Bazigh Izza, Asfour Mohamad, Muddassir Salman, Mughni Sami
Internal Medicine, Oak Hill Hospital, Spring Hill, USA.
Rheumatology, Oak Hill Hospital, Spring Hill, USA.
Cureus. 2022 Feb 23;14(2):e22540. doi: 10.7759/cureus.22540. eCollection 2022 Feb.
Belimumab is a B-cell depletion therapy that has emerged as an effective and safe treatment option for Systemic Lupus Erythematosus (SLE), but ongoing phase IV trials continue to report its common and rare adverse effects. Our case report seeks to add data to the existing literature on the safety profile of belimumab. We report an interesting and complicated case of a 30-year-old female with a 12-year history of SLE and multiple treatment failures who developed acute pancreatitis in the context of the initiation of belimumab. The temporal link between the two events made us undertake a review of literature on the efficacy and safety of belimumab. We used PubMed and Medline to shortlist eight studies that included phase III parent and extension clinical trials of belimumab that had been conducted in the past 10 years and illustrated the results in a tabulated form. The United States Food and Drug Administration has approved belimumab as a safe and effective treatment option for SLE. The BLISS-52, BLISS-76, and BLISS-SC trials along with their extension trials showed that SRI (SLE Responder Index) was higher in the patient cohorts that were treated with IV (intravenous) or SC (subcutaneous) belimumab. According to the website "eHealthMe.com", which tracks the incidence of adverse events from drugs by allowing people to report events, 14100 people reported side effects when taking belimumab and among them, 29 people (0.21%) reported acute pancreatitis. Time on belimumab when patients had acute pancreatitis was 1-2 years for 52% of the patients and 1-6 months for 40% of the patients; 96% of the patients were females. The age group at which it was most reported was 40-49 years. Additional data is needed to enable a better characterization of the pathophysiology and nature of acute pancreatitis as a possible side effect of belimumab.
贝利尤单抗是一种B细胞清除疗法，已成为系统性红斑狼疮（SLE）一种有效且安全的治疗选择，但正在进行的IV期试验仍在不断报告其常见和罕见的不良反应。我们的病例报告旨在为现有关于贝利尤单抗安全性的文献增添数据。我们报告了一例有趣且复杂的病例，一名30岁女性，有12年SLE病史且经历过多次治疗失败，在开始使用贝利尤单抗治疗的背景下发生了急性胰腺炎。这两个事件之间的时间关联促使我们对贝利尤单抗疗效和安全性的文献进行综述。我们使用PubMed和Medline筛选出八项研究，这些研究包括过去10年进行的贝利尤单抗III期主要和扩展临床试验，并以表格形式展示结果。美国食品药品监督管理局已批准贝利尤单抗作为SLE的一种安全有效的治疗选择。BLISS - 52、BLISS - 76和BLISS - SC试验及其扩展试验表明，接受静脉注射（IV）或皮下注射（SC）贝利尤单抗治疗的患者队列中，系统性红斑狼疮缓解指数（SRI）更高。根据“eHealthMe.com”网站（该网站通过允许人们报告药物不良事件来追踪药物不良事件的发生率）的数据，14100人报告在服用贝利尤单抗时出现副作用，其中29人（0.21%）报告了急性胰腺炎。发生急性胰腺炎的患者使用贝利尤单抗的时间，52%的患者为1 - 2年，40%的患者为1 - 6个月；96%的患者为女性。报告最多的年龄组为40 - 49岁。需要更多数据才能更好地描述急性胰腺炎作为贝利尤单抗可能的副作用的病理生理学和性质。
