Brodalumab in plaque psoriasis: Real‐world data on effectiveness, safety and clinical predictive factors of initial response and drug survival over a period of 104 weeks

医学 银屑病 内科学 临床试验 银屑病面积及严重程度指数 药品 药理学 免疫学
作者
Natalia Rompoti,Maria Politou,Irene Stefanaki,Charitomeni Vavouli,Marina Papoutsaki,Afroditi Neofotistou,Dimitrios Rigopoulos,Alexander Stratigos,Electra Nicolaidou
出处
期刊:Journal of The European Academy of Dermatology and Venereology [Wiley]
卷期号:37 (4): 689-697 被引量:25
标识
DOI:10.1111/jdv.18825
摘要

Abstract Background Brodalumab, a fully human IgG2k antibody blocking the receptor of IL17, is characterized by a rapid onset of action with high skin clearance rates in clinical trials. Since setting PASI90/100 or absolute PASI ≤ 3 as treatment goals have become attainable, evaluating the effectiveness and safety profile of biologic agents, such as brodalumab, in a real‐world setting is essential. Objective The aim of this study was to evaluate the effectiveness and safety profile of brodalumab over a period of 104 weeks in everyday practice. Clinical predictive factors of initial (week 12/16) response to treatment and long‐term drug survival were also investigated. Methods In this monocentric, retrospective study, PASI90/100 and absolute PASI ≤ 1/3 were assessed in 91 patients with moderate‐to‐severe skin psoriasis under brodalumab at weeks 12/16, 24, 52 and 104 of treatment. At week 12/16, patients with an absolute PASI ≤ 3 were defined as ‘initial responders’ and ≤1 as ‘super‐responders’. Clinical parameters, such as age, gender, BMI, comorbidities and previous systemic treatment, were assessed in order to predict ‘super‐responders’. Drug survival and its prognostic factors were also evaluated. Results PASI90/100 has reached 81.1/66.0% in week 12/16. This response rate increased at week 104, where 87.1/80.7% had PASI90/100 and 84.9% had absolute PASI ≤ 1. The presence of >3 comorbidities, prior treatment with >2 systemic agents and obesity tended to be negative predictive factors of ‘super‐response’. Previous exposure to IL17 inhibitors had no impact on both PASI < 1 and PASI < 3 initial response. One‐ and two‐year drug survival probability was 87.6% and 77.32%, respectively. ‘Initial responders’ and anti‐IL17 drug‐naïve patients had better drug survival. Drug discontinuation occurred in 24.2%, mostly due to secondary failure, and arthralgia was the most common adverse event that led to discontinuation. Conclusions Our study confirms the high effectiveness and good safety profile of brodalumab in the real‐world setting.
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