Phase 3 Data Shows Long-Term Efficacy, Safety of Stapokibart for Atopic Dermatitis

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In a recent phase 3 trial, stapokibart demonstrated long-term efficacy and safety in adults with moderate-to-severe atopic dermatitis.¹

“The results demonstrated that improvements in [atopic dermatitis] signs and symptoms observed after the first 16 weeks of stapokibart treatment were maintained or continued to improve through Week 52,” wrote investigators, led by Yan Zhao, from the department of dermatology at Peking University People's Hospital in China.

Although topical medications are first-line treatments for atopic dermatitis, it is not advised to use high-potency topical corticosteroids, oral corticosteroids, and systemic immunosuppressants for a long time due to safety concerns and insufficient efficacy data. According to the National Health Service, using corticosteroids for a long time can increase the risk of the medicine being absorbed into the bloodstream and leading to internal adverse events, including decreasing growth in children and Cushing’s syndrome.²

Phototherapy, the treatment recommended if symptoms linger after topical medications, can also be dangerous since it may increase the risk of skin cancer.¹ Investigators recognized the need for a long-term medication for atopic dermatitis, so they evaluated the effectiveness and safety of stapokibart over 52 weeks in a phase 3 study.

This trial extended off a multicenter, randomized, double-blind, placebo-controlled 16-week phase 3 trial evaluating stapokibart on adults with moderate-to-severe atopic dermatitis.The research was conducted from April 22, 2022, to November 1, 2022, across 59 hospitals in China.

The 16-week trial found a significantly greater proportion of patients on stapokibart than placebo achieved ≥ 75% improvement from baseline in atopic dermatitis, based on the Eczema Area and Severity Index (66.9% vs 25.8%; P < .001).³ Also, more patients on stapokibart than placebo had an Investigator’s Global Assessment score of 0/1 with a ≥ 2-point reduction (44.2% vs 16.1%; P < .0001).

Following the 16-week double-blind treatments, patients in both the stapokibart and placebo arms entered a 36-week maintenance treatment period where they received stapokibart 300 mg every 2 weeks.¹ Participants were required to apply moisturizers twice during the study and were allowed to use other topical medications for atopic dermatitis during the maintenance period.

Among the 476 patients who entered the maintenance period, 430 completed the treatment. At week 52, 92.5% of patients continuing stapokibart and 88.7% of patients who had switched from placebo to tapokibart achieved 75% improvement based on the Eczema Area and Severity Index.

Moreover, 67.3% continuing stapokibart and 88.7% switching from placebo to tapokibart achieved an Investigator’s Global Assessment score of 0 or 1 with a ≥ 2-point reduction. Additionally, 67.3% and 60.5%, respectively, achieved a ≥ 4-point reduction in the weekly average of the daily Peak Pruritus Numerical Rating Scale.

Many (88.1%) patients reported treatment-emergent adverse events, but most were mild or moderate. Common infections and infestations were COVID-19 (38.9%), upper respiratory tract infection (14.7%), and suspected COVID-19 (11.5%). They also observed conjunctivitis in 5.3% of patients and injection site reactions in 2% of patients.

“Stapokibart 300 mg Q2W demonstrated sustained efficacy in Chinese adults with moderate-to-severe [atopic dermatitis] for up to 52 weeks, with a favorable safety profile,” investigators concluded. “These data support the viability of stapokibart as a continuous, long-term treatment for adults with moderate-to-severe [atopic dermatitis].”

References

1. ^{Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Li J, Diao Q, Sun Q, Zhu X, Man X, Wang L, Li L, Feng Y, Zeng H, Cai T, Ren H, Lu J, Lu Q, Tao X, Xiao R, Ji C, Li F, Zhang J. Long-term efficacy and safety of stapokibart for moderate-to-severe atopic dermatitis: 52-week results from a phase 3 trial. Allergy. 2024 Oct 25. doi: 10.1111/all.16368. Epub ahead of print. PMID: 39450683.}
2. ^{Topical corticosteroids. NHS. https://www.nhs.uk/conditions/topical-steroids/#:~:text=If%20potent%20or%20very%20potent,Cushing's%20syndrome. Accessed November 1, 2024.}
3. ^{Zhao Y, Zhang L, Zhang J; CM310AD005 Study Investigators. Efficacy and safety of stapokibart (CM310) in adults with moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2024 Nov;91(5):984-986. doi: 10.1016/j.jaad.2024.07.1447. Epub 2024 Jul 20. PMID: 39038559.}