P148 LACK OF INFLUENCE OF ELDERLY AGE AND GENDER ON THE SAFETY PROFILE OF BUDESONIDE EXTENDED-RELEASE TABLETS FOR ULCERATIVE COLITIS: A POOLED ANALYSIS OF TWO RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIALS. (18th January 2018) - Lichtenstein, Gary R
Abstract: Background: Budesonide extended-release tablets (multimatrix [MMX]) are indicated for induction of remission of mild to moderate ulcerative colitis (UC). Budesonide MMX is a second-generation corticosteroid with low systemic bioavailability related to extensive first-pass hepatic metabolism. Aims: A pooled analysis was conducted to further analyze the safety profile of budesonide MMX and educate physicians on this oral, topically acting corticosteroid. Methods: Data were pooled from two phase 3, randomized, double-blind, placebo-controlled studies. Adults with mild to moderate UC symptoms for ≥6 months (Ulcerative Colitis Disease Activity Index score ≥4 and ≤10) received budesonide MMX 6 mg, budesonide MMX 9 mg (recommended dose), or placebo once daily for up to 8 weeks. Safety was determined overall and by age and gender subgroups. Results: 767 patients (budesonide MMX 6 mg [n=254], 9 mg [n=255], and placebo [n=258]) were included in this analysis. The majority of patients were ≤60 y of age (89.0%), male (56.1%), and white (74.6%). Budesonide MMX was generally well tolerated overall and across age and gender subgroups (Tables 1 and 2). The most common adverse events (AEs) in the overall population for budesonide MMX 6 mg vs 9 mg vs placebo were UC (16.5% vs 13.3% vs 14.0%), headache (14.6% vs 11.4% vs 10.5%), and nausea (4.7% vs 5.1% vs 4.3%). Common AEs for budesonide MMX 6 mg vs 9 mg vs placebo in patients ≤60 y were UC (15.8% vs 13.9% vs 13.8%), headache (15.3% vs 11.8% vs 11.6%), and nausea (4.5% vs 5.1% vs 4.5%); in patients >60 y, UC (21.9% vs 5.6% vs 14.7%), headache (9.4% vs 5.6% vs 2.9%), and upper abdominal pain (6.3% vs 16.7% vs 0.0%). The incidence of AEs within treatment groups were generally similar between males and females (eg, 9-mg group male vs female: UC, 12.7% vs 14.3%; headache, 8.7% vs 15.2%; nausea, 4.0% vs 6.7%). Conclusion: Budesonide MMX was generally safe and well tolerated and was not influenced by age or gender.