Leflunomide in the treatment of psoriasis: results of a phase II open trial.
BACKGROUND
Psoriasis is recognized as the most prevalent T-cell-mediated inflammatory disease in humans, with predominantly activated T-helper (Th) 1 cell effectors. Leflunomide exerts its anti-inflammatory activities by preventing the generation of proinflammatory Th1 effectors and promoting Th2 cell differentiation.


OBJECTIVE
To determine the safety and efficacy of leflunomide in patients with moderate to severe plaque-type psoriasis.


METHODS
In an open-label phase II trial, eight patients with psoriasis received oral leflunomide 20 mg daily for 12 weeks. Patients were evaluated for improvement in psoriasis, quality of life, histological changes and toxicity.


RESULTS
Antipsoriatic effects were obtained in all but two patients. A significant decrease was observed in the mean +/- SD Psoriasis Area and Severity Index score, from 20.08 +/- 6.85 before treatment to 12.51 +/- 11.83 after (P = 0.03). The antipsoriatic efficiency was confirmed histologically, with a significant mean +/- SD decrease in epidermal thickness, from 0.73 +/- 0.19 micro m before to 0.31 +/- 0.16 microm after (P = 0.01). The quality of life score showed an improvement, from 8.58 +/- 2.38 (mean +/- SD) before to 5.33 +/- 1.95 after (P = 0.02). The treatment was well tolerated; adverse reactions primarily consisted of transitory gastrointestinal events.


CONCLUSIONS
Our data suggest that leflunomide for plaque-type psoriasis is a safe and clinically effective option as monotherapy. However, double-blind, placebo-controlled studies are needed.
Tlacuilo-Parra
J A
JA
Medical Research Unit in Clinical Epidemiology, Hospital de Especialidades, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco and Universidad de Colima, Mexico. albtlacuilo@yahoo.com
Guevara-Gutiérrez
E
E
Rodríguez-Castellanos
M A
MA
Ornelas-Aguirre
J M
JM
Barba-Gómez
J F
JF
Salazar-Páramo
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D007555:Isoxazoles; D000077339:Leflunomide