Stapokibart for atopic dermatitis: Long-term efficacy and safety from Phase 3 trial

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Created On: 23/01/2025

Managing moderate-to-severe atopic dermatitis (AD) often requires long-term therapy. Stapokibart showed superior efficacy to placebo in a 16-week phase 3 trial. This study sought to explore the 52-week efficacy and safety results.

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Key take away

Stapokibart shows durable efficacy and a strong safety profile for the long-term management of moderate-to-severe AD.

Background

Method

After completing the double-blind therapy phase (16 weeks), volunteers in both the Stapokibart and placebo groups transitioned into a 36-week maintenance phase. During this phase, the volunteers received 300 mg of Stapokibart every two weeks. Throughout the maintenance period, the concomitant usage of topical AD therapies was allowed.

Result

Of the 476 subjects who entered the maintenance phase, 430 completed the intervention. At week 52, 92.5% of volunteers continuing Stapokibart attained a ≥75% betterment in the Eczema Area and Severity Index (EASI-75). Additionally, 88.7% of those switching from placebo to Stapokibart reached the same EASI-75 improvement.

Similarly, an Investigator's Global Assessment (IGA) score of 0/1 with a ≥2-point drop was attained in 67.3% and 64.2% of volunteers, respectively. A ≥4-point drop in the weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) was witnessed in 67.3% and 60.5% of patients, respectively. Treatment-emergent adverse events were experienced by 88.1% of volunteers over 52 weeks. These effects were primarily mild or moderate in nature.

Conclusion

In AD-affected adults, Stapokibart (monoclonal antibody targeting interleukin-4 receptor α subunit [IL-4Rα]) offered sustained effectiveness and maintained a favorable safety profile over 52 weeks.