WAIKOLOA, HAWAII (FRONTLINE MEDICAL NEWS) – Tazarotene remains an important and effective albeit greatly underutilized topical therapy in psoriasis – but it’s on its way to becoming an even better drug, Dr. Linda Stein Gold said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

The topical retinoid has been formulated together with the superpotent steroid halobetasol propionate 0.01% in an investigational fixed combination lotion known for now as IDP-118. This medication, under development by Valeant, is in an ongoing, phase III multicenter, double-blind randomized trial with the vehicle lotion serving as control in adults with moderate to severe plaque psoriasis. A year-long, open-label, phase III safety study is also in progress, according to Dr. Stein Gold of Henry Ford Hospital in Detroit.

Tazarotene (Tazorac) is approved by the Food and Drug Administration as a 0.05% and 0.1% cream or gel for psoriasis and in the 0.1% cream or gel for acne. But when Dr. Stein Gold asked her large Hawaii audience for a show of hands as to who is prescribing tazarotene for their psoriasis patients, not a hand went up.

“Tazarotene carries some baggage,” she observed. “It’s pregnancy category X, and it also is quite irritating. If you use tazarotene on psoriatic skin, you’ll get a lot of irritation. But if you do so in combination with a potent or superpotent topical steroid, you’re not only able to increase the efficacy, but you also minimize the tolerability issues.

These dual benefits are the result of the two treatments’ differing mechanisms of action. This has been known for a long time. Indeed, it was demonstrated in a randomized trial nearly 2 decades ago ( J Am Acad Dermatol. 1998 Oct;39[4 Pt 2]:S139-43 ). But only with the recent appreciation that 80% of psoriasis patients treat their disease exclusively with topical therapies has a pharmaceutical company moved to take advantage of these synergistic effects.

Dr. Stein Gold, director of dermatology research at Detroit’s Henry Ford Health System, said that the pharmaceutical industry has finally noted the considerable unmet need for additional topical psoriasis therapies that will be more effective and/or cosmetically elegant or have a novel mechanism of action. A slew of novel topical agents are now in the developmental pipeline in phase II studies for psoriasis. Among these new molecules are a topical formulation of methotrexate in a proprietary vehicle; the Janus kinase (JAK) 1 and 2 inhibitor ruxolitinib (Jakafi) in a cream for treatment of both psoriasis and atopic dermatitis; a tyrosine kinase inhibitor cream and ointment; an integrin inhibitor cream, and a phosphodiesterase-4 inhibitor ointment.

In addition, in October 2015, the FDA approved an aerosol foam fixed combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% (Enstilar) for psoriasis. It’s more effective and cosmetically elegant than the fixed-combination ointment, she noted.

“Topical therapy is still going strong. I think there is always going to be a need for topical psoriasis therapies,” the dermatologist declared.

She reported serving as a consultant to and/or scientific advisory board member for numerous pharmaceutical companies.

SDEF and this news organization are owned by the same parent company.


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