Galderma announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.[1] Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).[2] 

These late-breaking data were presented at the 2024 American Academy of Dermatology Association (AAD) annual meeting, taking place on March 8-12, 2024.

Building on the results of OLYMPIA 1 and OLYMPIA 2, the OLYMPIA open-label LTE study is an ongoing 184-week trial to evaluate the long-term efficacy and safety of nemolizumab monotherapy (without topical corticosteroids) in patients with moderate to severe prurigo nodularis who had received nemolizumab in phase 2 and 3 lead-in trials as well as those who had previously received placebo (nemolizumab-naïve).[1,4,5]

According to Garderma, results from an interim analysis of the OLYMPIA LTE study demonstrated that nemolizumab treatment provided continuous improvement in skin lesions and itch up to week 52:

• 69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator’s Global Assessment (IGA) score
• 89% of those who had received continuous nemolizumab treatment and 83% of nemolizumab-naïve patients achieved a significant response on itch intensity as measured by an at least four-point improvement on the peak-pruritus numerical rating scale (PP-NRS)

Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).

Results also reinforced nemolizumab’s rapid onset of action, with nemolizumab-naïve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week 4, consistent with the continuous-nemolizumab cohort. No new safety signals were observed.[1] 

Galderma also presented results from an analysis of maintenance data from two pivotal phase 3 trials of nemolizumab (administered with background topical corticosteroid therapy or topical calcineurin inhibitors) in adolescent and adult patients with moderate to severe atopic dermatitis (ARCADIA 1 and ARCADIA 2). is [2,3]

Out of the patients who had clinical responses to skin lesions* at week 16 in ARCADIA 1 and 2, the majority maintained skin and itch responses at week 48 when receiving nemolizumab Q4W or Q8W in the maintenance phase:

• 62% of those receiving nemolizumab Q4W and 60% of those receiving nemolizumab Q8W maintained clearance or almost-clearance of skin lesions, when assessed using the IGA score, compared to 50% receiving placebo
• The Eczema Area and Severity Index (EASI)-75 score was also maintained in 76% of those receiving nemolizumab—both Q4W and Q8W—compared to 64% receiving a placebo
• Itch response, as measured by an at least four-point improvement in weekly average PP-NRS score, was similarly maintained in the majority of patients receiving nemolizumab—both Q4W and Q8W—compared to placebo

*Defined as patients who achieved an IGA score of clear (0) or almost-clear (1), or a 75% or greater improvement in the EASI score

Response in sleep and quality of life, as measured by the SD-NRS and DLQI scales, respectively, were also well maintained. The safety profile was consistent across treatment arms and most treatment-related adverse events were non-serious and mild/moderate in intensity, according to Garderma.

The FDA and European Medicines Agency accepted filing submissions for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024. Nemolizumab was also granted FDA priority review for prurigo nodularis. Further submissions to regulatory authorities in additional countries are planned in 2024.

References:

1. Kwatra, S, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: an interim analysis. Late-breaking abstract presented at AAD 2024.
2. Silverberg, J, et al. Maintenance of efficacy and safety with nemolizumab at Week 48: results from two global phase III pivotal studies (ARCADIA 1 and ARCADIA 2) in patients with moderate-to-severe atopic dermatitis​. Late-breaking abstract presented at AAD 2024
3. Silverberg J, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented at EADV 2023
4. Ständer S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1). Late-breaking abstract presented at EADV 2023.
5. Kwatra SG, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. DOI: 10.1056/NEJMoa2301333