Recently published results highlight nemolizumab’s efficacy, safety in atopic dermatitis
Click Here to Manage Email Alerts
Key takeaways:
- After 16 weeks of treatment, 36% and 38% of patients treated with nemolizumab in ARCADIA 1 and 2, respectively, achieved IGA 0 or 1.
- This compared with 25% and 26% of the placebo groups.
New results evaluating the efficacy and safety of nemolizumab for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis were published in The Lancet, Galderma announced in a press release.
“Publication of the phase 3 ARCADIA program results for the first time in The Lancet reinforces both the robustness of our trial design and the potential of nemolizumab as an effective treatment option for patients living with atopic dermatitis,” Baldo Scassellati Sforzolini, MD, PhD, MBA, global head of R&D at Galderma, said in the press release.
Previously shared at the American Academy of Dermatology, ARCADIA 1 and ARCADIA 2 are identical, 48-week, randomized, double-blind, placebo-controlled phase 3 trials. In the combined trials, 1,728 adults and adolescents aged 12 years or older with moderate to severe atopic dermatitis that was inadequately controlled by topical steroids were enrolled. A total of 1,142 received nemolizumab and 586 received placebo. Both groups also received topical corticosteroids with or without topical calcineurin inhibitors.
Results showed that after 16 weeks of treatment, 36% and 38% of patients treated with nemolizumab in ARCADIA 1 and 2, respectively, achieved IGA 0 or 1 vs. 25% and 26% of the placebo group (P < .001).
In ARCADIA 1 and 2, 44% and 42% of nemolizumab-treated patients also achieved at least EASI 75 vs. 29% and 30% of placebo-treated patients, respectively (P < .001).
Compared with placebo, those treated with nemolizumab felt itch improvement as early as 1 week after treatment initiation with 16% of patients in both ARCADIA 1 and 2 achieving an “itch-free or nearly itch-free” state at week 4 after just one dose of nemolizumab. On the other hand, the same was achieved by only 4% and 3% of the placebo group, respectively (P < .001).
Sleep disturbance also greatly improved in the nemolizumab group vs. the placebo group in both ARCADIA 1 (38% vs. 20%) and ARCADIA 2 (34% vs. 16%; P < .001 for both).
Safety results were similar between groups with 50% and 41% of nemolizumab-treated patients and 45% and 44% of placebo-treated patients in ARCADIA 1 and 2, respectively, had at least one treatment-emergent adverse event.
There were 10 serious treatment-emergent adverse events in five nemolizumab-treated patients that were considered possibly related to nemolizumab. No deaths occurred.
Galderma now plans to submit a biologics license application to the FDA for nemolizumab in this indication based on these results. The company expects a decision from the FDA by the end of this year and also reports that they are in the process of submitting regulatory authorizations to health care authorities in other countries.
Reference:
Collapse
Press Release
Read more about
Click Here to Manage Email Alerts