Leflunomide/chloroquin combination therapy in rheumatoid arthritis: a pilot study.

The objective of this study was to assess the efficacy and tolerability of a combination of leflunomide (LEF) and chloroquin (ChL) in patients with rheumatoid arthritis (RA). Fifteen female RA patients (46-80 years, mean disease duration 100.7 months, ten patients RF+) were enrolled into this open trial. Patients were either treatment failures or partial responders to LEF (n=6) or ChL (n=9). At week 8 and 16, DAS28 and morning stiffness (MST) were evaluated. Moreover, safety was assessed by reporting of side effects, laboratory examinations, and blood pressure measurement. Baseline mean disease activity Index including a 28-joint count (DAS28) amounted to 5.61 and decreased to 4.54 at week 8 (p=0.023) and to 3.79 (p=0.00031) at week 16. MST remained unchanged. DAS28 values significantly decreased statistically in originally ChL-treated patients with additional LEF but did not in LEF patients with additional ChL (DAS28: 1.48; 2.29 vs 0.60; 0.87). Adverse reactions were observed in four patients. Three patients had to be withdrawn from the study. Combination therapy with LEF and ChL was effective and reasonably tolerated. The far higher treatment response could be observed in originally ChL-treated patients after initiation of LEF.