Review Addresses the Role of Anti-TNFs in Intestinal Behçet Disease

Intestinal Behçet disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.
The Center for Biosimilars Staff
June 28, 2018
Intestinal Behçet's Disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.

A recently published review, appearing in Gut and Liver, explains the current knowledge base concerning anti-TNF agents in intestinal BD.

Infliximab, say the authors, was first shown to be effective in treating patients with intestinal BD who were steroid-dependent in 2001. Patients in that study had healing of their ulcers within 10 days and sustained remission for 12 months. Another study showed that infliximab plus methotrexate led to improvement in as little as 2 weeks. The first phase 3 trial in patients with intestinal BD resulted in rates of complete response of 55%, 55%, and 60% at weeks 14, 30, and 54, respectively, and a second phase 3 trial is ongoing.

Adalimumab has fewer data available in intestinal BD; the first prospective, open-label, single-arm, phase 3 multicenter trial of adalimumab found that complete remission was achieved by 20% of patients at weeks 24 and 52. At weeks 52 and 100, 60% and 40% of patients, respectively, showed a clinical response. Combination of adalimumab and disease-modifying anti-rheumatic drugs (DMARDs) did not appear to be superior to monotherapy. A prospective, multicenter study lasting 50 weeks has been completed but not yet reported, and a phase 3 trial is currently recruiting.

Etanercept has not been the subject of a phase 3 study in intestinal BD, and questions remain as to whether it could prove useful in intestinal BD given its inefficacy in treating IBD. Etanercept has also demonstrated the ability to produce paradoxical IBD in patients undergoing treatment for idiopathic juvenile arthritis.

Golimumab, too, has very few data available in treating intestinal BD. A single retrospective study that assessed the long-term efficacy and safety of golimumab in this indication found that 17 patients with BD—6 of whom had intestinal BD—who received golimumab for poorly controlled disease and treatment failure of at least 1 other biologic agent improved after a mean treatment time of 5 weeks. Combination therapy with DMARDs resulted in better outcomes than did monotherapy.

Certolizumab pegol is the only pegylated anti-TNF agent approved by the FDA. This therapy also has limited data concerning its use in intestinal BD, but a study in 13 patients with BD, 5 of whom had intestinal involvement, resulted in 7 patients exhibiting a satisfactory response.

Because many patients with intestinal BD fail to respond adequately to conventional therapies, say the authors, and because anti-TNF therapy has thus far demonstrated favorable outcomes in this patient population, use of anti-TNF agents should be further studied to clarify the rationale underlying the outcomes of the small studies described in the review.

Reference
Park J, Cheon JH. Anti–tumor necrosis factor therapy in intestinal Bechet’s Disease. [Published online May 24, 2018.] Gut Liver. doi: 10.5009/gnl17462.

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