Department of Neurology, University Hospital, University of Lund, Sweden.
Mult Scler. 2011 Apr;17(4):431-40. doi: 10.1177/1352458511403642.
Risks that are potentially associated with long-term therapies should be assessed.
The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database.
The standard Medical Dictionary for Regulatory Activities query "malignancies" was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales volume. Malignancies were grouped by organ localization and classified as medically confirmed or not medically confirmed according to the source of each report. The number of reported cases of each type was compared with the expected number in the general population.
Analysis of pooled safety data from 12 key clinical trials did not show an increased incidence of malignancy per 1000 patient-years with sc IFN beta-1a (4.0; 95% confidence interval (CI): 2.9-5.5) compared with placebo (6.4; 95% CI: 3.3-11.2). Analysis of the database shows that among the medically confirmed cases, reported to expected ratios ranged from 1 : 6 to 1 : 18 for solid tumours and from 1 : 2 to 1 : 9 for lymphohaematopoietic tumours.
Safety data from both clinical trial and post-marketing settings suggest that treatment with sc IFN beta-1a does not increase the risk of malignancy in patients with MS.
应评估可能与长期治疗相关的风险。
本分析旨在使用关键性临床试验的汇总安全性数据和默克雪兰诺全球药物安全数据库的数据，确定接受皮下（sc）干扰素（IFN）β-1a 的多发性硬化症（MS）患者发生恶性肿瘤的风险。
使用标准的监管活动医学词典查询“恶性肿瘤”，从每个数据集检索相关病例。采用临床试验的汇总安全性数据计算每 1000 患者-年发生恶性肿瘤的发生率。根据销售量计算上市后环境中每种恶性肿瘤类型的报告率。根据每个报告的来源，将恶性肿瘤分为器官定位，并分为医学确诊和未医学确诊。将每种类型的报告病例数与一般人群中的预期病例数进行比较。
对 12 项关键性临床试验的汇总安全性数据进行分析，未显示 sc IFNβ-1a 与安慰剂相比每 1000 患者-年恶性肿瘤发生率增加（4.0；95%置信区间（CI）：2.9-5.5）。对数据库的分析表明，在医学确诊病例中，报告的实际病例数与预期病例数的比值范围为实体肿瘤为 1:6 至 1:18，淋巴造血系统肿瘤为 1:2 至 1:9。
临床试验和上市后环境的安全性数据表明，sc IFNβ-1a 治疗不会增加 MS 患者发生恶性肿瘤的风险。
