AB1066 EFFICACY AND SAFETY OF APREMILAST IN BEHÇET DISEASE PATIENTS
Authors: E. Vicens Bernabeu, E. Grau García, C. Alcañiz Escandell, F. M. Ortiz Sanjuan, R. Gonzalez Mazario, M. De la Rubia Navarro, C. Pávez Perales, S. Leal Rodriguez, J. Ivorra Cortés, L. Gonzalez Puig, I. Chalmeta Verdejo, R. Negueroles Albuixech, I. Martínez Cordellat, J. J. Fragio-Gil, J. E. Oller Rodríguez, C. Nájera Herranz, I. Cánovas Olmos, J. A. Román Ivorra
Journal: Annals of the Rheumatic Diseases (2020)

Background: Apremilast (APR), a small molecule inhibitor of phosphodiestersa-4, has been shown to be effective in the treatment of oral and genital ulcers in Behçet’s disease (BD). BD is a systemic vasculitis with great heterogeneity of symptoms and manifestations. It can affect the blood vessels, mucosa, skin, joints, eyes, nervous system and digestive system. APR is indicated for treatment of oral ulcers in BD in some countries such as the USA and Japan. Objectives: To evaluate the efficacy and safety of APR treatment in BD patients. Methods: Single-center descriptive study of BD patients on APR treatment from February 2017 to December 2019. Demographic, clinical and analytical data were collected. Results: 10 patients (9 women) were included, with a mean age at the beginning of APR treatment of 37±12 years and a mean disease evolution of 100±105 months. 8 of them showed HLAB51 positivity. Before treatment with APR, 4 patients were refractory to DMARDs (2 MTX, 2 AZA) and one patient to 2 anti-TNF (ADA, IFX). All patients were under treatment with colchicine and 5 with steroids before APR therapy. The concomitant treatment with APR were: corticosteroids (5), NSAIDs (2), colchicine (8), MTX (2), AZA (2). The main symptoms at the beginning of the APR treatment were: oral ulcers (100%), genital ulcers (60%) and arthritis/arthralgia (90%). We observed a clinical improvement after 3 months of treatment of 90% of oral ulcers, 100% of genitals and 55% of joint symptoms. The patients had a mean follow-up of 37±12 months and they maintain the therapy response during the APR treatment. Patients presented adverse events, some of them transitory: headache (5), diarrhea (5), nausea (3), dysthymia (1), tremors (2), herpes zoster (1) and autolytic ideation (1). The treatment was withdrawn in 4 patients with a mean duration of 11 ± 13 months. 2 of the 4 adverse events were by autolytic ideation and nausea, 1 for genesic desire and 1 for persistence of joint injury. The APR doses were reduced to 30 mg per day in 4 patients, resolving the adverse events and persisting with a good response. In addition, dose reduction of colchicine and prednisone was achieved in 4 patients. We observed other previous manifestations of BD such as uveitis (4), neurobehçet (3), cutaneous (folliculitis/pseudofoliculits) (4) and venous thrombosis (1). Cutaneous manifestations were resolved and the rest of previous manifestations remain without clinical changes during the follow-up. Conclusion: We observed an improvement in the most common manifestations of BD and a safety profile similar to those described in other studies. We observed a resolution of mucocutaneous manifestations, a variable response in joint manifestations and stability in neurological manifestations. Adverse effects referred included gastrointestinal and headache, most of which were transient and were resolved with adjustment of treatment. Disclosure of Interests: None declared