Foam Approved for Plaque Psoriasis of the Scalp

Sorilux^™ (calcipotriene) Foam, 0.005%

The FDA approved Sorilux^™ (calcipotriene) Foam, 0.005%, in September 2012 as a topical treatment for adults with plaque psoriasis of the scalp. The product, marketed by Stiefel Laboratories, Inc., is also approved for the topical treatment of plaque psoriasis of the body in patients 18 years of age and older.

Calcipotriene foam, a vitamin D analog, is intended only for topical use and not for facial, oral, ophthalmic, or intravaginal use. Patients are advised to apply the foam twice daily to the affected areas and rub in gently and completely. The product utilizes VersaFoam^® technology, which is free of ethanol, preservatives, parabens, and fragrance.

Plaque psoriasis, the most common form of psoriasis and a chronic condition, typically causes raised, red lesions covered with silvery white scales, according to a Stiefel news release. It commonly occurs on the scalp, knees, elbows, and torso.

Patients with known hypercalcemia should not use calcipotriene foam. In addition, although there have been no trials of calcipotriene foam in pregnant women, the product is intended for use in pregnancy only if the potential benefits to the fetus outweigh the potential risks. Patients <18 years of age should also not use calcipotriene foam.

The FDA approved calcipotriene foam based on the results of a randomized, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of patients with moderate scalp and body psoriasis.

This First Report Managed Care Product Spotlight provides a summary of the pivotal trial that evaluated the safety and efficacy of calcipotriene foam.

PHASE 3 TRIAL

Below is a summary of a randomized, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study that evaluated the efficacy and safety of calcipotriene foam compared with vehicle foam in treating plaque-type psoriasis of the scalp.

Reference

Feldman SR, Eastman WJ, Brundage T, et al. A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp. J Drugs Dermatol. 2013;12(3):300-306.

Study Objective

The trial was designed to assess the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.

Method

The authors randomized the patients in a 1:1 ratio to receive calcipotriene foam or vehicle foam. The foams had identical excipients and the same labeling. Patients had their first application at the baseline visit and then self-administered the foam to the existing and new lesion flares twice daily for 8 weeks. They were told to apply the smallest amount necessary to cover all affected areas on the body and scalp.

During the 8 weeks, the patients had 5 study visits: (1) at baseline, (2) week 1, (3) week 2, (4) week 4, and (5) week 8. They were assessed for percent of body surface area and scalp affected by psoriasis and Investigator’s Static Global Assessment (ISGA) of body psoriasis on a scale of 0 (clear) to 4 (severe) and of scalp psoriasis on a scale of 0 (clear) to 5 (very severe). They also had their target lesions evaluated for erythema, scaling, and plaque thickness on a psoriasis grading scale from 0 (clear) to 5 (very severe).

Population

The authors enrolled 363 patients, and 322 completed the study. The most common reasons for discontinuation were withdrawal by subject (4%), lost to follow-up (3%), and adverse events (2%). The groups were well balanced. Median age was 45.2 years, 87% of patients were white, and 60% were males. Mean scalp area affected was 32.2%, and mean body surface area affected was 6.1%.

Patients were included if they were at least 12 years of age, had plaque-type psoriasis involving 3% to 10% of total body surface area excluding the scalp and face, a discrete, evaluable target lesion >2 cm² on the trunk or extremities, and plaque-type psoriasis on 10% or more of the total scalp surface area.

The exclusion criteria included patients who participated in a previous study involving calcipotriene foam, used nonbiologic systemic antipsoriatic therapy, recently used topical therapies with a known beneficial effect on psoriasis, and had a history of an immunocompromising disease.

Primary end point

• Proportion of subjects with an ISGA score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement.

Secondary end points

·      Proportion of subjects with an ISGA score of 0 or 1 at week 8 for body involvement.

·      Target lesion score of 0 or 1 for each of erythema, scaling, and plaque thickness.

·      Improvement from baseline at week 8 of ≥2 grades.

Results

After 8 weeks of treatment, patients in the calcipotriene foam group had significant improvement in scalp psoriasis compared with those who received vehicle foam. The improvements were evident by week 2, according to the authors.

Of the patients in the calcipotriene foam group, 40.9% had an ISGA score of 0 or 1 for scalp psoriasis after 8 weeks compared with 24.2% of patients in the vehicle foam group (P<.001). At week 8, there was no difference in the percentage of patients with an ISGA score of 0 or 1 for body involvement (17.7% in the calcipotriene foam group vs 15.4% in the vehicle foam group; P=.544).

In addition, there were no significant differences in the percentage of patients who had a score of 0 or 1 and a ≥2 grade improvement for target lesion erythema (P=.112) or scaling (P=.059) or a score of 0 or 1 for target lesion plaque thickness (P=.116).

Product-related adverse events were found in 17% of patients taking calcipotriene foam compared with 7% of patients receiving vehicle foam. Five patients in the calcipotriene foam group and 4 patients in the vehicle foam group had an adverse event that led to discontinuation of the product. There were 4 serious adverse events (1 in the calcipotriene foam group and 3 in the vehicle foam group) and 8 severe adverse events (3 in the calcipotriene foam group and 5 in the vehicle foam group).

Safety Notes

The most common side effects associated with calcipotriene foam are redness and pain of the treated skin areas. The contents of the product are flammable, so patients should avoid exposure to fires and flames and should not smoke during and immediately after applying the foam.

Patients are advised to discontinue treatment if they have elevated serum calcium, but they can continue when normal calcium levels are restored. They should also avoid excessive exposure of the treated areas to natural or artificial sunlight.

Sorilux Facts

•   Sorilux was approved by the FDA on September, 7, 2012, to treat adult patients with plaque psoriasis of the scalp.

•    Sorilux is marketed by Stiefel Laboratories, Inc.

Additional Resource

Prescribing Information for Sorilux: stiefel.com