We found one systematic review.9
We found one RCT involving 39 people with DLE and 19 with SCLE, in which hydroxychloroquine, 400-1200 mg/day, was compared with acitretin, 50 mg/day, over 8 weeks.10 The groups in the two treatment arms were equal for age, sex and extent of disease, but SCLE was more strongly represented in the chloroquine group. Complete clearing or marked improvement occurred approximately equally in the two groups (50% versus 46%). Four patients dropped out because of treatment side-effects (all in the acitretin arm) and three because of total clearing of lesions (all in the hydroxychloroquine arm).
We found three RCTs of chloroquine in non-life-threatening SLE. In the Canadian study, people taking hydroxychloroquine for SLE were randomised to continue the drug (n = 25) or to take placebo (n = 22).11 At 6 months 16 of the 22 on placebo and 9 of 25 in the active arm had experienced disease flares, a 2-5-fold increase in flares in the untreated participants. Skin lesions were not specifically described. Williams compared hydroxychloroquine, 400 mg/day, with placebo in 71 people with mild SLE over 48 weeks.12 Although the study was designed to determine the effect of the trial drug on joint disease, cutaneous, neurological and cardiopulmonary systems were also evaluated. Placebo and active groups both improved but overall there was no significant difference in the outcome of skin lesions between the two groups at any stage in the study. The third RCT involved 23 participants, 11 randomised to receive chloroquine, and 12 to receive placebo.13 The chloroquine group showed less skin activity than the placebo group (9% compared with 42%; 95% confidence interval 9-74%). Overall, patients taking chloroquine experienced fewer flares and required lower doses of steroids. The nature of the skin lesions was not documented.
We found one double-blind but non-randomised trial comparing hydroxychloroquine with placebo in DLE.14 Forty-nine people were treated for 1 year, 24 with hydroxychloroquine and 25 with placebo. Results at both 3 and 12 months indicated that hydroxychloroquine was superior to placebo.
We found many observational trials of chloroquine or hydroxychloroquine in cutaneous lupus.15-21 Christiansen reviewed 13 case series up to 1956 and added his own, giving data on a total of 414 people treated in these studies. He noted that 265 (64%) experienced complete clearing or marked improvement. His series was notable for the duration of treatment (18-53 weeks) and the careful description of outcome, but was flawed by the absence of a parallel control group and the high dose of chloroquine (500-750 mg daily).
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