Long-term use of subcutaneous infliximab biosimilar CT-P13 in patients with inflammatory bowel disease in clinical practice.
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. 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. 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. 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.
Read more