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Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies

BACKGROUND: Monoclonal antibodies constitute a potent and broadly tolerable drug class, representing for some conditions the first newly approved treatment in years. As such, many are afforded “fast-track” or “breakthrough therapy” designations by the U.S. Food and Drug Administration, leading to pr...

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Autores principales: Di Palma-Grisi, James C., Vijayagopal, Kesav, Muslimani, Muhammad A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594346/
https://www.ncbi.nlm.nih.gov/pubmed/31308976
http://dx.doi.org/10.1155/2019/7595706
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author Di Palma-Grisi, James C.
Vijayagopal, Kesav
Muslimani, Muhammad A.
author_facet Di Palma-Grisi, James C.
Vijayagopal, Kesav
Muslimani, Muhammad A.
author_sort Di Palma-Grisi, James C.
collection PubMed
description BACKGROUND: Monoclonal antibodies constitute a potent and broadly tolerable drug class, representing for some conditions the first newly approved treatment in years. As such, many are afforded “fast-track” or “breakthrough therapy” designations by the U.S. Food and Drug Administration, leading to provisional approval before Phase III clinical trials are reported. Although these drugs are usually safe, some patients experience life-threatening complications—myositis and encephalitis have led to permanent or temporary recalls. Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a hypersensitivity condition easily missed due to its long incubation period and nonspecific presentation. This minireview is primarily intended as an abbreviated guide for practitioners who may be using these powerful treatments. METHODOLOGY: We searched PubMed using a string of symptoms consistent with DRESS syndrome and monoclonal antibodies approved by the FDA since 2015. Then, we excluded studies reporting dermatological complications of reactivation of nonherpetic infection, immunodeficiency-related infection, or reactions to the injection site or infusion. We searched for and accessed prior reviews and background studies via PubMed, Mendeley, and Google Scholar. RESULTS: Two cases of DRESS syndrome were identified in the literature, both the result of treatment with daclizumab. There was one additional case of encephalitis without cutaneous symptoms caused by daclizumab. Drug-induced hypersensitivity dermatitis was reported following treatment with nivolumab and two cases of combination treatment with ipilimumab and either nivolumab or durvalumab produced maculopapular rash and bullae in the first patient and lichenoid dermatitis and blisters in the second patient. CONCLUSIONS: Daclizumab was the only recently approved monoclonal antibody associated with DRESS syndrome as such. Limitations in the diagnostic reliability of DRESS syndrome as a clinical entity and the lack of negative clinical trial reporting suggest enhanced vigilance on the part of clinicians and regulators may be warranted.
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spelling pubmed-65943462019-07-15 Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies Di Palma-Grisi, James C. Vijayagopal, Kesav Muslimani, Muhammad A. Autoimmune Dis Review Article BACKGROUND: Monoclonal antibodies constitute a potent and broadly tolerable drug class, representing for some conditions the first newly approved treatment in years. As such, many are afforded “fast-track” or “breakthrough therapy” designations by the U.S. Food and Drug Administration, leading to provisional approval before Phase III clinical trials are reported. Although these drugs are usually safe, some patients experience life-threatening complications—myositis and encephalitis have led to permanent or temporary recalls. Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a hypersensitivity condition easily missed due to its long incubation period and nonspecific presentation. This minireview is primarily intended as an abbreviated guide for practitioners who may be using these powerful treatments. METHODOLOGY: We searched PubMed using a string of symptoms consistent with DRESS syndrome and monoclonal antibodies approved by the FDA since 2015. Then, we excluded studies reporting dermatological complications of reactivation of nonherpetic infection, immunodeficiency-related infection, or reactions to the injection site or infusion. We searched for and accessed prior reviews and background studies via PubMed, Mendeley, and Google Scholar. RESULTS: Two cases of DRESS syndrome were identified in the literature, both the result of treatment with daclizumab. There was one additional case of encephalitis without cutaneous symptoms caused by daclizumab. Drug-induced hypersensitivity dermatitis was reported following treatment with nivolumab and two cases of combination treatment with ipilimumab and either nivolumab or durvalumab produced maculopapular rash and bullae in the first patient and lichenoid dermatitis and blisters in the second patient. CONCLUSIONS: Daclizumab was the only recently approved monoclonal antibody associated with DRESS syndrome as such. Limitations in the diagnostic reliability of DRESS syndrome as a clinical entity and the lack of negative clinical trial reporting suggest enhanced vigilance on the part of clinicians and regulators may be warranted. Hindawi 2019-06-09 /pmc/articles/PMC6594346/ /pubmed/31308976 http://dx.doi.org/10.1155/2019/7595706 Text en Copyright © 2019 James C. Di Palma-Grisi et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Di Palma-Grisi, James C.
Vijayagopal, Kesav
Muslimani, Muhammad A.
Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
title Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
title_full Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
title_fullStr Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
title_full_unstemmed Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
title_short Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
title_sort case reports of dress syndrome and symptoms consistent with dress syndrome following treatment with recently marketed monoclonal antibodies
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594346/
https://www.ncbi.nlm.nih.gov/pubmed/31308976
http://dx.doi.org/10.1155/2019/7595706
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