SHP647 - an IgG2κ anti-MAdCAM human monoclonal antibody – is in development for induction and maintenance of remission in patients with CD and UC. OPERA II, a 72-week, multicentre, open-label, phase-2 extension study, successfully added evidence for the long-term safety and efficacy of SHP647 in patients with moderate-to-severe CD.
D’Haens et al. included 268 patients from OPERA I and the open-label study TOSCA. Patients had completed 12 weeks of treatment (placebo or 22.5, 75, or 225 mg SHP647, SC) in OPERA I, or had a clinical response (≥3-point decrease in Harvey-Bradshaw Index (HBI) score) on 225 mg SHP647 in TOSCA. Patients received SHP647 (75 mg, SC) every four weeks from baseline to week 72, and were followed up monthly for six months. Dose de-escalation to 22.5 mg, owing to intolerance/AEs, or escalation to 225 mg, owing to clinical deterioration/poor response, were subject to investigator evaluation.
Primary endpoints were frequency of AE...
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