Clinical Efficacy and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis: CLEAR Interim Results

Abstract

Background: Worldwide, leflunomide is a commonly used Disease-Modifying Anti-Rheumatic Drugs (DMARDs). It can be used as a monotherapy or in combination with other DMARDs to inhibit the production of inflammatory cells and accordingly reduce inflammation. Objectives: CLEAR is a multi-centric study that aims to assess the clinical efficacy and safety of leflunomide as first-line and/or add-on therapy to other DMARDs with or without steroids in Egyptian patients with active Rheumatoid Arthritis (RA). Methods: Egyptian patients with active RA for whom leflunomide was prescribed at physicians’ discretion were observed for 12 weeks. Clinical Disease Activity Index (CDAI) score, and Health Assessment Questionnaire Disability Index (HAQ-DI) score were acquired thrice during this period. This study was registered on clinicaltrials.gov (NCT03599986). Results: Interim analysis of the data collected from 337 patients (in 21 centers) showed a statistically significant decrease in the mean total CDAI score throughout the first 12 weeks of treatment (p<0.001); as the mean ±SD score decreased from 36.60 ±14.90 at baseline to reach 16.16 ±9.84 at week 12 (% reduction: 61.16 ±14.36). A statistically significant decrease (p<0.001) was also observed in HAQ-DI, as the mean ±SD score decreased from 1.46 ±0.69 at baseline to reach 0.67 ±0.54 at week 12 (% reduction: 56.11 ±27.59). Conclusion: Results of the interim analysis suggest that treatment of Egyptian patients with active RA with leflunomide (as first-line and/or add-on therapy to other DMARDs with or without steroids) for 12 weeks may be effective in terms of CDAI score and HAQ-DI score reduction and may offer an alternative for patients who experienced resistance, inadequate response or intolerance to other DMARDs.