Kokolakis Georgios, Vadstrup Kasper, Hansen Jes B, Carrascosa Jose Manuel
Clinic of Dermatology, Venereology and Allergology, Psoriasis Research and Treatment Centre, Charité-Universitätsmedizin Berlin, Luisenstrasse 2, 10117, Berlin, Germany.
LEO Pharma A/S, Industriparken 55, 2750, Ballerup, Denmark.
Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
INTRODUCTION: Obesity, smoking, and alcohol consumption are prevalent in psoriasis patients and have been associated with increased disease severity and reduced treatment adherence and response. This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials compared the efficacy of brodalumab versus ustekinumab in psoriasis patients with aggravating and potentially treatment-confounding lifestyle risk factors. METHODS: This post hoc analysis evaluated complete skin clearance, as measured by a 100% reduction of Psoriasis Area and Severity Index (PASI100) and quality of life (QoL), as measured by a Dermatology Life Quality Index (DLQI) score of 0/1, by the presence of risk factors (obesity, tobacco or alcohol use). A competing risk model assessed cumulative incidence over 52 weeks with outcomes of PASI100 or inadequate response. RESULTS: This analysis included 929 patients (brodalumab 210 mg, n = 339; ustekinumab, n = 590) with moderate-to-severe psoriasis. At week 52, odds ratios (95% confidence intervals [CIs]) for complete clearance with brodalumab versus ustekinumab were 2.50 (1.14-5.46, P = 0.0186), 4.64 (2.80-7.69, P < 0.0001), 2.06 (1.25-3.40, P = 0.0045), and 2.55 (0.55-11.91, P = 0.2117) in patients with no, one, two, or three risk factors, respectively. Corresponding odds ratios (ORs) (95% CIs) for DLQI 0/1 with brodalumab versus ustekinumab were 1.72 (0.78-3.79, P = 0.1883), 2.49 (1.54-4.02, P < 0.0002), 1.57 (0.97-2.54, P = 0.0666), and 2.07 (0.45-9.57, P = 0.3438). The 52-week cumulative incidence of patients achieving PASI100 was consistently higher for brodalumab versus ustekinumab, regardless of number of risk factors (P < 0.0001 for one or two risk factors and P = 0.0029 for three risk factors). CONCLUSIONS: Higher levels of complete skin clearance and QoL were achieved and maintained with brodalumab versus ustekinumab in patients with moderate-to-severe psoriasis, regardless of the presence of lifestyle risk factors. CLINICAL TRIAL REGISTRATION: AMAGINE-2 (NCT01708603); AMAGINE-3 (NCT01708629).
引言：肥胖、吸烟和饮酒在银屑病患者中普遍存在，且与疾病严重程度增加、治疗依从性降低及反应不佳相关。这项对3期AMAGINE - 2和 - 3试验汇总数据的事后分析，比较了布罗达单抗与优特克单抗在伴有加重病情且可能影响治疗的生活方式风险因素的银屑病患者中的疗效。 方法：这项事后分析通过银屑病面积和严重程度指数（PASI）降低100%（PASI100）来评估皮肤完全清除情况，并通过皮肤病生活质量指数（DLQI）评分为0/1来评估生活质量（QoL），同时考虑风险因素（肥胖、吸烟或饮酒）的存在情况。一个竞争风险模型评估了52周内达到PASI100或反应不足的累积发生率。 结果：该分析纳入了929例中重度银屑病患者（布罗达单抗210mg组，n = 339；优特克单抗组，n = 590）。在第52周时，无风险因素、有一个风险因素、有两个风险因素和有三个风险因素的患者中，布罗达单抗相对于优特克单抗实现完全清除的比值比（95%置信区间[CI]）分别为2.50（1.14 - 5.46，P = 0.0186）、4.64（2.80 - 7.69，P < 0.0001）、2.06（1.25 - 3.40，P = 0.0045）和2.55（0.55 - 11.91，P = 0.2117）。布罗达单抗相对于优特克单抗DLQI为0/1的相应比值比（OR）（95% CI）分别为1.72（0.78 - 3.79，P = 0.1883）、2.49（1.54 - 4.02，P < 0.0002）、1.57（0.97 - 2.54，P = 0.0666）和2.07（0.45 - 9.57，P = 0.3438）。无论风险因素数量如何，布罗达单抗实现PASI100的52周累积发生率始终高于优特克单抗（一个或两个风险因素时P < 0.0001，三个风险因素时P = 0.0029）。 结论：在中重度银屑病患者中，无论是否存在生活方式风险因素，布罗达单抗比优特克单抗能实现并维持更高水平的皮肤完全清除和生活质量。 临床试验注册：AMAGINE - 2（NCT01708603）；AMAGINE - 3（NCT01708629）。
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