Department of Health Sciences, University of Catanzaro "Magna Graecia", Catanzaro, Italy.
Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy.
PLoS One. 2018 Oct 24;13(10):e0205134. doi: 10.1371/journal.pone.0205134. eCollection 2018.
Post-marketing surveillance activities (namely pharmacovigilance) are crucial to favor the early detection of unexpected adverse events (AEs) and/or serious adverse reactions (SAEs). Indeed, spontaneous reporting of AEs has been demonstrated to underestimate the number of events in different clinical settings. Aim of the present study is to report the preliminary data of a Regional (Calabria, Italy) Pharmacovigilance Program (CBPP) aimed at improving AEs' reporting associated with biologics use in rheumatology.
We developed a simple, cost-effective pharmacovigilance program based on regular training sessions for physicians (stimulated reporting), periodical phone calls by a clinical pharmacologist aimed at identifying new events and stimulating self-awareness and encouraging reporting to the physician during the subsequent follow-up visit for minor AEs. To test this approach, all consecutive patients undergoing treatment with one biologic agent at eight rheumatology centers during a two-years period were invited to participate. Collected AEs were compared to the number of AEs spontaneously reported for the same molecules in the same centers before starting the protocol.
During the study period, 399 patients (245 females; mean age: 58 ± 11 years) were started on treatment with biologics for active RA (n = 211, 52.9%), PsA (n = 119, 29.8%) or AS (n = 69, 17.3%) at eight rheumatology centers. A total of 125 AEs (31.3%) and 9 SAEs (2.3%) were reported during the two-years study period. In the control cohort (comprising 368 consecutive patients started on treatment with bDMARDs during a two-years period before CBPP study) only 42 (11.4%) AEs and no SAEs were reported (p < 0.0001). The most common AEs were injection site reactions and skin disorders.
In conclusion, our study provides further evidence of a critical role of active pharmacovigilance in detection, reporting and analysis of AEs in rheumatology.
上市后监测活动（即药物警戒）对于早期发现意外不良事件（AE）和/或严重不良反应（SRE）至关重要。事实上，在不同的临床环境中，自发报告的 AE 已被证明低估了事件的数量。本研究的目的是报告一个旨在改善风湿病中生物制剂使用相关 AE 报告的区域（卡拉布里亚，意大利）药物警戒计划（CBPP）的初步数据。
我们开发了一种简单、具有成本效益的药物警戒计划，该计划基于定期为医生进行培训课程（激励报告）、临床药理学家定期电话联系，旨在发现新的事件，并在随后的随访中激发自我意识并鼓励医生报告轻微 AE。为了测试这种方法，邀请了在两年期间在八个风湿病中心接受一种生物制剂治疗的所有连续患者参与。收集到的 AE 与同一中心同一分子在开始方案前自发报告的 AE 数量进行了比较。
在研究期间，在八个风湿病中心，399 名患者（245 名女性；平均年龄：58 ± 11 岁）开始接受生物制剂治疗，用于治疗活动性 RA（n = 211，52.9%）、PsA（n = 119，29.8%）或 AS（n = 69，17.3%）。在两年的研究期间，共报告了 125 例 AE（31.3%）和 9 例 SRE（2.3%）。在对照组（包括在 CBPP 研究前两年期间开始接受 bDMARDs 治疗的 368 名连续患者）中，仅报告了 42 例（11.4%）AE 和无 SRE（p < 0.0001）。最常见的 AE 是注射部位反应和皮肤疾病。
总之，我们的研究进一步证明了积极的药物警戒在风湿病中检测、报告和分析 AE 中的关键作用。
