- 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
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 as early
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<0.001).
- 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<0.001).
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
<2 on the peak pruritus numerical rating scale) was achieved by
16% of patients in both ARCADIA 1 and 2 at Week 4, after just one
dose of nemolizumab, when compared to the placebo group (4% and 3%,
respectively; p<0.001).
- 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<0.001).
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.
Media can find more information about atopic dermatitis in this
media toolkit page.
About atopic dermatitis Atopic dermatitis a common,
chronic, and flaring inflammatory skin disease, characterized by
persistent itch and recurrent skin lesions.4,8,9 It affects more
than 230 million people worldwide and is the most common
inflammatory skin disease, impacting almost four times more people
than psoriasis.4,10 While currently available treatments for atopic
dermatitis show some improvements of signs and symptoms, not all
patients experience itch relief and clear skin to the same degree,
and many do not respond optimally to approved therapies.4,11
About nemolizumab Nemolizumab is a monoclonal antibody
developed by Galderma and is the first therapy designed to
specifically inhibit interleukin-31 (IL-31) cytokine signaling.2
IL-31 signaling is known to drive the most burdensome symptom for
people with atopic dermatitis and prurigo nodularis – itch.3-5
Nemolizumab is under review for both prurigo nodularis and
atopic dermatitis by several regulatory authorities worldwide,
including the U.S. Food and Drug Administration, European Medicines
Agency and in Australia, Singapore, Switzerland, and the United
Kingdom via the Access Consortium, with ongoing submissions in
additional countries.6,7
Nemolizumab was initially developed by Chugai Pharmaceutical
Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide
– except Japan and Taiwan. In Japan, nemolizumab is approved for
the treatment of pruritus associated with atopic dermatitis and for
prurigo nodularis.12,13
About the ARCADIA clinical trial program1,14,15 The
ARCADIA program included two identically designed, pivotal phase
III clinical trials, which enrolled more than 1,700 patients –
ARCADIA 1 and ARCADIA 2.
These global, randomized, multicenter, double-blind,
placebo-controlled phase III clinical trials, evaluated the
efficacy and safety of nemolizumab administered subcutaneously
every four weeks compared to placebo (both administered with
background topical corticosteroids with or without topical
calcineurin inhibitors).
The trials were conducted in adolescent and adult patients (12
years and over) with moderate-to-severe atopic dermatitis for an
initial treatment phase of 16 weeks. Patients who responded to
treatment (defined as patients who achieved an investigator’s
global assessment score of clear (0) or almost clear (1), or a 75%
or greater improvement in the eczema area and severity index score)
were then re-randomized to a maintenance treatment phase for up to
48 weeks.
About Galderma Galderma (SIX: GALD) is the emerging
pure-play dermatology category leader, present in approximately 90
countries. We deliver an innovative, science-based portfolio of
premium flagship brands and services that span the full spectrum of
the fast-growing dermatology market through Injectable Aesthetics,
Dermatological Skincare and Therapeutic Dermatology. Since our
foundation in 1981, we have dedicated our focus and passion to the
human body’s largest organ—the skin—meeting individual consumer and
patient needs with superior outcomes in partnership with healthcare
professionals. Because we understand that the skin we are in shapes
our lives, we are advancing dermatology for every skin story. For
more information: www.galderma.com
References:
- Silverberg JI, et al. Nemolizumab with concomitant topical
therapy in adolescents and adults with moderate-to-severe atopic
dermatitis (ARCADIA 1 & 2): results from two replicate,
double-blind, randomised controlled phase 3 trials. Lancet. 2024.
doi: 10.1016/S0140-6736(24)01203-0
- Silverberg JI, et al. Phase 2B randomized study of nemolizumab
in adults with moderate-to-severe atopic dermatitis and severe
pruritus. J Allergy Clin Immunol. 2020;145(1):173-182.
doi:10.1016/j.jaci.2019.08.013
- Bağci IS and Ruzicka T. IL-31: A new key player in dermatology
and beyond. J Allergy Clin Immunol. 2018;141(3):P858-866. doi:
10.1016/j.jaci.2017.10.045
- Langan SM, Irvine AD, Weidinger S. Atopic dermatitis [published
correction appears in Lancet. 2020;396(10253):758]. Lancet.
2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1
- Datsi A, et al. Interleukin-31: The “itchy” cytokine in
inflammation and therapy. Allergy. 2021;76:2982-2997. doi:
10.1016/j.jaard.2020.04.183
- Galderma. Galderma announces regulatory filing acceptance for
nemolizumab in prurigo nodularis and atopic dermatitis in the U.S.
and EU. Available online. Last accessed July 2024
- Galderma. Galderma receives filing acceptance for nemolizumab
in prurigo nodularis and atopic dermatitis in four additional
countries. Available online. Last accessed July 2024
- Yang G, et al. Skin Barrier Abnormalities and Immune
Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8): 2867.
doi: https://doi.org/10.3390/ijms21082867
- Ständer S. Atopic dermatitis. N Engl J Med.
2021;384(12):1136-1143. doi: 10.1056/NEJMra2023911
- Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond).
2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257
- Lobefaro F, et al. Atopic dermatitis: Clinical aspects and
unmet needs. Biomedicines. 2022;102927. doi:
10.3390/biomedicines10112927
- Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory
Approval for Mitchga, the first Antibody Targeting IL-31 for
Itching Associated with Atopic Dermatitis. Available online. Last
accessed July 2024
- Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in
Pediatric Atopic Dermatitis and Prurigo Nodularis, for its
Subcutaneous Injection 30mg Vials. Available online. Last accessed
July 2024
- ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in
Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349).
Available online. Last accessed July 2024
- ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in
Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943).
Available online. Last accessed July 2024
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Christian Marcoux, M.Sc. Chief Communications Officer
christian.marcoux@galderma.com +41 76 315 26 50
Sébastien Cros Corporate Communications Director
sebastien.cros@galderma.com +41 79 529 59 85
Emil Ivanov Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com +41 21 642 78 12
Jessica Cohen Investor Relations and Strategy Director
jessica.cohen@galderma.com +41 21 642 76 43