Takeda Korea said Monday that it has confirmed the efficacy and safety profile of Kynteles (ingredient: vedolizumab) in Asian adults with moderate to severely active ulcerative colitis.

The VARSITY study showed that Kynteles has superior efficacy and safety profile compared to adalimumab, meeting the primary and second endpoints in the study.

VARSITY is the first clinical study to compare the biologics in inflammatory bowel disease head-to-head in adult patients with ulcerative colitis. Researchers analyzed the results of the 769 moderate-to-severe adult ulcerative colitis patients treated with Kynteles and adalimumab from July 2015 to January 2019 at 245 institutions in 34 countries.

In the post-hoc analysis of the clinical trial of 45 moderate-to-severe patients at 21 institutions from Korea, Hong Kong, and Taiwan, Kynteles showed modified clinical, corticosteroid-free, and endoscopic remission compared to adalimumab, the company said.

About 28.6 percent of participants who received Kynteles sustained clinical remission, the study's primary endpoint, while 16.7 percent of those treated with adalimumab achieved clinical remission.

The study also met the secondary endpoint, as 42.9 percent of patients showed improvement in endoscopy, and 33.3 percent displayed corticosteroid-free remission in the Kynteles group.

Patients who joined the study showed fewer overall adverse events when treated with Kynteles, and they also rated higher scores in the Inflammatory Bowel Disease Questionnaire.

"VARSITY trial was the first study to directly compare the efficacy and safety of the biologics in adults with moderate-to-severe ulcerative colitis, and we are glad to have the opportunity to check the profiles once again through the study," Takeda Korea Therapeutic Area Lead Kim Il-su said.

Professor Kim Joo-sung of the Department of Gastroenterology at Seoul National University Hospital participated in the study as the lead author. The post-hoc analysis was presented at the online meetings of the European Crohn's and Colitis Organization (ECCO) held from July 2-3 and July 8-10.