Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy

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Published in	Cancer treatment reviews Vol. 45; pp. 7 - 18
Main Authors	Eigentler, Thomas K, Hassel, Jessica C, Berking, Carola, Aberle, Jens, Bachmann, Oliver, Grünwald, Viktor, Kähler, Katharina C, Loquai, Carmen, Reinmuth, Niels, Steins, Martin, Zimmer, Lisa, Sendl, Anna, Gutzmer, Ralf
Format	Journal Article
Language	English
Published	Netherlands Elsevier Ltd 01.04.2016
Subjects	Adverse drug reaction Antibodies, Monoclonal - immunology Antibodies, Monoclonal - pharmacology Antibodies, Monoclonal, Humanized - immunology Antibodies, Monoclonal, Humanized - pharmacology Antineoplastic Agents - immunology Antineoplastic Agents - pharmacology B7-H1 Antigen - antagonists & inhibitors Disease Management Drug-Related Side Effects and Adverse Reactions - drug therapy Drug-Related Side Effects and Adverse Reactions - etiology Drug-Related Side Effects and Adverse Reactions - immunology Early Diagnosis Hematology, Oncology and Palliative Medicine Humans Immune-related adverse events Immunosuppressive Agents - therapeutic use Immunotherapy Monitoring, Immunologic Neoplasms - drug therapy Nivolumab PD-1 Pembrolizumab Programmed Cell Death 1 Receptor - immunology Pembrolizumab Immune-related adverse events Adverse drug reaction PD-1 Immunotherapy Nivolumab
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AbstractList	PD-1 checkpoint inhibitors are associated with a specific spectrum of immune-related adverse events. This spectrum is different from toxicities known for kinase inhibitors or cytotoxic drugs. Since PD-1 directed therapies show effectivity in an increasing number of malignant diseases, their clinical usage will increase rapidly. Therefore clinicians from different specialities such as medical oncology, internal medicine, family doctors and emergency unit staff should be aware of the adverse effects of PD-1 checkpoint inhibitors to avoid delays in diagnosis and treatment. Based on pooled data from pivotal trials as reported by the European Medicines Agency, the present paper reviews incidences and kinetics of onset and resolution of immune-mediated "adverse events of specific interest" (AEOSI) of both approved PD-1 inhibitors nivolumab and pembrolizumab. In general, the severity of AEOSI is mild to moderate (grade 1-2); the frequency of immune-mediated but also idiopathic grade 3-4 adverse drug reactions is ⩽2% for any event term. Recommendations for the diagnosis, monitoring and management of the relevant dermatological, gastrointestinal, pulmonary, endocrine, renal and hepatic toxicities are convened by an expert panel that consolidated and clarified treatment recommendations after the onset of AEOSI. Although the time of onset is not predictable - the medians range from 1 to 6months - the huge majority of events is reversible, with no impact of the time of onset. By the systemic use of glucocorticoids, notably methylprednisolone or equivalents, most AEOSI are well manageable. Non-steroidal immunosuppressants may be used in certain cases of refractory/recalcitrant, long-lasting immune toxicities. With regard to the outstanding clinical activity of the anti-PD-1 antibodies, therapy restart is the principal therapeutic option after recovery of grade 2 AEOSI, or diminution of higher grade skin or endocrine events to mild severity. Early diagnosis and close clinical monitoring are essential for successful management of immune-related adverse events. Graphical abstract [Display omitted] •Immune-mediated adverse drug reactions of grade 3–4 occur in up to 2% in the standard organ classes (according to MedDRA).•Early diagnosis and treatment is a key to manage immune-mediated adverse events.•Most immune-related adverse events are clinically well-manageable by use of systemic corticosteroids.•Anti-PD-1 therapy restart is indicated after recovery of events of mild or moderate severity. PD-1 checkpoint inhibitors are associated with a specific spectrum of immune-related adverse events. This spectrum is different from toxicities known for kinase inhibitors or cytotoxic drugs. Since PD-1 directed therapies show effectivity in an increasing number of malignant diseases, their clinical usage will increase rapidly. Therefore clinicians from different specialities such as medical oncology, internal medicine, family doctors and emergency unit staff should be aware of the adverse effects of PD-1 checkpoint inhibitors to avoid delays in diagnosis and treatment. Based on pooled data from pivotal trials as reported by the European Medicines Agency, the present paper reviews incidences and kinetics of onset and resolution of immune-mediated “adverse events of specific interest” (AEOSI) of both approved PD-1 inhibitors nivolumab and pembrolizumab. In general, the severity of AEOSI is mild to moderate (grade 1–2); the frequency of immune-mediated but also idiopathic grade 3–4 adverse drug reactions is ⩽2% for any event term. Recommendations for the diagnosis, monitoring and management of the relevant dermatological, gastrointestinal, pulmonary, endocrine, renal and hepatic toxicities are convened by an expert panel that consolidated and clarified treatment recommendations after the onset of AEOSI. Although the time of onset is not predictable – the medians range from 1 to 6months – the huge majority of events is reversible, with no impact of the time of onset. By the systemic use of glucocorticoids, notably methylprednisolone or equivalents, most AEOSI are well manageable. Non-steroidal immunosuppressants may be used in certain cases of refractory/recalcitrant, long-lasting immune toxicities. With regard to the outstanding clinical activity of the anti-PD-1 antibodies, therapy restart is the principal therapeutic option after recovery of grade 2 AEOSI, or diminution of higher grade skin or endocrine events to mild severity. Early diagnosis and close clinical monitoring are essential for successful management of immune-related adverse events.
Author	Berking, Carola Grünwald, Viktor Gutzmer, Ralf Kähler, Katharina C Eigentler, Thomas K Hassel, Jessica C Sendl, Anna Bachmann, Oliver Aberle, Jens Zimmer, Lisa Reinmuth, Niels Loquai, Carmen Steins, Martin
Author_xml	– sequence: 1 fullname: Eigentler, Thomas K – sequence: 2 fullname: Hassel, Jessica C – sequence: 3 fullname: Berking, Carola – sequence: 4 fullname: Aberle, Jens – sequence: 5 fullname: Bachmann, Oliver – sequence: 6 fullname: Grünwald, Viktor – sequence: 7 fullname: Kähler, Katharina C – sequence: 8 fullname: Loquai, Carmen – sequence: 9 fullname: Reinmuth, Niels – sequence: 10 fullname: Steins, Martin – sequence: 11 fullname: Zimmer, Lisa – sequence: 12 fullname: Sendl, Anna – sequence: 13 fullname: Gutzmer, Ralf
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/26922661$$D View this record in MEDLINE/PubMed
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Keywords	Pembrolizumab Immune-related adverse events Adverse drug reaction PD-1 Immunotherapy Nivolumab
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Snippet	Graphical abstract [Display omitted] •Immune-mediated adverse drug reactions of grade 3–4 occur in up to 2% in the standard organ classes (according to MedDRA).•Early diagnosis... PD-1 checkpoint inhibitors are associated with a specific spectrum of immune-related adverse events. This spectrum is different from toxicities known for...
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SubjectTerms	Adverse drug reaction Antibodies, Monoclonal - immunology Antibodies, Monoclonal - pharmacology Antibodies, Monoclonal, Humanized - immunology Antibodies, Monoclonal, Humanized - pharmacology Antineoplastic Agents - immunology Antineoplastic Agents - pharmacology B7-H1 Antigen - antagonists & inhibitors Disease Management Drug-Related Side Effects and Adverse Reactions - drug therapy Drug-Related Side Effects and Adverse Reactions - etiology Drug-Related Side Effects and Adverse Reactions - immunology Early Diagnosis Hematology, Oncology and Palliative Medicine Humans Immune-related adverse events Immunosuppressive Agents - therapeutic use Immunotherapy Monitoring, Immunologic Neoplasms - drug therapy Nivolumab PD-1 Pembrolizumab Programmed Cell Death 1 Receptor - immunology
Title	Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy
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