APREMILAST FOR TREATMENT OF ORAL APHTOSIS: REAL-WORD DATA MULTICENTER STUDY

N. De la Torre Rubio, N. Franco Domingo, I. Pérez - Sancristóbal, M. Pavía Pascual, L. F. Montaño Tapia, M. Machattou, P. Navarro Palomo, M. Alonso de Francisco, C. Navarro Joven, C. Merino Argumánez, M. Fernandez Castro, H. Godoy, C. Barbadillo Mateos, B. Garcia-Magallon, L. F. De Villa, C. Isasi Zaragoza, J. Sanz, J. L. Andreu Sánchez, J. CamposHospital Universitario Puerta de Hierro Majadahonda, Rheumatology, Majadahonda, Spain Hospital Universitario 12 de Octubre, Rheumatology, Madrid, Spain Hospital Universitario Clínico San Carlos, Rheumatology, Madrid, Spain Hospital Universitario Príncipe de Asturias, Rheumatology, Alcalá de Henares, Spain  Background The main manifestation of Behçet’s disease is oral aphthae. Treatment consists of topical corticosteroids and colchicine in recurrent cases. Drugs such as azathioprine, thalidomide, interferon-alpha, tumour necrosis factor-alpha inhibitors or apremilast should be considered in selected cases. A phase 3, double-blind, placebo-controlled RELIEF study suggests that apremilast is an effective agent for the management of oral aphtae in Behçet’s disease and benefits were sustained up to 64 weeks. Its onset of action occurred within 2 weeks after treatment was started. Adverse events, including nausea, vomiting, and diarrhea, occurred more frequently with apremilast than with placebo. It has also been shown to be effective in the treatment of psoriasis. Objectives To assess the effectiveness of apremilast in the treatment of oral aphtosis. Methods Retrospective descriptive multicentre study of patients treated with apremilast for oral aphtosis associated with Behçet’s disease, as well as patients with oral aphtosis who have received apremilast for another indication (psoriasis) or off-label use. Four hospitals participated in the study. The following variables were collected: age, sex, diagnosis, oral aphtosis at the time of starting apremilast, aphtosis response at 3 and 6 months (partial improvement, total improvement, lack of response, discontinuation due to side effects), ESR, CRP, ferritin, 25-OH-Vitamin D, folic acid, cyanocobalamin and concomitant treatment (none, corticosteroids, methotrexate, colchicine or anti-TNF). Descriptive statistics were performed using mean and standard deviation (SD) for continuous quantitative variables. Results A total of 15 patients were being treated with apremilast for oral aphtosis. Ten of them were diagnosed with Behçet’s disease, one with psoriasis with oral aphtosis and four with recurrent oral aphtosis. Mean age was 47.1 ± 12.4 years, 67 % were female. All patients had active oral aphtosis at the time of starting apremilast. After 3 months of treatment, 87 % of the patients had improvement of the aphtosis (61.5 % partially and 38.5 % completely resolved); 13 % of the patients had to discontinue treatment due to side effects (diarrhea), none had to discontinue treatment due to lack of response. After 6 months, all the patients maintained improvement and only two of them discontinued apremilast after 12 months due to lack of response. Results of serological data analyzed were (mean ± SD): ESR 11.4 ± 6.7, CRP 3.7 ± 6.5, ferritin 100.8 ± 167.3, 25-OH-Vitamin D 31.4 ± 18.9, folic acid 11.7 ± 9.8, cyanocobalamin 585.8 ± 527. One patient maintained concomitant treatment with an anti-TNF drug, two with corticoids and five with colchicine. Conclusion Treatment with apremilast seems to improve oral aphthae in over 87% of patients. References Hatemi G, Christensen R, Bang D, Bodaghi B, Celik AF, Fortune F, et al. 2018 update of the EULAR recommendations for the management of Behçet’s syndrome. Ann Rheum Dis 2018 -06;77(6):808-818. Hatemi G, Mahr A, Takeno M, Kim DY, Saadoun D, Direskeneli H, Melikoğlu M, Cheng S, McCue S, Paris M, Chen M, Yazici Y. Apremilast for oral ulcers associated with active Behçet’s syndrome over 68 weeks: long-term results from a phase 3 randomised clinical trial. Clin Exp Rheumatol. 2021 Sep-Oct;39 Suppl 132(5):80-87. doi: 10.55563/clinexprheumatol/ra8ize. Epub 2021 Oct 6. PMID: 34622764. Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, et al. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol 2022 -01;86(1):77-85. Image/graph:Graph 1. Treatment response of oral aphtae after 12 months Acknowledgements: NIL. Disclosure of Interests None Declared. Keywords: Real-world evidence, Rare/orphan diseases DOI: 10.1136/annrheumdis-2023-eular.3977Citation: , volume 82, supplement 1, year 2023, page 1990Session: Other orphan diseases (Publication only)