Objectives To study the clinical efficacy and safety for the treatment in patients with rheumatoid arthritis (RA) with Leflunomide.
Methods We included 15 patients with diagnostic of the RA according to American College of Rheumatology (ACR) criterias for at least 6 months and active disease by the following inclusion criteria: > 18 years old, > 6 tender and swollen joints, > 15 mg/dl C-reactive protein (CRP), > 28 mm/h erythrocyte sedimentation rate (ESR) and morning stiffness. We treated with Leflunomide loading dose 100 mg/day for 3 days, and after we continued with 20 mg/day. The clinical controls were the first and the end of a period of time, 26 weeks: general examination (weight, arterial pressure, morning stiffness), locomotor system (tender and swollen joint count score), acute- phase reactant (PCR, ESR) inmunology (ANA, anti-DNA, FR, C3, C4) hepatic serologies, simple radiography study (thorax, hands and feet). Evaluation of patients with a general pain, analogic visual (EVA) and the Stanford Healt Assessment Questionaire (HAQ). Non steroidal antiinflamatories drugs and steroids were allowed provided the subject had been receiving a continuous dose for at least 28 days prior to entry in the study. Intra-articular corticosteroid were not allowed.
Results The 15 patients 3 are men and 12 women, with a mean age of 68 years. After 3 months, the mean changes were -6.9 swollen joints, -10.4 tender joints, -44.8 for ESR, -26 for CRP. The most common adverse events with this treatment were three: one cutaneous allergic reaction (in this case was necessary stopping the treatment) and 2 diarrhoea. In one case the clinical was disappear after reducing in 10 mg/day, and the other it should interrupt the treatment.
Conclusion Leflunomide seems to be efficacious and safety for treatment in RA. Every way, must follow evaluation for a long time to recommend treatment like a first election.
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