The term “off-label” is described by the FDA as an unapproved use of an approved drug. Recently, a study conducted at Kaiser Permanente Colorado found that off-label uses of Rituximab, particularly to treat demyelinating neurologic diseases, now account for more than half of patients receiving rituximab. Originally approved in the United States in 1997 for treatment of non-Hodgkin lymphoma, the monoclonal antibody has multiple additional approvals for orphan and nonorphan indications.
The study included 1674 patients who received their first rituximab infusion between 2009 and 2017. Overall during that period, 1111 patients (66.4%) received rituximab for an approved indication and 563 (33.6%) received the drug for an off-label indication. However, off-label uses grew more common as the study went on, particularly in the latter half of the study period. By 2017, off-label indications were more common than approved indications; off-label use of rituximab rose from 1.2% of patients in 2009 to 55.6% by the end of the study in 2017. In contrast, use for approved orphan indications dropped from 92.8% of patients in 2009 to 38.8% in 2017.
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