Analysis of real-world safety,tolerability,and cost efficiency of Sub-Cutaneous administration of Daratumumab in Manitoba

Abstract

Introduction

Daratumumab is an anti-CD38 monoclonal antibody used in the treatment of myeloma and other related disorders. To mitigate the risk of infusion related reactions with IV Daratumumab the product monograph suggested a slow administration schedule that extends over several hours. ¹ This leads to a significant burden for the outpatients’ treatment administration units and indirect costs to the patients such as time toxicity. Time toxicity is the time spent coordinating care and making frequent visits for follow-up and treatment. ² In 2020 the COLUMBA trial ³ demonstrated that subcutaneous Daratumumab has a similar efficacy and safety profile as intravenous Daratumumab with considerably less side effects. ¹ This retrospective study aims to document our local real-world experience with subcutaneous Daratumumab, with special emphasis on reducing time toxicity.

Methods

Patients with a plasma cell disorder over the age of 18 who had received at least one dose of subcutaneous Daratumumab between March 2022 and March 2023 were included. Data for this retrospective study was collected from Aria, which included: baseline patient demographics (gender, age); prior exposures to intravenous Daratumumab; and, whether a reaction to either intravenous or subcutaneous Daratumumab occurred. Descriptive statistics were used to summarize the data.

Results

A total of 197 patients were included in the analysis. There were no recorded reactions to subcutaneous Daratumumab.

Conclusions

The results of our study were used to eliminate our facility's 3-h post-injection observation period. In the future we plan to publish another study on the cost efficiency of subcutaneous Daratumumab.