Upadacitinib reduced all clinical disease measures including itch-related outcomes at 16 weeks in patients with moderate to severe atopic dermatitis, according to phase 2b study results published in Journal of Allergy and Clinical Immunology.
“This is a JAK inhibitor that achieved an Eczema Area and Severity Index of 90% improvement in 50% of the patients,” Emma Guttman-Yassky, MD, PhD, of the department of dermatology and laboratory of inflammatory skin diseases at Icahn School of Medicine at Mount Sinai, told Healio in an interview. “This is one of the best rates we have seen so far. It’s looking very hopeful.”
Sixteen weeks of the 88-week double-blind, placebo-controlled, parallel-group trial were dose ranging. Adults with moderate to severe disease and inadequate control with topical treatment were randomly assigned 1:1:1:1 to once-daily upadacitinib oral monotherapy 7.5 mg (n = 42), 15 mg (n = 42), 30 mg (n = 42) or placebo (n = 41).
By week 4, patients achieved maximum response, which was maintained to week 16, Guttman-Yassky said.
“I had many of my own patients in the study, and they were very happy,” she said. “They got relief very quickly. They felt some relief within 2 hours, and within a few days there was a major change. In fact, I had patients who didn’t want to leave the study.”
The mean primary efficacy endpoint was 39%, 62% and 74% for the upadacitinib 7.5 mg, 15 mg and 30 mg groups, respectively, compared with 23% for placebo (P = .03, P < .001 and P < .001, respectively). Serious adverse events occurred in 4.8% (n = 2), 2.4% (n = 1) and 0% (n = 0) of the respective upadacitinib dosage groups vs. 2.5% (n =1) for placebo.
Researchers reported the greatest clinical benefit with the 30 mg once-daily dosage.
A phase 3 trial includes patients aged 12 years and older and is completing enrollment now. Guttman predicted the approval of an oral medication in atopic dermatitis in the next few years.
“At the end of the day, we will need both biologics that are injectable and oral medication in eczema,” she said. “There will be patients that want an injection every 2 weeks and to forget about it, and others won’t want an injection and will want an oral medication. It’s good to have options.” – by Abigail Sutton
Disclosure: Guttman-Yassky reports she is a consultant/researcher for AbbVie, Anacor, AnaptysBio, Asana Biosciences, Botanix, Celgene, DBV, Dermira, DS Biopharma, Escalier, Galderma, Glenmark, Innovaderm, Janssen, Kyowa Kirin, Leo Pharma, Lilly, MedImmune/AstraZeneca, Mitsubishi Tanabe, Novan, Novartis, Pfizer, Promius, Ralexar, Regeneron, Sanofi Aventis, Stiefel/GSK, UCB and Vitae.