Trial results for Galderma ’s 24-week Phase IIb trial testing the safety and efficacy of nemolizumab in adults with moderate-severe atopic dermatitis were presented at the 2019 Annual Meeting of the American Association of Dermatology in Washington DC, US.
The results were positive, with participants on the 30mg dose of nemolizumab achieving a 68.8% skin improvement from baseline Eczema Area and Severity Index (EASI ) at Week 24, compared to those on placebo achieving a 52.1% improvement in EASI.
Compared to the 10mg and 90mg doses tested, the 30mg dose was most effective at all endpoints, including percentage change from baseline EASI, Investigator’s Global Assessment success, and Peak Pruritus Numerical Rating Scale (PP NRS) improvement of four or more points at Weeks 16 and 24. Improvements in pruritus were seen as early as Week 1.
Secondary endpoints achieved
Secondary endpoints achieved by Week 24 in the study included the following:
• 45.6% of patients on the 30mg nemolizumab dose achieved a skin improvement of 75% or more in the EASI (EASI-75), compared to 26.3% of the placebo group achieving EASI-75.
• PP NRS improvement for the 30mg dose group peaked at Week 16 with 68.4% of participants improving by four or more points (49.1% at Week 24). 24.6% of those in the placebo group improved by four or more points by Week 24.
• Other secondary endpoints included a proportion of participants achieving an IGA score of 0-1 (clear or almost clear) and an improvement in sleep NRS.
In terms of study design, this Phase IIb study had adults who were uncontrolled by topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) randomised into the placebo group, the 10mg dose group, the 30mg dose group, or the 90mg dose group.
To qualify for the study, participants had to have an EASI of 12 or greater, an IGA score of three or more, a body surface area (BSA) involvement of at least 10%, and PP NRS of seven or greater. Participants had a run-in period of four weeks with mid-potency TCS used for stabilisation.
Safety profile of nemolizumab
The safety profile nemolizumab was positive, with the nemolizumab patients of all dose groups combined having either a similar or lower rate of treatment-emergent adverse events (TEAEs).
The most common TEAEs were nasopharyngitis (found in 26.6% of nemolizumab participants versus 21.4% in the placebo group), exacerbation of atopic dermatitis (24.9% in the nemolizumab groups versus 32.1% in the placebo group), and non-herpes skin infection (13% in the nemolizumab groups versus 12.5% in the placebo group).
One concerning TEAE found to be more common in the nemolizumab groups was the onset of asthma events, with a rate of 11.2% compared to 1.8% in the placebo group. In terms of serious AEs (SAEs), nemolizumab had a rate of 4.1% compared to 1.8% in the placebo group, although nemolizumab had a lower rate severe AEs than placebo, with rates of 5.9% and 8.9%, respectively.