THU0181 Efficacy and Safety of Concomitant Methotrexate and Leflunomide Use for The Treatment of Rheumatoid Arthritis. Cross -Sectional Study
Authors: H. Sánchez Pérez, M. García González, L. Expόsito Pérez, E. Trujillo, E. Delgado Frías, J. Bethencourt Baute, S. Bustabad
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Treatment of RA is based on the use of DMARDs, both synthetic and biological,and the mayor goal is to achieve clinical remission. Several Scientific Societies (EULAR, ACR, SER) recommend that all patients with RA should be treated with DMARDs as soon as the clinical diagnosis is established. Methotrexate (MTH) is the first line treatment. In case of unsatisfactory response (development of toxicity or failure), it is recommended to use Leflunomide (LEF), Sulfasalazine or an anti-TNF agent as a second line treatment, in monotherapy or associated with MTH <h3>Objectives</h3> To describe the current situation, baseline characteristics and reasons for discontinuing or changing treatment of RA patients seen during 1 year in our department,that were or had been treated with concomitant MTH-LEF therapy <h3>Methods</h3> Observational cross-sectional study. Clinical records of RA patients, attended in our Rheumatology Department during 2014 who were or had been treated with MTH-LEF, were reviewed. Demographic (age and sex), clinical (years of disease progression, RF/ACPA, ESR/CRP, NTJ/NSJ, DAS28) and treatment variables (duration in months, other treatments, reasons for discontinuing or changing)were analyzed <h3>Results</h3> 483 patients were analyzed, 104 were finally included. Mean age was 55.18 years (±11,82), 88.6% were women. 39.4% were currently receiving MTH-LEF therapy, with a mean disease course in years of 6.15 (±5.03) and a mean duration of treatment in months of 22,84 (±17.45).53.7% took corticosteroids and 12.2% NSAIDs on a daily basis. RF/ACPA was positive in 85.4%/51.2%; mean NTJ/NSJ was 0.41 (±1.16)/0.32 (±069); the mean value of ESR/CRP was 32.13 (±17.99)/6.92 (±10.61). According to DAS28 score, 14.6% of patient were in remission, 70.7% at low disease activity, 12.2% at moderate disease activity and 2.4% at high disease activity. <i>Patients no longer with MTH-LEF therapy</i> had similar baseline characteristics except for ACPA positive in a higher % (77.97% vs. 51.2%,p=0.05). No differences in drug dosing were found, being the higher doses the most used ones (MTH&gt;15 mg/week, LEF 20 mg/day). The main reason for combined therapy discontinuation was inefficacy (54%), followed by adverse effects in 35% (gastrointestinal intolerance 36.36%, nonspecific skin disorders 18.18% and hematological disorders, cough, headache and others) and low clinical activity (11%). No significant differences between patients according to the reason for discontinuation of treatment were observed. Higher drug dose use was not found in patients who experienced adverse effects (as it would have been expected). A longer disease course was found in patients presenting inefficiency as so a higher positive % of RF/ACPA <h3>Conclusions</h3> The 39.4% of patients responded to the MTH-LEF therapy, avoiding the use of biological agents. It appears to be a valid alternative for our patients, since 85.3% of them had low clinical activity. However, it had to be discontinued in up to 60.6% of patients, noting in this group a higher % of ACPA+ patients. The main causes for treatment discontinuation were ineffacy and gastrointestinal intolerance. No significant differences were seen regarding the therapy discontinuation cause, although it seems to be more common in RF/ACPA positive patients and we observed a longer disease course if inneficacy happened. No differences in drug dosing were found. <h3>Disclosure of Interest</h3> None declared