3 AC&R Study Summaries: Prescribing Patterns, PMR & Glucocorticoids, & Infection Screening

A Shift in Prescribing Patterns

Safety issues prompt discontinuation of tofacitinib

By Stephanie Song, MD, & Joshua F. Baker, MD, MSCE

Why was this study done? The ORAL Surveillance study highlighted risks of cardiac events, thromboembolism (VTE) and malignancy associated with use of Janus kinase inhibitors (JAKi). We sought to determine the impact of safety data on prescribing patterns by describing the characteristics of patients initiating and discontinuing advanced therapies for rheumatoid arthritis (RA) before and after the trial results were released in January 2021.

What were the study methods? This was a national retrospective study of U.S. Veterans with RA receiving advanced therapies including tofacitinib, tumor necrosis factor inhibitors (TNFi’s), and non-TNFi agents from April 2019 through September 2022. Patient characteristics were defined for each therapy initiation. We tested for interactions to determine whether changes observed in characteristics over time for tofacitinib users were different from changes observed for the other therapies. Time to discontinuation for active users at the time of the press release was determined, censoring for death and end of follow-up. We used Cox models adjusted for age, sex and duration of therapy and evaluated associations between patient characteristics and therapy discontinuation, testing for interaction across the therapy types.

What were the key findings? Characteristics of patients initiating tofacitinib after the release of safety data in January 2021 included lower mean age, lower proportion of men, less comorbidity and fewer cardiovascular comorbidities. Similar changes were not seen in patients initiating TNFi’s or non-TNFi’s. The likelihood of discontinuation was higher for tofacitinib than for TNFi’s, and the higher rate of tofacitinib discontinuation was more pronounced in the presence of cardiovascular comorbidities.

What were the main conclusions? Significant changes in age, gender and cardiovascular comorbidity burden were seen in patients initiating tofacitinib following the release of safety data. Patients using tofacitinib were more likely than those using TNFi’s to discontinue therapy, and this finding was pronounced in the setting of cardiovascular comorbidities.

What are the implications for patients and clinicians? This study saw a marked change in characteristics of patients initiating and discontinuing tofacitinib after the release of safety data compared with other advanced therapies. It emphasizes the importance of safety studies and their impact on prescribing practices.

The study: Song S, England BR, Sauer B, et al. Changes in characteristics of patients initiating and discontinuing advanced therapies for rheumatoid arthritis following the release of safety data. Arthritis Care Res (Hoboken). 2023 Nov 1. doi: 10.1002/acr.25268. Epub ahead of print.