Incidence and Management of Olaratumab Infusion-Related Reactions

Brian A. Van Tine, Rangaswamy Govindarajan, Steven Attia, Neeta Somaiah, Scott S. Barker, Ashwin Shahir, Emily Barrett, Pablo Lee, Volker Wacheck, Samuel C. Ramage, William D. Tap

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

PURPOSE: Olaratumab is a human monoclonal immunoglobulin G1 antibody against platelet-derived growth factor receptor-α. We report the nature and frequency of infusion-related reactions (IRRs) with olaratumab in clinical trials and postmarketing reports. METHODS: Data from patients exposed to olaratumab across nine clinical trials were reviewed for IRRs. Blood samples were also analyzed for pre-existing immunoglobulin E anti-galactose-α-1,3-galactose (anti-α-Gal) antibodies. RESULTS: In the clinical trials, IRRs were identified in 70 of 485 patients (14.4%). The most frequent symptoms included flushing, fever or chills, and dyspnea. For 68 of 70 patients (97.1%), the first IRR occurred during the first two cycles of treatment. Grade 3 or worse IRRs were reported in 11 patients (2.3%), all during the first infusion and usually within 15 minutes of the start of the infusion. One IRR-related fatality (0.2%) occurred in a nonpremedicated patient with grade 3 or worse cardiac comorbidities. There was an association between grade 3 or worse IRRs and pre-existing anti-α-Gal antibodies, with a trend toward higher IRR rates in US geographies known to have a higher prevalence of anti-α-Gal antibodies. IRRs in postmarketing reports were consistent in nature and severity with those in the clinical trials. CONCLUSION: Premedication with corticosteroids and antihistamines should occur in all patients before olaratumab infusion, as indicated in labels in the United States and the European Union. Patients receiving olaratumab should be monitored for IRRs in a setting where resuscitation equipment is available for the treatment of IRRs.

Original languageEnglish (US)
Pages (from-to)e925-e933
JournalJournal of oncology practice
Volume15
Issue number11
DOIs
StatePublished - Nov 1 2019

Fingerprint

Galactose
Incidence
Clinical Trials
Antibodies
Platelet-Derived Growth Factor Receptors
Chills
Geography
Premedication
Histamine Antagonists
European Union
olaratumab
Resuscitation
Dyspnea
Immunoglobulin E
Comorbidity
Immunoglobulins
Adrenal Cortex Hormones
Fever
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Oncology
  • Oncology(nursing)
  • Health Policy

Cite this

Van Tine, B. A., Govindarajan, R., Attia, S., Somaiah, N., Barker, S. S., Shahir, A., ... Tap, W. D. (2019). Incidence and Management of Olaratumab Infusion-Related Reactions. Journal of oncology practice, 15(11), e925-e933. https://doi.org/10.1200/JOP.18.00761

Incidence and Management of Olaratumab Infusion-Related Reactions. / Van Tine, Brian A.; Govindarajan, Rangaswamy; Attia, Steven; Somaiah, Neeta; Barker, Scott S.; Shahir, Ashwin; Barrett, Emily; Lee, Pablo; Wacheck, Volker; Ramage, Samuel C.; Tap, William D.

In: Journal of oncology practice, Vol. 15, No. 11, 01.11.2019, p. e925-e933.

Research output: Contribution to journalArticle

Van Tine, BA, Govindarajan, R, Attia, S, Somaiah, N, Barker, SS, Shahir, A, Barrett, E, Lee, P, Wacheck, V, Ramage, SC & Tap, WD 2019, 'Incidence and Management of Olaratumab Infusion-Related Reactions', Journal of oncology practice, vol. 15, no. 11, pp. e925-e933. https://doi.org/10.1200/JOP.18.00761
Van Tine BA, Govindarajan R, Attia S, Somaiah N, Barker SS, Shahir A et al. Incidence and Management of Olaratumab Infusion-Related Reactions. Journal of oncology practice. 2019 Nov 1;15(11):e925-e933. https://doi.org/10.1200/JOP.18.00761
Van Tine, Brian A. ; Govindarajan, Rangaswamy ; Attia, Steven ; Somaiah, Neeta ; Barker, Scott S. ; Shahir, Ashwin ; Barrett, Emily ; Lee, Pablo ; Wacheck, Volker ; Ramage, Samuel C. ; Tap, William D. / Incidence and Management of Olaratumab Infusion-Related Reactions. In: Journal of oncology practice. 2019 ; Vol. 15, No. 11. pp. e925-e933.
@article{2945a848fdda4a4a978bf33b4691ffe4,
title = "Incidence and Management of Olaratumab Infusion-Related Reactions",
abstract = "PURPOSE: Olaratumab is a human monoclonal immunoglobulin G1 antibody against platelet-derived growth factor receptor-α. We report the nature and frequency of infusion-related reactions (IRRs) with olaratumab in clinical trials and postmarketing reports. METHODS: Data from patients exposed to olaratumab across nine clinical trials were reviewed for IRRs. Blood samples were also analyzed for pre-existing immunoglobulin E anti-galactose-α-1,3-galactose (anti-α-Gal) antibodies. RESULTS: In the clinical trials, IRRs were identified in 70 of 485 patients (14.4{\%}). The most frequent symptoms included flushing, fever or chills, and dyspnea. For 68 of 70 patients (97.1{\%}), the first IRR occurred during the first two cycles of treatment. Grade 3 or worse IRRs were reported in 11 patients (2.3{\%}), all during the first infusion and usually within 15 minutes of the start of the infusion. One IRR-related fatality (0.2{\%}) occurred in a nonpremedicated patient with grade 3 or worse cardiac comorbidities. There was an association between grade 3 or worse IRRs and pre-existing anti-α-Gal antibodies, with a trend toward higher IRR rates in US geographies known to have a higher prevalence of anti-α-Gal antibodies. IRRs in postmarketing reports were consistent in nature and severity with those in the clinical trials. CONCLUSION: Premedication with corticosteroids and antihistamines should occur in all patients before olaratumab infusion, as indicated in labels in the United States and the European Union. Patients receiving olaratumab should be monitored for IRRs in a setting where resuscitation equipment is available for the treatment of IRRs.",
author = "{Van Tine}, {Brian A.} and Rangaswamy Govindarajan and Steven Attia and Neeta Somaiah and Barker, {Scott S.} and Ashwin Shahir and Emily Barrett and Pablo Lee and Volker Wacheck and Ramage, {Samuel C.} and Tap, {William D.}",
year = "2019",
month = "11",
day = "1",
doi = "10.1200/JOP.18.00761",
language = "English (US)",
volume = "15",
pages = "e925--e933",
journal = "Journal of Oncology Practice",
issn = "1554-7477",
publisher = "American Society of Clinical Oncology",
number = "11",

}

TY - JOUR

T1 - Incidence and Management of Olaratumab Infusion-Related Reactions

AU - Van Tine, Brian A.

AU - Govindarajan, Rangaswamy

AU - Attia, Steven

AU - Somaiah, Neeta

AU - Barker, Scott S.

AU - Shahir, Ashwin

AU - Barrett, Emily

AU - Lee, Pablo

AU - Wacheck, Volker

AU - Ramage, Samuel C.

AU - Tap, William D.

PY - 2019/11/1

Y1 - 2019/11/1

N2 - PURPOSE: Olaratumab is a human monoclonal immunoglobulin G1 antibody against platelet-derived growth factor receptor-α. We report the nature and frequency of infusion-related reactions (IRRs) with olaratumab in clinical trials and postmarketing reports. METHODS: Data from patients exposed to olaratumab across nine clinical trials were reviewed for IRRs. Blood samples were also analyzed for pre-existing immunoglobulin E anti-galactose-α-1,3-galactose (anti-α-Gal) antibodies. RESULTS: In the clinical trials, IRRs were identified in 70 of 485 patients (14.4%). The most frequent symptoms included flushing, fever or chills, and dyspnea. For 68 of 70 patients (97.1%), the first IRR occurred during the first two cycles of treatment. Grade 3 or worse IRRs were reported in 11 patients (2.3%), all during the first infusion and usually within 15 minutes of the start of the infusion. One IRR-related fatality (0.2%) occurred in a nonpremedicated patient with grade 3 or worse cardiac comorbidities. There was an association between grade 3 or worse IRRs and pre-existing anti-α-Gal antibodies, with a trend toward higher IRR rates in US geographies known to have a higher prevalence of anti-α-Gal antibodies. IRRs in postmarketing reports were consistent in nature and severity with those in the clinical trials. CONCLUSION: Premedication with corticosteroids and antihistamines should occur in all patients before olaratumab infusion, as indicated in labels in the United States and the European Union. Patients receiving olaratumab should be monitored for IRRs in a setting where resuscitation equipment is available for the treatment of IRRs.

AB - PURPOSE: Olaratumab is a human monoclonal immunoglobulin G1 antibody against platelet-derived growth factor receptor-α. We report the nature and frequency of infusion-related reactions (IRRs) with olaratumab in clinical trials and postmarketing reports. METHODS: Data from patients exposed to olaratumab across nine clinical trials were reviewed for IRRs. Blood samples were also analyzed for pre-existing immunoglobulin E anti-galactose-α-1,3-galactose (anti-α-Gal) antibodies. RESULTS: In the clinical trials, IRRs were identified in 70 of 485 patients (14.4%). The most frequent symptoms included flushing, fever or chills, and dyspnea. For 68 of 70 patients (97.1%), the first IRR occurred during the first two cycles of treatment. Grade 3 or worse IRRs were reported in 11 patients (2.3%), all during the first infusion and usually within 15 minutes of the start of the infusion. One IRR-related fatality (0.2%) occurred in a nonpremedicated patient with grade 3 or worse cardiac comorbidities. There was an association between grade 3 or worse IRRs and pre-existing anti-α-Gal antibodies, with a trend toward higher IRR rates in US geographies known to have a higher prevalence of anti-α-Gal antibodies. IRRs in postmarketing reports were consistent in nature and severity with those in the clinical trials. CONCLUSION: Premedication with corticosteroids and antihistamines should occur in all patients before olaratumab infusion, as indicated in labels in the United States and the European Union. Patients receiving olaratumab should be monitored for IRRs in a setting where resuscitation equipment is available for the treatment of IRRs.

UR - http://www.scopus.com/inward/record.url?scp=85074962037&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85074962037&partnerID=8YFLogxK

U2 - 10.1200/JOP.18.00761

DO - 10.1200/JOP.18.00761

M3 - Article

C2 - 31268811

AN - SCOPUS:85074962037

VL - 15

SP - e925-e933

JO - Journal of Oncology Practice

JF - Journal of Oncology Practice

SN - 1554-7477

IS - 11

ER -