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HS-20137 significantly increases PASI 90 response rates and maintains durable efficacy through 52 weeks in patients with moderate-to-severe plaque psoriasis.
Psoriasis remains a chronic immune-mediated inflammatory disease that imposes a substantial burden on patients and negatively affects quality of life (QoL). HS-20137, a novel interleukin-23 (IL-23) inhibitor targeting the IL-23 p19 subunit, has demonstrated promising activity in earlier clinical evaluation. This study examined the potency of HS-20137 for moderate-to-severe plaque psoriasis.
A randomized, placebo-controlled phase 2 trial was carried out at 22 sites across China. Overall, 159 adult participants were randomized in a 1:1:1:1 ratio to receive:
Subcutaneous dosing was administered at weeks 0 and 4, followed by maintenance treatment. Those in the placebo arm crossed over to HS-20137 200 mg Q8W at week 16 or week 28. The primary endpoint was the proportion of patients achieving psoriasis area and severity index (PASI)-90 at week 16. Secondary endpoints included PASI 75, PASI 100, investigator global assessment (IGA) responses, body surface area involvement, and dermatology life quality index (DLQI) outcomes.
HS-20137 demonstrated significantly greater efficacy than placebo across all dosing regimens. At week 16, PASI 90 responses were achieved by 67.5%, 76.9%, and 65.0% of patients receiving HS-20137 100 mg Q8W, 200 mg Q8W, and 200 mg Q12W, respectively, compared with 7.5% of patients receiving placebo (P<0.001). Clinical responses continued to improve with treatment, with PASI 90 rates approaching 90% by week 28 and remaining durable through week 52. HS-20137 also improved DLQI scores, reducing the impact of psoriasis on QoL, while higher IGA response rates were observed versus placebo.
Safety outcomes were favorable. During the placebo-controlled period, treatment-emergent adverse event rates were similar across treatment groups, ranging from 67.5% to 77.5%. The majority of adverse events were found to be mild, and only one serious treatment-related adverse event was noted during the study; it resolved following treatment.
HS-20137 illustrated robust and sustained efficacy together with a favorable safety profile. These results supported the continued clinical development of this IL-23 inhibitor as a valuable treatment option for psoriasis.
Dermatology and Therapy
HS-20137 for Chinese Moderate-to-Severe Psoriasis: A Randomized, Double-Blinded, Phase 2 Study
Lin Cai et al.
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