Background Leflunomide (LEF) is a new disease modifying agent for rheumatoid arthritis (RA). It was successful in treating relatively recent onset rheumatoid patients with a good safety record.1
Objectives Our aim was to assess the safety and efficacy of LEF in difficult to treat and chronic rheumatoid patients in a district general hospital.
Methods Patients with difficult to treat RA (n = 39) were commenced on LEF. Patients were followed every 4 for 6 months for side effect profiles and efficacy recordings. We documented all side effects of LEF, routine blood test results and blood pressure measurements. Pre-treatment and 6th month erythrocyte sedimentation rate (ESR) and haemoglobin (Hb) levels, patients’ and doctors’ global disease activity Visual Analogue Scores (VAS) were Statistically compared.
Results Mean age of patients was 48+14 and duration of disease was 13+10 years. Combination of methotrexate with LEF was the choice of treatment for 12 patients. Until now 25 patients completed 6 months evaluation and 9 out of 39 patients discontinued LEF due to side effects or infections. 6 further patients discontinued LEF after 6 months. Alopecia, diarrhoea and rash were the most common side effects (28%, 26% and 23% respectively). The most serious adverse effect was sensory neuropathy of the lower limbs in a young male patient. This occurred within 10 months of LEF treatment and showed some improvement 2 months after discontinuation. Another elderly male was admitted to hospital twice with severe abdominal pains and diverticulitis.
Patients felt better on LEF treatment and showed significant improvement in reduction of ESR (p < 0.02), increase of Hb (p < 0.02) and a reduction of VAS of patients’ (0.0001) and doctors’ (p < 0.0001) global disease activity over a 6 month period (Wilcox Rank Sum Test). Due to clinical improvement we were able to stop or reduce dosage of other concominant treatment.
Conclusion In conclusion LEF was reasonably well tolerated by difficult to treat rheumatoids even though side effects were more frequent than published studies (1). The clinical response was good considering the long disease duration and history of poor response to treatment in our group.
Emery P, Breedvekd FC, Lemmek EM, Kaltwasser JP, Dawes PT, et al. A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology 2000;39:655–65