Rheum Round-up: FDA Rejects RA Drug, SLE Racial Disparities, and more

By Kaitlyn D’Onofrio - August 21, 2020

Here are the top stories recently covered by DocWire News in the rheumatology section. In this edition, read about why the Food and Drug Administration (FDA) rejected Gilead’s arthritis drug, safe hydroxychloroquine discontinuation for older systemic lupus erythematosus (SLE) patients, helping black patients cope with osteoarthritis (OA), vigorous physical activity at a young age and later hip strength, and racial disparities in SLE medication adherence.

The FDA will not approve filgotinib, a rheumatoid arthritis (RA) drug from Gilead and Galapagos NV, in its current form, Gilead announced in a press release. According to the company, the FDA issued a complete response letter for the New Drug Application (NDA) for the drug, requesting additional data. The data the FDA requested are from the MANTA and MANTA-RAy studies, according to Gilead, which investigate the effect of filgotinib on sperm parameters. The FDA also raised concerns about the filgotinib 200 mg’s overall benefit/risk profile. Gilead submitted the NDA for filgotinib in December along with a priority review voucher.

For SLE patients, benefits of hydroxychloroquine include reduced flares, neonatal lupus risk, and thrombosis risk, as well as improvements in bone mineral density and survival. However, prolonged exposure to the drug is associated with potential adverse effects including maculopathy and cardiomyopathy. Because of these risks, a study assessed whether older SLE patients can safely terminate hydroxychloroquine therapy.

OA is one of the top causes of pain and disability in the United States and has a disproportionate effect on black patients compared to white ones. Previous research has found that black OA patients report higher pain catastrophizing levels, which may be in part due to differences in pain coping patterns by race. To address this disparity, researchers analyzed the effectiveness of a pain Coping Skills Training (CST) program among black OA patients, which was assessed in the Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study. A study published in BMC Musculoskeletal Disorders evaluated the use of the pain CST program in patients who enrolled in the STAART trial.

A study observed a correlation between moderate to vigorous physical activity performed early in life and stronger hips later in life. The correlation between light activity and hip strength was less clear.

Racial disparities among SLE patients have been documented, with previous research showing poorer incidence, prevalence, and long-term outcomes among racial minorities compared to white patients. Data have also suggested that black SLE patients have lower medication adherence, which significantly contributes to increased morbidity and mortality. A recent study analyzed racial disparities in SLE medication adherence and possible factors associated with lower medication adherence.

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