The P-IV study (EARNEST) evaluating vedolizumab vs PBO in patients who had undergone a proctocolectomy & IPAA, had developed active chronic pouchitis & had an inadequate response with or lost response to antibiotics therapy
The trial met its primary efficacy EPs of clinical & endoscopic remission as measured by mPDAI @14wk. in 31% vs 10%. This improved outcome was also seen at the equivalent 2EPs at 34wk., 35% vs 18% achieved mPDAI remission
Improved clinical response at 14 & 34wk., serious AEs (6% vs 8%) with no new safety signals & the therapy was more effective than PBO for inducing remission in chronic pouchitis after IPAA for patients with UC. Vedolizumab has been granted marketing authorization in ~70 countries, incl. the US & EU
Ref: Businesswire | Image: Takeda
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