Effectiveness of Switching From Intravenous to Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease: An individual participant data meta-analysis.

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.