Results of a Time and Motion Survey Regarding Subcutaneous versus Intravenous Administration of Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma

Abstract

Purpose

Daratumumab (DARA) is a humanized anti-CD38 monoclonal antibody and approved as monotherapy or in combination with standard of care regimens for the treatment of multiple myeloma (MM). DARA intravenous (IV) administration is time-consuming; availability of DARA subcutaneous (SC) is expected to reduce this burden. A time and motion survey was undertaken to elicit healthcare providers’ (HCPs’) understanding of the workflow and time estimates for administration of DARA IV and SC (beyond treatment time) in patients with relapsed/refractory MM.

Patients and Methods

This web-based, prospective survey collected data from HCPs at sites that actively enrolled patients in the phase 3 COLUMBA trial, a multicenter, noninferiority study of DARA IV versus DARA SC. Data collection included time actively spent on pre-specified drug preparation and drug administration/patient care activities; active HCP and chair time were extrapolated for first and subsequent treatments.

Results

Compared with DARA IV, DARA SC reduced median total active HCP time by 63.8% (from 265.9 to 96.3 minutes) and 49.5% (from 179.2 to 90.4 minutes) for first and subsequent treatments, respectively. When extrapolated to the anticipated number of treatments per year (23 in Year 1 and 13 in Year 2, per label), estimated active HCP time per patient was reduced by 50% in Years 1 (from 70.1 to 34.8 hours) and 2 (from 38.8 to 19.6 hours) for DARA SC versus DARA IV. Estimated chair time for DARA SC was decreased by 97% versus DARA IV for first (from 456.9 to 13.3 minutes) and subsequent treatments (from 238.0 to 8.1 minutes).

Conclusion

These results suggest that DARA SC is associated with less active HCP involvement during drug preparation and drug administration/patient care compared with DARA IV, potentially reducing burdens on patients and caregivers and creating efficiencies for HCPs and healthcare facilities, allowing more patients access to care.

Keywords:

• daratumumab
• subcutaneous
• treatment burden
• survey

Abbreviations

DARA, daratumumab; HCP, healthcare provider; HRQoL, health-related quality of life; ISR, injection site reaction; IRR, infusion-related reaction; IV, intravenous; MM, multiple myeloma; RRMM, relapsed/refractory MM; SC, subcutaneous; SOC, standard of care; T&M, time and motion.

Acknowledgments

This study was supported by Janssen Global Services, LLC. The authors would like to thank the HCPs who participated in the survey and the staff members involved in data collection. Editorial and medical writing support were provided by Corey Eagan, MPH, of Eloquent Scientific Solutions and were funded by Janssen Global Services, LLC.

Author Contributions

All authors meet the International Committee of Medical Journal Editors criteria for authorship of this manuscript and take responsibility for the integrity of the work as a whole. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

MS, AS, TM, CH, and AL are employees of Janssen. EA and EDC are employees of Syneos Health and were compensated by Janssen for conducting the study. CH has a patent US appl# 62/825,244 pending, a patent US appl# 62/825,252, a patent US appl# 62/825,268, a patent US appl# 62/825,278. Interim results from this survey were presented at the 62nd American Society of Hematology Annual Meeting & Exposition as a poster presentation. The abstract was published in Blood 2020; 136 (supplement 1); DOI: https://doi.org/10.1182/blood-2020-139995.