Infliximab vs interferon-alpha in the treatment of Behcet's syndrome: clinical data from the BIO-BEHCET'S randomized controlled trial.

OBJECTIVES: Whilst biologic therapy is used for Behcet's syndrome of all subtypes refractory to first-line immunomodulation, there has been an absence of high-quality evidence and no predictive biomarkers to optimally inform choice. BIO-BEHCET'S was a randomized, controlled, head-to-head clinical trial comparing the two most frequently used biologics in active refractory Behcet's. METHODS: This was a Bayesian-designed, pragmatic, standard of care, two-arm, parallel head-to-head trial at four UK centres. Patients with active disease were randomized to infliximab or IFN-alpha2a, and received follow-up with symptom-directed examination at weeks 12 and 24. The primary outcome was the Behcet's Disease Activity Index (BDAI) at 12 weeks. Secondary outcomes included BDAI at 24 weeks and significant improvement in individual organ systems, including ocular symptoms, oral and genital ulcers, arthritis pain, quality of life, disease activity and steroid use. Biomarkers were also investigated but are reported elsewhere. RESULTS: Seventy-nine patients were recruited. Both treatments were equally effective, with a mean difference of 0.13 in BDAI (80% confidence interval: -0.19, 0.46). No significant differences were observed for secondary outcomes, though there were clinically significant within-group reductions for each over time. A modest steroid-sparing effect was observed, with complete cessation of steroids in 20% and 44% of those randomized to infliximab and IFN-alpha2a, respectively. There was a trend for minor benefit in favour of infliximab in terms of tolerability and persistence. CONCLUSION: In this first reported, high-quality, head-to-head trial of two biologics in Behcet's, both infliximab and IFN-alpha2a showed comparable short-term clinical efficacy and safety in refractory active disease of all subtypes. TRIAL REGISTRATION: EudraCT: 2014-005390-36; ISRCTN: ISRCTN49793874.