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| ORIGINAL ARTICLE |
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| Year : 2009 | Volume
: 75
| Issue : 6 | Page : 579-582 |
Association of HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome among Indians
Timir Y Mehta1, Laxman M Prajapati2, Bharti Mittal3, Chaitanya G Joshi4, Jayesh J Sheth5, Dinesh B Patel6, Dinkar M Dave1, Ramesh K Goyal7
1 Dr. Rasiklal Shah Sarvajanik Hospital, Modasa 383315, India
2 Shri B. M. Shah College of Pharmaceutical Education and Research, Modasa 383315, India
3 Department of Molecular Biology, Krishna Institute of Medical Sciences, Hyderabad 500003, India
4 Deparment of Animal Biotechnology, Anand Agricultural University, Anand 388001, India
5 Institute of Human Genetics, Ahmedabad 380015, India
6 Deep Hospital, Modasa 383315, India
7 Department of Pharmacology, L M College of Pharmacy, Ahmedabad 380009, India
| Date of Web Publication | 12-Nov-2009 |
Correspondence Address:
Timir Y Mehta
Dr. Rasiklal Shah Sarvajanik Hospital, Modasa - 383 315, Gujarat
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0378-6323.57718
Background: Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis are severe cutaneous reactions caused by certain drugs, including antiepileptic carbamazepine. A strong association has been reported between human leucocyte antigen (HLA)-B*1502 and carbamazepine-induced SJS in Han Chinese patients. European studies suggested that HLA-B*1502 is not a universal marker but is ethnicity-specific for Asians. Aim: To study the association between HLA-B*1502 and carbamazepine-induced SJS in Indian patients. Methods: Eight individuals who fulfilled the diagnostic criteria of SJS induced by carbamazepine were identified and HLA-B molecular typing was performed. HLA-B genotyping was carried out by polymerase chain reaction using sequence-specific primers. Results: Out of eight patients studied for genotype, six patients were found to have the HLA-B*1502 allele. Conclusion: This study suggests an association between HLA-B*1502 and carbamazepine-induced SJS in Indian patients.
Keywords: Carbamazepine, HLA-BFNx011502, Hindu, Indian, Stevens-Johnson syndrome
How to cite this article:
Mehta TY, Prajapati LM, Mittal B, Joshi CG, Sheth JJ, Patel DB, Dave DM, Goyal RK. Association of HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome among Indians. Indian J Dermatol Venereol Leprol 2009;75:579-82 |
How to cite this URL:
Mehta TY, Prajapati LM, Mittal B, Joshi CG, Sheth JJ, Patel DB, Dave DM, Goyal RK. Association of HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome among Indians. Indian J Dermatol Venereol Leprol [serial online] 2009 [cited 2021 Jan 24];75:579-82. Available from: https://www.ijdvl.com/text.asp?2009/75/6/579/57718 |
| Introduction | |  |
Stevens-Johnson syndrome More Details (SJS) and toxic epidermal necrolysis (TEN) are acute life-threatening reactions of the skin to drugs. SJS and TEN are two related mucocutaneous blistering disorders with significant mortality (especially with TEN) and prolonged morbidity. Patients develop an acute exanthema, which progresses toward a widespread blistering (TEN) or more limited purpura, vesicles (SJS) and erosion of the skin and mucous membranes, resulting from apoptosis of keratinocytes. The incidence of SJS is estimated to be one to six cases per million person-years and of TEN at 0.4-1.2 cases per million person-years. Various drugs are reported to be associated with a high risk for SJS and TEN. These include several antiepileptic agents, especially carbamazepine, phenytoin, phenobarbital and lamotrigine, antibacterials, anti-inflammatory drugs of the oxicam family and allopurinol. [1],[2]
Chung and colleagues [3] reported a very strong association between carbamazepine-induced SJS in Han Chinese patients and the human leucocyte antigen (HLA)-B*1502 allele. They studied 44 Han Chinese patients with carbamazepine-induced SJS and two groups of controls, 101 tolerant patients and 93 healthy controls. All 44 SJS or TEN patients had an HLA-B*1502 allele in contrast with 3% of the carbamazepine-tolerant patients and 8.6% of the unexposed controls, respectively. [3] In Europe, HLA-B genotyping was carried out in 12 patients of carbamazepine-induced SJS. Of the 12, only four had HLA-B*1502. Remarkably, all the four had an Asian ancestry and originated from China, Vietnam, Cambodia, and the Reunion Island. It was suggested that HLA-B*1502 is not a universal marker for carbamazepine-induced SJS but is ethnicity-specific for Asians. [4] Studies in other Asian populations from Malaysia, Thailand and Hong Kong have also reported an association between HLA-B*1502 and SJS induced by carbamazepine. [5],[6],[7] None of these studies have been reported from India although the incidences of SJS were found to be higher among Indians compared with Europeans. [8],[9],[10],[11] Carbamazepine is a widely prescribed antiepileptic in India and is found to be the most commonly implicated drug responsible for SJS/TEN among Indians. [12] In the light of the above observations, we have undertaken an HLA genotyping study of Indian patients suffering from carbamazepine-induced SJS.
| Methods | | |
Patient recruitment and sample collection
Eight individuals who fulfilled the diagnostic criteria of SJS induced by carbamazepine were identified at Dr. Rasiklal Shah Sarvajanik Hospital and Samarpan Centre for Treatment of Diseases of Skin, STD and Leprosy, Modasa, India. All the patients were assessed by dermatologists who had received photographs, pathological slides and medical records. Patients with definite diagnosis and ready to sign written consent were included in the study. Ten unrelated normal controls from the same population were selected randomly. The study was approved by the Institutional Review Board of Dr. Rasiklal Shah Sarvajanik Hospital, Modasa. The diagnostic criteria of SJS were based on the clinical morphology defined by Roujeau. [13] We defined SJS as skin detachment up to 10% of the body surface area and overlap SJS/TEN as skin detachment of 10-30%. Our five patients (no. 2, 3, 4, 7, 8) received carbamazepine as an antiepileptic therapy. Two patients (no. 5, 6) received carbamazepine as a post head injury anticonvulsant prophylaxis. In the remaining one patient (no. 1), trigeminal neuralgia was the indication for carbamazepine. Peripheral blood was collected in ethylene diammine tetra acetic acid-coated sterile vials and stored in a refrigerator. [Table 1] shows the clinical characteristics of eight patients with carbamazepine-induced SJS identified in our study.
DNA extraction
Genomic DNA from peripheral lymphocytes was extracted by the standard phenol-chloroform method.
HLA-B genotyping
The quality and quantity of the extracted DNA was checked on 0.8% agarose gel and a spectrophotometer. The concentration of each DNA sample was finally adjusted to 30 ng/µl, which was used for HLA-B molecular typing. HLA-B genotyping was carried out by polymerase chain reaction (PCR) using sequence-specific primers (Micro SSP HLA-B kits; One Lambda Inc., Canoga Park, CA, United States. Low-resolution HLA-B genotyping was carried out with the One Lambda HLA-B kit in a PCR with sequence-specific primers according to the protocol and recommendations of the manufacturer (PCR-SSP, One Lambda Inc.).
Statistical analysis
Allele frequency between the two groups was compared by the Chi-square method with Yates' correction by constructing 2 x 2 tables. The odds ratio was calculated with Haldane's modification, which adds 0.5 to all cells to accommodate a possible zero count.
| Results | | |
We determined the HLA-B genotypes of eight carbamazepine-induced cases and 10 normal controls by PCR using sequence-specific primers (Micro SSP HLA-B kits; One Lambda Inc.). We found that six out of eight patients had the HLA-B*1502 allele (all being heterozygous). One patient was found to be homozygous with HLA-B*1508 allele. All the 10 controls were found to be negative for HLA-B*1502. The genotypes observed are shown in [Table 2]. The odds ratio was found to be 71.40 (95% CI, 3.0-1698) and the P-value was found to be 0.0014.
| Discussion | | |
HLA-B*1502 as a marker for carbamazepine-induced SJS is well established in the Han Chinese by different studies. The allele frequency of HLA-B*1502 in the Han Chinese population is 8%, which is relatively higher than any other population of the world. [14] From India, a 0-6% (average 2.5%) prevalence of HLA-B*1502 in different communities has been reported. Most of them are sub-Hindu communities, except Parsi, in which a 0% prevalence is reported. [15],[16],[17],[18],[19],[20] Our eight patients also belong to the Hindu community, which is the biggest community of India comprising of one billion Indians. Our six out of eight patients had HLA-B*1502 while none of the 10 controls were found to be positive. This clearly indicates a significant association (Odds ratio: 71.40 [95% CI, 3.0-1698]; P = 0.0014) between carbamazepine-induced SJS and HLA-B*1502 among Indians.
Because the association is not 100%, as observed in the Han Chinese community, other genes or combinations of genes might be playing a role. To conclude, we suggest HLA-B*1502 testing before initiating carbamazepine drug therapy in Indians. To obtain a clear Indian picture, the study should be extended to different subethnic groups from different regions.
| References | | |
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[Table 1], [Table 2]
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| Hiroyuki NIIHARA,Kunie KOHNO,Takeshi TAKETANI,Sakae KANEKO,Takahumi ITO,Takashi SUGAMORI,Nobuyuki TAKAHASHI,Tuyoshi MIYAOKA,Shihoh OKAZAKI,Hideaki YASUDA,Motohide FURUYA,Michiharu NAGAHAMA,Eishin MORITA | | Journal of Dermatological Science. 2013; | | [Pubmed] | [DOI] | | | 48 |
Specific HLA types are associated with antiepileptic drug-induced Stevens–Johnson syndrome and toxic epidermal necrolysis in Japanese subjects |
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A Review of Pharmacogenetics of Adverse Drug Reactions in Elderly People |
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HLA-B*1502 allele is associated with a cross-reactivity pattern of cutaneous adverse reactions to antiepileptic drugs |
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A recent update of pharmacogenomics in drug-induced severe skin reactions |
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HLA-B*1502 Strongly Predicts Carbamazepine-Induced Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Thai Patients with Neuropathic Pain |
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Genome-wide mapping for clinically relevant predictors of lamotrigine- and phenytoin-induced hypersensitivity reactions |
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Integration of Pharmacogenetics and Pharmacogenomics in Drug Development: Implications for Regulatory and Medical Decision Making in Pediatric Diseases |
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A Recent Update of Pharmacogenomics in Drug-induced Severe Skin Reactions |
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HLA-A31 strongly associates with carbamazepine-induced adverse drug reactions but not with carbamazepine-induced lymphocyte proliferation in a Japanese population |
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HLA-B*1502 Strongly Predicts Carbamazepine-Induced Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Thai Patients with Neuropathic Pain |
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Carbamazepine-induced severe cutaneous adverse reactions and HLA genotypes in Koreans |
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The Genetics of Antiepileptic Drug–Induced Skin Reactions |
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Shared and restricted T-cell receptor use is crucial for carbamazepine-induced Stevens-Johnson syndrome |
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Pharmacogenetics of cutaneous adverse drug reactions |
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| Michiko AIHARA | | The Journal of Dermatology. 2011; 38(3): 246 | | [Pubmed] | [DOI] | | | 88 |
Strong association between HLA-B*1502 and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in mainland Han Chinese patients |
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| Yan Zhang,Jin Wang,Li-Mei Zhao,Wei Peng,Guo-Qing Shen,Ling Xue,Xiao-Xian Zheng,Xiao-Jing HE,Chun-Yan Gong,Li-Yan Miao | | European Journal of Clinical Pharmacology. 2011; 67(9): 885 | | [Pubmed] | [DOI] | | | 89 |
HLA-A*3101 and Carbamazepine-Induced Hypersensitivity Reactions in Europeans |
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PharmGKB summary |
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Analysis of Body Constitution of Fifty-two Patients with Stevens-Johnson Syndrome (SJS) Using Kampo Medical Questionnaires: Prediction of SJS based on Body Constitution Using Decision Tree |
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Phenytoin-induced Stevens–Johnson syndrome with negative HLA-B*1502 allele in mainland China: Two cases |
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Pilot association study of oxcarbazepine-induced mild cutaneous adverse reactions with HLA-B*1502 allele in Chinese Han population |
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| Fa-yun Hu,Xin-tong Wu,Dong-mei An,Bo Yan,Hermann Stefan,Dong Zhou | | Seizure. 2011; 20(2): 160 | | [Pubmed] | [DOI] | | | 94 |
Exploratory Study on Biomarkers Associated with Severe Cutaneous Adverse Reactions |
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Epidemiology and risk factors for drug allergy |
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Carbamazepine-induced Stevens-Johnson syndrome: Genetic predisposition of Asian patients | [Stevens-Johnson-syndrom unter carbamazepin: Genetische prädisposition asiatischer patienten] |
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| Spindelegger, C., Konstantinidis, A., Kasper, S. | | Journal fur Neurologie, Neurochirurgie und Psychiatrie. 2011; 12(2): 176-178 | | [Pubmed] | | | 97 |
Carbamzepine-induced toxic epidermal necrolysis |
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| Chowta, N.K., Chowta, M.N., Ramapuram, J., Kumar, P., Fazil, A. | | Indian Journal of Critical Care Medicine. 2011; 15(2): 123-125 | | [Pubmed] | | | 98 |
Phenotype Standardization for Immune-Mediated Drug-Induced Skin Injury |
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| M Pirmohamed,P S Friedmann,M Molokhia,Y K Loke,C Smith,E Phillips,L La Grenade,B Carleton,M Papaluca-Amati,P Demoly,N H Shear | | Clinical Pharmacology & Therapeutics. 2011; 89(6): 896 | | [Pubmed] | [DOI] | | | 99 |
Toxic epidermal necrolysis and Stevens-Johnson syndrome: A review* |
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| Roland Gerull,Mathias Nelle,Thomas Schaible | | Critical Care Medicine. 2011; 39(6): 1521 | | [Pubmed] | [DOI] | | | 100 |
Drug reaction with eosinophilia and systemic symptoms (DRESS): A clinical update and review of current thinking |
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Phenotype standardization for immune-mediated drug-induced skin injury |
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| Pirmohamed, M., Friedmann, P.S., Molokhia, M., Loke, Y.K., Smith, C., Phillips, E., La Grenade, L., (...), Shear, N.H. | | Clinical Pharmacology and Therapeutics. 2011; 89(6): 896-901 | | [Pubmed] | | | 102 |
Analysis of body constitution of fifty-two patients with stevens-johnson syndrome (SJS) using kampo medical questionnaires: Prediction of SJS based on body constitution using decision tree |
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| Ohshima, S., Hatori, Y., Honma, S., Terasawa, K., Saitoh, Y., Kobayashi, D. | | Yakugaku Zasshi. 2011; 131(5): 745-756 | | [Pubmed] | | | 103 |
Epidemiology and risk factors for drug allergy |
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| Thong, B.Y.-H., Tan, T.-C. | | British Journal of Clinical Pharmacology. 2011; 71(5): 684-700 | | [Pubmed] | | | 104 |
HLA-A*3101 and carbamazepine-induced hypersensitivity reactions in Europeans |
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| McCormack, M., Alfirevic, A., Bourgeois, S., Farrell, J.J., Kasperavičiute, D., Carrington, M., Sills, G.J., (...), Pirmohamed, M. | | New England Journal of Medicine. 2011; 364(12): 1134-1143 | | [Pubmed] | | | 105 |
Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan |
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Pharmacogenetics of cutaneous adverse drug reactions |
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| Aihara, M. | | Journal of Dermatology. 2011; 38(3): 246-254 | | [Pubmed] | | | 107 |
Pilot association study of oxcarbazepine-induced mild cutaneous adverse reactions with HLA-B*1502 allele in Chinese Han population |
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Drug hypersensitivity: Pharmacogenetics and clinical syndromes |
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| Alfirevic, A., Pirmohamed, M. | | Pharmaceuticals. 2011; 4(1): 69-90 | | [Pubmed] | | | 110 |
Exploratory study on biomarkers associated with severe cutaneous adverse reactions |
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| Kaniwa, N. | | Yakugaku Zasshi. 2011; 131(2): 255-261 | | [Pubmed] | | | 111 |
Do no harm-But first we need to know more: The case of adverse drug reactions with antiepileptic drugs |
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Carbamazepine-induced severe cutaneous adverse reactions and HLA genotypes in Koreans |
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Strong association between HLA-Bz.ast1502 and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in mainland Han Chinese patients |
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| Zhang, Y., Wang, J., Zhao, L.-M., Peng, W., Shen, G.-Q., Xue, L., Zheng, X.-X., (...), Miao, L.-Y. | | European Journal of Clinical Pharmacology. 2011; 67(9): 885-887 | | [Pubmed] | | | 114 |
Antiepileptic drugs |
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Shared and restricted T-cell receptor use is crucial for carbamazepine-induced Stevens-Johnson syndrome |
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PharmGKB summary: Carbamazepine pathway |
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| Thorn, C.F., Leckband, S.G., Kelsoe, J., Steven Leeder, J., Müller, D.J., Klein, T.E., Altman, R.B. | | Pharmacogenetics and Genomics. 2011; 21(12): 906-910 | | [Pubmed] | | | 117 |
Phenytoin-induced Stevens-Johnson syndrome with negative HLA-B*1502 allele in mainland China: Two cases |
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The genetics of antiepileptic drug-induced skin reactions |
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Toxic epidermal necrolysis and Stevens-Johnson syndrome: A review |
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Drug Induced Hypersensitivity and the HLA Complex |
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Carbamazepine-induced Stevens-Johnson syndrome sparing the skin previously affected by herpes zoster infection in a patient with systemic lupus erythematosus: A reverse isotopic phenomenon |
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| Tenea, D. | | Case Reports in Dermatology. 2010; 2(2): 140-145 | | [Pubmed] | | | 122 |
Association study of lamotrigine-induced cutaneous adverse reactions and HLA-B*1502 in a Han Chinese population |
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HLA-B*1511 is a risk factor for carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Japanese patients |
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Genetic markers and danger signals in Stevens-Johnson syndrome and toxic epidermal necrolysis |
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Association study of lamotrigine-induced cutaneous adverse reactions and HLA-B*1502 in a Han Chinese population |
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HLA-B*1511 is a risk factor for carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Japanese patients |
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Genetic Markers and Danger Signals in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis |
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Genetic and ethnic risk factors associated with drug hypersensitivity |
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