Clofazimine effective for cutaneous SLE

Janis Kelly

October 26, 2005

October 26, 2005

Natal, Brazil - Antimalarials such as chloroquine (CDP) have proven remarkably effective for treating cutaneous lesions in patients with systemic lupus erythematosus (SLE), but at the cost of considerable skin and gastrointestinal side effects. The leprosy drug clofazimine (CFZ) (Lamprene, Novartis Pharmaceuticals) may offer an alternative, Dr Elaine Bezerra reports in the October 2005 issue of Arthritis & Rheumatism [ 1 ].

"Our most important finding was that clofazimine and chloroquine were equally effective in cutaneous SLE," Bezerra tells rheuma wire .

A possible new option for solely cutaneous SLE

Our most important finding was that clofazimine and chloroquine were equally effective in cutaneous SLE .

Bezerra and colleagues at Universidade Federal do Rio Grande do Norte (Natal, Brazil) and Universidade Federal de S¿o Paulo (Brazil) randomized 33 patients to six months of treatment with either clofazimine (100 mg/day) or chloroquine (250 mg/day). All patients met American College of Rheumatology (ACR) criteria for SLE and had active cutaneous lesions, typically malar rash and/or discoid lesions and/or clinically characterized subacute cutaneous lupus. Doubtful cases were biopsied to establish diagnosis. Exclusion criteria included current or recent use of either of the test drugs, contraindications to either drug, and recent use of any immunosuppressive drug, as well as pregnancy or nursing.

Bezerra reported data for 27 patients who completed the study (11 on clofazimine, 16 on chloroquine).

The authors note that five of the clofazimine-assigned patients were withdrawn from the study between months 2 and 4 due to serious lupus flares.

Based on intention-to-treat analysis, 75% of patients in the clofazimine group and 82.4% in the chloroquine group achieved good responses. This was defined as a score of 5 or better on the Mexican version of the SLE Disease Activity Index (MEX-SLEDAI). Complete response (score of 6) was seen in 18.8% of patients treated with clofazimine vs 41.2% of those treated with chloroquine. This difference was not significant, perhaps reflecting the small size of the study.

This trial is notable because it is one of the very few controlled studies comparing antimalarials and other drugs for the treatment of cutaneous lesions in SLE patients. "In our study, CFZ proved to be as efficacious as CDP in controlling the lupus cutaneous lesions. However, we cannot exclude the possibility that the CFZ itself could be the cause of systemic lupus flare. The relatively small number of patients in this study and lack of data on the long-term efficacy and safety of CFZ in SLE patients means that additional controlled clinical trials will be necessary to confirm our results," Bezerra says. "The results of this study suggest that CFZ is indicated as a therapeutic option for lupus patients with exclusively cutaneous lesions and with contraindications to chloroquine."


  1. Bezerra ELM, Vilar MJP, da Trindade Neto PB, et al. Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus. Arthritis Rheum 2005; 52:3073-3078.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.