LAS VEGAS — Older patients diagnosed with ulcerative colitis appear have a safety and tolerability profile similar to that of younger counterparts when treated with extended-release budesonide tablets (Uceris), a post hoc analysis of a randomized clinical trial reveals, researchers reported here.
In the study presented at the Crohn’s & Colitis Congress, the team stratified patients by those age 60 or younger and older than 60 and found that ulcerative colitis exacerbations occurred in 15.8% of the younger group receiving a 6 mg daily dose of budesonide, compared with 21.9% of the older patients; among patients taking the higher daily dose of 9 mg, 13.6% of the younger patients had exacerbations, compared with 5.6% of the older patients; and the exacerbation rates for patients taking placebo were 13.8% and 14.7% for the younger and older groups, respectively.
“That basically shows there is no major difference by age group,” said Gary Lichtenstein, MD, director of the Inflammatory Bowel Disease Center at the University of Pennsylvania in Philadelphia, who reported the results in a poster presentation. “What we showed with this analysis is that with this drug, one-size does fit all.”
The pattern was similar for the other major adverse events — headache and nausea — although the outcomes could have been influenced because there were few patients older than 60 in two studies of extended-release budesonide, he noted. A total of 254 patients were assigned to receive the 6 mg dose, 255 were assigned to the 9 mg dose, and 258 were assigned to receive placebo. Of the patients over 60, a total of 32 were assigned to 6 mg budesonide; 18, to 9 mg budesonide; and 34, to placebo.
“We also found no differences in safety concerns when we looked at gender,” Lichtenstein told MedPage Today. Of the 130 men assigned to 6 mg budesonide, 55% had any type of adverse event, and of the 124 women who received the same dose of the drug, 66% had an adverse event. Of the 150 men assigned to receive the 9 mg dose of extended-release budesonide, 55% experienced an adverse event, compared with 58% of of the 105 women assigned to the higher dose. Of the 150 men assigned to placebo, 50% had an adverse event, compared with 58% of the 108 women assigned to placebo in the pooled studies.
The main study determined that 9 mg of extended-release budesonide was effective in inducing remission and promoting mucosal healing among patients with ulcerative colitis. Lichtenstein explained that he and his colleagues conducted the post hoc analysis to try to answer the question of whether the drug maintained its effectiveness as patients age or if there are safety issues in older populations.
The researchers pooled data from two phase III, randomized, double-blind, placebo-controlled studies. Adults diagnosed with mild to moderate ulcerative colitis symptoms for at least 6 months — defined as a score of 4 to 10 on the Ulcerative Colitis Disease Activity Index — received extended-release budesonide at 6 mg, extended-release budesonide at 9 mg, or placebo once daily for up to 8 weeks.
Overall the average age of the patients in the study was about 43, and a little more than 50% of the patients across the studies were men; approximately 70% of the patients where white, 18% Asian, 9% black, and 3% were Hispanic.
Asked for his perspective, Francis Farraye, MD, co-director of the Center for Digestive Disorders at Boston University School of Medicine, who was not involved with the study, told MedPage Today: “Gastroenterologists are hesitant to use steroids in older patients because of the risk of infectious and other complications. This analysis by Dr. Lichtenstein was reassuring in that budesonide use in patients above the age of 60 did not result in an increased rate of complications when contrasted to younger age groups. I would be comfortable using this agent in the appropriate patient for induction of remission in mild-to-moderate ulcerative colitis.”
The study was sponsored by Salix.
Lichtenstein reported financial relationships with Salix, as well as numerous relationships with other pharmaceutical companies either directly or through his institution.
Farraye reported having no relevant relationships with industry.