Comparable clinical efficacy was achieved with Humira monotherapy and combination therapy with Humira and azathioprine in patients with Crohn’s disease who were naive to both medications, but significantly better endoscopic improvement was achieved with the combination therapy, according to results from the DIAMOND study presented at the European Crohn’s and Colitis Organization’s Congress.
To better characterize the efficacy and safety profile of Humira (adalimumab, AbbVie) and azathioprine combination therapy in Crohn’s disease, a research team from Japan performed a prospective, randomized, multicenter, open-label trial involving 177 patients with moderate to severe disease who had not been previously exposed to biologics or thiopurines. All patients received subcutaneous adalimumab at 160 mg at week 0, 80 mg at week 2 and 40 mg every other week thereafter for 52 weeks, whereas 91 patients were randomly assigned to have 25 mg to 100 mg daily azathioprine added to their regimen.
Clinical remission at 26 weeks served as the primary endpoint, and simple endoscopic severity score was determined by capsule endoscopy at weeks 26 and 52.
In the monotherapy and combination therapy groups, respectively, 21.2% vs. 7.7% of patients withdrew because of active disease and 2.4% vs. 16.5% of patients withdrew because of medication side effects.
Intention-to-treat analysis with nonresponder imputation showed week 26 remission rate was comparable between groups (71.8% with monotherapy vs. 68.1% with combination therapy), whereas week 26 endoscopic improvement rate was higher in the combination group (84.2% vs. 63.8%; P = .019).
“Pharmacokinetic analyses of adalimumab at 26 weeks showed trends toward higher trough levels of adalimumab ... (P = .084) and lower prevalence of antibody to adalimumab (4% vs. 13.2%; P = .078) in the combination group than in the monotherapy group,” the researchers wrote. – by Adam Leitenberger
Matsumoto T, et al. Abstract OP011. Presented at: ECCO Congress; March 16-19, 2016; Amsterdam.
Disclosure: Matsumoto reports receiving grants from Eizai Corp., and Tanabe-Mitsubishi Pharmaceutical, and personal fees from AbbVie. Please see the ECCO disclosures database for all other researchers’ relevant financial disclosures.