Takeda Published P-IV Study (EARNEST) Results of Vedolizumab for Chronic Pouchitis in NEJM
Shots:
- 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: takeda | Image: takeda
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
