基于美国FAERS数据库的阿巴西普不良事件信号挖掘与分析

高茂威; 杨小娟; 纵尚尚

doi:10.6039/j.issn.1001-0408.2023.15.18

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基于美国FAERS数据库的阿巴西普不良事件信号挖掘与分析

药物与临床 | 更新时间：2023-08-10

- 基于美国FAERS数据库的阿巴西普不良事件信号挖掘与分析
- Signal mining and analysis of adverse drug events of abatacept based on FAERS database
- 中国药房 2023年34卷第15期页码：1884-1890
- 作者机构：
  
  1.皖北煤电集团总医院药学部，安徽宿州　234000
  2.皖北煤电集团总医院药物临床试验机构办公室，安徽宿州　234000
- 作者简介：
  
  主管药师。研究方向：临床药学、药物警戒。E-mail：403349212@qq.com
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.15.18
  中图分类号： R969.3
- 纸质出版日期：2023-08-15，
  
  收稿日期：2022-11-29，
  
  修回日期：2023-07-13，
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高茂威,杨小娟,纵尚尚.基于美国FAERS数据库的阿巴西普不良事件信号挖掘与分析[J].中国药房,2023,34(15):1884-1890.

GAO Maowei,YANG Xiaojuan,ZONG Shangshang.Signal mining and analysis of adverse drug events of abatacept based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(15):1884-1890.
高茂威,杨小娟,纵尚尚.基于美国FAERS数据库的阿巴西普不良事件信号挖掘与分析[J].中国药房,2023,34(15):1884-1890. DOI： 10.6039/j.issn.1001-0408.2023.15.18.

GAO Maowei,YANG Xiaojuan,ZONG Shangshang.Signal mining and analysis of adverse drug events of abatacept based on FAERS database[J].ZHONGGUO YAOFANG,2023,34(15):1884-1890. DOI： 10.6039/j.issn.1001-0408.2023.15.18.

摘要

目的

为阿巴西普的临床安全使用提供参考依据。

方法

以美国FDA不良事件报告系统（FAERS）数据库为基础，以药品通用名“abatacept”与商品名“Orencia”作为检索关键词，检索首要怀疑药物为阿巴西普的药物不良事件（ADE）信号，并采用比例失衡法中的报告比值比法和比例报告比值法以及Excel 2020软件对信号进行挖掘与分析。

结果

共检索出阿巴西普ADE报告93 189份，以女性病例（75.98%）为主，年龄主要集中于18～64岁（35.17%）；数据上报的主要国家为美国（47.41%）与加拿大（30.59%），上报的数量总体呈逐年递增的趋势。共筛选出ADE信号3 092个，其中与阿巴西普的药品说明书描述相似的是与原发疾病相关的ADE信号，如类风湿性关节炎、关节痛、关节肿胀等；其次是与输液反应相关的ADE信号，包括疼痛、乏力、皮疹等。所有筛选出的ADE信号共涉及27个系统器官分类，主要为全身疾病及给药部位各种反应，肌肉骨骼和结缔组织疾病，伤害、中毒和手术并发症，感染和侵袭类疾病，胃肠疾病，神经系统疾病，呼吸、胸腔和纵隔疾病，心脏疾病，良性、恶性和未特指的肿瘤，生殖系统和乳腺疾病等。报告例数排前50位的ADE信号中未被阿巴西普药品说明书收录的共有22个，包括乏力、药物不耐受、腹部不适、肿胀、红斑狼疮、周围肿胀、天疱疮、腹泻、肝酶升高与下呼吸道感染等。

结论

临床在使用阿巴西普的过程中应格外注意感染及其致癌性，同时评估患者的呼吸及心血管系统疾病风险，当患者合并这2类基础疾病时，应权衡利弊后谨慎选用；此外，该药在神经、胃肠及生殖系统的ADE也不容忽视。

Abstract

OBJECTIVE

To provide a reference for the safe use of abatacept in clinic.

METHODS

Based on the United States FDA Adverse Event Reporting System （FAERS） database， the generic name of the drug “abatacept” and the trade name “Orencia” were used as the search keywords to retrieve drug adverse event （ADE） signal of abatacept as primary suspected drug. The reported odds ratio method and proportional reporting ratio method in the proportional imbalance method and Excel 2020 software were used to mine and analyze the signals.

RESULTS

A total of 93 189 abatacept-induced ADE reports were retrieved， mainly female cases （75.98%）， and the age was mainly concentrated in 18-64 years old （35.17%）； main countries reporting data were the United States （47.41%） and Canada （30.59%）， and the number of reports was generally increasing year by year. A total of 3 092 ADE signals were screened， of which the signals associated with the primary disease were similar to those described in the drug instruction of abatacept， such as rheumatoid arthritis， arthralgia， joint swelling， etc.； followed by ADE signals related to infusion reactions， including pain， fatigue， rash， etc. All selected ADE signals involved 27 system organ classes， mainly involved systemic diseases and drug site conditions， musculoskeletal and connective tissue diseases， injury， poisoning and surgical complications， infections and invasive diseases， gastrointestinal diseases， neurological diseases， respiratory， thoracic and mediastinal diseases， heart diseases， benign， malignant and unspecified tumors and reproductive system and breast diseases， etc. A total of 22 ADE signals were not included in the drug instructions of abatacept among the top 50 ADE signals in the number list of reported cases， including fatigue， drug intolerance， abdominal discomfort， swelling， lupus erythematosus， peripheral swelling， cell sores， diarrhea， elevated liver enzymes and lower respiratory tract infection， etc.

CONCLUSIONS

In the process of clinical use of abatacept， special attention should be paid to infection and its carcinogenicity， while assessing the risk of respiratory and cardiovascular system diseases in patients； when patients suffer from these two underlying diseases， the pros and cons should be weighed carefully before selecting drug； in addition， the drug-induced ADE in the neurological， gastrointestinal and reproductive system cannot be ignored.

关键词

阿巴西普药物不良事件数据挖掘药物不良反应比例失衡法

Keywords

adverse drug eventsdata miningadverse drug reactionsproportional imbalance method

references

OTÓN T，CARMONA L. The epidemiology of established rheumatoid arthritis[J]. Best Pract Res Clin Rheumatol，2019，33（5）：101477.

RADU A F，BUNGAU S G. Management of rheumatoid arthritis：an overview[J]. Cells，2021，10（11）：2857.

POMBO-SUAREZ M，GOMEZ-REINO J J. Abatacept for the treatment of rheumatoid arthritis[J]. Expert Rev Clin Immunol，2019，15（4）：319-326.

BERGMAN M，TUNDIA N，MARTIN N，et al. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs：12- and 24-week results of a phase 3 trial[J]. Arthritis Res Ther，2022，24（1）：155.

LAUPER K，IUDICI M，MONGIN D，et al. Effectiveness of TNF-inhibitors，abatacept，IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration[J]. Ann Rheum Dis，2022，81（10）：1358-1366.

CHOE H，FERRARA J L M. New therapeutic targets and biomarkers for acute graft-versus-host disease （GVHD）[J]. Expert Opin Ther Targets，2021，25（9）：761-771.

HARIGAI M，ISHIGURO N，INOKUMA S，et al. Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis[J]. Mod Rheumatol，2016，26（4）：491-498.

李莉，杨卓，蔡江晖，等. 基于FARES数据库的贝利尤单抗ADE风险信号挖掘[J]. 中国药房，2021，32（24）：3024-3030.

王郁薇，蒙龙，刘箫. 基于美国FDA不良事件数据库的注射用紫杉醇（白蛋白结合型）不良反应信号挖掘[J]. 中国药房，2021，32（3）：328-333.

徐婷，陈辉清. 基于OpenFDA数据库的乌司奴单抗不良事件信号检测与分析[J]. 中国药房，2023，34（2）：185-189.

ROTHMAN K J，LANES S，SACKS S T. The reporting odds ratio and its advantages over the proportional repor- ting ratio[J]. Pharmacoepidemiol Drug Saf，2004，13（8）：519-523.

YAMANAKA H，SUGIYAMA N，INOUE E，et al. Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort：Ⅰ[J]. Mod Rheumatol，2014，24（1）：33-40.

RAVAEI A，ZIMMER-BENSCH G，GOVONI M，et al. lncRNA-mediated synovitis in rheumatoid arthritis：a perspective for biomarker development[J]. Prog Biophys Mol Biol，2022，175：103-119.

FIGUEREDO ZAMORA E，CALLEN J P，SCHADT C R. Drug-induced subacute cutaneous lupus erythematosus associated with abatacept[J]. Lupus，2021，30（4）：661-663.

SMOLEN J S. Insights into the treatment of rheumatoid arthritis：a paradigm in medicine[J]. J Autoimmun，2020，110：102425.

YUN H F，XIE F L，DELZELL E，et al. Comparative risk of hospitalized infection associated with biologic agents in rheumatoid arthritis patients enrolled in medicare[J]. Arthritis Rheumatol，2016，68（1）：56-66.

MORI S，YOSHITAMA T，HIDAKA T，et al. Comparative risk of hospitalized infection between biological agents in rheumatoid arthritis patients：a multicenter retrospective cohort study in Japan[J]. PLoS One，2017，12（6）：e0179179.

GEORGE M D，BAKER J F，WINTHROP K，et al. Risk of biologics and glucocorticoids in patients with rheumatoid arthritis undergoing arthroplasty[J]. Ann Intern Med，2019，171（9）：680.

FURFARO F，ALFARONE L，GILARDI D，et al. TL1A：a new potential target in the treatment of inflammatory bowel disease[J]. Curr Drug Targets，2021，22（7）：760-769.

GRAFF R M，JENNINGS K，LAVOY E C P，et al. T-cell counts in response to acute cardiorespiratory or resistance exercise in physically active or physically inactive older adults：a randomized crossover study[J]. J Appl Physiol，2022，133（1）：119-129.

SCOTT ALGOOD H M. T cell cytokines impact epithelial cell responses during Helicobacter pylori infection[J]. J Immunol，2020，204（6）：1421-1428.

SPAGNOLO P，DISTLER O，RYERSON C J，et al. Mechanisms of progressive fibrosis in connective tissue disease （CTD）-associated interstitial lung diseases （ILDs）[J]. Ann Rheum Dis，2021，80（2）：143-150.

MIRA-AVENDANO I，ABRIL A，BURGER C D，et al. Interstitial lung disease and other pulmonary manifestations in connective tissue diseases[J]. Mayo Clin Proc，2019，94（2）：309-325.

PUNDOLE X，SUAREZ-ALMAZOR M E. Cancer and rheumatoid arthritis[J]. Rheum Dis Clin North Am，2020，46（3）：445-462.

CURTIS J R，SARSOUR K，NAPALKOV P，et al. Incidence and complications of interstitial lung disease in users of tocilizumab，rituximab，abatacept and anti-tumor necrosis factor α agents，a retrospective cohort study[J]. Arthritis Res Ther，2015，17：319.

KANG E H，JIN Y Z，DESAI R J，et al. Risk of exacerbation of pulmonary comorbidities in patients with rheumatoid arthritis after initiation of abatacept versus TNF inhibitors：a cohort study[J]. Semin Arthritis Rheum，2020，50（3）：401-408.

SUISSA S，HUDSON M，DELL’ANIELLO S，et al. Comparative safety of abatacept in rheumatoid arthritis with COPD：a real-world population-based observational study[J]. Semin Arthritis Rheum，2019，49（3）：366-372.

LEE Y K，AHN G Y，LEE J，et al. Excess mortality persists in patients with rheumatoid arthritis[J]. Int J Rheum Dis，2021，24（3）：364-372.

CARBONE F，BONAVENTURA A，LIBERALE L，et al. Atherosclerosis in rheumatoid arthritis：promoters and opponents[J]. Clin Rev Allergy Immunol，2020，58（1）：1-14.

HOISNARD L，PINA VEGAS L，DRAY-SPIRA R，et al. Risk of major adverse cardiovascular and venous thromboembolism events in patients with rheumatoid arthritis exposed to JAK inhibitors versus adalimumab：a nationwide cohort study[J]. Ann Rheum Dis，2023，82（2）：182-188.

OZEN G，PEDRO S，MICHAUD K. The risk of cardiovascular events associated with disease-modifying antirheumatic drugs in rheumatoid arthritis[J]. J Rheumatol，2021，48（5）：648-655.

BUXEDA A，REDONDO-PACHÓN D，PÉREZ-SÁEZ M J，et al. Sex differences in cancer risk and outcomes after kidney transplantation[J]. Transplant Rev，2021，35（3）：100625.

GRULICH A E，VAN LEEUWEN M T，FALSTER M O，et al. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients：a meta-analysis[J]. Lancet，2007，370（9581）：59-67.

DE GERMAY S，BAGHERI H，DESPAS F，et al. Abatacept in rheumatoid arthritis and the risk of cancer：a world observational post-marketing study[J]. Rheumatology，2020，59（9）：2360-2367.

WADSTRÖM H，FRISELL T，ASKLING J，et al. Malignant neoplasms in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors，tocilizumab，abatacept，or rituximab in clinical practice：a nationwide cohort study from Sweden[J]. JAMA Intern Med，2017，177（11）：1605-1612.

SIMON T A，BOERS M，HOCHBERG M，et al. Comparative risk of malignancies and infections in patients with rheumatoid arthritis initiating abatacept versus other biologics：a multi-database real-world study[J]. Arthritis Res Ther，2019，21（1）：228.

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