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OPERA II study: MAdCAM-1 antibody SHP647

ECCO 2019
SHP647 is a fully human IgG2 anti-mucosal addressin cell adhesion molecule 1 (MAdCAM-1) antibody in development for the treatment of Crohn's disease. In the extension study of the placebo-controlled OPERA II trial, remission rates were sustained over 72 weeks with SHP647, regardless of initial response to induction treatment or dose-escalation status [1]. Patients enrolled in OPERA II completed either 12 weeks induction treatment (placebo or SHP647 22.5 mg, 75 mg, or 225 mg subcutaneous) in the OPERA trial regardless of response or had a clinical response to SHP647 225 mg in the TOSCA trial. In OPERA II, they received SHP647 (75 mg) every 4 weeks from week 0–72 and were followed up monthly for safety for a further 24 weeks. Dose reduction to 22.5 mg or escalation to 225 mg was allowed from week 8 as judged by the investigator. High-sensitivity C-reactive protein (hsCRP), faecal calprotectin (FC), and Harvey-Bradshaw Index (HBI) score were assessed as explo...

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