- Detailed results from the phase III ARCADIA 1 and 2 trials evaluating the safety and efficacy of nemolizumab in atopic dermatitis were published for the first time in The Lancet1
- Data from this phase III program demonstrate the potential of nemolizumab (in combination with background therapy) to improve key aspects of atopic dermatitis; skin lesions, itch, and sleep disturbance in adolescent and adult patients with moderate-to-severe atopic dermatitis1
- In the ARCADIA trials, statistically significant improvements in itch were observed as early as one week after nemolizumab treatment initiation1
- Nemolizumab is a first-in-class monoclonal antibody that inhibits the signaling of IL-31, a neuroimmune cytokine known to drive key signs and symptoms of atopic dermatitis2-5
ZUG, Switzerland--BUSINESS WIRE--
Galderma today announced that full results from the phase III ARCADIA 1 and 2 clinical trials in atopic dermatitis were published in The Lancet.1The trials evaluated the efficacy and safety of nemolizumab in combination with background topical corticosteroids (TCS), with or without topical calcineurin inhibitors (TCI), versus placebo in combination with TCS, with or without TCI, in adolescent and adult patients with moderate-to-severe atopic dermatitis.1 Results show that the trials met their co-primary and all key secondary endpoints, showing that nemolizumab significantly improved skin lesions, itch and sleep disturbance by Week 16 when compared to placebo, with significant itch relief observed asearly as Week 1.1
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"Publication of the phase III 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. We are working closely with regulators in the U.S., Europe, and elsewhere to bring nemolizumab to those in need as soon as possible." BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA |
The phase III ARCADIA 1 and 2 trials enrolled 1,728 adolescent and adult patients with moderate-to-severe atopic dermatitis.1 Results demonstrated that patients treated with nemolizumab, administered subcutaneously every four weeks in combination with TCS, with or without TCI, showed statistically significant improvements in both co-primary endpoints, when compared to placebo in combination with TCS, with or without TCI, after 16 weeks of treatment:1
- 36% and 38% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved clear skin, defined by an investigator's global assessment score of clear (0) or almost-clear (1), when compared to the placebo group (25% and 26%, respectively; p
- 44% and 42% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved at least a 75% improvement in the eczema area and severity index score, when compared to the placebo group (29% and 30%, respectively; p
The trials also met all key secondary endpoints confirming rapid responses on itch, and statistically significant improvements in sleep disturbance with nemolizumab in combination with TCS, with or without TCI, when compared to placebo in combination with TCS, with or without TCI:1
- Clinically meaningful improvements in itch were observed as early as one week after nemolizumab treatment initiation when compared to placebo.
- An itch-free or nearly itch-free state (defined as a score of
- At Week 16, 38% and 34% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved at least a four-point improvement in the sleep disturbance numerical rating scale, when compared to the placebo group (20% and 16%, respectively; p
The safety profile was consistent between nemolizumab and placebo groups; most treatment-emergent adverse events were non-serious, and of mild-to-moderate severity.1
Nemolizumab is a first-in-class monoclonal antibody specifically designed to target the interleukin-31 (IL-31) receptor alpha and inhibit IL-31 signaling.2 In atopic dermatitis, IL-31 drives itch and is involved in inflammation and skin barrier disruption.3-5
"As a practicing dermatologist, I'm excited about the potential of nemolizumab for atopic dermatitis patients. These phase III data demonstrate that, by blocking the activity of IL-31, nemolizumab could effectively address itch, skin lesions and sleep disturbance. Many patients complain that chronic itch negatively impacts their overall quality of life. Reducing itch within just one week of treatment could significantly ease the burden of disease." Prof. Jonathan Silverberg LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, Professor of Dermatology, George Washington University School of Medicine and Health Sciences, United States |
Based on the results of the ARCADIA 1 and 2 trials, the U.S. Food and Drug Administration accepted for review Galderma's Biologics License Application for nemolizumab for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis, with a decision expected by the end of the year.6 Galderma is awaiting decisions from several other regulatory authorities on its filing applications for both atopic dermatitis and prurigo nodularis, including the European Medicines Agency, Health Canada, and the Access Consortium.7 Regulatory submissions to other healthcare authorities around the world are ongoing.
