BACKGROUND The hidradenitis suppurativa clinical response (HiSCR) is the gold standard primary outcome measure for hidradenitis suppurativa clinical trials; however, it does not assess the presence of draining tunnels, a common finding in advanced disease. It is unclear what the effect of the presence or absence of draining tunnels has on the efficacy of adalimumab therapy in moderate and advanced disease. OBJECTIVES We evaluated the efficacy of adalimumab versus placebo using the International Hidradenitis Suppurativa Severity Scoring System (IHS4). Additionally, we assessed the effect of draining tunnels on therapeutic response as measured by both the HiSCR and change in nodule counts. METHODS Reanalysis was conducted with the IHS4 and PIONEER 1 and 2 individual patient data. Both binary outcomes (achieving HiSCR and achieving change in IHS4 severity category) and continuous outcomes (nodule counts and IHS4 score) were calculated with R. Regression modeling was undertaken to assess the effect of draining tunnels and other variables. P < .05 was considered statistically significant. RESULTS The significance of adalimumab therapy depended on the outcome measure used. Placebo response rates were highest when binary outcome measures were used. Draining tunnels, smoking, antibiotics, and body mass index influenced HiSCR response in PIONEER 2. Significant differences in disease severity were observed between PIONEER 1 and 2 data sets. CONCLUSIONS Elevated placebo response rates in PIONEER 1 and 2 are partially attributable to the use of binary outcome measures. Draining tunnels influence clinical response as measured by HiSCR and nodule counts in PIONEER 2. Further investigation into the effect of body mass index on clinical response is required.

中文翻译：

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临床反应率，安慰剂反应率和显着相关的协变量取决于化脓性汗腺炎的结局指标的选择：对PIONEER 1和2个人患者数据的事后分析。

背景技术化脓性汗腺炎的临床反应（HiSCR）是化脓性汗腺炎临床试验的金标准主要结局指标。但是，它没有评估引流管的存在，而引流管是晚期疾病的常见发现。目前尚不清楚存在或不存在引流隧道对阿达木单抗治疗中度和晚期疾病的疗效有何影响。目的我们使用国际化脓性汗腺炎严重程度评分系统（IHS4）评估了阿达木单抗与安慰剂的疗效。此外，我们通过HiSCR和结节计数的变化评估了引流隧道对治疗反应的影响。方法使用IHS4和PIONEER 1和2个人患者数据进行重新分析。用R计算二进制结果（达到HiSCR并实现IHS4严重性类别的变化）和连续结果（结节计数和IHS4得分）。采用回归模型来评估排水隧道和其他变量的影响。P <.05被认为具有统计学意义。结果阿达木单抗治疗的重要性取决于所使用的结果指标。使用二元结果量度时，安慰剂反应率最高。排水通道，吸烟，抗生素和体重指数影响了PIONEER 2中的HiSCR反应。在PIONEER 1和2组数据之间观察到疾病严重程度的显着差异。结论PIONEER 1和PIONE 2中安慰剂反应率升高部分归因于使用二元结果量度。