Patient-Reported Outcome Labeling for Antidiabetic Agents Approved in the United States, 2011–2017

Abstract

Background: Patient-reported outcomes (PROs), defined as any report on the status of a patient’s health condition that comes directly from the patient without interpretation by any other party, have been the subject of increased focus during drug development. The U.S. FDA issued final guidance on the use of PRO measures to support labeling claims in 2009, as a means of integrating patients’ experience. Diabetes is a chronic condition requiring patient self-management. Achieving optimal glycemic control necessitates patient engagement and commitment to treatment adherence. Given the significant patient burden, data regarding quality of life (QoL) and treatment satisfaction may be important to patients and clinicians in considering treatment options. This paper evaluates the incorporation of PROs into labeling for antidiabetic agents approved by the FDA between 2011 and 2017. Methods: The FDA’s Novel New Drug Summaries (2011-2017) were reviewed to identify antidiabetic agents. Drug approval packages and product labels were accessed via the Drugs@FDA database and analyzed for PRO endpoints, measures, and labeling claims. Clinical trial designs were ascertained via the ClinicalTrials.gov website. Results: Of 250 novel drugs approved by the FDA between 2011 and 2017, 11 (4.4%) were for antidiabetic indications. None of the 11 incorporated PROs in their labeling. However, 5 of the 11 (45.5%) collected QoL or treatment satisfaction data as a secondary or tertiary endpoint in at least 1 of the trials supporting approval. Measures included the EQ-5D, SF-36, and the Diabetes Treatment Satisfaction Questionnaire. Conclusions: Although nearly half of all antidiabetic agents approved in the past 7 years assessed PROs during drug development, none acquired PRO label claims. As diabetes can have a significant impact on patients’ day-to-day functioning and QoL, failure to integrate PROs into labeling may represent a missed opportunity for patients, clinicians, and industry sponsors. Disclosure M.E. Zettler: None. R. Sandoval: None.