Abstract:
Goals: We assessed clinical outcomes over 6 months in an integrated analysis of inflammatory bowel disease (IBD) patients switching from intravenous (IV) to subcutaneous (SC) infliximab (IFX).
Background: Real-world data from large multinational IBD patient populations treated with SC IFX are lacking.
Study: This individual participant data meta-analysis combined anonymized data from 3 real-world cohorts and evaluated clinical remission [Crohn’s disease (CD): Harvey-Bradshaw Index (HBI)/modified HBI (mHBI) <5; ulcerative colitis (UC): Simple Clinical Colitis Activity Index (SCCAI)/partial Mayo score (PMS) <3], disease activity (HBI/mHBI/SCCAI/PMS), treatment persistence, pharmacokinetics, immunogenicity, biomarkers [fecal calprotectin (FCP); C-reactive protein (CRP)], and reasons for discontinuation. Subgroup analyses determined the effect of clinical parameters on outcomes.
Results: Of 428 patients (CD, n=302; UC, n=126), 85.4% were in clinical remission at baseline, which was maintained at 6 months (84.7%), and was higher in patients with CD versus UC (89.8% vs. 71.9%; P<0.001); disease activity scores remained low. High treatment persistence was observed (94.5%) at 6 months. Median serum IFX levels increased from 5.6 μg/mL at baseline to 16.0 μg/mL at 6 months. Most patients (96.1%) maintained negative antidrug antibody status and low levels of FCP and CRP up to 6 months. Drug discontinuation rate was low (5.8%). Intensified preswitch IV IFX was the only factor negatively associated with CD remission at 6 months [intensified vs. standard estimated marginal mean probability difference -0.107 (95% CI: -0.191, -0.024); P=0.012].
Conclusions: Switching from IV to SC IFX maintains clinical effectiveness in patients with IBD regardless of various patient factors.
Reference:Cummings F, Smith PJ, Fumery M, Rahmany S, Subramanian S, Kwon B, Park S, Lee YN, Buisson A. Effectiveness of Switching From Intravenous to Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease: An individual participant data meta-analysis. J Clin Gastroenterol. 2025 Aug 6. doi: 10.1097/MCG.0000000000002228. Epub ahead of print. PMID: 40824626.