Abstract：
UNASSIGNED: This article reviews clinical trial data that assesses the safety, efficacy, and clinical application of spesolimab, an interleukin-36 (IL-36) blocker, for the treatment of generalized pustular psoriasis (GPP).
UNASSIGNED: A review of the literature was conducted using the search terms: \"spesolimab,\" \"BI 655130,\" and \"spevigo\" in MEDLINE (PubMed) and Clinicaltrials.gov from January 1, 1950 to October 31, 2023.
UNASSIGNED: Relevant articles in English relating to the pharmacodynamics, pharmacokinetics, efficacy, and safety of spesolimab were included.
UNASSIGNED: In one phase 2 clinical trial evaluating single dose IV spesolimab for GPP flares at day 8, 54% of patients receiving spesolimab had a GPP physician global assessment (GPPGA) pustulation subscore of 0, and 43% had a GPPGA total score of 0 compared with 6% and 11% for the placebo group, respectively. Another phase 2 clinical trial assessing subcutaneous spesolimab found 23% of patients in low-dose, 29% in medium-dose, and 10% of high-dose spesolimab had flares by week 48 compared with 52% of the placebo group. Hazard ratios for time to GPP flare compared with placebo were 0.16 (P = 0.0005), 0.35 (P = 0.0057), and 0.47 (P = 0.027) for the spesolimab groups, respectively. Infection rates were similar across treatment and placebo groups, and severe adverse events such as drug reactions with eosinophilia and systemic symptom (DRESS), cholelithiasis, and breast cancer occurred with spesolimab.
UNASSIGNED: Spesolimab is a first-in-class IL-36 monoclonal antibody receptor antagonist approved for the treatment of acute GPP flares. It is a safe and effective therapeutic agent in preventing future GPP flares, with no current comparator trials with other GPP agents.
UNASSIGNED: Spesolimab is a safe and effective treatment for acute GPP flares in adults. Future clinical trials can establish safety and efficacy compared with other agents.
UNASSIGNED: A review of the literature was conducted using the search terms: \"spesolimab,\" \"BI 655130,\" and \"spevigo\" in MEDLINE (PubMed) and Clinicaltrials.gov from January 1, 1950 to October 31, 2023.
UNASSIGNED: Relevant articles in English relating to the pharmacodynamics, pharmacokinetics, efficacy, and safety of spesolimab were included.
UNASSIGNED: In one phase 2 clinical trial evaluating single dose IV spesolimab for GPP flares at day 8, 54% of patients receiving spesolimab had a GPP physician global assessment (GPPGA) pustulation subscore of 0, and 43% had a GPPGA total score of 0 compared with 6% and 11% for the placebo group, respectively. Another phase 2 clinical trial assessing subcutaneous spesolimab found 23% of patients in low-dose, 29% in medium-dose, and 10% of high-dose spesolimab had flares by week 48 compared with 52% of the placebo group. Hazard ratios for time to GPP flare compared with placebo were 0.16 (P = 0.0005), 0.35 (P = 0.0057), and 0.47 (P = 0.027) for the spesolimab groups, respectively. Infection rates were similar across treatment and placebo groups, and severe adverse events such as drug reactions with eosinophilia and systemic symptom (DRESS), cholelithiasis, and breast cancer occurred with spesolimab.
UNASSIGNED: Spesolimab is a first-in-class IL-36 monoclonal antibody receptor antagonist approved for the treatment of acute GPP flares. It is a safe and effective therapeutic agent in preventing future GPP flares, with no current comparator trials with other GPP agents.
UNASSIGNED: Spesolimab is a safe and effective treatment for acute GPP flares in adults. Future clinical trials can establish safety and efficacy compared with other agents.
摘要：
■本文回顾了评估安全性的临床试验数据，功效,和spesolimab的临床应用，白细胞介素-36（IL-36）阻断剂，用于治疗泛发性脓疱型银屑病（3GPP）。
■使用以下搜索词对文献进行了回顾：\“spesolimab，从1950年1月1日至2023年10月31日，MEDLINE（PubMed）和Clinicaltrials.gov中的“BI655130”和“spevigo”。
■有关药效学的英文相关文章，药代动力学，功效,包括spesolimab的安全性。
■在一项第2期临床试验中，评估了在第8天单剂量静脉注射spesolimab治疗3GPP耀斑的情况，接受spesolimab治疗的患者中，54%的患者的GMP医生整体评估（GPPGA）脓疱症子评分为0，43%的患者的GPPGA总分为0，而安慰剂组为6%和11%，分别。另一项评估皮下spesolimab的2期临床试验发现，有23％的患者服用低剂量，中剂量29%，到第48周,10%的高剂量spesolimab出现耀斑,而安慰剂组为52%.与安慰剂组相比，在时间上对PPI发作的危害比为0.16（P=0.0005），0.35（P=0.0057），和0.47（P=0.027）的spesolimab组，分别。治疗组和安慰剂组的感染率相似，和严重的不良事件，如药物反应与嗜酸性粒细胞增多和全身症状（DRESS），胆石症,和乳腺癌发生在spesolimab。
■Spesolimab是一类IL-36单克隆抗体受体拮抗剂，被批准用于治疗急性3GPP耀斑。它是一种安全有效的治疗剂，可以预防未来的3GPP耀斑，目前没有与其他3GPP代理进行比较试验。
■Spesolimab是一种安全有效的治疗成人急性3GPP耀斑的方法。与其他药物相比，未来的临床试验可以确定安全性和有效性。
■使用以下搜索词对文献进行了回顾：\“spesolimab，从1950年1月1日至2023年10月31日，MEDLINE（PubMed）和Clinicaltrials.gov中的“BI655130”和“spevigo”。
■有关药效学的英文相关文章，药代动力学，功效,包括spesolimab的安全性。
■在一项第2期临床试验中，评估了在第8天单剂量静脉注射spesolimab治疗3GPP耀斑的情况，接受spesolimab治疗的患者中，54%的患者的GMP医生整体评估（GPPGA）脓疱症子评分为0，43%的患者的GPPGA总分为0，而安慰剂组为6%和11%，分别。另一项评估皮下spesolimab的2期临床试验发现，有23％的患者服用低剂量，中剂量29%，到第48周,10%的高剂量spesolimab出现耀斑,而安慰剂组为52%.与安慰剂组相比，在时间上对PPI发作的危害比为0.16（P=0.0005），0.35（P=0.0057），和0.47（P=0.027）的spesolimab组，分别。治疗组和安慰剂组的感染率相似，和严重的不良事件，如药物反应与嗜酸性粒细胞增多和全身症状（DRESS），胆石症,和乳腺癌发生在spesolimab。
■Spesolimab是一类IL-36单克隆抗体受体拮抗剂，被批准用于治疗急性3GPP耀斑。它是一种安全有效的治疗剂，可以预防未来的3GPP耀斑，目前没有与其他3GPP代理进行比较试验。
■Spesolimab是一种安全有效的治疗成人急性3GPP耀斑的方法。与其他药物相比，未来的临床试验可以确定安全性和有效性。
