Nemolizumab shows long-term efficacy in treatment of prurigo nodularis, atopic dermatitis
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Key takeaways:
- Nemolizumab continuously improved prurigo nodularis in up to 69% of patients by week 52.
- Up to 62% of nemolizumab-treated patients with atopic dermatitis achieved IGA 0 or 1 by week 48.
SAN DIEGO — At the American Academy of Dermatology Annual Meeting, Galderma announced new data demonstrating nemolizumab’s long-term efficacy in treating prurigo nodularis and atopic dermatitis, according to a press release.
The data presented included 52-week results from an interim analysis of the OLYMPIA LTE study for prurigo nodularis and 48-week results from the ARCADIA 1 and 2 trials for AD.
"These new data demonstrate nemolizumab’s long-lasting impact on skin lesions and itch in prurigo nodularis, building on previous results seen with the OLYMPIA clinical program — the largest phase 3 investigation into this debilitating skin condition to date,” Shawn Kwatra, MD, associate professor of dermatology at the John Hopkins University School of Medicine, told Healio concerning the ongoing 148-week OLYMPIA LTE study.
In this study, the efficacy and safety of nemolizumab monotherapy without topical corticosteroids was evaluated in patients with severe prurigo nodularis who had previously received nemolizumab or placebo in phase 2 and 3 trials.
The interim analysis showed that nemolizumab treatment continuously improved skin lesions and itch up to 52 weeks with 69% and 65% of those previously treated with nemolizumab and those previously treated with placebo, respectively, reaching clear or almost clear IGA scores.
At least a 4-point improvement on the peak-pruritus numerical rating scale was also achieved by 89% and 83% of the aforementioned groups, respectively. As a result, sleep disturbance scores and quality of life improved.
According to the release, the rapid improvement seen in nemolizumab-naïve patients as early as week 4 solidifies nemolizumab’s rapid onset of action. Additionally, no new safety signals were observed.
Galderma also presented results from an analysis of maintenance data from two pivotal phase 3 trials of nemolizumab accompanied by background topical corticosteroid therapy or topical calcineurin inhibitors for the treatment of moderate to severe AD in adults and adolescents.
As Healio previously reported, nemolizumab achieved positive results in patients in the earlier stages of ARCADIA 1 and 2, which amounted to 16 weeks. Patients that responded to therapy then continued treatment up to 48 weeks, receiving treatment once every 4 weeks or once every 8 weeks.
The newly presented data showed that 62% of those treated once every 4 weeks and 60% of those treated once every 8 weeks maintained IGA scores of 0 or 1 vs. 50% of placebo. Also, 76% of both nemolizumab groups also achieved EASI 75 vs. 64% of placebo. According to the release, improvements in itch were also maintained in a larger proportion of nemolizumab-treated patients vs. placebo.
As Healio previously reported, the FDA and European Medicines Agency accepted filing submissions for nemolizumab in both indications in February, and the FDA granted the drug priority review for prurigo nodularis. According to the press release, Galderma plans to submit more filings to regulatory authorities in additional countries this year.
References:
- Silverberg JI, et al. S050 late-breaking research: session 2. Presented at: American Academy of Dermatology Annual Meeting; March 8-13, 2024; San Diego.