Revista espanola de enfermedades digestivas · 2026
Long-term use of subcutaneous infliximab biosimilar CT-P13 in patients with inflammatory bowel disease in clinical practice.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Huguet José María, Martí Romero Lidia, Boscá-Watts Marta Maia, Ramirez José J, Sanchis Artero Laura, Paredes José M, Cambralla María, Ruiz Lucía, Alemany Pérez Gloria, Garrido Alejandro, Pastor Miguel A, Iborra Marisa
Аннотация
BACKGROUND: Subcutaneous (SC) infliximab biosimilar CT-P13 has shown comparable efficacy and safety to the intravenous (IV) formulation in inflammatory bowel disease (IBD). However, long-term real-world data remain limited. This study assessed the three-year effectiveness, safety, and pharmacokinetics profile of SC CT-P13 in IBD patients switched from IV infliximab.
METHODS: Prospective, observational, multicenter study conducted in eight hospitals (Valencian Community, Spain). Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) receiving IV infliximab were switched to SC CT-P13 and followed for up to 3 years. Clinical activity, inflammatory biomarkers, adverse events, treatment persistence, and infliximab trough levels were assessed, including analyses according to immunomodulatory therapy (IM) use and dosing intensities.
RESULTS: Seventy-four patients were included (43% UC, 57% CD). Mean SC CT-P13 trough levels increased significantly from baseline to 3 years (8.15 ± 5.93 to 15.89 ± 7.99 µg/mL, p<0.001), with consistent results across disease type, intensified dosing, and perianal CD subgroups. Inflammatory markers (CRP, calprotectin) remained stable throughout follow-up. Concomitant IM use decreased from 51% at baseline to 26.3% at study end, without changes in pharmacokinetics, clinical outcomes, or biomarkers. Treatment persistence at 3 years was 80% overall and 88% when considering only discontinuations due to loss of efficacy or adverse events. Fourteen patients (19%) experienced adverse events, predominantly mild.
CONCLUSIONS: Switching from intravenous to subcutaneous infliximab biosimilar CT-P13 was associated with sustained treatment persistence, stable disease control, favorable pharmacokinetics, and good tolerability over 3 years. These real-world findings support SC CT-P13 as a convenient long-term maintenance option in routine clinical practice.
METHODS: Prospective, observational, multicenter study conducted in eight hospitals (Valencian Community, Spain). Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) receiving IV infliximab were switched to SC CT-P13 and followed for up to 3 years. Clinical activity, inflammatory biomarkers, adverse events, treatment persistence, and infliximab trough levels were assessed, including analyses according to immunomodulatory therapy (IM) use and dosing intensities.
RESULTS: Seventy-four patients were included (43% UC, 57% CD). Mean SC CT-P13 trough levels increased significantly from baseline to 3 years (8.15 ± 5.93 to 15.89 ± 7.99 µg/mL, p<0.001), with consistent results across disease type, intensified dosing, and perianal CD subgroups. Inflammatory markers (CRP, calprotectin) remained stable throughout follow-up. Concomitant IM use decreased from 51% at baseline to 26.3% at study end, without changes in pharmacokinetics, clinical outcomes, or biomarkers. Treatment persistence at 3 years was 80% overall and 88% when considering only discontinuations due to loss of efficacy or adverse events. Fourteen patients (19%) experienced adverse events, predominantly mild.
CONCLUSIONS: Switching from intravenous to subcutaneous infliximab biosimilar CT-P13 was associated with sustained treatment persistence, stable disease control, favorable pharmacokinetics, and good tolerability over 3 years. These real-world findings support SC CT-P13 as a convenient long-term maintenance option in routine clinical practice.