AB0420 A PROSPECTIVE, OBSERVATIONAL STUDY ON THE CLINICAL EFFICACY AND SAFETY OF LEFLUNOMIDE IN EGYPTIAN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: CLEAR STUDY
Authors: Adel Elsayed
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Due to its anti-inflammatory and immunomodulatory properties, leflunomide can be used as a monotherapy or in combination with other conventional synthetic DMARDs (csDMARDs) in treating active RA.<sup>1</sup> <h3>Objectives:</h3> The aim of this observational study was to assess efficacy and safety of leflunomide in Egyptian patients with active RA, whether used as first-line and/or add-on therapy to other csDMARDs, with or without steroids. <h3>Methods:</h3> Adult Egyptian patients with active RA, fulfilling the ACR/EULAR 2010 classification criteria, for whom leflunomide was prescribed, were included and followed up for 9 months. Leflunomide was prescribed at the physicians' sole discretion for patients who have previously experienced resistance, inadequate response or intolerance to other csDMARDs. Data about CDAI score and HAQ-DI score were acquired from patients who fulfilled the eligibility criteria, along with patients' demographics, medical history, physical examination, concomitant medications, and RA history including disease duration, previous RA medications and treatment response. This study was registered on clinicaltrials.gov (NCT03599986) and the preliminary results were previously published in 2018.<sup>2</sup> <h3>Results:</h3> A total of 398 patients were enrolled in this study. Three hundred sixty-six patients with a mean age of 43.7 (SD 10.2) years and median disease duration of 2 (IQR 5.5) years were eligible for efficacy evaluation; 309 (84.4%) were female. We found that 86.1% of patients were leflunomide naïve. Patients who previously received leflunomide (13.9%) had a wash out period of at least 6 months prior to study enrolment. Patients were either prescribed leflunomide 20 mg/day (37.7%) or were prescribed a loading dose of 100 mg/day for the first 3 days of treatment then maintained with 20 mg/day (62.3%). Leflunomide was prescribed as first-line therapy in 21.1% of patients, as add-on therapy to other csDMARDs without steroids in 34%, and as add-on therapy to other csDMARDs with steroids in 44.9%. The mean total CDAI score was significantly decreased (p&lt;0.001) from 36.8 (14.9) at baseline, to reach 12.5 (10.3) after 9 months of treatment, with a reduction of 64%. In a similar pattern, the mean HAQ-DI score was significantly decreased (p&lt;0.001) from 1.5 (0.7) at baseline to reach 0.6 (0.6) after 9 months of treatment, with a reduction of 57%. Figures 1 and 2 show changes in both CDAI and HAQ-DI scores throughout the study. Twenty-three adverse events (AEs) were reported in 20 patients (5%) throughout the study period; most frequently, increased hepatic enzymes (6 cases, 1.5%), increased swollen/tender joint count (2 cases, 0.5%), decreased white blood cell count (2 cases, 0.5%), and abdominal discomfort (2 cases, 0.5%). None of the reported AEs were related to treatment with leflunomide. <h3>Conclusion:</h3> Results from this study demonstrate that leflunomide may offer an effective, tolerable and safe treatment –whether used as a monotherapy or in combination with other csDMARDs- in Egyptian patients with active RA. <h3>References</h3> [1] Alldred A, Emery P. Leflunomide: a novel DMARD for the treatment of rheumatoid arthritis. Expert opinion on pharmacotherapy. 2001;2(1):125-137. [2] El Sayed A, Clinical efficacy and safety of leflunomide in Egyptian patients with active rheumatoid arthritis: CLEAR interim results. The open rheumatology journal. 2018;12(1):323-331. <h3>Acknowledgement:</h3> Thanks to all Investigators: A Abd El Hamid, A Darwish, AE Hilal, A Elgerby, AF Abou Gamal, A Labib, AS Omar, D Abd El Mohsen, D Fayez, E Abda, F Elshabacy, M El Shehaly, M El Tayel, M El Wakd, M Mortada, N Mohannad, R Abd El Kader, S El Bakry, S Refaat, and S Zaki. Data management, statistical analysis, site monitoring activities, and editorial support were provided by DATACLin CRO and funded by EVAPHARMA. <h3>Disclosure of Interests:</h3> Adel Elsayed Grant/research support from: This study was funded by EVAPHARMA.