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Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease
- Source :
- Gastroenterology. 160:2340-2353
- Publication Year :
- 2021
- Publisher :
- Elsevier BV, 2021.
-
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–naive 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.
- Subjects :
- Adult
Male
0301 basic medicine
congenital, hereditary, and neonatal diseases and abnormalities
medicine.medical_specialty
Adolescent
Injections, Subcutaneous
Severity of Illness Index
Gastroenterology
Inflammatory bowel disease
Maintenance Chemotherapy
law.invention
Feces
Young Adult
03 medical and health sciences
0302 clinical medicine
Crohn Disease
Gastrointestinal Agents
Randomized controlled trial
law
Internal medicine
Injection site reaction
Clinical endpoint
medicine
Humans
Biosimilar Pharmaceuticals
Aged
Crohn's disease
Hepatology
Drug Substitution
business.industry
Antibodies, Monoclonal
Middle Aged
medicine.disease
Crohn's Disease Activity Index
Ulcerative colitis
Infliximab
C-Reactive Protein
Treatment Outcome
030104 developmental biology
Administration, Intravenous
Colitis, Ulcerative
Female
030211 gastroenterology & hepatology
business
Leukocyte L1 Antigen Complex
medicine.drug
Subjects
Details
- ISSN :
- 00165085
- Volume :
- 160
- Database :
- OpenAIRE
- Journal :
- Gastroenterology
- Accession number :
- edsair.doi.dedup.....567552f53d04ad1b31887b430adddbf8