Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study

• Published in: Drugs - Real World Outcomes 2021-06, Vol.8 (2), p.187-195
• Main Authors: Gordan, Lucio, Chang, Melody, Lafeuille, Marie-Hélène, Romdhani, Hela, Paramasivam, Fuad, Maiese, Eric M., McKay, Caroline
• Format: Article
• Language: English
• Subjects: Cancer therapies; Clinical outcomes; Clinical trials; Community health care; Drug dosages; Drug therapy; FDA approval; Immunotherapy; Internal Medicine; Intravenous therapy; Medicine; Medicine & Public Health; Monoclonal antibodies; Multiple myeloma; Observational studies; Oncology; Original; Original Research Article; Patient outcomes; Patient safety; Patients; Pharmacology/Toxicology; Pharmacotherapy; Targeted cancer therapy; Transplants & implants
• ISSN: 2199-1154; 2198-9788
• DOI: 10.1007/s40801-020-00226-3

Background Some institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h. Objective This study sought to understand the utilization, effectiveness, and infusion reactions (IRs) observed in patients with MM who received daratumumab rapid infusions. Methods Electronic medical records from Florida Cancer Specialists & Research Institute were used. Adult patients with MM who received one or more rapid daratumumab infusion (full dose in ≤ 110 min) at their third or later infusion of the first daratumumab-containing regimen (index date: 16 November 2015 to 15 March 2019) were included. IRs included events that (1) occurred ≤ 24 h post-daratumumab infusion or (2) were stated as an IR in the patient charts. Non-IR adverse events (AEs) were events attributed to daratumumab in patient charts that did not meet the IR definition. Results In total, 147 patients received one or more rapid infusion in their first daratumumab-containing regimen. Median time from initial MM diagnosis to index date was 2.5 years. Non-IR AEs occurred in 10.2% of patients during treatment, and 36.7% experienced one or more IR after receiving a daratumumab infusion. No IRs occurred after a rapid infusion. The overall response rate was 91.1% (after rapid infusions only: 71.3%). Conclusions This study provides real-world evidence on the practice patterns of daratumumab rapid infusions in a large community-based oncology clinic system. These results suggest that treatment regimens including daratumumab rapid infusions at the third infusion or later were well-tolerated, and their effectiveness was comparable to that observed in clinical trials.