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Cited by 279Inflammatory Bowel DiseasePsoriasis: Treatment and PathogenesisRheumatoid Arthritis Research and Therapies

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Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn’s Disease: A Phase 2a Study

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Sands, Bruce E., Chen, Jingjing, Feagan, Brian G., Penney, Mark, Rees, William A., Danese, Silvio, Higgins, Peter D.R., Newbold, Paul, Faggioni, Raffaella, Patra, Kaushik, Li, Jing, Klekotka, Paul, Morehouse, Chris, Pulkstenis, Erik, Drappa, Jörn, van der Merwe, René, Gasser, Robert A.·2017·Gastroenterology
DOI 10.1053/j.gastro.2017.03.049
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Abstract

BACKGROUND & AIMS: MEDI2070 is a human monoclonal antibody that selectively inhibits interleukin 23 (IL23), a cytokine implicated in the pathogenesis of Crohn's disease (CD). We analyzed its safety and efficacy in treatment of CD in a phase 2a study. METHODS: We conducted a double-blind, placebo-controlled study of 119 adults with moderate to severe CD failed by treatment with tumor necrosis factor antagonists. Patients were randomly assigned (1:1) to groups given MEDI2070 (700 mg) or placebo intravenously at weeks 0 and 4. Patients received open-label MEDI2070 (210 mg) subcutaneously every 4 weeks from weeks 12 to 112. The CD Activity Index was used to measure disease activity. RESULTS: The primary outcome, clinical response (either a 100-point decrease in CD Activity Index score from baseline or clinical remission, defined as CD Activity Index score <150) at week 8 occurred in 49.2% of patients receiving MEDI2070 (n = 59) compared with 26.7% receiving placebo (n = 60; absolute difference, 22.5%; 95% confidence interval, 5.6%-39.5%; P = .010). Clinical response at week 24 occurred in 53.8% of patients who continued to receive open-label MEDI2070 and in 57.7% of patients who had received placebo during the double-blind period and open-label MEDI2070 thereafter. The most common adverse events were headache and nasopharyngitis. Higher baseline serum concentrations of IL22, a cytokine whose expression is induced by IL23, were associated with greater likelihood of response to MEDI2070 compared with placebo. CONCLUSIONS: In a phase 2a trial of patients with moderate to severe Crohn's disease who had failed treatment with tumor necrosis factor antagonists, 8 and 24 weeks of treatment with MEDI2070 were associated with clinical improvement. ClinicalTrials.gov ID: NCT01714726.

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Authors
Sands, B. E., Chen, J., Feagan, B. G., Penney, M., Rees, W. A., Danese, S., Higgins, P. D. R., Newbold, P., Faggioni, R., Patra, K., Li, J., Klekotka, P., Morehouse, C., Pulkstenis, E., Drappa, J., van der Merwe, R., & Gasser, R. A.
Affiliations
  • Icahn School of Medicine at Mount Sinai (US)
  • Western University (CA)
  • University of Michigan (US)
  • Amgen (United States) (US)
Corresponding author
Sands, Bruce E.
ORCID
Venue
Gastroenterology
Publisher
Elsevier BV
Published
2017-07
Volume
153
Issue
1
Pages
77-86.e6
ISSN
0016-5085 (ISSN-L)
DOI
10.1053/j.gastro.2017.03.049
OpenAlex
W2604523348
Cited by
279
References
26
Citations by year
2026: 9 · 2025: 10 · 2024: 25 · 2023: 36 · 2022: 35 · 2021: 34 · 2020: 35 · 2019: 50 · 2018: 40 · 2017: 5
FWCI
23.63
Type
journal article
Language
en
Open access
Licence
Locations
  • Gastroenterology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
  • INFM-OAR (INFN Catania) (submittedVersion, cc-by-nc-nd)
  • Zenodo (CERN European Organization for Nuclear Research) (public-domain)
Topics
  • Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
  • Life Sciences › Immunology and Microbiology › Immunology › Psoriasis: Treatment and Pathogenesis
  • Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
Keywords
interleukin-23 inhibition, Crohn's disease, monoclonal antibodies, clinical response, clinical remission, CD activity index, IL-22, treatment safety, biologic therapy
MeSH terms
Interleukin-22, Adult, Antibodies, Monoclonal, Crohn Disease, Double-Blind Method, Female, Headache, Humans, Interleukins, Male, Middle Aged, Nasopharyngitis, Severity of Illness Index, Treatment Outcome, Retreatment, Interleukin-23, Young Adult, Antibodies, Monoclonal, Humanized

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