Switching from intravenous to subcutaneous infliximab maintenance therapy in inflammatory bowel disease: Post hoc longitudinal analysis of a randomized trial

Stefan Schreiber; Geert D'Haens; Fraser Cummings; Peter M Irving; Byong Duk Ye; Shomron Ben-Horin; Dong-Hyeon Kim; Ae Lee Jeong; Walter Reinisch

doi:10.1016/j.dld.2023.12.013

Switching from intravenous to subcutaneous infliximab maintenance therapy in inflammatory bowel disease: Post hoc longitudinal analysis of a randomized trial

Dig Liver Dis. 2024 Feb 15:S1590-8658(23)01121-0. doi: 10.1016/j.dld.2023.12.013. Online ahead of print.

Authors

Stefan Schreiber¹, Geert D'Haens², Fraser Cummings³, Peter M Irving⁴, Byong Duk Ye⁵, Shomron Ben-Horin⁶, Dong-Hyeon Kim⁷, Ae Lee Jeong⁷, Walter Reinisch⁸

Affiliations

¹ Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Arnold-Heller Straße 3, 24105 Kiel, Germany.
² Department of Gastroenterology, Amsterdam University Medical Centers, De Boelelaan 1117, HV 1081, Amsterdam, The Netherlands.
³ Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, Hampshire SO16 6YD, UK.
⁴ Department of Gastroenterology, Guy's and St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK; School of Immunology and Microbial Sciences, King's College London, Great Maze Pond, London SE1 1UL, UK.
⁵ Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, South Korea.
⁶ Gastroenterology Department, Chaim Sheba Medical Center, Tel Aviv University, 2 Derech Sheba, Tel-Hashomer 5261900, Israel.
⁷ Medical Division, Celltrion Healthcare Co., Ltd, Academy-ro 51beon-gil, Yeonsu-gu, Incheon 22014, South Korea.
⁸ Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna 1090, Austria. Electronic address: walter.reinisch@meduniwien.ac.at.

PMID: 38365502
DOI: 10.1016/j.dld.2023.12.013

Abstract

Background: Pharmacokinetic non-inferiority of subcutaneous (SC) to intravenous (IV) CT-P13 maintenance therapy was demonstrated in a randomized trial (NCT02883452). This post hoc analysis evaluated longitudinal clinical outcomes with the two infliximab treatment strategies.

Methods: Patients with Crohn's disease or ulcerative colitis received CT‑P13 IV loading doses (5 mg/kg; Week [W] 0 and W2) before randomization (1:1) to receive CT-P13 SC (body weight-based dosing every 2 weeks [Q2W]; W6-54; 'SC maintenance group') or CT‑P13 IV (5 mg/kg Q8W; W6-22) then CT-P13 SC (Q2W; W30-54; 'IV-to-SC switch group'). Paired W30/W54 patient-level data were analyzed.

Results: Fifty-three (IV-to-SC switch) and fifty-nine (SC maintenance) patients were analyzed. Median trough serum CT-P13 concentrations were significantly higher at W54 versus W30 in the IV-to-SC switch group (20.4 versus 2.3 µg/mL; p < 0.00001), while remaining consistent in the SC maintenance group. Statistically significant improvements in pharmacokinetics, efficacy, fecal calprotectin levels, and quality of life were seen following switch to SC administration at W30 in the IV-to-SC switch group; safety findings were similar pre- and post-switch.

Conclusion: Formulation switching from IV to SC infliximab maintenance therapy was well tolerated and may provide additional clinical improvements. Findings require confirmation in larger prospective studies.

Keywords: CT-P13; Crohn's disease; Tumor necrosis factor inhibitor; Ulcerative colitis.