Efficacy and Safety of Risankizumab in Patients with Psoriatic Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Autor: Su QY; Department of Rheumatology, The Second Hospital of Shanxi Medical University, 382 Wuyi Road, Taiyuan, Shanxi, China.; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Zhou HN; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Xia GM; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Zhang RY; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Tian HY; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Su C; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Liu YX; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Zhang HY; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Cheng T; Department of Rheumatology, The Second Hospital of Shanxi Medical University, 382 Wuyi Road, Taiyuan, Shanxi, China.; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Huo YH; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China.; Department of Rheumatology, The Fifth People's Hospital of Datong, Datong, Shanxi, China., Li Q; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China., Zhang SX; Department of Rheumatology, The Second Hospital of Shanxi Medical University, 382 Wuyi Road, Taiyuan, Shanxi, China. zhangshengxiaol@sxmu.edu.cn.; Key Laboratory of Cellular Physiology at Shanxi Medical University, Ministry of Education, Taiyuan, China. zhangshengxiaol@sxmu.edu.cn.; Shanxi Provincial Key Laboratory of Rheumatism Immune Microecology, The Shanxi Medical University, Taiyuan, Shanxi, China. zhangshengxiaol@sxmu.edu.cn.
Jazyk: angličtina
Zdroj: Rheumatology and therapy [Rheumatol Ther] 2024 Apr; Vol. 11 (2), pp. 227-237. Date of Electronic Publication: 2024 Feb 01.
DOI: 10.1007/s40744-024-00638-5
Abstrakt: Introduction: Currently, the cause of psoriatic arthritis (PsA) is unknown, and the effectiveness of current drug treatments is unsatisfactory. In March 2019, the US Food and Drug Administration (FDA) approved risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, for the treatment of PsA in adults. This study aimed to conduct a meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the effectiveness and safety of risankizumab in moderate-to-severe PsA.
Methods: We conducted a thorough search of relevant databases from the establishment of the databases to October 1, 2023. We conducted a meta-analysis using Stata 12.0 and utilized I 2 and Egger tests to assess heterogeneity and publication bias among the studies. Bias assessment was performed using the risk bias map and bias risk summary diagram generated by Revman5.4 software. The review protocols were registered on PROSPERO (CRD42023451894) and adhered to the preferred reporting item of system evaluation (PRISMA) guideline.
Results: Six randomized controlled trials (RCTs) involving 5038 patients with PsA treated with either risankizumab or placebo were included in the analysis. At 24 weeks, the risankizumab group demonstrated a significantly higher American College of Rheumatology-20 (ACR20) response rate compared to the placebo group (RR 1.760, 95% CI 1.568-1.977, P < 0.001). Additionally, the risankizumab group showed a significantly higher Minimal Disease Activity (MDA) response rate compared to the placebo group (RR 1.827, 95% CI 1.048-3.184, P < 0.05). The risankizumab group also exhibited improvement in Short Form 36 Questionnaire (SF-36) score (SMD 0.51, 95% CI 0.33-0.69, P < 0.001), with significantly lower Health Assessment Questionnaire Disability Index (HAQ-DI) score (SMD - 0.27, 95% CI - 0.37 to - 0.17, P < 0.001) and higher Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score (SMD 0.27, 95% CI 0.20-0.35, P < 0.001) compared to the placebo group. Moreover, the risankizumab group had a significantly lower Psoriasis Area and Severity Index (PASI) score (SMD - 6.12, 95% CI - 10.02 to 2.23, P < 0.001). A study by Mease et al. indicated that patients receiving risankizumab generally demonstrated numerical improvements in the Leeds Enthesitis Index (LEI), although the small sample size limits the evidence. Further research is necessary to provide evidence-based guidelines. There were no significant differences in the incidence of serious adverse events (SAE) and serious treatment-emergent adverse events (STEAE) between the risankizumab and placebo groups (RR 0.76, 95% CI 0.45-1.28, P = 0.31; RR 0.99, 95% CI 0.49-1.99, P = 0.97, respectively), and the overall incidence of adverse events (AE) was not comparable (RR 1.10, 95% CI 0.63-1.94, P = 0.73).
Conclusion: Risankizumab showed superior efficacy across multiple outcome measures compared to placebo, with no significant increase in adverse events. Our findings endorse risankizumab as an excellent treatment option for PsA, offering valuable insights for clinicians and patients when choosing appropriate therapeutic interventions.
Trial Registration: Retrospectively registered (CRD42023451894, 16 August 2023).
(© 2024. The Author(s).)
Databáze: MEDLINE
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