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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
Open accessAbstract
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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Metadata
- 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)
- 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
- hybrid
- doi.org
- 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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