Rademikibart maintains efficacy in atopic dermatitis through 1 year
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Key takeaways:
- Rademikibart showed continued efficacy with 2-week and 4-week dosing in patients who reached EASI 75 in stage 1 trials.
- Improvements in both pruritus and quality of life were also maintained.
Long-term trial results showed efficacy of rademikibart in Chinese patients with moderate to severe atopic dermatitis, Connect Biopharma announced in a press release.
The clinical trial included two phases. In the first phase, 255 patients were randomly assigned to receive rademikibart 300 mg or placebo every 2 weeks (Q2W) for 16 weeks. An additional 75 patients were added at the back end of the trial phase. In the second stage, patients who achieved EASI 50 in the first phase were randomly assigned to receive rademikibart every 2 weeks or every 4 weeks (Q4W), whereas those who did not achieve EASI 50 were assigned to an open label every 2-week arm. This regimen continued through week 52.
In patients who had achieved IGA 0/1 or EASI 75 at week 16, 91.9% of the Q4W group and 91.7% of the Q2W group maintained EASI 75 at week 52. Further, 87.2% of the Q4W group and 76% of the Q2W group maintained an IGA score of 0 or 1 (clear or almost clear), along with at least a 2-point reduction.
In patients who achieved EASI 50 at week 16, 62.6% of the Q4W group and 59.1% of the Q2W group achieved IGA 0/1, and 84.6% and 84.8% achieved EASI 75 by week 52, respectively.
Of the patients who had achieved at least a 4-point reduction in the peak pruritus numerical rating scale (PP-NRS) at week 16, 95.2% of the Q4W group and 81.6% of the Q2W group maintained that level.
For subjects who achieved an improvement in the Dermatology Quality of Life Index (DLQI) of at least 5 points at week 16, this improvement was maintained in 93.4% and 90% of the Q2W and Q4W groups.
“We are very pleased with the stage 2 results of our pivotal China trial, showing that the strong improvements observed in patients at week 16 in stage 1 were maintained with both every 2 weeks and every 4 weeks dosing regimens,” Zheng Wei, PhD, co-founder and CEO of Connect Biopharma, said in the release. “This study demonstrated that rademikibart has a best-in-class potential, and if approved as a Q4W treatment, we believe could offer patients with AD a highly efficacious treatment with less frequent dosing than current approved treatments.”
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