Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial

Clin Drug Investig. 2023 Apr;43(4):277-288.doi: 10.1007/s40261-023-01252-z. Epub 2023 Apr 1


Geert D'Haens 1Walter Reinisch 2Stefan Schreiber 3Fraser Cummings 4Peter M Irving 5 6Byong Duk Ye 7Dong-Hyeon Kim 8SangWook Yoon 8Shomron Ben-Horin 9


Author information

1Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

2Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

3Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.

4Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

5Department of Gastroenterology, Guy's and St Thomas' Hospital, London, UK.

6School of Immunology and Microbial Sciences, King's College London, London, UK.

7Department of Gastroenterology and Inflammatory Bowel Disease Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

8Medical Department, Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea.

9Gastroenterology Department, Chaim Sheba Medical Center, Tel Aviv University, Ramat Gan, Tel-Hashomer, Israel. shomron.benhorin@gmail.com.


Background and objective: Whether benefits and risks of intravenous (IV) infliximab combotherapy with immunosuppressants versus infliximab monotherapy apply to subcutaneous (SC) infliximab is unknown. This post hoc analysis of a pivotal randomised CT-P13 SC 1.6 trial aimed to compare SC infliximab monotherapy with combotherapy in inflammatory bowel disease (IBD).

Methods: Biologic-naïve patients with active Crohn's disease or ulcerative colitis received CT-P13 IV 5 mg/kg at Week (W) 0 and 2 (dose-loading phase). At W6, patients were randomised (1:1) to receive CT-P13 SC 120 or 240 mg (patients < 80 or ≥ 80 kg) every 2 weeks until W54 (maintenance phase), or to continue CT-P13 IV every 8 weeks until switching to CT-P13 SC from W30. The primary endpoint-non-inferiority of trough serum concentrations-was assessed at W22. We report a post hoc analysis comparing pharmacokinetic, efficacy, safety and immunogenicity outcomes up to W54 for patients randomised to CT-P13 SC, stratified by concomitant immunosuppressant use.

Results: Sixty-six patients were randomised to CT-P13 SC (37 monotherapy, 29 combotherapy). At W54, there were no significant differences in the proportions of patients achieving target exposure (5 µg/mL; 96.6% monotherapy vs 95.8% combotherapy; p > 0.999) or meeting efficacy or biomarker outcomes including clinical remission (62.9% vs 74.1%; p = 0.418). Monotherapy and combotherapy groups had comparable immunogenicity (anti-drug antibodies [ADAs]: 65.5% vs 48.0% [p = 0.271], neutralising antibodies [in ADA-positive patients]: 10.5% vs 16.7% [p = 0.630], respectively).

Conclusions: Pharmacokinetics, efficacy and immunogenicity were potentially comparable between SC infliximab monotherapy and combotherapy in biologic-naïve IBD patients.

Trial registration: ClinicalTrials.gov: NCT02883452.

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