OP08 Long-term efficacy and pharmacodynamics of the anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) monoclonal antibody SHP647 in Crohn’s disease: the OPERA II study

New targets in inflammatory bowel disease therapy: 2021

“…In CD, the phase 2 OPERA study did not reach statistical significance in terms of clinical endpoints (19). The OPERA II study, an open label extension study showed that remission rates were sustained over a period of 72 weeks and the drug was generally well tolerated (20,21). There are currently five phase 3 studies underway to investigate the use of ontamalimab in both UC and CD.…”

The role of integrins in the pathogenesis of inflammatory bowel disease: Approved and investigational anti‐integrin therapies

“…In the phase 1 safety study, TOSCA, in patients with active CD, 12 weeks of SHP647/ontamalimab induction therapy did not result in a reduction in CSF lymphocytes or T‐cell subsets or CD4:CD8 ratio . The data from extension studies for UC (TURNADOT II) and CD (OPERA and TOSCA) demonstrated that efficacy achieved with SHP647/ontamalimab induction were maintained for up to 144 weeks and 72 weeks, respectively . Although SHP647/ontamalimab demonstrated a favorable safety profile in both UC and CD, its efficacy was less robust for CD, highlighting the complexity of the mechanisms underlying IBD as well as the therapeutic challenges.…”