Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial.

BACKGROUND: Chronic plaque psoriasis is frequently associated with obesity. The effect of a hypoenergetic diet on psoriasis has not been investigated.

OBJECTIVE: The objective was to investigate whether moderate weight loss (ie, 5-10% of body weight) increases the therapeutic response to a low dose of cyclosporine in obese patients with moderate-to-severe chronic plaque psoriasis.

DESIGN: A 24-wk randomized, controlled, investigator-blinded clinical trial was conducted in 61 patients. The efficacy of 2.5 mg x kg(-1)d(-1) cyclosporine combined with a low-calorie diet (intervention group) was compared with cyclosporine alone (control group) in obese patients [body mass index (in kg/m(2)) > 30] with moderate-to-severe psoriasis. The primary endpoint was an improvement from baseline of >or=75% in the Psoriasis Area and Severity Index (PASI 75 response) at week 24.

RESULTS: At week 24, the mean (+/- SD) reduction in body weight was 7.0% +/- 3.5 in the intervention group and was 0.2% +/- 0.9 in the control group (P < 0.001). The PASI 75 response was achieved by 20 of 30 patients (66.7%) treated with cyclosporine plus a low-calorie diet and by 9 of 31 (29.0%) patients treated with cyclosporine alone (P < 0.001). Four patients (13.3%) from the intervention group and 14 (45.1%) from the control group withdrew prematurely from the study (P < 0.001).

CONCLUSIONS: Obese patients with moderate-to-severe psoriasis increase their response to low-dose cyclosporine if a calorie-controlled diet is included in the treatment regimen. Lifestyle modifications, including a low-calorie diet, may supplement the pharmacologic treatment of obese psoriasis patients. This trial was registered at clinicaltrials.gov as NCT00512187.