Clinical Unit for Research Trials and Outcomes in Skin, Massachusetts General Hospital, Harvard Medical School, 50 Staniford Street, No. 246, Boston, MA 02114, USA.
Ann Intern Med. 2012 Dec 18;157(12):846-55. doi: 10.7326/0003-4819-157-12-201212180-00004.
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, painful skin disease characterized by abscesses, nodules, and draining fistulas in the axilla and groin of young adults. OBJECTIVE: To evaluate the efficacy and safety of adalimumab, an anti-tumor necrosis factor-α antibody, in patients with moderate to severe HS. DESIGN: Phase 2, parallel, randomized, placebo-controlled trial consisting of a blinded 16-week period (period 1) and an open-label 36-week period (period 2). All study personnel, investigators, and patients remained blinded to treatment group throughout the study. (ClinicalTrials.gov: NCT00918255) SETTING: 26 academic and private practice medical centers in the United States and Europe. PATIENTS: 154 adult patients with moderate to severe HS who were unresponsive or intolerant to oral antibiotics. INTERVENTION: Patients were assigned in a 1:1:1 ratio to adalimumab, 40 mg/wk; adalimumab, 40 mg every other week (EOW); or placebo. All patients received adalimumab, 40 mg EOW, at the beginning of period 2 but switched to weekly dosing if the response was suboptimal (HS Physician's Global Assessment [PGA] score of moderate or worse) at weeks 28 or 31. MEASUREMENTS: The primary outcome measure (clinical response) was the proportion of patients achieving an HS-PGA score of clear, minimal, or mild with at least a 2-grade improvement relative to baseline at week 16. RESULTS: At week 16, 3.9% of placebo patients (2 of 51), 9.6% of EOW patients (5 of 52), and 17.6% of weekly patients (9 of 51) achieved clinical response (EOW vs. placebo strata-adjusted difference, 5.6% [95% CI, -4.0% to 15.3%]; P = 0.25; weekly vs. placebo strata-adjusted difference, 13.7% [CI, 1.7% to 25.7%]; P = 0.025). Serious adverse event rates were 3.9%, 5.8%, and 7.8% for placebo, EOW, and weekly patients, respectively (EOW vs. placebo difference, 1.8% [CI, -6.4% to 10.1%]; weekly vs. placebo difference, 3.9% [CI, -5.2% to 13.0%]). Significantly greater improvements in patient-reported outcomes and pain were seen in the weekly dosing group than in the placebo group. A decrease in response was seen after the switch from weekly to EOW dosing in period 2. LIMITATIONS: Weeks 16 to 52 of the study were open-label. The study was not powered to assess the risk for known serious adverse effects of adalimumab, such as tuberculosis, other serious infections, and demyelinating disorders. CONCLUSION: Adalimumab dosed once per week alleviates moderate to severe HS. PRIMARY FUNDING SOURCE: Abbott Laboratories.
背景：化脓性汗腺炎（HS）是一种慢性、疼痛性皮肤病，其特征为青壮年腋窝和腹股沟出现脓肿、结节和瘘管。
目的：评估阿达木单抗（一种抗肿瘤坏死因子-α 抗体）在中重度 HS 患者中的疗效和安全性。
设计：这是一项为期 16 周的双盲期（第 1 期）和 36 周的开放标签期（第 2 期）的 2 期、平行、随机、安慰剂对照试验。整个研究过程中，所有研究人员、研究者和患者均对治疗组保持盲态。（临床试验.gov：NCT00918255）
地点：美国和欧洲的 26 个学术和私人医疗中心。
患者：154 例中重度 HS 成年患者，对口服抗生素无反应或不耐受。
干预：患者以 1:1:1 的比例随机分配至阿达木单抗 40mg/周组、阿达木单抗 40mg 每两周一次（EOW）组或安慰剂组。所有患者在第 2 期开始时均接受阿达木单抗 40mg EOW，但如果在第 28 或 31 周时应答不理想（HS 医师总体评估 [PGA] 为中度或更差），则切换为每周一次给药。
测量：主要结局指标（临床应答）为在第 16 周时，PGA 评分达到清除、轻微或轻度（与基线相比至少改善 2 级）的患者比例。
结果：第 16 周时，安慰剂组（51 例中的 2 例）、EOW 组（52 例中的 5 例）和每周组（51 例中的 9 例）分别有 3.9%、9.6%和 17.6%的患者达到临床应答（EOW 与安慰剂分层调整差异为 5.6%[95%CI，-4.0%至 15.3%]；P=0.25；每周与安慰剂分层调整差异为 13.7%[CI，1.7%至 25.7%]；P=0.025）。安慰剂组、EOW 组和每周组的严重不良事件发生率分别为 3.9%、5.8%和 7.8%（EOW 与安慰剂差异为 1.8%[CI，-6.4%至 10.1%]；每周与安慰剂差异为 3.9%[CI，-5.2%至 13.0%]）。每周一次给药组的患者报告结局和疼痛均有显著改善，而安慰剂组无改善。在第 2 期从每周一次给药切换为 EOW 给药后，应答情况有所下降。
局限性：研究的第 16 周至 52 周为开放标签期。该研究未对阿达木单抗已知严重不良事件（如结核病、其他严重感染和脱髓鞘疾病）的风险进行评估。
结论：阿达木单抗每周一次给药可缓解中重度化脓性汗腺炎。
主要资金来源：雅培实验室。
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