ORLANDO — A newly synthesized nonsteroidal anti-inflammatory drug, benvitimod, is a safe and effective topical treatment for mild to moderate plaque psoriasis, according to phase 3 trial results.
There hasn't been a breakthrough topical treatment since vitamin D analogs hit the market in the 1980s, said Jianzhong Zhang, MD, PhD, with the department of dermatology at Peking University People's Hospital in Beijing, China.
Benvitimod is a first-in-class drug, but the mechanism of action is not yet fully understood, he told Medscape Medical News.
Dr Zhang presented the results of the study here at the American Academy of Dermatology Annual Meeting.
He and his colleagues tested benvitimod in a randomized, multicenter, placebo- and comparator-controlled trial of 686 patients. Participants were adults with mild to moderate psoriasis for at least 6 months, a Physician Global Assessment (PGA) score of 2 or higher (on a 6-point scale), and a body surface area (BSA) of less than 10%.
Patients were randomized to 1% benvitimod cream (n = 344), 0.005% calcipotriol ointment (n = 169), or placebo (n = 173) twice a day for 12 weeks.
After 3 months, significantly more patients who used benvitimod achieved Psoriasis Area Severity Index (PASI) 75 (51.2%), than with calcipotriol (37.9%) or placebo (14.5%) (P < .001).
And more patients achieved PASI 90 at 3 months with benvitimod (32.6%; P < .05) than calcipotriol (20.1%; P < .0001) or placebo (3.5%; P < .0001).
More patients in the benvitimod and calcipotriol groups had a PGA of 0/1 (clear or almost clear), at 66.3% and 63.9%, respectively, after 3 months, almost twice that of the placebo group (33.5%; P < .001).
After discontinuation of benvitimod, 59 patients completed a 40-week follow-up. Of these, 29 patients (49.2%) remained in remission and 30 (50.8%) had recurrence at 40 weeks. Median recurrence time was 36 weeks.
"We haven't had a new topical mechanism of action approved for psoriasis in a long time. If this bears out, it could be a significant advance for patients," said Joel M. Gelfand, MD, director of the Psoriasis and Phototherapy Treatment Center at Penn Medicine in Philadelphia.
Adverse events were higher in the benvitimod group (44.5%) compared with calcipotriol (19.5%) and placebo (20.2%). However, most commonly reported adverse events were transient mild to moderate erythema, sting, or a warming feeling at the application site.
"Benvitimod has some local irritation, but it is mild to moderate. If you continue to use it, the irritation will disappear," said Dr Zhang.
No treatment-related systemic adverse events were reported. Two patients experienced severe adverse events, both contact dermatitis, he said.
The study was a late-breaking session, which was particularly competitive this year. Only 48 of 180 abstracts were accepted as late-breakers, explained Hensin Tsao, MD, PhD, clinical director of the Melanoma and Pigmented Lesion Center at Massachusetts General Hospital in Boston, and coordinator for the late-breakers at the congress.
The study was supported in part by a grant from the Ministry of Science and Technology, China. Dr Zhang has reported no relevant financial relationships. Dr Gelfand reports financial relationships with AbbVie, Coherus BioSciences, Eli Lilly, Elsevier, Janssen, Merck, Novartis, Pfizer, Regeneron, Sanofi, and Valeant.
American Academy of Dermatology (AAD) Annual Meeting. Abstract 5269. Presented March 4, 2017.
Medscape Medical News © 2017
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Cite this: New Topical for Mild to Moderate Psoriasis in the Works - Medscape - Mar 05, 2017.