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Efficacy of brodalumab in the treatment of scalp and nail psoriasis: results from three phase 3 trials

机译:brodalumab 治疗头皮和指甲银屑病的疗效:三项 3 期试验的结果

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Introduction: We evaluated the efficacy of brodalumab in patients with nail or scalp psoriasis in three phase 3 studies (AMAGINE-1/-2/-3). Methods: In AMAGINE-1, scalp clearance, measured by the psoriasis scalp severity index (PSSI), was reported for patients who received brodalumab 210 mg every 2 weeks (Q2W) or placebo through 12 weeks. In AMAGINE-2/-3, nail clearance, measured by the nail psoriasis severity index (NAPSI), was reported for patients receiving either brodalumab 210 mg Q2W or ustekinumab continuously through 52 weeks. Results: At week 12, significantly more patients receiving brodalumab achieved 75 and 100 improvement rates from baseline PSSI and had lower mean PSSI across 12 weeks compared with placebo, with significant improvement in PSSI evident with brodalumab 210 mg Q2W vs placebo by week 2. Across 52 weeks, patients receiving brodalumab achieved significantly greater complete clearance of nail psoriasis (NAPSI 0), lower mean NAPSI, and higher mean percent improvement rates from baseline NAPSI than patients receiving ustekinumab. At week 52, 63.8 of patients receiving brodalumab achieved NAPSI 0 vs 39.1 of patients receiving ustekinumab. Conclusions: Brodalumab was associated with clearance of scalp psoriasis through 12 weeks and improvements in nail psoriasis, including complete nail clearance, through 52 weeks.
机译:简介:我们在三项 3 期研究 (AMAGINE-1/-2/-3) 中评估了 brodalumab 对指甲或头皮银屑病患者的疗效。方法:在 AMAGINE-1 中,报告了每 2 周 (Q2W) 接受 brodalumab 210 mg 或安慰剂治疗 12 周的患者的头皮清除率,通过银屑病头皮严重程度指数 (PSSI) 测量。在 AMAGINE-2/-3 中,报告了连续接受 brodalumab 210 mg Q2W 或乌司奴单抗治疗 52 周的患者的指甲清除率,通过指甲银屑病严重程度指数 (NAPSI) 测量。结果:在第 12 周,与安慰剂相比,接受 brodalumab 治疗的患者比基线 PSSI 的改善率明显更高,并且在 12 周内的平均 PSSI 更低,到第 2 周,brodalumab 210 mg Q2W 与安慰剂相比,PSSI 明显改善。在 52 周内,与接受乌司奴单抗的患者相比,接受 brodalumab 治疗的患者实现了指甲银屑病完全清除率 (NAPSI 0)、更低的平均 NAPSI 和更高的基线 NAPSI 平均改善率百分比。在第 52 周时,接受 brodalumab 治疗的患者中有 63.8% 达到 NAPSI 0,而接受乌司奴单抗治疗的患者为 39.1%。结论:Brodalumab在12周内与头皮银屑病的清除率和52周内指甲银屑病的改善(包括完全清除指甲)相关。

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