Clinico-Epidemiological Characteristics of Severe Cutaneous Adverse Drug Reactions at the Kenyatta National Hospital
Résumé
Severe Cutaneous Adverse Reactions (SCARs) including Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) among others, are rare but potentially fatal drug-induced skin reactions. They pose a significant burden in resource-constrained settings like Kenya, where data on their epidemiology remains limited. Understanding the clinical characteristics of SCARs is crucial for improving patient outcomes, enhancing pharmacovigilance efforts and strengthening drug safety measures in Kenya. The study aimed to describe the clinical and epidemiological characteristics of SCARs, identify clinical phenotypes and describe the drugs associated with SCAR cases at Kenyatta National Hospital (KNH). A hybrid cross-sectional design was employed, comprising both retrospective and prospective data collection. A total of 102 patients were recruited via consecutive sampling. Data was collected through file reviews, clinical examinations, and interviews, focusing on demographics, clinical features and etiologies. Statistical analyses were conducted using SPSS-v26, with ethical approval from the KNH-UoN ERC. SJS/TEN was the most common phenotype (55.9%), followed by Drug-Induced Erythroderma (DIE) (17.6%) and Drug-Induced Erythema Multiforme (DIEM) (11.8%). The mean participant age was 29.4 years, with a slight female predominance (51%). Antimicrobials (60.8%) and anticonvulsants (13.5%) were the main implicated drug classes, with co-trimoxazole, ceftriaxone and carbamazepine identified as common culprits. HIV was the most prevalent comorbidity (23.9%). Common complications included acute kidney injury (11.8%) and drug-induced liver injury (8.8%). In-hospital mortality was 16.7%, with SJS/TEN having the highest case fatality rate (21.05%). SCARs in Kenya exhibit unique clinical and demographic patterns, with high mortality and organ involvement. Antimicrobials and anticonvulsants are major culprits. This underscores the need for early diagnosis, pharmacovigilance, public awareness, and healthcare provider training to improve patient outcomes. Future research should explore pharmacogenetics, long-term SCAR sequelae and the role of HIV in these severe reactions.
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Références
Agbabiaka, T. B., Savović, J., & Ernst, E. (2008). Methods for Causality Assessment of Adverse Drug Reactions: A Systematic Review. Drug Safety, 31(1), 21– 37. https://doi.org/10.2165/00002018-200831010-00003
Ajayi, F. O., Sun, H., & Perry, J. (2000). Adverse Drug Reactions: A Review of Relevant Factors. The Journal of Clinical Pharmacology, 40(10), 1093– 1101. https://doi.org/10.1177/009127000004001003
Anderson, H. J., & Lee, J. B. (2021). A Review of Fixed Drug Eruption with a Special Focus on Generalized Bullous Fixed Drug Eruption. Medicina, 57(9), 925. https://doi.org/10.3390/medicina57090925
Ardern-Jones, M. R., & Mockenhaupt, M. (2019). Making a diagnosis in severe cutaneous drug hypersensitivity reactions. Current Opinion in Allergy & Clinical Immunology, 19(4), 283–293. https://doi.org/10.1097/ACI.0000000000000546
Barry, A., Olsson, S., Minzi, O., Bienvenu, E., Makonnen, E., Kamuhabwa, A., Oluka, M., Guantai, A., Bergman, U., Van Puijenbroek, E., Gurumurthy, P., & Aklillu, E. (2020). Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania. Drug Safety, 43(4), 339–350. https://doi.org/10.1007/s40264-019-00898-z
Brahimi, N., Routier, E., Raison-Peyron, N., Tronquoy, A.-F., Pouget-Jasson, C., Amarger, S., Machet, L., Amsler, E., Claeys, A., Sassolas, B., Leroy, D., Grange, A., Dupuy, A., Cordel, N., Bonnetblanc, J.-M., Milpied, B., Doutre, M.-S., Guinnepain, M.-T., Barbaud, A., … Descamps, V. (2010). A three-year-analysis of fixed drug eruptions in hospital settings in France. European Journal of Dermatology, 20(4), 461–464. https://doi.org/10.1684/ejd.2010.0980
Cardona, V., Ansotegui, I. J., Ebisawa, M., El-Gamal, Y., Fernandez Rivas, M., Fineman, S., Geller, M., Gonzalez-Estrada, A., Greenberger, P. A., Sanchez Borges, M., Senna, G., Sheikh, A., Tanno, L. K., Thong, B. Y., Turner, P. J., & Worm, M. (2020). World Allergy Organization Anaphylaxis Guidance 2020. World Allergy Organization Journal, 13(10), 100472. https://doi.org/10.1016/j.waojou.2020.100472
Clark Huff, J., Weston, W. L., & Tonnesen, M. G. (1983). Erythema multiforme: A critical review of characteristics, diagnostic criteria, and causes. Journal of the American Academy of Dermatology, 8(6), 763– 775. https://doi.org/10.1016/S0190-9622(83)80003-6
Creadore, A., Desai, S., Alloo, A., Dewan, A. K., Bakhtiar, M., Cruz-Diaz, C., Femia, A., Fox, L., Katz, K. L., Micheletti, R., Nelson, C. A., Ortega-Loayza, A. G., Patrinely, J. R., Plovanich, M., Rosenbach, M., Shaigany, S., Shields, B. E., Saleh, J. Z., Sharif-Sidi, Z., … Mostaghimi, A. (2022). Clinical Characteristics, Disease Course, and Outcomes of Patients With Acute Generalized Exanthematous Pustulosis in the US. JAMA Dermatology, 158(2), 176. https://doi.org/10.1001/jamadermatol.2021.5390
Devarbhavi, H., & Raj, S. (2019). Drug‐induced liver injury with skin reactions: Drugs and host risk factors, clinical phenotypes and prognosis. Liver International, 39(5), 802–811. https://doi.org/10.1111/liv.14004
Ensina, L. F., Félix, M. M. R., & Aranda, C. S. (2016). Drug-Induced Anaphylaxis: Clinical Scope, Management, and Prevention. Current Treatment Options in Allergy, 3(3), 243–252. https://doi.org/10.1007/s40521-016-0085-1
Feldmeyer, L., Heidemeyer, K., & Yawalkar, N. (2016). Acute Generalized Exanthematous Pustulosis: Pathogenesis, Genetic Background, Clinical Variants and Therapy. International Journal of Molecular Sciences, 17(8), 1214. https://doi.org/10.3390/ijms17081214
Foer, D., Buchheit, K. M., Gargiulo, A. R., Lynch, D. M., Castells, M., & Wickner, P. G. (2016). Progestogen Hypersensitivity in 24 Cases: Diagnosis, Management, and Proposed Renaming and Classification. The Journal of Allergy and Clinical Immunology: In Practice, 4(4), 723–729. https://doi.org/10.1016/j.jaip.2016.03.003
Guzman, A. I., & Paliza, A. C. (2018). Epidemiology of severe cutaneous adverse drug reactions in a University Hospital: A Five-year review. Journal of Medicine, University of Santo Tomas, 2(1), 171–184. https://doi.org/10.35460/2546-1621.2017-0031
Hiransuthikul, A., Rattananupong, T., Klaewsongkram, J., Rerknimitr, P., Pongprutthipan, M., & Ruxrungtham, K. (2016). Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DIHS/DRESS): 11 years retrospective study in Thailand. Allergology International, 65(4), 432–438. https://doi.org/10.1016/j.alit.2016.04.001
Irungu, K., Nyamu, D., & Opanga, S. (2017). Characterization of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Among Patients Admitted to Kenyatta National Hospital: A Retrospective Cross-Sectional Study. Drugs - Real World Outcomes, 4(2), 79–85. https://doi.org/10.1007/s40801-017-0105-x
Kang, D. Y., Yun, J., Lee, S.-Y., Koh, Y.-I., Sim, D. W., Kim, S., Nam, Y. H., Park, J.-W., Kim, S. H., Ye, Y.-M., Park, H.-K., Kim, M.-H., Jee, Y.-K., Jung, J.-W., Yang, M.-S., Kim, S.-H., Lee, J. K., Kim, C.-W., Hur, G. Y., … Kang, H.-R. (2021). A Nationwide Study of Severe Cutaneous Adverse Reactions Based on the Multicenter Registry in Korea. The Journal of Allergy and Clinical Immunology: In Practice, 9(2), 929-936.e7. https://doi.org/10.1016/j.jaip.2020.09.011
Kardaun, S. H., Sekula, P., Valeyrie-Allanore, L., Liss, Y., Chu, C. Y., Creamer, D., Sidoroff, A., Naldi, L., Mockenhaupt, M., Roujeau, J. C., & the RegiSCAR study group. (2013). Drug reaction with eosinophilia and systemic symptoms (DRESS): An original multisystem adverse drug reaction. Results from the prospective RegiSCAR study. British Journal of Dermatology, 169(5), 1071–1080. https://doi.org/10.1111/bjd.12501
Khaled, A., Sellami, A., Fazaa, B., Kharfi, M., Zeglaoui, F., & Kamoun, M. (2010). Acquired erythroderma in adults: A clinical and prognostic study. Journal of the European Academy of Dermatology and Venereology, 24(7), 781–788. https://doi.org/10.1111/j.1468-3083.2009.03526.x
Kim, D.-H., & Koh, Y.-I. (2014). Comparison of Diagnostic Criteria and Determination of Prognostic Factors for Drug Reaction With Eosinophilia and Systemic Symptoms Syndrome. Allergy, Asthma & Immunology Research, 6(3), 216. https://doi.org/10.4168/aair.2014.6.3.216
Kliniec, K., Snopkowska, A., Łyko, M., & Jankowska-Konsur, A. (2024). Erythroderma: A Retrospective Study of 212 Patients Hospitalized in a Tertiary Center in Lower Silesia, Poland. Journal of Clinical Medicine, 13(3), 645. https://doi.org/10.3390/jcm13030645
Lee, C.-H., Chen, Y.-C., Cho, Y.-T., Chang, C.-Y., & Chu, C.-Y. (2012). Fixed-drug eruption: A retrospective study in a single referral center in northern Taiwan. Dermatologica Sinica, 30(1), 11– 15. https://doi.org/10.1016/j.dsi.2012.02.002
Lee, E. Y., & Koh, M. J. A. (2021). Acute generalized exanthematous pustulosis in children and adolescents in Singapore: A ten‐year retrospective review. Pediatric Dermatology, 38(2), 424–430. https://doi.org/10.1111/pde.14482
Lehloenya, R. J., & Kgokolo, M. (2014). Clinical Presentations of Severe Cutaneous Drug Reactions in HIV-Infected Africans. Dermatologic Clinics, 32(2), 227–235. https://doi.org/10.1016/j.det.2013.11.004
Lerch, M., Mainetti, C., Terziroli Beretta-Piccoli, B., & Harr, T. (2018). Current Perspectives on Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Clinical Reviews in Allergy & Immunology, 54(1), 147–176. https://doi.org/10.1007/s12016-017-8654-z
Lipowicz, S., Sekula, P., Ingen-Housz-Oro, S., Liss, Y., Sassolas, B., Dunant, A., Roujeau, J.-C., & Mockenhaupt, M. (2013). Prognosis of generalized bullous fixed drug eruption: Comparison with Stevens-Johnson syndrome and toxic epidermal necrolysis: Prognosis of GBFDE vs. SJS/TEN. British Journal of Dermatology, 168(4), 726–732. https://doi.org/10.1111/bjd.12133
Machoń, N., Lewandowska, J., Zdanowska, N., Placek, W., & Owczarczyk-Saczonek, A. (2022). Cutaneous Adverse Drug Reactions (CADRs)—Statistical Analysis of the Causal Relationship between the Drug, Comorbidities, Cofactors, and the Cutaneous Reaction—A Single-Centered Study. International Journal of Environmental Research and Public Health, 19(13), 7982. https://doi.org/10.3390/ijerph19137982
McNish, A. J. S., Ho, J. D., & East-Innis, A. D. C. (2024). Severe cutaneous adverse reactions in a tertiary care center in Jamaica. JAAD International, 15, 139–146. https://doi.org/10.1016/j.jdin.2024.02.007
Micheletti, R. G., Chiesa-Fuxench, Z., Noe, M. H., Stephen, S., Aleshin, M., Agarwal, A., Boggs, J., Cardones, A. R., Chen, J. K., Cotliar, J., Davis, M. D. P., Dominguez, A., Fox, L. P., Gordon, S., Hamrick, R., Ho, B., Hughey, L. C., Jones, L. M., Kaffenberger, B. H., … Rosenbach, M. (2018). Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Multicenter Retrospective Study of 377 Adult Patients from the United States. Journal of Investigative Dermatology, 138(11), 2315–2321. https://doi.org/10.1016/j.jid.2018.04.027
Miyashiro, D., & Sanches, J. A. (2020). Erythroderma: A prospective study of 309 patients followed for 12 years in a tertiary center. Scientific Reports, 10(1), 9774. https://doi.org/10.1038/s41598-020-66040-7
Mockenhaupt, M. (2017). Epidemiology of cutaneous adverse drug reactions. Allergologie Select, 1(1), 96–108. https://doi.org/10.5414/ALX01508E
Ocan, M., Obuku, E. A., Bwanga, F., Akena, D., Richard, S., Ogwal-Okeng, J., & Obua, C. (2015). Household antimicrobial self-medication: A systematic review and meta-analysis of the burden, risk factors and outcomes in developing countries. BMC Public Health, 15(1), 742. https://doi.org/10.1186/s12889-015-2109-3
Owen, C. E., & Jones, J. M. (2021). Recognition and Management of Severe Cutaneous Adverse Drug Reactions (Including Drug Reaction with Eosinophilia and Systemic Symptoms, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis). Medical Clinics of North America, 105(4), 577–597. https://doi.org/10.1016/j.mcna.2021.04.001
Pande, S. (2018). Causality or Relatedness assessment in adverse drug reaction and its relevance in dermatology. Indian Journal of Dermatology, 63(1), 18. https://doi.org/10.4103/ijd.IJD_579_17
Panthalla, V. L., Swamy, M. S., Y., A. K., & I., C. S. R. (2019). CLINICO-EPIDEMIOLOGICAL STUDY OF ERYTHEMA MULTIFORME. Journal of Evidence-Based Medicine and Healthcare, 6(19), 1427–1431. https://doi.org/10.18410/jebmh/2019/291
Pavlos, R., Mallal, S., & Phillips, E. (2012). HLA and pharmacogenetics of drug hypersensitivity. Pharmacogenomics, 13(11), 1285–1306. https://doi.org/10.2217/pgs.12.108
Pudukadan, D., & Thappa, D. M. (2004). Adverse cutaneous drug reactions: Clinical pattern and causative agents in a tertiary care center in South India. 70(1).
Regateiro, F. S., Marques, M. L., & Gomes, E. R. (2020). Drug-Induced Anaphylaxis: An Update on Epidemiology and Risk Factors. International Archives of Allergy and Immunology, 181(7), 481–487. https://doi.org/10.1159/000507445
Saka, B., Barro‐Traoré, F., Atadokpédé, F. A., Kobangue, L., Niamba, P. A., Adégbidi, H., Yedomon, H. G., Traoré, A., & Pitché, V. P. (2013). Stevens-Johnson syndrome and toxic epidermal necrolysis in sub-Saharan Africa: A multicentric study in four countries. International Journal of Dermatology, 52(5), 575–579. https://doi.org/10.1111/j.1365-4632.2012.05743.x
Salami, T. A. T., Enahoro Oziegbe, O., & Omeife, H. (2012). Exfoliative dermatitis: Patterns of clinical presentation in a tropical rural and suburban dermatology practice in Nigeria. International Journal of Dermatology, 51(9), 1086–1089. https://doi.org/10.1111/j.1365-4632.2011.05400.x
Sassolas, B., Haddad, C., Mockenhaupt, M., Dunant, A., Liss, Y., Bork, K., Haustein, U. F., Vieluf, D., Roujeau, J. C., & Le Louet, H. (2010). ALDEN, an Algorithm for Assessment of Drug Causality in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Comparison With Case-Control Analysis. Clinical Pharmacology & Therapeutics, 88(1), 60–68. https://doi.org/10.1038/clpt.2009.252
Sidoroff, A., Halevy, S., Bavinck, J. N. B., Vaillant, L., & Roujeau, J. (2001). Acute generalized exanthematous pustulosis (AGEP) – A clinical reaction pattern. Journal of Cutaneous Pathology, 28(3), 113– 119. https://doi.org/10.1034/j.1600-0560.2001.028003113.x
Singh, G. K., Mitra, B., Arora, S., Akhoon, N., Verma, R., Sharma, P., & Mitra, D. (2021). A retrospective, 5‐year, clinicoepidemiological study of severe cutaneous adverse reactions (SCARs). International Journal of Dermatology, 60(5), 579–588. https://doi.org/10.1111/ijd.15416
Tee, C. T., Abdullah, N. H., Kristummoonthy, P., & Lee, C. S. (2022). Severe cutaneous adverse reactions: A 5-year retrospective study at Hospital Melaka, Malaysia, from December 2014 to February 2020. The Medical Journal of Malaysia, 77(4), 409–414.
Verma, R., Vasudevan, B., & Pragasam, V. (2013). Severe cutaneous adverse drug reactions. Medical Journal Armed Forces India, 69(4), 375– 383. https://doi.org/10.1016/j.mjafi.2013.01.007
Zaouak, A., Ben Salem, F., Ben Jannet, S., Hammami, H., & Fenniche, S. (2019). Bullous fixed drug eruption: A potential diagnostic pitfall: a study of 18 cases. Therapies, 74(5), 527–530. https://doi.org/10.1016/j.therap.2019.01.009
Zhang, C., Van, D. N., Hieu, C., & Craig, T. (2019). Drug-induced severe cutaneous adverse reactions. Annals of Allergy, Asthma & Immunology, 123(5), 483–487. https://doi.org/10.1016/j.anai.2019.08.004
Zhu, W., Fang, D., & Fang, H. (2021). Drug-induced erythroderma in patients with acquired immunodeficiency syndrome. World Journal of Emergency Medicine, 12(4), 299. https://doi.org/10.5847/wjem.j.1920-8642.2021.04.008
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