THU0307 RESPONSE OF BEHÇET’S REFRACTORY ORAL AND/OR GENITAL ULCERS TO APREMILAST IN COMBINATION VS MONOTHERAPY. NATIONAL MULTICENTER STUDY OF 51 CASES OF CLINICAL PRACTICE
Authors: A. Herrero Morant, B. Atienza Mateo, J. Loricera, V. Calvo del Rio, J. L. Martín-Varillas, J. Graña, G. Espinosa, C. Moriano, T. Pérez Sandoval, M. Martín Martínez, E. Diez, M. D. García-Armario, E. Martínez, I. Castellví, P. Moya Alvarado, F. Sivera, J. Calvo, I. De la Morena, F. Ortiz Sanjuán, J. A. Román Ivorra, A. Pérez Gómez, S. Heredia, A. Olive, Á. Prior, C. Díez, J. J. Alegre-Sancho, D. Ybáñez-García, Á. Martínez-Ferrer, J. Narváez, I. Figueras, A. I. Turrión, S. Romero-Yuste, P. Trénor, S. Ojeda, M. Á. González-Gay, R. Blanco
Journal: Annals of the Rheumatic Diseases (2020)

Background: Apremilast (APR) has demonstrated efficacy in the treatment of oral and/or genital aphthous ulcers in Behçet´s disease (BD). Combination of APR to other disease-modifying anti-rheumatic drugs (DMARDs) has not been assessed. Objectives: To compare the efficacy and safety of APR in monotherapy or combined with DMARDs in refractory BD. Methods: National multicenter open-label study on 51 BD patients with oral and/or genital ulcers refractory to conventional treatment. Results: We included 51 patients (35 women/16 men), mean age 44.7±13.2 years. Before APR, all patients had received several systemic conventional drugs. The main clinical symptoms for starting APR were oral (n=19) and genital (2) aphthous ulcers or both (30). Excluding corticosteroids, colchicine or NSAIDs, APR was given at standard dose of 30 mg twice daily in monotherapy (n=31), or combined with conventional DMARDs in 16 cases (6 azathioprine, 5 methotrexate, 4 hydroxychloroquine, 4 sulfasalazine, 1 dapsone) or with biologic DMARDs in 4 (2 tocilizumab, 1 adalimumab, 1 infliximab). There were not found statistically significant differences in demographic features, previous therapy, clinical manifestations or reported adverse effects. After a median follow-up of 6 [3-12] months, most of the patients experienced improvement of the orogenital ulcers in both groups (89.8% in the first 2 weeks), without statistically significant differences. (TABLE ) Conclusion: APR leads to a rapid and maintained improvement in most patients with refractory BD orogenital ulcers. APR seems as effective and safe in monotherapy as combined. TABLE: Week 1-2 Week 4 Month 6 Month 12 Month 24 Outcome of oral and/or genital ulcers n, (% ) C n=19 M n=30 C n=19 M n=26 C n=12 M n=17 C n=7 M n=6 C n=1 M n=1 Complete resolution 8 (42.1) 11 (36.7) 12 (63.2) 20 (77) 7 (58.4) 14 (82.4) 3 (42.8) 3 (50) 1 (100) 1 (100) Partial resolution 9 (47.4) 16 (53.4) 7 (36.8) 3 (11.5) 5 (41.6) 2 (11.7) 4 (57.2) 3 (50) 0 0 No response 2 (10.5) 3 (9.9) 0 3 (11.5) 0 1 (5.9) 0 0 0 0 p value 0.9 0.1 0.1 0.8 0.7 Abbreviations : C= combined; M= monotherapy; n= available data. Disclosure of Interests: Alba Herrero Morant: None declared, Belen Atienza Mateo: None declared, J. Loricera: None declared, Vanesa Calvo del Rio Grant/research support from: MSD and Roche, Speakers bureau: Abbott, Lilly, Celgene, Grünenthal, UCB Pharma, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Jenaro Graña: None declared, Gerard Espinosa: None declared, Clara Moriano: None declared, Trinidad Pérez Sandoval: None declared, Manuel Martín Martínez: None declared, Elvira Diez: None declared, María Dolores García-Armario: None declared, Esperanza Martínez: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Patricia Moya Alvarado: None declared, Francisca Sivera: None declared, Jaime Calvo Grant/research support from: Lilly, UCB, Consultant of: Abbvie, Jansen, Celgene, Isabel de la Morena: None declared, 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: None declared, Carolina Díez: None declared, Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis, D Ybáñez-García Speakers bureau: Lilly, Roche, Sanofi, Ángels Martínez-Ferrer: None declared, J. Narváez: None declared, Ignasi Figueras: None declared, Ana Isabel Turrión: None declared, Susana Romero-Yuste: None declared, Pilar Trénor: None declared, Soledad Ojeda Speakers bureau: AMGEN, LILLY, GEBRO, Miguel Á. González-Gay Grant/research support from: AbbVie, MSD and Roche, Speakers bureau: AbbVie, MSD and Roche, Ricardo Blanco Grant/research support from: Abbvie, MSD and Roche, Consultant of: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD