The company presented the data at Digestive Disease Week 2016, May 21 to May 24 in San Diego.
The Phase 3 maintenance study evaluated 388 patients who achieved clinical response eight weeks after a single intravenous infusion of STELARA in the UNITI-1 and UNITI-2 Phase 3 induction studies.
Here are four insights:
1. The study showed that 53 percent of patients receiving a STELARA 90 mg SC injection every eight weeks and 49 percent of patients receiving a STELARA 90 mg SC injection every 12 weeks were in clinical remission at week 44. This was the study’s primary endpoint.
2. Comparatively, 36 percent of patients receiving placebo achieved the study’s primary end point.
3. Additionally, 47 percent of patients receiving STELARA 90 mg SC Q8W and 43 percent of patients receiving STELARA 90 mg SC Q12W, who were not receiving concomitant corticosteroids, were in clinical remission at week 44, compared with 30 percent of patients receiving placebo.
4. The use of STELARA for the treatment of moderate-to-severe Crohn’s disease is currently under review in the United States and Europe.
More articles on GI/endoscopy:
EndoChoice releases RescueNet retrieval device: 4 points
33 winners of AGA Research Foundation’s 2016 awards
Northwestern Medicine Digestive Health Foundation raises $1.2M: 3 notes
