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Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease.

Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany. Gastroenterology Department, Chaim Sheba Medical Center and Sackler School of Medicine, Tel Aviv University, Tel-Hashomer, Israel. Department of Gastroenterology, Melita Medical, Wroclaw, Poland. Department of Gastroenterology, Melita Medical, Wroclaw, Poland; Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland. Department of Gastroenterology, Twoja Przychodnia-Szczecińskie Centrum Medyczne, Szczecin, Poland. Center of Gastroenterology, Hepatology and Nutrition, Pauls Stradins Clinical University Hospital, Riga, Latvia. Endoskopia sp. z o.o., Sopot, Poland. Department of Clinical Pharmacology, Szent Imre Egyetemi Oktatókórház, Budapest, Hungary. Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw, Poland. Gastroenterology Department, Centrum Diagnostyczno-Lecznicze Barska sp. z o.o., Wloclawek, Poland. Clinical Development Division, Celltrion, Inc., Incheon, Republic of Korea. Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea. Biometrics Department, Celltrion, Inc., Incheon, Republic of Korea. Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. Electronic address: bdye@amc.seoul.kr. Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria. Electronic address: walter.reinisch@meduniwien.ac.at.

Gastroenterology. 2021;(7):2340-2353
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Abstract

BACKGROUND & AIMS This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD). METHODS This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (Ctrough,W22), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%. RESULTS Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for Ctrough,W22 of 1154.17% (90% CI 786.37-1694.00; n = 59 [CT-P13 SC]; n = 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy, safety, and immunogenicity assessments were also broadly comparable between arms, including after switching. CONCLUSIONS The pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, and the comparable efficacy, safety, and immunogenicity profiles, support the potential suitability of CT-P13 SC treatment in IBD. ClinicalTrials.gov ID: NCT02883452.

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