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This research evaluates the effectiveness and safety of subcutaneous infliximab (CT-P13) in inflammatory bowel disease patients.

January 23, 2026

P0572Subcutaneous infliximab (CT-P13) in Inflammatory Bowel Disease: Real-World Effectiveness and Safety. Observational retrospective single tertiary centre study.

Key Points

This research evaluates the effectiveness and safety of subcutaneous infliximab (CT-P13) in inflammatory bowel disease patients.
Retrospective observational study at a single tertiary centre
Included adult patients with inflammatory bowel disease receiving SC infliximab
Primary endpoint was clinical remission rate at week 14 and end of follow-up
Clinical remission in Crohn's disease patients increased from 58.3% at baseline to 91.3% at week 14 and 75.0% by end of follow-up
Significant increase in serum infliximab trough levels from 5.5 µg/mL at baseline to 18.6 µg/mL at week 14
Adverse events occurred in 21.4% of patients, with one serious case noted

Abstract

Abstract Background Infliximab (IFX) is an approved biological therapy for Crohn’s disease (CD) and ulcerative colitis (UC). The subcutaneous (SC) formulation of IFX (CT-P13) has shown comparable efficacy to intravebous (IV) IFX, with higher IFX through levels and reduced immunogenicity. This study aimed to evaluate the clinical effectiveness and safety of SC IFX (CT-P13) in a real-world cohort of patients with inflammatory bowel disease (IBD). Methods A retrospective, single-centre, observational study was conducted including adult patients with IBD receiving SC IFX (CT-P13). The primary endpoint was the rate of clinical remission at week 14, and at the end of follow-up. Clinical remission was defined as a Harvey–Bradshaw Index (HBI) ≤ 4 for CD, and a partial Mayo Score (pMS) ≤ 2 for UC or unclassified colitis (IBD-U). Secondary outcomes included changes in faecal calprotectin (FC), serum IFX trough levels, presence of anti-drug antibodies (ADA), and treatment-related adverse events (AEs). Results Baseline characteristics are presented in Table 1. Clinical remission rate, in CD patients, increased from 58.3% at baseline to 91.3% at week 14 (p = 0.0156), and 75.0% at the end of follow-up (p = 0.2891; median 26.6 weeks IQR 15.6–43.9). HBI significantly decreased through follow up Figure1A. No significant changes were observed in clinical remission or pMS among patients with UC or IBD-U. Median FC levels (µg/g) decreased from 684 (113.6–2335) at baseline to 583 (135–1855) at week 14, and further to 288.5 (128–1531.3) at the end of follow-up (median 21.4 weeks IQR 13–41), although differences were not statistically significant (p 0.05; Figure 1B). Median serum IFX trough levels (µg/mL) increased significantly from 5.5 (3.2–8.9) at baseline to 18.6 (10.5–38.2) at week 14 (p = 0.0042), and to 18.9 (8.8–31.7) at the end of follow-up (p = 0.0025; Figure 1C). Anti-IFX antibodies were detected in 4 patients (14.3%), one of whom had pre-existing antibodies prior to switching. AEs occurred in 6 patients (21.4%), including 1 case of drug-induced liver injury resembling autoimmune hepatitis, 3 cutaneous reactions, 1 case of arthralgia, and 1 of headache. SC IFX was discontinued in 8 patients (28.6%): 5 due to AEs, 2 due to persistent disease activity with low IFX levels, and 1 due to ongoing clinical activity despite adequate drug levels. Conclusion Subcutaneous IFX (CT-P13) appears to be an effective and well-tolerated therapeutic option for patients with Crohn’s disease in clinical practice. The observed increase in serum IFX concentrations is consistent with previous publications. References: 1. Schreiber S, Ben-Horin S, Leszczyszyn J, et al. Randomized controlled trial: subcutaneous vs intravenous infliximab CT-P13 maintenance in inflammatory bowel disease. Gastroenterology. 2021;160(7):2340-2353. doi:10.1053/j.gastro.2021.02.068. 2. Buisson A, Nachury M, Reymond M, et al. Effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases: the REMSWITCH study. Clin Gastroenterol Hepatol. 2023;21(9):2338-2346.e3. doi:10.1016/j.cgh.2022.08.011 3. Smith PJ, Critchley L, Storey D, et al. Efficacy and safety of elective switching from intravenous to subcutaneous infliximab (CT-P13): a multicentre cohort study. J Crohns Colitis. 2022;16(9):1436-1446. doi:10.1093/ecco-jcc/jjac053 4. Smith PJ, Fumery M, Leong RW, Novak K, Dignass A. Real-world experience with subcutaneous infliximab: broadening treatment strategies for inflammatory bowel disease. Expert Rev Clin Immunol. 2023;19(9):1143-1156. doi:10.1080/1744666X.2023.2231148 Conflict of interest: Cárdenas Patiño, Jenny Victoria: No conflict of interest Mr. Moralejo Lozano, Óscar: I have received educational funding from Abbvie, Johnson & Johnson, Takeda, Kern Pharma, Alfasigma, Pfizer, Lilly, Sandoz, Dr. Falk Pharma, Ferring, and Tillotts. I have also served as a speaker for Abbvie, Takeda, Alfasigma, and Lilly. Abanades Tercero, María: No conflict of interest Carrillo Ramos, Maria Jesus: María Jesús Carrillo Ramos has served as a speaker for Takeda and Alfasigma. Gigante González De La Aleja, Gema: No conflicts Ruano Díaz, Lucía: No conflict of interest Salmoral Luque, Rosario: Alfasigma, Janssen Gómez Rodriguez, Rafael Ángel: No conflict of interest

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P0572Subcutaneous infliximab (CT-P13) in Inflammatory Bowel Disease: Real-World Effectiveness and Safety. Observational retrospective single tertiary centre study.

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