Journal of Crohn's & colitis · 2025
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).
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Colombel Jean-Frederic, Sandborn William J, Schreiber Stefan, Danese Silvio, Kłopocka Maria, Kierkuś Jarosław, Kulynych Roman, Gonciarz Maciej, Sołtysiak Artur, Smoliński Patryk, Srećković Slobodan, Valuyskikh Ekaterina, Lahat Adi, Horyński Marek, Gasbarrini Antonio, Osipenko Marina, Borzan Vladimir, Kowalski Maciej, Saenko Daria, Sardinov Ruslan, Lee Sang Joon, Kim Sunghyun, Bae Yunju, Lee Sunhee, Lee Seulgi, Lee Joon Ho, Kim Jong Min, Park Gahee, Lee Jimin, Lee Juhyun, Ryu Jae Yeoul, Sands Bruce E, Hanauer Stephen B
Аннотация
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).
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).