The novel anti-OX40 antibody amlitelimab has shown promising one-year efficacy in treatment of atopic dermatitis, according to results from a phase 2b trial that involved Australian patients.

Amlitelimab has a novel mechanism of action, targeting OX40 ligand axis antigen-presenting cells, part of a secondary costimulatory pathway that promotes persistent immune responses in atopic dermatitis.

Late breaking results from the Phase 2b extension study STREAM-AD study presented at the 2024 AAD annual meeting showed that adult patients with moderate to severe atopic dermatitis treated with amlitelimab showed sustained improvements in atopic dermatitis signs and symptoms up to 52 weeks.

The international multicentre study involved 190 patients from a cohort of 390 participants who had responded to amlitelimab in a preceding 24-week study who were randomised to withdraw treatment or continue subcutaneous dosing at four-week intervals.

Patients who continued amlitelimab treatment maintained high EASI-75 and/or IGA 0/1, IGA 0/1, and EASI-75 responder rates for a further 28 weeks. High responder rates were also demonstrated among patients who were taken off treatment, according to study investigators.

In 69.2% of patients with continued treatment with amlitelimab 250 mg with a 500 mg loading dose vs 58.8% of patients withdrawn from treatment IGA 0/1 and/or EASI-75 response was maintained.

An analysis including pooled dose-arms showed that IGA 0/1 response was maintained in 71.9% of patients with continued treatment vs 57% of patients withdrawn from treatment. In this analysis, EASI-75 response was maintained in 69% of patients with continued treatment vs. 61.6% of patients withdrawn from treatment.

The safety profile for patients dosed to 52 weeks was consistent with initial amlitelimab data showing it to be well-tolerated with no new safety concerns identified, according to a press statement released by study sponsor Sanofi.

The company said it is now progressing with amlitelimab to phase 3 trials.

Study investigator Professor Stephan Weidinger, Chair of Dermatology and Allergy, University Hospital Schleswig-Holstein, Germany, said there was a need for therapies for patients with moderate-to-severe atopic dermatitis who do not respond sufficiently to current treatments, and many continue to suffer from skin lesions and symptoms such as persistent itch, which can have a high impact on their day-to-day lives.

“Results from this part of the study indicate amlitelimab’s potential for durable off-drug efficacy which supports the evaluation of a less frequent every 12-week dosing. This could offer an important benefit in the treatment of AD patient,” he said.

JAK inhibitor

There were also positive results reported at AAD 2024 for the topical JAK-inhibitor delgocitinib for the treatment of adults with chronic hand eczema.

The DELTA 3 extension trial investigated delgocitinib cream in 801 adults with moderate-to-severe chronic hand eczema who had con continued treatment from preceding 16-week DELTA 1 and 2 trials. Patients were treated with twice daily delgocitinib cream as needed to control their chronic hand eczema for 36 weeks.

According to study investigator Dr Melinda Gooderham, the extension trial showed that patients continued to show good responses to topical delgocitinib, and the therapy was well tolerated.

The proportion of patients achieving an Investigator’s Global Assessment for CHE (IGA-CHE) score of 0/1 (clear/almost clear) and a ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) improved from baseline (24.6%, 51.8%, and 31.8%, respectively) to week 36 (30.0%, 58.6%, and 36.6%, respectively) among delgocitinib cream-treated subjects in parent trials.

Among those treated with cream vehicle in parent trials, response rates improved from baseline (9.1%, 23.7%, and 12.0%, respectively) to week 36 (29.5%, 51.5%, and 35.7%, respectively).

“The results from DELTA 3 offer hope to adults living with chronic hand eczema, a patient group who have been left to deal with their debilitating condition with minimal treatment options,” said Dr Gooderham, Medical Director at the SKiN Centre for Dermatology, Ontario, Canada.

The study was funded by LEO Pharma.