LAUSR

Background: Oral and/or genital aphthous ulcers are the most common symptoms of Behçet’s disease (BD), and are often refractory to conventional treatment. The inhibitor of phosphodiesterase-4 Apremilast (APR) has demonstrated efficacy in the treatment of this manifestations. Objectives: To assess the efficacy and safety of APR in BD patients with oral and/or genital ulcers refractory to conventional treatment. Methods: National multicenter open-label study on 49 BD patients treated with APR at maintained standard dose of 30 mg twice daily, with the initial 5-day titration schedule in 38 cases. The main outcome was achievement of oral and/or genital ulcers remission. Results: We included 49 patients (35 women/14 men), mean age of 44.5±13.4 years. Before APR, all patients had received several systemic conventional and/or biological drugs: oral corticosteroids (n=45), colchicine (n=48), NSAIDs (n=21), methotrexate (n=27), azathioprine (n=23), cyclosporine (n=9), dapsone (n=6), adalimumab (n=12), infliximab (n=8), tocilizumab (n=3), etanercept (n=3), sulfasalazine (n=2), cyclophosphamide (n=2) and/or others (pentoxifylline, thalidomide, mycophenolate mofetil, hydroxychloroquine, golimumab, 1 each). The main clinical symptoms for starting APR were oral (n=18) and genital (n=2) aphthous ulcers or both (n=29). After a mean follow-up of 8.3±6.8 months, most of the patients experienced main clinical improvement and prednisone dose was reduced or discontinued (TABLE). In this period of time, 31 patients developed any side-effect, most of them transitory: nausea (n=12), diarrhea (n=11), dyspepsia (n=9), abdominal pain (n=7), headache (n=5), loss of appetite (n=4), weight loss (n=3), halitosis (n=1), dry mouth (n=1), palpitations (n=1) and/or depression (n=1). Six patients had to reduce the dose to 30 mg/day. APR was discontinued in 11 patients due to: not obtaining the expected improvement (n=5), intense gastrointestinal adverse effects (n=3), desire of pregnancy (n=1), persistent erythema nodosum (n=1) and development of neurological involvement (n=1). Conclusion: Our data show a rapid and maintained improvement with APR in patients with mucocutaneous ulcers of BD refractory to several systemic drugs, including biologic therapy. References: [1] Davatchi F, et al. The International Criteria for Behçet’s Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatology Venereol. 2014;28(3):338–47. [2] Gulen Hatemi, et al. Apremilast for Behçet’s Syndrome — A Phase 2, Placebo-Controlled Study. N Engl J Med 2015; 372:1510-1518. Disclosure of Interests: Belén Atienza-Mateo: None declared, José Luis Martín-Varillas: None declared, J. Loricera: None declared, Vanesa Calvo-Río: None declared, Jenaro Graña: None declared, Gerard Espinosa: None declared, Clara Moriano: None declared, Trinidad Pérez-Sandoval: None declared, Manuel Martín-Martínez: None declared, Elvira Diez Alvarez: None declared, María Dolores García-Armario: None declared, Esperanza Martínez: None declared, Ivan Castellví Consultant for: I received fees less than 5000USD as a consultant for Kern and Actelion, Paid instructor for: I received fees less than 2000USD as a instructor for Boehringer -Ingelheim, Novartis and Gebro, Speakers bureau: ND, Patricia Moya: None declared, Francisca Sivera: None declared, Jaime Calvo Consultant for: Bristol-Myers Squibb, Janssen, Celgene, Sanofi Genzyme, Speakers bureau: Bristol-Myers Squibb, Isabel de la Morena Speakers bureau: Abbvie, Celgene, Pfzier, UCB, Ghebro, Roche, Sanofi, Janssen., Francisco Ortiz-Sanjuán: None declared, José Andrés Román-Ivorra: None declared, Ana Pérez Gómez: None declared, Sergi Heredia: None declared, Alejandro Olive: None declared, Águeda Prior-Español: None declared, Carolina Díez: None declared, Juanjo J Alegre-Sancho: None declared, D Ybáñez-García: None declared, Ángels Martínez-Ferrer: None declared, J. Narváez Consultant for: Bristol-Myers Squibb, Ignasi Figueras: None declared, Ana Isabel Turrión : None declared, Susana Romero-Yuste: None declared, Pilar Trénor: None declared, Soledad Ojeda Grant/research support from: AMGEN, Speakers bureau: AMGEN, Santos Castañeda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Monica Calderón-Goercke: None declared, D. Prieto-Peña: None declared, Iñigo González-Mazón: None declared, Lara Sánchez Bilbao: None declared, Miguel Á. González-Gay: None declared, Ricardo Blanco: None declared