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Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • William J Sandborn
  • Marcoli Cyrille
  • Mark Berner Hansen
  • Brian G Feagan
  • Edward V Loftus
  • Gerhard Rogler
  • Severine Vermeire
  • Martha L Cruz
  • Jun Yang
  • Michael J Boedigheimer
  • Lubna Abuqayyas
  • Christine M Evangelista
  • Barbara A Sullivan
  • Walter Reinisch
Vis graf over relationer

Background & Aims: The α 4 β 7 integrin is a validated target in inflammatory bowel disease. This randomized, phase 2b, placebo-controlled, double-blind study evaluated the efficacy and safety of the anti-α 4 β 7 antibody abrilumab in patients with moderate-to-severe ulcerative colitis despite treatment with conventional therapies. Methods: Patients (total Mayo Score 6–12, recto-sigmoidoscopy score ≥2) with inadequate response or intolerance to conventional therapies were randomized to receive subcutaneous abrilumab (7, 21, or 70 mg) on day 1, weeks 2 and 4, and every 4 weeks; abrilumab 210 mg on day 1; or placebo. The primary end point was remission (total Mayo Score ≤2 points, no individual sub-score >1 point) for the 2 highest dosages at week 8. Key secondary end points were response and mucosal healing (centrally read) at week 8. Results: For 354 patients who received ≥1 dose of investigational product (placebo, n = 116; 7 mg, n = 21; 21 mg, n = 40; 70 mg, n = 98; 210 mg, n = 79), non-adjusted remission rates at week 8 were 4.3%, 13.3%, and 12.7% for the placebo and abrilumab 70-mg and 210-mg groups, respectively (P <.05 for 70 and 210 mg vs placebo); odds of achieving remission were significantly greater with abrilumab 70 mg (odds ratio 3.35; 90% CI 1.41–7.95; P =.021) and 210 mg (odds ratio 3.33; 90% confidence interval 1.34–8.26; P =.030) than with placebo. Response and mucosal healing rates with these dosages also were significantly greater than with placebo. Higher baseline α 4 β 7 levels on naïve CD4 + T cells were a prognostic indicator for overall outcome, but not a predictive biomarker of abrilumab response. There were no cases of progressive multifocal leukoencephalopathy or deaths. Conclusions: Abrilumab treatment for 8 weeks induced remission, clinical response, and mucosal healing in patients with moderate-to-severe ulcerative colitis. ClinicalTrials.gov, number NCT01694485.

OriginalsprogEngelsk
TidsskriftGastroenterology
Vol/bind156
Udgave nummer4
Sider (fra-til)946-957.e18
ISSN0016-5085
DOI
StatusUdgivet - mar. 2019

Bibliografisk note

Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.

ID: 57240550