PT  - JOURNAL ARTICLE
AU  - George Karanikolas
AU  - Dionisios Charalambopoulos
AU  - Alexandros Andrianakos
AU  - Christos Antoniades
AU  - Nikolaos Katsilambros
TI  - Combination of cyclosporine and leflunomide versus single therapy in severe rheumatoid arthritis.
DP  - 2006 Mar 01
TA  - The Journal of Rheumatology
PG  - 486--489
VI  - 33
IP  - 3
4099  - http://www.jrheum.org/content/33/3/486.short
4100  - http://www.jrheum.org/content/33/3/486.full
SO  - J Rheumatol2006 Mar 01; 33
AB  - OBJECTIVE: This study assessed the efficacy and safety of combination (COMB) of cyclosporine (CSA) and leflunomide (LEF) versus each drug alone, in the treatment of severe rheumatoid arthritis (RA). METHODS: One hundred six patients with active RA refractory to at least one disease modifying antirheumatic drug (methotrexate obligatorily) were entered into a 12-month open, prospective trial and were randomly allocated to receive either CSA 2.5 to 5 mg/kg/day, or LEF 20 mg/day, or the combination of both at the same initiating dose. RESULTS: The American College of Rheumatology 50% (ACR50) response rates for the 3 groups were COMB 80%, CSA 40%, and LEF 42% (p = 0.001). Combination therapy was also significantly better than CSA and LEF at the more stringent 70% response rate (69% vs 34% vs 30%, respectively; p = 0.001). Comparable Disease Activity Score 28 reduction rates were noted at trial termination for all 3 treatment arms: COMB -2.74 vs CSA -2.53 vs LEF -2.28 (p nonsignificant). Discontinuation rates were more common in LEF vs CSA arm (p = 0.046). No unexpected or serious adverse drug effects were identified in the combination group during the 12-month period. CONCLUSION: The combination of CSA and LEF in patients with refractory RA provided statistically significant benefit in ACR50 and ACR70. Adverse events were not substantially increased.