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.


METHODS
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.
Gisondi
Paolo
P
Section of Dermatology and Venereology, Department of Biomedical and Surgical Science, University of Verona, Verona, Italy. paolo.gisondi@univr.it
Del Giglio
Micol
M
Di Francesco
Vincenzo
V
Zamboni
Mauro
M
Girolomoni
Giampiero
G
D003131:Combined Modality Therapy; D016572:Cyclosporine / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004038:Diet, Reducing; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000178:diet therapy*; D011565:Psoriasis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015431:Weight Loss / Q000502:physiology*
D003879:Dermatologic Agents; D016572:Cyclosporine