Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY).

Abstract

Background and aims: In the LIBERTY phase 3 studies in Crohn's disease (CD) or ulcerative colitis (UC), maintenance CT-P13 subcutaneous (SC) 120 mg was more effective than placebo after 1 year. Here we report 2-year data from the LIBERTY open-label extensions.

Methods: Two randomized, placebo-controlled, double-blind studies evaluated the efficacy and safety of CT-P13 SC maintenance in moderate-to-severe CD or UC. Responders to CT-P13 intravenous induction were randomized at week (W) 10 to CT-P13 SC 120 mg or placebo biweekly, until W54. From W22, dose adjustment to CT-P13 SC 240 mg was permitted for loss of response. At W56, patients could enter an open-label extension, receiving CT-P13 SC 120 mg (or 240 mg if dose-adjusted), biweekly, until W102.

Results: The extension comprised 278/343 (81.0%) and 348/438 (79.5%) patients in the CD and UC studies, respectively. In those continuing on-study, efficacy (non-responder imputation) was well maintained in the CT-P13 SC group at W102: 63.5% (as-observed: 70.5%) and 49.0% (as-observed: 58.8%) of CD patients (N = 192) achieved clinical remission and endoscopic response, respectively; 45.1% (as-observed: 60.1%) and 41.4% (as-observed: 52.4%) of UC patients (N = 237) achieved clinical remission and endoscopic-histologic mucosal improvement, respectively. No new safety signals were identified from longer-term CT-P13 SC treatment or starting CT-P13 SC 120 mg after placebo, with similar adverse event rates for patients undergoing dose adjustment to CT-P13 SC 240 mg from CT-P13 SC 120 mg or placebo.

Conclusion: CT-P13 SC is an effective and well-tolerated long-term maintenance treatment in moderate-to-severe CD and UC.

Clinicaltrials.gov identifiers: NCT03945019 (CD) and NCT04205643 (UC).