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A post hoc analysis shows the investigative drug significantly improved atopic dermatitis symptoms versus placebo as soon as the first week into a phase 2 trial.
Nemolizumab was associated with significant and nearly immediate improvements in measures of atopic dermatitis relief in adult patients, according to post hoc data from a phase 2b trial.1
In an abstract presented at the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this week, a multinational team of investigators reported findings from an assessment indicating significant improvement of SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) scores among patients treated with nemolizumab—as early as week 1 post-treatment.
The data contribute to the profile of the investigative interleukin 31 receptor A (IL-31A) inhibitor, which to this point has been assessed in late-stage trials for atopic dermatitis and prurigo nodularis. In a Peer Exchange panel discussion last year, Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, expressed excitement for nemolizumab as an agent that may mutually benefit itch and skin disease severity in treated patients.
“That could be really different and presumably will not have too much of a dampening effect on the immune system,” Lio said regarding its mechanism of action. “It might be a little more of a pure anti-itch (medication), although we know it has an effect in some of the earlier trials we’ve seen on the lesions themselves.”2
A research team led by Jean-David Bouaziz, MD, PhD, of the department of dermatology at Paris VII Sorbonne City University, sought to interpret the impact of nemolizumab on adult patient SCORAD and EASI scores. Though the Galderma agent is currently in phase 3 assessment, the team analyzed post-hoc data from a phase 2b trial that showed a rapid and sustained rate of improvement in cutaneous signs of inflammation and pruritus among patients with atopic dermatitis receiving care for 24 weeks.3
The patient population had received either 30 mg subcutaneous nemolizumab every 4 weeks following a 60 mg loading dose (n = 50) or placebo (n =44), plus steroids for all patients with baseline EASI ≥16.
The SCORAD provides a combined score of ≤103 based on weighted scales of disease severity, and the extent of and patient-reported burden of symptoms for their atopic dermatitis. The EASI assessment grades up to 100, combining body surface area burden plus the severity of skin lesions to calculate its score. Along the overall scores, investigators sought components including SCORAD itch and sleep visual analog scale (VAS) outcomes in patients.
Bouaziz and colleagues observed similar patient demographics and clinical characteristics at baseline. Approximately 3 in every 5 patients reported moderate disease at baseline; the rest reported severe disease.
Mean decrease in total SCOARD score was 57.1% at 16 weeks among patients receiving nemolizumab; patients receiving placebo reported a mean 28.2% decrease in that same time period (P <.001). The separation in SCORAD improvement was distinct by week 1 post-treatment; nemolizumab-treated patients reported a 13.4 percentage-point reduction in its mean score versus patients on placebo (P <.001). Investigators similarly observed a separation in improved SCORAD sleep VAS by week 1 through the observed timepoints to week 16 (P <.001).
Overall EASI score decreased 68.6% among nemolizumab-treated patients from baseline to week 16; patients on placebo reported a mean decrease of 42.6%. Investigators additionally noted improvements per EASI and SCORAD components speaking to reductions in erythema, excoriation, papulation, and lichenification.
They additionally observed a consistent safety profile with nemolizumab; the most commonly-reported adverse events were nasopharyngitis and respiratory infections.
“Improvement of the clinical signs of atopic dermatitis as indicated by SCORAD components were apparent at week 1 and increased through week 16,” the team concluded.