Welcome to visit Zhongnan Medical Journal Press Series journal website!

Home Articles Vol 33,2024 No.9 Detail

HLA-B*5801 gene polymorphisms detection in prediction of severe drug eruption associated allopurinol: a rapid health technology assessment

Published on Oct. 01, 2024Total Views: 1133 times Total Downloads: 227 times Download Mobile

Author: CAO Jinjin LING Ya ZHANG Jie ZHANG Jingjing ZHU Jianguo CAO Xiufang

Affiliation: Department of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, China

Keywords: Allopurinol HLA-B*5801 gene testing Severe drug eruption Rapid health technology assessment

DOI: 10.12173/j.issn.1005-0698.202403063

Reference: CAO Jinjin, LING Ya, ZHANG Jie, ZHANG Jingjing, ZHU Jianguo, CAO Xiufang.HLA-B*5801 gene polymorphisms detection in prediction of severe drug eruption associated allopurinol: a rapid health technology assessment[J].Yaowu Liuxingbingxue Zazhi,2024, 33(9):1044-1053.DOI:10.12173/j.issn.1005-0698.202403063.[Article in Chinese]

  • Abstract
  • Full-text
  • References
Abstract

Objective  To evaluate the accuracy, sensitivity, specificity and economy of HLA-B*5801 gene polymorphisms detection in predicting allopurinol-related severe drug eruption before receiving allopurinol treatment using rapid health technology assessment (rHTA), to provide clinicians and policymakers with an efficient and convenient evidence-based basis.

Methods  PubMed, Cochrane Library, Web of Science, Embase, WanFang Data, CNKI databases and the official website of health technology assessment (HTA) agency were electronically searched to collect HTA reports, systematic reviews/Meta-analyses and pharmacoeconomic literature on the HLA-B*5801 gene polymorphisms detection from inception to December 31, 2023. Two reviewers independently screened studies, extracted data, assessed the included studies' quality, and analyzed and summarised the results.  

Results  A total of 16 literature were included, of which 5 systematic reviews/Meta-analyses and 11 pharmacoeconomic studies. The results showed that the HLA-B*5801 gene mutation rate was significantly higher in patients presenting with severe drug eruption than in the allopurinol-tolerant group (P<0.05). Two studies reported the sensitivity and specificity of the HLA-B*5801 gene polymorphisms assay for predicting severe drug eruption, the sensitivity of 0.78, 0.93, and specificity of 0.96, 0.89, respectively. The economic study showed that HLA-B*5801 gene polymorphisms detection before allopurinol treatment was cost-effective in Chinese Han, Korean, Thai populations, but not in British, American (Caucasian or Hispanic), Singaporean and Malaysian populations.

Conclusion  HLA-B*5801 gene polymorphisms detection before allopurinol treatment and guiding drug use according to the screening results in Chinese Han population can reduce the risk of severe drug eruption and treatment costs.

Full-text
Please download the PDF version to read the full text: download
References

1.FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American college of rheumatology guideline for the management of gout[J]. Arthritis Care Res (Hoboken), 2020, 72(6): 744-760. DOI: 10.1002/acr.24180.

2.徐东, 朱小霞, 邹和建, 等. 痛风诊疗规范[J]. 中华内科杂志, 2023, 62(9): 1068-1076. [Xu D, Zhu XX, Zou HJ, et al. Recommendations for the diagnosis and treatment of gout in China[J]. Chinese Journal of Internal Medicine, 2023, 62(9): 1068-1076.] DOI: 10.3760/cma.j.cn112138-20221027-00796.

3.Khor AH, Lim KS, Tan CT, et al. HLA-A*31 ∶ 01 and HLA-B*15 ∶ 02 association with Stevens-Johnson syndrome and toxic epidermal necrolysis to carbamazepine in a multiethnic Malaysian population[J]. Pharmacogenet Genomics, 2017, 27(7) : 275-278. DOI: 10.1097/FPC. 0000000000000287.

4.Garg VK, Buttar HS, Bhat SA, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: an overview of diagnosis, therapy options and prognosis of patients[J]. Recent Adv Inflamm Allergy Drug Discov, 2023, 17(2): 110-120. DOI: 10.2174/2772270817666230821102441.

5.Wu R, Cheng YJ, Zhu LL, et al. Impact of HLA-B*58 ∶  01 allele and allopurinol-induced cutaneous adverse drug reactions: evidence from 21 pharmacogenetic studies[J]. Oncotarget, 2016, 7(49) : 81870-81879. DOI: 10.18632/oncotarget.13250.

6.Cheng H, Yan D, Zuo X, et al. A retrospective investigation of HLA-B*5801 in hyperuricemia patients in a Han population of China[J]. Pharmacogenet Genomics, 2018, 28(5) : 117-124. DOI: 10.1097/FPC.0000000000000334.

7.Jutkowitz E, Dubreuil M, Lu N, et al. The cost-effectiveness of HLA-B*5801 screening to guide initial urate-lowering therapy for gout in the United States[J]. Semin Arthritis Rheum, 2017, 46(5): 594-600. DOI: 10.1016/j.semarthrit.2016.10.009.

8.O'Rourke B, Oortwijn W, Schuller T. Response to redefining health technology assessment: a comment on "the new definition of health technology assessment: a milestone in international collaboration"[J]. Int J Technol Assess Health Care, 2022, 38(1): e55. DOI: 10.1017/S0266462322000344.

9.刘梦娜, 吴斌, 艾丹丹, 等. 药物快速卫生技术评估方法学研究-以抗肿瘤用药为例[J]. 中国药房,2022, 33(11): 1386-1391. [Liu MN, Wu B, Ai DD, et al.Methodological study of rapid health technology assessment of drugs: taking antitumor drugs as an example[J]. China Pharmacy, 2022, 33(11): 1386-1391.] DOI: 10.6039/j.issn.1001- 0408.2022.11.18.

10.Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both[J]. BMJ, 2017, 358: j4008. DOI: 10.1136/bmj.j4008.

11.Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations[J]. Value Health, 2022, 25(1): 3-9. DOI: 10.1016/j.jval.2021. 11.1351.

12.Hailey D. Toward transparency in health technology assessment: a checklist for HTA reports[J]. Int J Technol Assess Health Care, 2003, 19(1): 1-7. DOI: 10.1017/s0266462303000011.

13.刘威, 黎颖然, 张文渊, 等. 中国汉族人群HLA-B* 58 ∶ 01等位基因与别嘌醇引起严重皮肤不良反应关联性的Meta分析[J]. 今日药学, 2019, 29(3): 177-181. [Liu W, Li YR, Zhang WY, et al. Meta-analysis of the association between HLA-B*58 ∶ 01 allele and allopurinol-induced SCAR in Chinese Han population[J]. Pharmacy Today, 2019, 29(3): 177-181.] DOI: 10.12048/j.issn.1674-229X.2019.03.005.

14.尚鹏超, 金璐艳, 张晓飐, 等. 中国汉族人群HLA-B* 5801等位基因与别嘌醇致重症药疹的相关性Meta分析[J]. 中国皮肤性病学杂志, 2017, 31(11): 1179-1182, 1187. [Shang PC, Jin LY, Zhang XZ, et al. Correlation between HLA-B* 5801 alleles and SCAR in Chinese Han population: a meta analysis[J]. The Chinese Journal of Dermatovenereology, 2017, 31(11): 1179-1182, 1187.] DOI: 10.13735/j.cjdv.1001-7089.201706044.

15.Yu KH, Yu CY, Fang YF. Diagnostic utility of HLA-B*5801 screening in severe allopurinol hypersensitivity syndrome: an updated systematic review and meta-analysis[J]. Int J Rheum Dis, 2017, 20(9): 1057-1071. DOI: 10.1111/1756-185X.13143.

16.Somkrua R, Eickman EE, Saokaew S, et al. Association of HLA-B*5801 allele and allopurinol-induced Stevens Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis[J]. BMC Med Genet, 2011, 12(1): 118. DOI: 10.1186/1471-2350-12-118.

17.Hong Y, Chen X, Li Z, et al. A lifetime economic research of universal HLA-B*58 ∶ 01 genotyping or febuxostat initiation therapy in Chinese gout patients with mild to moderate chronic kidney disease[J]. Pharmacogenet Genomics, 2023, 33(2): 24-34. DOI: 10.1097/FPC.0000000000000488.

18.Wong CS, Yeung CK, Chan CY, et al. HLA-B*58 ∶ 01 screening to prevent allopurinol-induced severe cutaneous adverse reactions in Chinese patients with chronic kidney disease[J]. Arch Dermatol Res, 2022, 314(7): 651-659. DOI: 10.1007/s00403-021-02258-3.

19.Teng GG, Tan-Koi WC, Dong D, et al. Is HLA-B*

58 ∶ 01 genotyping cost effective in guiding allopurinol use in gout patients with chronic kidney disease?[J]. Pharmacogenomics, 2020, 21(4): 279-291. DOI: 10.2217/pgs-2019-0160.

20.Chong HY, Lim YH, Prawjaeng J, et al. Cost-effectiveness analysis of HLA-B*58 ∶ 01 genetic testing before initiation of allopurinol therapy to prevent allopurinol-induced Stevens-Johnson syndrome/toxic epidermal necrolysis in a Malaysian population[J]. Pharmacogenet Genomics, 2018, 28(2): 56-67. DOI: 10.1097/FPC.0000000000000319.

21.Plumpton CO, Alfirevic A, Pirmohamed M, et al. Cost effectiveness analysis of HLA-B*58 ∶ 01 genotyping prior to initiation of allopurinol for gout[J]. Rheumatology (Oxford), 2017, 56(10): 1729-1739. DOI: 10.1093/rheumatology/kex253.

22.Ke CH, Chung WH, Wen YH, et al. Cost-effectiveness analysis for genotyping before allopurinol treatment to prevent severe cutaneous adverse drug reactions[J]. J Rheumatol, 2017, 44(6): 835-843. DOI: 10.3899/jrheum.151476.

23.Dong D, Tan-Koi WC, Teng GG, et al. Cost-effectiveness analysis of genotyping for HLA-B*5801 and an enhanced safety program in gout patients starting allopurinol in Singapore[J]. Pharmacogenomics, 2015, 16(16): 1781-1793. DOI: 10.2217/pgs.15.125.

24.Saokaew S, Tassaneeyakul W, Maenthaisong R, et al. Cost-effectiveness analysis of HLA-B*5801 testing in preventing allopurinol-induced SJS/TEN in Thai population[J]. PLoS One, 2014, 9(4): e94294. DOI: 10.1371/journal.pone.0094294.

25.Park DJ, Kang JH, Lee JW, et al. Cost-effectiveness analysis of HLA-B5801 genotyping in the treatment of gout patients with chronic renal insufficiency in Korea[J]. Arthritis Care Res (Hoboken), 2015, 67(2): 280-287. DOI: 10.1002/acr.22409.

26.Wei BM, Fox LP, Kaffenberger BH, et al. Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms. Part I. Epidemiology, pathogenesis, clinicopathological features, and prognosis[J]. J Am Acad Dermatol, 2023, 90(5): 885-908. DOI: 10.1016/j.jaad.2023.02.072.

27.Lin C, Chen Y, Hung S. The pathogenic role of HLA-B*5801 in allopurinol-induced severe cutaneous adverse reactions[C]. Presented at: Drug Hypersensitivity Meeting-DHM5, Munich, 2012, Programme and Abstract Book, 2012: 125.

28.Manson LEN, Swen JJ, Guchelaar HJ. Diagnostic test criteria for HLA Genotyping to prevent drug hypersensitivity reactions: a systematic review of actionable HLA recommendations in CPIC and DPWG guidelines[J]. Front Pharmacol, 2020, 11: 567048. DOI: 10.3389/fphar.2020.567048.

Popular papers
Last 6 months