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Background  The effect of IL-1 blocking therapy on mucocutaneous manifestations of Behçet’s disease is incompletely understood.    Methods  Six patients with Behçet’s disease and ongoing oral/genital ulcers for ≥1 month were enrolled into an adaptive, two-phase clinical trial and included in the analysis. Study duration was 6 months with extension up to 16 months. All were treated non-blinded with anakinra 100 mg subcutaneous daily with the option to escalate the dose to 200 mg in partial responders after 1 month and 300 mg after 6 months. Patients recorded the number and severity of ulcers in daily diaries. The primary outcome was remission defined as no ulcers on physical exam for two consecutive monthly visits between months 3 and 6. Secondary outcomes included the number and severity of patient-reported ulcers, patient/physician global scores, and standardized disease activity scores.    Results  Two of six patients achieved the primary outcome. Five of six patients had improvement in the number and severity of ulcers. Non-statistically significant improvements were seen in secondary outcomes. Over the entire study, patients reported ≥1 oral and ≥1 genital ulcer on 665 (66%) and 139 (14%) days, respectively. On anakinra 200 mg vs 100 mg, patients reported fewer days with oral ulcers (65% vs 74% of days,  p  = 0.01) and genital ulcers (10% vs 22% of days,  p  < 0.001) and milder oral ulcer severity ( p  < 0.001). Increase of anakinra to 300 mg did not result in further improvements. Adverse events were notable for mild infections.    Conclusion  Anakinra at an optimal dose of 200 mg daily had an acceptable safety profile and was partially effective in the treatment of resistant oral and genital ulcers in Behçet’s disease.    Trial registration  Clinicaltrials.gov.  NCT01441076 . Registered on 24 September 2011.

Treatment of mucocutaneous manifestations in Behçet’s disease with anakinra: a pilot open-label study