American Academy of Dermatology Meeting

American Academy of Dermatology Meeting

Source:

Guttman-Yassky E, et al. Phase 2b ADVISE trial evaluating the safety and efficacy of etrasimod in participants with moderate-to-severe atopic dermatitis. Presented at: AAD VMX 2021; April 23-25, 2021 (virtual meeting).

Disclosures: Guttman-Yassky reports she is a paid consultant and researcher for Arena Pharmaceuticals.
April 24, 2021
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Etrasimod significantly improves atopic dermatitis in phase 2b trial

Source:

Guttman-Yassky E, et al. Phase 2b ADVISE trial evaluating the safety and efficacy of etrasimod in participants with moderate-to-severe atopic dermatitis. Presented at: AAD VMX 2021; April 23-25, 2021 (virtual meeting).

Disclosures: Guttman-Yassky reports she is a paid consultant and researcher for Arena Pharmaceuticals.
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Etrasimod, an investigational drug for moderate to severe atopic dermatitis, demonstrated statistically significant improvements in a phase 2b clinical trial, according to a study presented at AAD VMX 2021.

“Etrasimod demonstrated clinically meaningful improvements in both clinical signs of atopic dermatitis and patient-reported outcomes,” Emma Guttman-Yassky, MD, PhD, Waldman Professor and chairwoman of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, said in a press release from Arena Pharmaceuticals.

The multicenter, randomized, double-blinded, placebo-controlled ADVISE trial included 140 participants with chronic moderate to severe AD for at least 1 year. Participants received etrasimod 2 mg, etrasimod 1 mg or placebo. Treatment occurred once daily for 12 weeks, and outcome measures included the Peak Pruritis Numeric Rating Scale, Dermatology Life Quality Index, Patient-Oriented Eczema Measure and validated Investigator Global Assessment.

Emma Guttman-Yassky

At baseline, participants had an Eczema Area and Severity Index of 16 or greater, a vIGA score of 3 or greater and AD over 10% or more of their body.

In the etrasimod 2 mg cohort after 12 weeks, 29.8% had a decrease in vIGA score to 0 or 1 and an improvement of at least 2 points compared with 13% for placebo (P = .0450).

Significant improvement in PP-NRS for the 2 mg cohort began after 2 weeks. At week 4, there was a decrease of 15.3% in the 2 mg group compared with 1% in the placebo group (P = .0380), suggesting a rapid onset of action. PP-NRS was lower in the 2 mg group than the placebo group at week 12, but the difference was not statistically significant.

For DLQI, the etrasimod 2 mg cohort experienced a statistically significant decrease in degree of impairment, with a decrease of 7.6 points by the end of 12 weeks compared with a decrease of 4.2 points for placebo (P = .0122).

Patients in the 2 mg cohort experienced a reduction of 8.4 points in POEM compared with a reduction of 4 points for those in the placebo group (P = .0045).

The decline in degree of impairment would have been greater if the dose was increased to 3 mg and continued for longer than 12 weeks, according to Guttman-Yassky.

“This is a novel mechanism of action that prevents lymphocytes from going into the skin. Of course, we need more studies, but with this mechanism, it may be that lymphocytes or T cells will stay away from the skin and prevent inflammation and may provide long-term efficacy,” Guttman-Yassky told Healio.