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Clofazimine effective for cutaneous SLE

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Clofazimine effective for cutaneous SLE



October 26, 2005



Janis



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 rheumawire.

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 São o (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withdrawn from the study between months 2 and 4 due to serious lupus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. "

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. 16200586

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