Eczema, also known as atopic dermatitis, is a chronic skin disorder that is often confused with dry, itchy, and inflamed skin. It is most common in infants and children, but it is most prevalent in young people.
In the Lancet, Mount Sinai researchers describe the most remarkable outcomes from a clinical study of rocatinlimab, a new monoclonal antibody therapy tailored to specific patients. The benefits continued for up to 20 weeks after the treatment was discontinued.
According to the researchers, rocatinlimab has the potential to improve a person's eczema genetic makeup in the long run, and it might be effective for years after the therapy is discontinued.
Emma Guttman, Ph.D., director of the Kimberly and Eric J. Waldman Department of Dermatology, and Director of the Icahn School of Medicine's Laboratory of Inflammatory Skin Diseases, said she is very optimistic about the findings of this study and the potential for disease modification and long-term effects to improve patients' quality of life.
274 patients were 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 until week 18, with an 18-week active-treatment extension and 20-week follow-up in this phase 2b multicenter, double-blind placebo-controlled experiment.
At week 16, the primary endpoint was assessed as the Eczema Area and Severity Index (EASI) score, and significant versus placebo was achieved with all active rocatinlimab doses (-48% to -61%) doses, compared to placebo (-15%), and most patients maintained the response for at least 20 weeks off treatment.
rocatinlimab is a safe and effective therapy for moderate to severe atopic dermatitis, with potentially long-term efficacy and disease modification. Common adverse events during the double-blind period included fever, chills, headache, and nausea.
“We saw that while the medication met its primary endpoints in all dosages, it also improved over time, which is remarkable among currently available treatment options.“
Researchers intend to continue this research in a phase 3 study in 2023. Future research will also include a larger sample size, longer follow-up, and research into combination therapies (such as rocatinlimab plus topical corticosteroids).
Emma Guttman-Yassky, Eric L Simpson, Kristian Reich, Kenji Kabashima, Tetsuya Suzuki, Hirotaka Mano, Takeshi Matsui, Ehsanollah Esfandiari, and Masutaka Furue, published in The Lancet on 9 December 2022. DOI: 10.1016/S0140-6736(22)02037-2
The study has been registered on ClinicalTrials.gov (NCT03703102).