Mucosal healing has emerged as an important therapeutic endpoint in the management of inflammatory bowel disease IBD, but few clinical trials have incorporated it as an outcome, and limited data exist to guide the selection of therapy based on comparative effectiveness in achieving this endpoint.
A recent review of FDA-approved drugs that treat IBD concludes that biologic treatments not only relieve IBD symptoms, they also maintain intestinal health. The study, published on March 22, 2017, in Alimentary Pharmacology & Therapeutics, aimed to examine the efficacy of each therapeutic class of FDA-approved IBD drugs in inducing and maintaining mucosal healing in moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC) by performing a meta-analysis of existing data on these therapeutic endpoints.
Researchers led by Aurada Cholapranee, MD, of the Department of Internal Medicine at Montefiore Medical Center, New York, analyzed the following medications: azathioprine (Imuran), methotrexate (Trexall), mercaptopurine (Purinethol), infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), natalizumab (Tysabri), and vedolizumab (ENTYVIO). These medications comprise drug classes of immunosuppressive agents, anti-tumor necrosis factor alpha (anti-TNF), and anti-integrin monoclonal antibody therapy.
The meta-analysis was conducted using 12 randomized, controlled trials that included studies of both induction and maintenance for UC and CD. The follow-up durations were 6 to 12 weeks for induction and 32 to 54 weeks for maintenance trials.
The researchers concluded that, in general, the biologic treatments Remicade and Humira, both of which target TNF-alpha, were much more effective at maintaining mucosal healing in CD compared with placebo controls (28% versus 1%, respectively). With respect to UC, medicines targeting both TNFs and integrins (proteins involved in cellular adhesion and stability) were more effective than placebo controls in inducing (45% versus 30%) and maintaining (33% versus 18%) mucosal healing.
The investigators found that in UC, Humira was inferior to Remicade for the induction of mucosal healing; both medications were similar for CD. “We demonstrated that both anti-TNF and anti-integrin biological agents are effective for inducing and maintaining mucosal healing in UC, and anti-TNF therapies in CD,” the authors concluded. But between-drug differences in efficacy do exist within each therapeutic class, they noted, particularly for induction of mucosal healing in UC, with Remicade or combination therapy being the preferred strategy.
The researchers noted that there is an important and urgent need for data demonstrating efficacy of all approved agents in achieving mucosal healing to truly inform comparative effectiveness and patient care to achieve better outcomes.