New Biologic is 'Potential Blockbuster' for Eczema Treatment

Marcia Frellick

March 06, 2017

ORLANDO — Dupilumab, a new biologic generating excitement in dermatology, can be used in combination with topical corticosteroids to safely control the symptoms of moderate to severe eczema over the long term, including itch, according to new research.

"You've got these patients with miserable disease; they can't be controlled with topical steroids. The only option they've had are these systemic immunosuppressants that knock down the whole immune system and have a whole host of side effects," said lead investigator Andrew Blauvelt, MD, president and owner of the Oregon Medical Research Center in Portland.

"This is the very first internal treatment that will be able to change the game for these patients, essentially giving them long-term and safe control of their widespread disease," he explained.

Dupilumab has not been approved by the US Food and Drug Administration for labeling or advertising, "but that is expected to occur within the next month," Dr Blauvelt told Medscape Medical News.

He presented 1-year results from the phase 3 randomized placebo-controlled CHRONOS trial of dupilumab (NCT02260986) during a late-breaking abstract session here at the American Academy of Dermatology Annual Meeting.

CHRONOS Trial

The study builds on previous 16-week studies that showed that, used alone, the monoclonal antibody — marketed as Dupixent by Regeneron and Sanofi — significantly improved the signs and symptoms of moderate to severe eczema and had an acceptable safety profile.

In CHRONOS, the 740 adults who had moderate to severe eczema and a poor response to topical corticosteroids were randomized to one of three treatment regimens for 1 year: dupilumab 300 mg once a week; dupilumab 300 mg once every 2 weeks; or placebo. In addition, all patients received low to medium potency topical corticosteroids, which could be tapered or stopped.

The study had two coprimary end points: a 75% improvement in the Eczema Area and Severity Index (EASI 75) score; and an Investigator Global Assessment score of 0 or 1 (IGA 0/1), indicating clear or almost clear, plus an improvement from baseline of at least 2 points.

Table: Achievement of the Coprimary End Points

End Point Weekly Dupilumab Group, % Biweekly Dupilumab Group, % Placebo Group, % P Value
Week 16        
   EASI 75 64 69 23 <.0001
   IGA 0/1 39 39 12 <.0001
Week 52        
   EASI 75 64 65 22 <.0001
   IGA 0/1 40 36 13 <.0001

 

In the dupilumab groups, itch declined as early as week 2 and the reduction was maintained throughout the year.

Overall, the drug was well tolerated. However, one adverse effect that no one expected in the dupilumab group was conjunctivitis, which occurred in 14% to 19% of patients, Dr Blauvelt reported.

"We're not sure why it occurred. More studies are needed to understand it," he said.

Another adverse effect of note was injection-site reaction, which occurred in 15% to 19% of patients receiving dupilumab and in 8% of those receiving placebo.

 
This is the very first internal treatment that will be able to change the game for these patients.
 

Dr Blauvelt emphasized the distinction between mild to moderate eczema and moderate to severe eczema. In the CHRONOS patients, he pointed out, the average body surface area affected by eczema was 55%.

"For these patients, topical therapy is not an option, and itching is a major symptom. They're creating scratch marks on their body, they can't function well at work or home, they're not sleeping well," he said.

On the basis of the safety and efficacy profile observed in large replicated studies, it is expected that dupilumab will be a major breakthrough in the management of moderate to severe atopic dermatitis, said Andrew Alexis, MD, chair of the Department of Dermatology at Mount Sinai St. Luke's and Mount Sinai West in New York City.

"This treatment is likely to be transformative for patients who have failed existing therapies or who have not been able to use systemic treatments because of concerns about their safety profiles," he told Medscape Medical News. "These patients will likely be less reliant on corticosteroids and oral immunosuppressive therapies," he added.

This research was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr Blauvelt, a scientific adviser and clinical study investigator, reports ties to AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Sandoz, Sanofi Genzyme, Sun Pharma, UCB, and Valeant. Dr Alexis reports ties to Aclaris Therapeutics, Allergan, Amgen, Anacor Pharmaceuticals, Derma Instruments, Ferndale Laboratories, Galderma Laboratories, L'Oreal USA, Leo Pharma, Mitsibushi Pharma, Novan, Novartis, Novartis Pharmaceuticals Corp., Roche Laboratories, Sandoz, Sanova Works, Solta Medical, Springer Science & Business Media, Suneva Medical, Trevi Therapeutics, Valeant Pharmaceuticals North America, and Wiley–Blackwell.

American Academy of Dermatology (AAD) Annual Meeting: Abstract 5267. Presented March 4, 2017.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....