Mirikizumab治疗中重度炎症性肠病的疗效和安全性：一项系统综述和最新荟萃分析

IF 5.3 2区医学 Q2 IMMUNOLOGY

Inflammopharmacology Pub Date : 2025-09-29 DOI:10.1007/s10787-025-01971-z

Joel Gabin Konlack Mekontso, Joseph Yvan Bena Nnang, Samuel G J Fodop, Bishoy I B Elkoumes, Guy Loic Nguefang Tchoukeu, Anifatou B Kortim, Ticha B T Tembi, Akil Olliverre, Jarin Prasa, John Trillo

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引用次数: 0

摘要

背景和目的：尽管生物疗法取得了进展，但炎症性肠病（IBD）的治疗仍然具有挑战性。Mirikizumab是一种选择性抗il -23p19单克隆抗体，显示出希望，但其在IBD人群中的有效性和安全性需要全面评估。方法：我们对比较Mirikizumab和安慰剂治疗中重度IBD的随机对照试验（rct）进行了系统回顾和荟萃分析。我们评估了临床反应、临床缓解、内镜缓解、不良事件（ae）和停药情况。我们采用随机效应模型并计算治疗（NNT）和伤害（NNH）所需的数值。结果：我们纳入4项rct（2380例患者）。Mirikizumab显著提高临床缓解可能性69%(61.0%比36.6%;RR 1.69; 95% CI [1.35, 2.10]; p < 0.00001; NNT = 4)，临床缓解74%(37.1%比20.0%;RR 1.74; 95% CI [1.50, 2.02]; p < 0.00001; NNT = 7)，内镜下缓解92%（28.7%比15.4%;RR 1.92; 95% CI [1.63, 2.27]; p < 0.00001; NNT = 8）。这种疗效扩展到生物学失败的患者和两种IBD人群。Mirikizumab是安全的，严重ae （5.2% vs. 9.1%; RR 0.53; 95% CI [0.41, 0.70]; p < 0.00001; NNH = 24）、停药（2.5% vs. 7.5%; RR 0.33; 95% CI [0.20, 0.56]; p < 0.0001; NNH = 20）和IBD恶化（3.3% vs. 13%; RR 0.26; 95% CI [0.19, 0.36]; p < 0.00001; NNT = 11）的发生率降低。结论：Mirikizumab显著改善了中重度IBD的临床和内镜预后，对生物难治性疾病具有一致的疗效和良好的安全性，使其成为一种有价值的治疗选择。

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Efficacy and safety of Mirikizumab in the treatment of moderate to severe inflammatory bowel diseases: a systematic review and updated meta-analysis.

Background and aims: Inflammatory bowel diseases (IBD) remain challenging to treat despite advances in biologic therapies. Mirikizumab, a selective anti-IL-23p19 monoclonal antibody, shows promise, but its efficacy and safety across IBD populations require a comprehensive evaluation.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing Mirikizumab to placebo in moderate-to-severe IBD. We assessed clinical response, clinical remission, endoscopic remission, adverse events (AEs) and treatment discontinuation. We applied a random-effects model and calculated numbers needed to treat (NNT) and harm (NNH).

Results: We included four RCTs (2380 patients). Mirikizumab significantly increased the likelihood of clinical response by 69% (61.0% vs. 36.6%; RR 1.69; 95% CI [1.35, 2.10]; p < 0.00001; NNT = 4), clinical remission by 74% (37.1% vs. 20.0%; RR 1.74; 95% CI [1.50, 2.02]; p < 0.00001; NNT = 7), and endoscopic remission by 92% (28.7% vs. 15.4%; RR 1.92; 95% CI [1.63, 2.27]; p < 0.00001; NNT = 8). This efficacy extended to biologic-failed patients and across both IBD populations. Mirikizumab was safe, with reduced rates of serious AEs (5.2% vs. 9.1%; RR 0.53; 95% CI [0.41, 0.70]; p < 0.00001; NNH = 24), treatment discontinuation (2.5% vs. 7.5%; RR 0.33; 95% CI [0.20, 0.56]; p < 0.0001; NNH = 20), and IBD worsening (3.3% vs. 13%; RR 0.26; 95% CI [0.19, 0.36]; p < 0.00001; NNT = 11).

Conclusion: Mirikizumab significantly improves clinical and endoscopic outcomes in moderate-to-severe IBD, with consistent efficacy in biologic-refractory disease and a favorable safety profile, making it a valuable therapeutic option.

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来源期刊

Inflammopharmacology IMMUNOLOGYTOXICOLOGY-TOXICOLOGY

CiteScore

8.00

自引率

3.40%

发文量

200

期刊介绍： Inflammopharmacology is the official publication of the Gastrointestinal Section of the International Union of Basic and Clinical Pharmacology (IUPHAR) and the Hungarian Experimental and Clinical Pharmacology Society (HECPS). Inflammopharmacology publishes papers on all aspects of inflammation and its pharmacological control emphasizing comparisons of (a) different inflammatory states, and (b) the actions, therapeutic efficacy and safety of drugs employed in the treatment of inflammatory conditions. The comparative aspects of the types of inflammatory conditions include gastrointestinal disease (e.g. ulcerative colitis, Crohn''s disease), parasitic diseases, toxicological manifestations of the effects of drugs and environmental agents, arthritic conditions, and inflammatory effects of injury or aging on skeletal muscle. The journal has seven main interest areas: -Drug-Disease Interactions - Conditional Pharmacology - i.e. where the condition (disease or stress state) influences the therapeutic response and side (adverse) effects from anti-inflammatory drugs. Mechanisms of drug-disease and drug disease interactions and the role of different stress states -Rheumatology - particular emphasis on methods of measurement of clinical response effects of new agents, adverse effects from anti-rheumatic drugs -Gastroenterology - with particular emphasis on animal and human models, mechanisms of mucosal inflammation and ulceration and effects of novel and established anti-ulcer, anti-inflammatory agents, or antiparasitic agents -Neuro-Inflammation and Pain - model systems, pharmacology of new analgesic agents and mechanisms of neuro-inflammation and pain -Novel drugs, natural products and nutraceuticals - and their effects on inflammatory processes, especially where there are indications of novel modes action compared with conventional drugs e.g. NSAIDs -Muscle-immune interactions during inflammation [...]