Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.
Oregon Health & Science University, Portland, OR, USA.
Br J Dermatol. 2021 Nov;185(5):935-944. doi: 10.1111/bjd.20136. Epub 2021 Jun 8.
Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long-term robust studies.
To assess the malignancy risk in patients with secukinumab-treated psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
This integrated safety analysis from both the secukinumab clinical trial programme and postmarketing safety surveillance data included any patient receiving at least one approved dose of secukinumab with a maximum of 5 years of follow-up. Safety analyses evaluated the rate of malignancy using exposure-adjusted incidence rates [EAIR; incidence rates per 100 patient treatment-years (PTY)]. Standardized incidence ratios (SIRs) were reported using the Surveillance, Epidemiology, and End Results Program (SEER) database as a reference population. Crude incidence of malignancy was also reported using postmarketing surveillance data.
Safety data from 49 clinical trials with secukinumab-treated patients were included: 10 685 patients with psoriasis, 2523 with PsA and 1311 with AS. Across indications over a 5-year period, the EAIR of malignancy was 0·85 per 100 PTY [95% confidence interval (CI) 0·74-0·98] in secukinumab-treated patients, corresponding to 204 patients per 23 908 PTY. Overall, the observed vs. expected number of malignancies from secukinumab clinical trial data were comparable, as indicated by an SIR of 0·99 (95% CI 0·82-1·19) across indications. The estimated crude cumulative incidence reporting rate per 100 PTY for malignancy was 0·27 in the postmarketing surveillance data across indications with a cumulative exposure of 285 811 PTY.
In this large safety analysis, the risk of malignancy was low for up to 5 years of secukinumab treatment. These data support the long-term use of secukinumab in these indications.
由于缺乏长期有力的研究，生物疗法和恶性肿瘤风险的数据并不一致。
评估司库奇尤单抗治疗银屑病、银屑病关节炎（PsA）和强直性脊柱炎（AS）患者的恶性肿瘤风险。
这项来自司库奇尤单抗临床试验项目和上市后安全监测数据的综合安全性分析纳入了至少接受过一次批准剂量司库奇尤单抗治疗且随访时间最长达 5 年的所有患者。安全性分析采用暴露调整发病率（EAIR；每 100 患者治疗年（PTY）发病率）评估恶性肿瘤的发生率。采用监测、流行病学和最终结果计划（SEER）数据库作为参考人群，报告标准化发病率比（SIR）。也使用上市后监测数据报告恶性肿瘤的粗发病率。
纳入了 49 项司库奇尤单抗治疗患者临床试验的安全性数据：10685 例银屑病患者、2523 例 PsA 患者和 1311 例 AS 患者。在 5 年期间，司库奇尤单抗治疗患者的恶性肿瘤 EAIR 为 0.85/100 PTY（95%CI 0.74-0.98），相当于每 23908 PTY 发生 204 例恶性肿瘤。总体而言，从司库奇尤单抗临床试验数据观察到的与预期的恶性肿瘤数量相当，各适应症的 SIR 为 0.99（95%CI 0.82-1.19）。在各适应症中，上市后监测数据中每 100 PTY 报告的恶性肿瘤累积发生率为 0.27，累积暴露量为 285811 PTY。
在这项大型安全性分析中，司库奇尤单抗治疗长达 5 年的恶性肿瘤风险较低。这些数据支持在这些适应症中长期使用司库奇尤单抗。
