Atopic dermatitis improvement seen with AMG451/KHK4083 in phase 2 trial
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Significant improvements were seen in atopic dermatitis symptoms in patients treated with an anti-OX40 monoclonal antibody, as well as continued improvement after discontinuation, according to phase 2 trial results.
The multicenter, randomized, double-blind, placebo-controlled phase 2 trial evaluated four doses of AMG451/KHK4083, an investigational drug from Kyowa Kirin and Amgen, in adult patients with moderate to severe atopic dermatitis.
“What is unique about this drug is it achieved a significant efficacy in all the doses as compared to placebo and it continued improvement until week 36,” Emma Guttman-Yassky, MD, PhD, Waldman Professor and system chair of the Kimberly and Eric J. Waldman Department of Dermatology at Icahn School of Medicine at Mount Sinai and lead investigator on the study, told Healio.
At 16 weeks an Eczema Area Severity Index Score mean improvement of –48.33% occurred in the 150 mg every 4 weeks (Q4W) group, –49.72% in the 600 mg Q4W group, –61.07% in the 300 mg every 2 weeks (Q2W) group and –57.35% in the 600 mg Q2W group. The placebo group had a mean change of –15.01.
Each treatment group had continued improvement through week 36 with the proportion of patients achieving EASI75 being 51.9% of the 150 mg Q4W group, 57.7% of the 600 mg Q4W group, 63.5% of the 300 mg Q2W group and 57.4% of the 600 mg Q2W group.
Investigator Global Assessment scores also improved in all four treatment groups. The 150 mg Q4W group had 19.2% of patients achieving a 0/1 IGA score at week 16 and 34.6% at week 36; the 600 mg Q4W cohort had 15.4% at week 16 and 26.9% at week 36; the 300 mg Q2W group had 30.8% at week 16 and 51.9% at week 36; and the 600 mg Q2W group had 18.5% at week 16 and 35.2% at week 36.
Many patients showed a durable response in the off-drug period during the 20 weeks of follow-up after treatment cessation.
“What is most impressive, beyond the clinical efficacy, is that at week 36 the drug was stopped, and you could see the two highest doses maintained the EASI75 results for an additional 20 weeks,” Guttman-Yassky said. “This gives us a hint of disease modification and I think that’s the most interesting item for our patients who ask if they can stop the drug at some point.”
Treatment emergent adverse events were reported in 81% of patients in the treatment groups and 71.9% of those in the placebo group, the most common being pyrexia, nasopharyngitis, worsening of AD and chills.
“The future is bright in treating atopic dermatitis — not only for controlling the disease, but also potentially in achieving long-term disease modification with a single drug,” Guttman-Yassky said. “It’s an exciting time for atopic dermatitis and potentially other inflammatory conditions that could be treated with this drug.”