Monoclonal antibody therapy treatment for moderate to severe atopic dermatitis shows promise: Mount Sinai Research

Eczema, also known as atopic dermatitis, is a
disorder that results in dry, itchy, and inflamed skin. Although it can happen
to anyone, it is more frequent in young children. Atopic dermatitis is
persistent (chronic) and occasionally flares up. Although it is not contagious,
it can be unpleasant.

Patients with moderate to severe atopic
dermatitis who participated in a clinical trial of rocatinlimab-a novel,
patient-tailored monoclonal antibody therapy-showed promising results both
while taking the drug and up to 20 weeks after the therapy was stopped, Mount
Sinai researchers reported in The Lancet.

The researchers said the results indicate that
rocatinlimab has the potential to change the genetic makeup of a person’s
atopic dermatitis for the long term, and possibly help sustain lasting results
without continued use. Rocatinlimab inhibits OX40-an immune molecule involved
in activating inflammatory cells that play a key role in the development of
atopic dermatitis and other inflammatory diseases.

“Atopic dermatitis, the most common type of
eczema, is a debilitating chronic inflammatory skin disease that affects 1 in
10 Americans and millions of people worldwide,” said Emma Guttman, MD, PhD,
Waldman Professor and System Chair, The Kimberly and Eric J. Waldman Department
of Dermatology; Director, Center of Excellence in Eczema; and Director,
Laboratory of Inflammatory Skin Diseases, at the Icahn School of Medicine at
Mount Sinai. “It often develops at a very young age, causing the skin to become
inflamed, red, extremely itchy, painful, and very dry-all symptoms that greatly
affect a patient’s quality of life. We are very optimistic about the results of
this trial and the potential for disease modification and long-lasting effects
to improve patients’ quality of life.”

In this phase 2b multicenter, double-blind,
placebo-controlled study, 274 patients were recruited and (rocatinlimab: n=217;
placebo: n=57) randomly assigned 1:1:1:1:1 to rocatinlimab every four weeks
(150 mg or 600 mg) or every two weeks (300 mg or 600 mg) or subcutaneous
placebo up to week 18, with an 18-week active-treatment extension and 20-week
follow-up. This trial was conducted at 65 sites within the United States,
Canada, Japan, and Germany.

Percent change from baseline in the Eczema
Area and Severity Index (EASI) score was assessed as the primary endpoint at
week 16, and significance versus placebo was achieved with all active
rocatinlimab doses (-48% to -61%) doses compared to placebo (-15%). All active
dose cohorts also continued improving after week 16, and most patients maintained
the response for at least 20 weeks off treatment.

The results support rocatinlimab as a safe and
effective treatment for moderate to severe atopic dermatitis, with potentially
long-lasting efficacy and disease modification. Adverse events reported were generally
similar between rocatinlimab groups. Common adverse events during the
double-blind period included fever, chills, headache, aphthous ulcers (canker
sores), and nausea.

“At week 36, all participants had been on the
treatment for at least 18 weeks,” added Dr. Guttman, senior author of the
study. “By this time, we saw that while the drug achieved the primary endpoints
in all doses versus the placebo, it’s also a drug that improves over time,
which is really unusual and unique among currently available treatment
options.”

Researchers plan to continue this
investigation in a phase 3 program in 2023. Future studies will also include a
larger study population, longer follow-up, and exploration of combination
therapy (such as rocatinlimab plus topical corticosteroids).

Reference:

Emma Guttman et al, The Lancet, DOI 0.1016/S0140-6736(22)02037-2

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