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Phase III results of vunakizumab for moderate-to-severe chronic plaque psoriasis
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Vunakizumab, a novel anti-IL-17A monoclonal antibody, was investigated in a randomized, double-blind phase III trial (NCT04839016) for treating moderate-to-severe chronic plaque psoriasis.1 The trial enrolled 690 patients, who were randomized 2:1 to receive either vunakizumab 240 mg (n = 461) or placebo (n = 229) over 12 weeks, followed by a maintenance period of up to 52 weeks. The co-primary endpoints were the proportion of patients achieving PASI 90 and a sPGA 0/1 score at Week 12.1 |
| Key learnings |
| At Week 12, a higher proportion of patients treated with vunakizumab vs placebo achieved PASI 90 and sPGA 0/1 (76.8% vs 0.9% and 71.8% vs 0.4%, respectively; p<0.0001). Efficacy was maintained through Week 52 with continuous vunakizumab. |
| Median time to PASI 90 response was 8.3 weeks in the vunakizumab group and was not reached in the placebo group. At 12 weeks, a higher proportion of patients in the vunakizumab group showed improved HR-QoL by achieving DLQI 0/1 compared with placebo (62.0% vs 12.1%). |
| The incidence of AEs in the first 12 weeks was similar between the vunakizumab and placebo groups (69.1% vs 71.6%). Serious treatment-related AEs occurred in 0.9% of patients in the vunakizumab group compared with none in the placebo group. No new safety signals were observed with continuous treatment with vunakizumab up to 52 weeks. |
| Vunakizumab demonstrated rapid, deep, and durable responses with favorable tolerability, offering a promising therapeutic option for chronic plaque psoriasis, comparable with other IL-17A inhibitors. The safety and efficacy of vunakizumab compared with other approved therapies for psoriasis require further investigation. |
Abbreviations: AE, adverse event; DLQI, dermatology life quality index; HR-QoL, health-related quality of life; IL, interleukin; PASI 90, 90% improvement in Psoriasis Area and Severity Index; sPGA, Static Physician's Global Assessment.
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