Monoclonal antibody utilization characteristics in patients with multiple myeloma.

Abstract

This study analyzed 91 multiple myeloma patients who received two monoclonal antibodies, Daratumumab and Elotuzumab, over a year and report the adverse event profile, infusion practices and utilization of these drugs in the real world. All current reported data on monoclonal antibodies is from clinical trials, without any real-world experience. Patients from Mayo Clinic Florida or Arizona diagnosed with relapsed or refractory multiple myeloma who were treated with Daratumumab or Elotuzumab alone or in combination between 1 January 2016 and 31 December 2016 were included in the analysis. Daratumumab-treated patients (n = 78) were more heavily pre-treated than that in published clinical trials, whereas the elotuzumab patient (n = 13) profile was similar to that published before. Infusion time was on average 2 hours less than the prescribing guidelines and premedication use varied noticeably after the initial monoclonal antibody infusion, with an overall decrease over time. We noted higher than reported haematologic adverse events, especially neutropenia and fewer non-haematologic adverse events. 91.7% infusion-related reactions were observed during the first monoclonal antibody infusion, with a subsequent decrease. All infusion-related reactions were grade 2 or less, and none of the patients discontinued treatment due to infusion-related reactions. Baseline allergy profile or laboratory tests were not associated with the likelihood of developing monoclonal antibody-related infusion-related reactions. The real-world safety profile of monoclonal antibodies showed varying adverse event patterns than those reported in previous clinical trials. The infusion-related reaction patterns were similar to previous reports. Despite changes in premedication regimens safety was maintained in succeeding infusions. Such treatment utilization data is vital to broaden our knowledge of approved therapeutic agents and maximize their benefits for patients.

• Authors: Sikander Ailawadhi, Taimur Sher, Abdel-Ghani Azzouqa, Zahara Meghji, Tania Jain, Prachi Jani, Salman Ahmed, Nancy Diehl, Vivek Roy, Vishal Shah, David Hodge, Meghna Ailawadhi, Victoria R Alegria, Aneel Paulus, Asher Chanan-Khan, Rafael Fonseca
• Journal: Anti-cancer drugs (Anticancer Drugs) Vol. 30 Issue 8 Pg. 859-865 (09 2019) ISSN: 1473-5741 [Electronic] England
• PMID: 31415286 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• elotuzumab
• daratumumab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage, therapeutic use)
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Drug Resistance, Neoplasm (drug effects, immunology)
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Follow-Up Studies
• Humans
• Incidence
• Male
• Middle Aged
• Multiple Myeloma (drug therapy, immunology, pathology)
• Neoplasm Recurrence, Local (drug therapy, immunology, pathology)
• Prognosis
• Salvage Therapy
• Survival Rate
• United States (epidemiology)