guidelines.

Results: This analysis of three RCTs involving 1,649 adult patients over 16-52 weeks demonstrated mirikizumab's significant efficacy in treating psoriasis. At 16 weeks, mirikizumab substantially reduced Body Surface Area (BSA) to < 1% (RR: 34.53, p < 0.001) and improved PASI scores (PASI 100 RR: 25.94, PASI 90 RR: 11.50, PASI 75 RR: 10.47, all p < 0.001). Static Physician's Global Assessment (sPGA) scores of 0/1 were achieved (RR: 12.48, p < 0.001). Quality of life measures also improved significantly, with increases in SF-36 Physical and Mental Component Summaries (MD: 4.02 and 3.53 respectively, p < 0.01) and Dermatology Life Quality Index (DLQI) scores of 0/1 (RD: 0.51, p < 0.00001). Importantly, the safety profile of mirikizumab was comparable to the control, with no significant differences in the overall incidence of adverse effects (RR: 0.97; 95% CI: 0.86-1.10) or in serious adverse effects (RR: 1.61; 95% CI: 0.55-4.73). These results collectively demonstrate the efficacy and safety of mirikizumab in treating psoriasis, with significant improvements across multiple clinical and quality-of-life measures.

Conclusion: This meta-analysis demonstrates that mirikizumab significantly reduces psoriasis severity and improves quality of life, with a favourable safety profile. These findings support its use as a valuable treatment option for moderate-to-severe plaque psoriasis. Further research is needed to assess long-term outcomes and comparative effectiveness.

Keywords: Interleukin-23 inhibitor; Mirikizumab; Psoriasis.