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Cortiment for UC Launches in Europe
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Cortiment, an oral controlled release budesonide treatment for active mild-to-moderate ulcerative colitis patients who failed mesalazine treatment, has launched in Europe, the manufacturer announced.
The announcement coincided with the presentation of data from the CONTRIBUTE trial at the 10th Congress of ECCO in Barcelona, which demonstrated that 9 mg Cortiment (budesonide, Ferring) was superior to placebo at inducing clinical and endoscopic remission in ulcerative colitis patients with a flare up despite oral mesalazine (5-aminosalicylic acid [5-ASA]).
David T. Rubin, MD, from the University of Chicago Medicine and member of the Healio Gastroenterology Peer Perspective Board, and colleagues performed a prospective, randomized, double-blind, placebo-controlled trial with an intent-to-treat population of 230 patients who received 9 mg budesonide and 228 who received placebo (46% women; mean age, 44.5 years) daily for 8 weeks in addition to at least 2.4 g/day ongoing 5-ASA therapy.
David T. Rubin
Combined clinical and endoscopic remission at week 8 was achieved in 13% of the budesonide group compared with 7.5% of the placebo group (P = .0488). Mucosal appearance subscore accounted for the majority of the treatment effect with 20% of the budesonide group vs. 12.3% of the placebo group achieving a zero score indicating endoscopic remission (P = .0248). Furthermore, 27% of the budesonide group achieved histological healing compared with 17.5% of the placebo group (P = .0155). Adverse events were reported in 31.8% of the budesonide group compared with 27.1% of the placebo group, most of which were mild or moderate, and 4.7% of the budesonide group vs. 3.5% of the placebo group discontinued the study due to an adverse event.
“The data confirm the efficacy and safety of Cortiment in patients experiencing an active flare of [ulcerative colitis] despite initial oral 5-ASA therapy, and in a controlled setting that is consistent with clinical practice and the ECCO treatment guidelines,” Rubin said in a press release. “Cortiment is an important new option for treating active mild-to-moderate ulcerative colitis.” – by Adam Leitenberger
Reference:
Rubin DT, et al. Abstract OP011. Presented at: 10th Congress of ECCO, Feb. 18-21, 2015; Barcelona, Spain.
Disclosure: Rubin reports grants and personal fees from Abbvie, Genentech, Janssen, Pfizer, Shire, Takeda and UCB, personal fees from Ironwood, grants from Salix and other support from the American College of Gastroenterology and Cornerstones Health during the conduct of the study. Please see the ECCO website for all other researchers’ relevant financial disclosures.