Department of Pharmacy, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
Division of Rheumatology, Allergy and Immunology, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan.
BioDrugs. 2020 Oct;34(5):669-679. doi: 10.1007/s40259-020-00442-x.
The last decade has witnessed the increasing use of biologics for the treatment of ankylosing spondylitis (AS). Drug survival is an outcome incorporating real-world effectiveness and safety. However, the drug survival of biologics in treating AS is unclear.
The aim was to assess the drug survival of biologics (tumor necrosis factor inhibitors and anti-interleukin-17 monoclonal antibodies) in treating AS.
We conducted a systematic review and meta-analysis and searched the PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase databases up to 13th May 2020. Studies that analyzed the drug survival of biologics for AS and reported the respective annual data for each biologic for at least 1 year were included. Two authors independently screened and selected studies and assessed their risk of bias. A third author was available for arbitrating discrepancies. The Newcastle-Ottawa Scale was employed to evaluate the risk of bias of included studies. We conducted a random-effects model meta-analysis to obtain pooled drug survival from year 1 to 5. We performed subgroup analyses for biologic-naïve patients, first-line versus second- and third-line biologics, discontinuation due to loss of effectiveness and adverse effects, and high-quality studies.
We included 39 studies with 32,493 patients. The drug survival decreased from 76% at year 1 to 51% at year 5 for etanercept, from 75 to 51% for adalimumab, from 76 to 53% for infliximab, from 72 to 49% for golimumab, and from 63 to 57% for certolizumab pegol. The drug survival rate for secukinumab was 0.77 (95% confidence interval 0.64‒0.90) at year 1. Subgroup analyses on biologic-naïve patients and discontinuation due to adverse effects found no differences in the drug survival of various biologics except for a lower drug survival of infliximab in biologic-naïve patients. The drug survival for first-line biologics was higher than for second- and third-line biologics.
To the best of our knowledge, this study is the first systematic review and meta-analysis on the drug survival of biological therapies for AS patients. The drug survival of all biologics in treating AS appeared comparable, but is higher in first-line biologics than second- and third-line biologics. To date there are scarce data on the drug survival of newly available biologics, for example, anti-interleukin-17 biologics.
CRD42018114204.
过去十年见证了生物制剂在治疗强直性脊柱炎(AS)中的应用日益增多。药物存活率是一个综合了实际疗效和安全性的结果。然而,生物制剂治疗 AS 的药物存活率尚不清楚。
评估生物制剂(肿瘤坏死因子抑制剂和抗白细胞介素-17 单克隆抗体)治疗 AS 的药物存活率。
我们进行了系统评价和荟萃分析,检索了 PubMed、Cochrane 中央对照试验注册中心(CENTRAL)和 Embase 数据库,截至 2020 年 5 月 13 日。纳入分析生物制剂治疗 AS 的药物存活率并报告每种生物制剂至少 1 年的各自年度数据的研究。两位作者独立筛选和选择研究,并评估其偏倚风险。第三位作者可用于仲裁分歧。采用纽卡斯尔-渥太华量表评估纳入研究的偏倚风险。我们采用随机效应模型荟萃分析,从第 1 年到第 5 年获得汇总药物存活率。我们进行了亚组分析,包括生物制剂初治患者、一线与二线和三线生物制剂、因疗效丧失和不良反应而停药,以及高质量研究。
我们纳入了 39 项研究,共 32493 名患者。依那西普的药物存活率从第 1 年的 76%降至第 5 年的 51%,阿达木单抗从 75%降至 51%,英夫利昔单抗从 76%降至 53%,戈利木单抗从 72%降至 49%,而培塞利珠单抗从 63%降至 57%。司库奇尤单抗的药物存活率在第 1 年为 0.77(95%置信区间 0.64‒0.90)。在生物制剂初治患者和因不良反应停药的亚组分析中,除生物制剂初治患者中英夫利昔单抗的药物存活率较低外,各种生物制剂的药物存活率无差异。一线生物制剂的药物存活率高于二线和三线生物制剂。
据我们所知,这是第一项关于 AS 患者生物治疗药物存活率的系统评价和荟萃分析。所有生物制剂治疗 AS 的药物存活率似乎相当,但一线生物制剂的药物存活率高于二线和三线生物制剂。迄今为止,新出现的生物制剂(例如抗白细胞介素-17 生物制剂)的药物存活率数据很少。
PROSPERO 注册号:CRD42018114204。