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

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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-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 CTP13 SC treatment in IBD.
Author(s)
Stefan SchreiberShomron Ben-HorinJaroslaw LeszczyszynRobert DudkowiakAdi LahatBeata Gawdis-WojnarskaAldis PukitisMarek HorynskiKatalin FarkasJaroslaw KierkusMaciej KowalskiSang Joon LeeSung Hyun KimJee Hye SuhMi Rim KimSeul Gi Lee예병덕Walter Reinisch
Issued Date
2021
Type
Article
Keyword
Crohn’s diseaseCT-P13infliximabsubcutaneousulcerative colitis
DOI
10.1053/j.gastro.2021.02.068
URI
http://oak.ulsan.ac.kr/handle/2021.oak/7082
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_gale_infotracacademiconefile_A663045511&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Randomized%20Controlled%20Trial:%20Subcutaneous%20vs%20Intravenous%20Infliximab%20CT-P13%20Maintenance%20in%20Inflammatory%20Bowel%20Disease&offset=0&pcAvailability=true
Publisher
GASTROENTEROLOGY
Location
미국
Language
영어
ISSN
0016-5085
Citation Volume
160
Citation Number
7
Citation Start Page
2340
Citation End Page
2353
Appears in Collections:
Medicine > Medicine
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