Rituximab utilization for approved and off-label nononcology indications and patients' experiences with the Patient Alert Card

Khaled Sarsour, Senam Beckley-Kartey, Simone Melega, Adefowope Odueyungbo, Petra Kirchner, Natasha Khalife, Joanne Bangs, Khaled Sarsour, Senam Beckley-Kartey, Simone Melega, Adefowope Odueyungbo, Petra Kirchner, Natasha Khalife, Joanne Bangs

Abstract

This study used retrospective chart review and survey data to evaluate: (1) off-label use of rituximab (MabThera®/Rituxan®) in autoimmune conditions and (2) patients' receipt and knowledge of the Patient Alert Card (PAC), a risk minimization measure for progressive multifocal leukoencephalopathy (PML) and serious infections. Anonymized patient data were collected from infusion centers in Europe from December 2015 to July 2017. Adults receiving rituximab in the same centers were provided a self-administered survey. Outcomes included patterns of off-label rituximab use for nononcology indications, and evaluation of patients' receipt and knowledge of the PAC and its impact. Of 1012 patients in the retrospective chart review, 70.2% received rituximab for rheumatoid arthritis or granulomatosis with polyangiitis/microscopic polyangiitis, and 29.8% received rituximab off label. Among 524 survey participants, 32.8% reported receiving the PAC, 59.3% reported not receiving the PAC and 7.9% did not know whether they received the PAC. A total of 72.4% of patients reported that they were unaware that some patients receiving rituximab experience PML. A higher proportion of PAC recipients identified PML as a potential risk of rituximab than nonrecipients (37.8% vs 19.9%); 58.3% of PAC recipients had poor awareness of PML. Most PAC recipients (90.0%) and nonrecipients (85.5%) correctly answered that they should seek medical attention for infection symptoms. In conclusion, approximately 30% of patients received off-label rituximab. Most patients reported not receiving the PAC or having knowledge of PML but demonstrated understanding of the recommended action in the event of infection symptoms, regardless of PAC receipt.

Trial registration: ClinicalTrials.gov NCT02654379.

Keywords: Patient Alert Card; anti‐CD20; infection; off‐label; progressive multifocal leukoencephalopathy; rituximab.

Conflict of interest statement

The study sponsor, F. Hoffmann‐La Roche Ltd, was involved in the study design, collection, analysis, and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. K. Sarsour is an employee of Genentech, Inc. S. Beckley‐Kartey, S. Melega, and P. Kirchner are employees of F. Hoffmann‐LaRoche Ltd. A. Odueyungbo was an employee of Roche Products, Ltd, at the time of this study. N. Khalife is an employee of IQVIA. J. Bangs was an independent regulatory consultant to F. Hoffmann‐LaRoche Ltd at the time of the study.

© 2020 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

Figures

Figure 1
Figure 1
Study Design. † Data abstraction of medical records spanning June 2014 to June 2015 (“look‐back period”)
Figure 2
Figure 2
Patients’ Receipt and Review of the PAC. PAC, Patient Alert Card. † Number of patients who answered the question
Figure 3
Figure 3
Proportion of Patients With Correct Responses to Key Knowledge Questions by PAC Receipt. PAC, Patient Alert Card

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Source: PubMed

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