Late-breaking abstract reports on Phase 3 data for non-steroidal ointment
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Los Angeles, CA – Results from two multicenter, double-blind, vehicle-controlled studies of a novel, non-steroidal treatment for atopic dermatitis, also known as eczema, were announced in a late-breaking abstract at the 2016 AAAAI Annual Meeting.
The phase 3 studies addressed the safety and efficacy of crisaborole 2% ointment, a novel boron-based anti-inflammatory phosphodiesterase 4 inhibitor for patients with mild-to-moderate atopic dermatitis.
“Atopic dermatitis, a common, chronic inflammatory skin disease affecting children and adults, is a global health problem with significant comorbidities. Of note, many more patients with mild or moderate disease have persistence into their adult years than was previously recognized. Phosphodiesterase 4 enzymes are overexpressed in the inflammatory cells of patients and may participate in the complex pathophysiology of the disease,” first author Mark Boguniewicz, MD, FAAAAI, said.
“Current treatments include topical steroids and calcineurin inhibitors, which are beneficial but have limitations. We are always looking for new treatments that are both safe and effective for our patients. Crisaborole 2% ointment is a novel topical anti-inflammatory ointment without steroids. If it is approved by the Food and Drug Administration (FDA), it would represent a new treatment option for health care providers to offer their patients who have mild-to-moderate atopic dermatitis,” Boguniewicz explained.
Patients 2-years and older with mild-to-moderate eczema were randomized to crisaborole ointment or a vehicle control twice daily, with evaluations performed on days 8, 15, 22 and 29. They were enrolled in study 1 (503 crisaborole: 256 vehicle) and study 2 (531 crisaborole: 250 vehicle). At day 29, more crisaborole-treated patients reported their eczema as ‘‘clear’’ or ‘‘almost clear’’ (study 1: 51.7% versus 40.6% and study 2: 48.5% versus 29.7%). Overall, a greater proportion of crisaborole-treated patients achieved success for all clinical signs of atopic dermatitis by day 29 and treatment-related adverse events were infrequent, transient and mild/moderate in severity.
“Improvements in pruritus were achieved earlier with crisaborole than with vehicle – and getting relief from itching is so important for our patients – and a greater proportion of crisaborole-treated patients saw improvement for all clinical signs of atopic dermatitis by day 29,” Boguniewicz concluded.
For more information on eczema or the AAAAI Annual Meeting , visit the AAAAI website. Results from the study have been published in an online supplement to The Journal of Allergy and Clinical Immunology .
The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 6,800 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home. Editor's notes:
· This study was presented during the 2016 Annual Meeting of the American Academy of
Allergy, Asthma & Immunology, March 4-7 in Los Angeles. However, it does not necessarily reflect the policies or the opinions of the AAAAI.
· A link to all abstracts presented at the 2016 Annual Meeting is available at annualmeeting.aaaai.org . Additional Information
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