Department of Internal Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.
S Afr Med J. 2020 Nov 27;110(12):1231-1237. doi: 10.7196/SAMJ.2020.v110i12.14695.
Biological disease-modifying antirheumatic drug therapies have become the gold standard of treatment for refractory rheumatic conditions in well-resourced countries. There is a significant risk of infection and reactivation of latent infections, in particular tuberculosis, with the use of biological therapies. Their safety and reasons for discontinuation in a resource-limited environment are still unclear.
The primary objective was to describe the nature and frequency of adverse events as well as the main reason for discontinuation of biological treatment.
We conducted a retrospective, descriptive folder review of all patients started on biological therapy for rheumatic conditions from November 2011 to December 2016.
A total of 31 patients were included. The rheumatic diseases included in the study were ankylosing spondylitis (AS) (35%), rheumatoid arthritis (RA) (19%), systemic lupus erythematosus (16%), juvenile idiopathic arthritis (13%), vasculitides (10%) and psoriatic arthritis (7%). Adverse events occurred in 26 patients (84%). Serious adverse events occurred in 14 patients (45%) with recurrent uveitis being the most common, occurring in 5 patients (16%). One patient developed pulmonary tuberculosis (PTB). Discontinuation or switching of biological therapy occurred in 13 patients (42%), with the main reasons being serious adverse events in 7 patients (23%) and treatment failure in 6 (19%). The median (interquartile range (IQR)) Bath Ankylosing Spondylitis Disease Activity Index score improved from 6.4 (5 - 7.4) to 2.8 (0.9 - 5.0), a statistically significant difference of -3.5 (p=0.001) (95% confidence interval (CI) -5.3 - -1.7) over a median (IQR) of 20 (9 - 30) months in the AS group. The median (IQR) Clinical Disease Activity Index score improved from 39 (34.5 - 43) to 21 (18.7 - 25.5), a statistically significant difference of -17.4 (p=0.044) (95% CI -34.1 - -0.7) over a median (IQR) of 39 (21 - 50) months in the RA group.
Recurrent uveitis occurred in almost half of the patients with AS and was also the main reason for discontinuation of biological therapy. We did not document an increased risk of PTB. Disease activity scores showed significant improvement. The study is limited by the small number of patients on biological therapy, a reflection of the impact of severe resource constraints.
生物改善病情抗风湿药物疗法已成为资源丰富国家治疗难治性风湿疾病的金标准。使用生物疗法存在感染和潜伏感染（尤其是结核分枝杆菌感染）再激活的重大风险。在资源有限的环境中，其安全性和停药原因仍不清楚。
主要目的是描述不良事件的性质和频率以及生物治疗停药的主要原因。
我们对 2011 年 11 月至 2016 年 12 月期间开始接受生物治疗的所有风湿性疾病患者的病历进行了回顾性、描述性文件夹审查。
共纳入 31 例患者。研究中包括的风湿性疾病包括强直性脊柱炎（AS）（35%）、类风湿关节炎（RA）（19%）、系统性红斑狼疮（16%）、幼年特发性关节炎（13%）、血管炎（10%）和银屑病关节炎（7%）。26 例（84%）患者出现不良事件。14 例（45%）患者出现严重不良事件，其中最常见的是复发性虹膜炎，共 5 例（16%）。1 例患者发生肺结核（PTB）。13 例（42%）患者停止或更换了生物治疗，主要原因是 7 例（23%）出现严重不良事件和 6 例（19%）治疗失败。AS 组 Bath 强直性脊柱炎疾病活动指数评分中位数（四分位距（IQR））从 6.4（5-7.4）降至 2.8（0.9-5.0），差异有统计学意义（p=0.001）（95%置信区间（CI）-5.3 至-1.7），中位数（IQR）为 20（9-30）个月。RA 组的临床疾病活动指数评分中位数（IQR）从 39（34.5-43）降至 21（18.7-25.5），差异有统计学意义（p=0.044）（95%CI-34.1 至-0.7），中位数（IQR）为 39（21-50）个月。
近一半的 AS 患者出现复发性虹膜炎，也是生物治疗停药的主要原因。我们没有发现结核分枝杆菌感染风险增加的证据。疾病活动评分显示出显著改善。该研究受到生物治疗患者数量较少的限制，这反映了严重资源限制的影响。
