Combination biologic therapy may be an attractive therapeutic option for treating inflammatory bowel disease (IBD), however, data on the safety and efficacy of this approach is limited. A new review published in the journal Clinical Gastroenterology and Hepatology evaluates the data surrounding the use of combined biologic therapy with regard to IBD, as well as other immune-mediated inflammatory disorders (ie, psoriasis).
Researchers from Mount Sinai, NY, and the University of Birmingham (UK) conducted a literature search specific to IBD which revealed 1 placebo-controlled trial (Sands, 2017), 2 case reports (Hirten, 2015; Bethge, 2017), and 1 case series (Yzet, 2016) describing the use of combination biologic therapy in these patients.
The placebo-controlled trial involved patients with active Crohn’s disease (CD) who were taking infliximab, an anti-tumor necrosis factor alpha (anti-TNF) agent. These patients were randomized to receive either natalizumab (a humanized IgG4 monoclonal antibody) or placebo every 4 weeks for an 8-week period. The results showed no difference in adverse events between the two groups. Similarly, no adverse events were noted in the 2 case reports and the case series in which other biologics (ie, vedolizumab, ustekinumab) were combined with anti-TNF agents. In one of the cases, infliximab and vedolizumab were used at the same time in a patient with active CD, resulting in symptomatic improvement.
The authors point out how, unlike other autoinflammatory conditions, “IBD has the benefit of effective and safe gut specific anti-integrin therapies which can provide a platform off of which combinations can be employed.” Although the few studies that have been conducted to assess combination therapy in IBD have shown no adverse events, “further information from larger trials is needed to document efficacy and confirm safety before the routine combination of biologic agents with anti-integrin therapy can be employed,” write the authors.
The authors acknowledge the Phase 4 EXPLORER trial, an open label study involving 60 moderate-to-severe CD patients. They conclude that this study, which will be assessing the use of vedolizumab in combination with adalimumab and methotraxate, and others like it, may provide the data needed to consider combination therapy more broadly.
For more information visit CGHjournal.org.