Laboratory of Investigative Dermatology, Rockefeller University, New York, NY, USA.
Department of Biostatistics, Rockefeller University, New York, NY, USA.
Clin Exp Dermatol. 2020 Oct;45(7):859-865. doi: 10.1111/ced.14264. Epub 2020 May 26.
The association of adalimumab therapy with malignancy and infection is established in other inflammatory diseases; however, rates of hidradenitis suppurativa (HS) are based on case reports or retrospective healthcare data and the effect of adalimumab therapy on these rates is unknown. Previously reported rates in the PIONEER OLE Phase 3 study reported on rates only in a subpopulation of 88 participants rather than the entire cohort.
To quantify rates of malignancy and serious infection in all patients with HS treated with adalimumab 40 mg weekly.
Reanalysis was undertaken of individual patient data from the PIONEER 1, PIONEER 2 and PIONEER open-label extension Phase 3 trial data encompassing 591 unique patients with HS administered adalimumab 40 mg weekly without concurrent antibiotic exposure. Incidence rates of serious infection and malignancy were calculated.
Incidence rates of serious infection and malignancy were 2.14 and 0.46 per 100 patient-years, respectively. Rates of infection and malignancy were comparable to those in other inflammatory conditions examined.
Incidence of serious infection in patients with HS on adalimumab is comparable to those with psoriasis and inflammatory arthropathies, but the incidence of malignancy is increased. This may reflect disease-specific malignancy risk rather than an effect of adalimumab.
阿达木单抗疗法与恶性肿瘤和感染的关联已在其他炎症性疾病中得到证实；然而，化脓性汗腺炎（HS）的发病率基于病例报告或回顾性医疗数据，阿达木单抗治疗对这些发病率的影响尚不清楚。先前在 PIONEER OLE 三期研究中的报告率仅报告了 88 名参与者亚组的发病率，而不是整个队列的发病率。
定量评估每周接受阿达木单抗 40mg 治疗的所有 HS 患者的恶性肿瘤和严重感染发病率。
对来自 PIONEER 1、PI ONEER 2 和 PIONEER 开放标签扩展三期临床试验的患者个体数据进行重新分析，这些患者共有 591 例 HS 患者，每周接受阿达木单抗 40mg 治疗，没有同时使用抗生素。计算严重感染和恶性肿瘤的发生率。
严重感染和恶性肿瘤的发生率分别为每 100 患者年 2.14 和 0.46 例。感染和恶性肿瘤的发生率与其他炎症性疾病相似。
HS 患者接受阿达木单抗治疗的严重感染发生率与银屑病和炎症性关节炎相当，但恶性肿瘤的发生率增加。这可能反映了疾病特异性的恶性肿瘤风险，而不是阿达木单抗的影响。
