Pimecrolimus Thorough and Fast for Inverse Psoriasis
KOHALA COAST, HAWAII — Pimecrolimus cream 1% did a better and faster job of clearing inverse psoriasis in a randomized, double-blind, vehicle-controlled study of 57 patients, according to Mark Lebwohl, M.D.
The patients applied either the topical immunomodulator pimecrolimus cream 1% or a vehicle cream of identical appearance twice a day for 8 weeks. There were no significant differences at baseline in the two groups. All patients were adults with moderate to severe inverse psoriasis, a T-cell-mediated inflammatory skin disease involving intertriginous areas such as the groin, axilla, and skin folds or creases of the breasts and buttocks, he said in a poster presentation at a conference on clinical dermatology sponsored by the Center for Bio-Medical Communication Inc.
Skin in these areas is very susceptible to the cutaneous side effects of more common topical treatments for psoriasis such as corticosteroids, which can cause irritation or corticosteroid-induced atrophy and striae, wrote Dr. Lebwohl, professor and chairman of dermatology at the Mount Sinai School of Medicine, New York.
Previous data have shown pimecrolimus cream 1%, a nonsteroid topical calcineurin inhibitor, to be effective in treating psoriasis when used under occlusion. It is not approved by the Food and Drug Administration for this indication.
Investigators in the current study rated disease severity on a four-point Global Assessment Scale from 0 (clear) to 4 (severe disease). They selected a target area on each patient and rated erythema, induration, and scaling on a scale of 0 (absent) to 3 (severe); the sum of those three scores comprised the Target Area Score.
At week 8, 20 of 28 patients in the pimecrolimus group had an Investigator Global Assessment score of 0-1 (clear or almost clear), compared with 6 of 29 patients in the vehicle group, Dr. Lebwohl wrote.
Four patients in the pimecrolimus group and none in the vehicle group achieved a global assessment score of 0-1 by the third day of applying the cream.
The Target Area Scores (TAS) were significantly better in the pimecrolimus group than in the vehicle group at each assessment date: days 3 and 7, and weeks 2, 4, 6, and 8 of treatment. The TAS declined from 5.2 at baseline to 1.1 at the end of the study in the pimecrolimus group, and from 5.5 at baseline to 2.9 in the vehicle group.
The pimecrolimus cream was well tolerated, Dr. Lebwohl and his associates wrote. No serious adverse events were reported, and no patient in either group discontinued the cream because of adverse events.
Overall, two patients in the pimecrolimus group reported adverse events: One developed paresthesia at the application site, and the other developed shaving folliculitis, which was thought to be unrelated to the cream. Of the 10 adverse events reported in the vehicle group, only 1 was considered to be related to application of the vehicle cream: tenderness in the target area.
