Dermavant Sciences has reported positive top-line results from a phase 3 trial of its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children as young as two years of age with atopic dermatitis.

More commonly referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone and up to 10% of adults worldwide.

Dermavent’s ADORING 2 trial met its primary endpoint, with 46.4% of Vtama-treated patients experiencing a significant improvement in an investigator assessment of lesions.
Benefits were also seen across key secondary endpoints, including 59.1% of patients experiencing improvements on the EASI test, which is used to measure the extent and severity of the condition.

The company’s chief medical officer, Philip Brown, said the results suggest that Vtama cream could be “a potentially important non-steroidal, topical treatment option for atopic dermatitis patients, including children as young as two years of age.”

Brown added that the company expects top-line results from its identically designed ADORING 1 trial in May this year.

This latest data supports positive results recently released by the company from a paediatric maximal usage pharmacokinetics study of Vtama cream in atopic dermatitis.

Bristol Myers Squibb’s (BMS) plaque psoriasis treatment, Sotyktu (deucravacitinib), has been approved by the European Commission (EC) for adults with moderate-to-severe cases who are candidates for systemic therapy.

The approval, which follows a recommendation from the Committee for Medicinal Products for Human Use earlier this year, makes Sotyktu the first oral, selective, allosteric tyrosine kinase 2 inhibitor in the EU for the treatment of any disease.

Psoriasis affects at least 100 million people worldwide, including around 14 million in Europe. Up to 90% of patients with psoriasis have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales.

Despite the availability of effective systemic therapy, BMS reports that many patients with moderate-to-severe psoriasis remain under-treated, untreated or dissatisfied with current treatment options.

The EC’s decision was supported by positive results from the phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily Sotyktu in patients with moderate-to-severe plaque psoriasis versus placebo and twice-daily Otezla (apremilast), as well as an additional two years of data from the POETYK PSO long-term extension trial.

Sotyktu was shown to produce significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla.