Network meta-analysis to evaluate the comparative efficacy of biologics for maintenance treatment of adult patients with crohn's disease

INFLAMMATORY BOWEL DISEASES(2024)

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摘要
Introduction: Despite currently expanding therapeutic options in Crohn’s disease (CD), direct evidence on comparative efficacy of various treatments is lacking. CT-P13 subcutaneous (SC) provides patients with a new opportunity for maintenance treatment of their disease. Methods: A network meta-analysis (NMA) was conducted to evaluate comparative efficacy of biologics. Phase 3 randomised controlled trials (RCTs) evaluating biologics approved by the European Medicines Agency or United States Food and Drug Administration as of 31 March 2023 for maintenance treatment of adult patients with moderate-to-severe CD were included. Each study was either controlled with placebo (PBO) or an active comparator. Head-to-head studies directly comparing efficacy of licensed biologics (including those with treat-through designs) were also included. Clinical remission rates were compared in a Bayesian NMA fixed-effect model. Results: Overall, 8 RCTs were included in the analysis (ACCENT I, LIBERTY-CD, CHARM, SEAVUE, GEMINI 2, VISIBLE 2, IM-UNITI, FORTIFY). Most studies enrolled both naïve and biologic- and/or Janus kinase inhibitor-exposed patients, apart from ACCENT-1 and SEAVUE which enrolled only anti-tumour necrosis factor- and biologic-naïve patients, respectively. The present NMA was conducted using data pooled from all patients. Among 8 comparator arms, infliximab (IFX) SC 120 mg every 2 weeks (Q2W) showed the highest odds ratio (95% confidence interval [CI]) vs. PBO (3.52 [2.18–5.65]), followed by adalimumab (ADL) SC 40 mg Q2W (2.92 [1.90–4.47]), ustekinumab (UST) SC 90 mg every 8 weeks (Q8W) (2.79 [1.85–4.21]), IFX IV 5 mg/kg Q8W (2.55 [1.29–5.27]), vedolizumab (VDZ) IV 300 mg Q8W (2.33 [1.43–3.86]), risankizumab (RZB) SC 180 mg Q8W (1.80 [1.15–2.84]), VDZ SC 108 mg Q2W (1.76 [1.14–2.70]), and RZB SC 360 mg Q8W (1.60 [1.00–2.52]). In addition, IFX SC 120 mg Q2W ranked highest in terms of SUCRA values (0.887), followed by ADL SC 40 mg Q2W (0.763), UST SC 90 mg Q8W (0.718), IFX IV 5 mg/kg Q8W (0.630), VDZ IV 300 mg Q8W (0.566), RZB SC 180 mg Q8W (0.353), VDZ SC 108 mg Q2W (0.327), RZB SC 360 mg Q8W (0.252), and PBO (0.005). Conclusion: IFX SC 120 mg Q2W ranked first for achieving clinical remission. Our data might help place IFX SC into the perspective of other therapies and address knowledge gaps on the comparative efficacy of licensed biologics for CD. Disclosures: Data have been first submitted to UEGW 2023. References are to be listed in the presentation as per the Abstract Submission Instruction of ACG 2023.
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