Safety Trends Following DMARD Treatment in Patients With RA

Among individuals with rheumatoid arthritis (RA), beginning use of disease‐modifying antirheumatic drugs (DMARDs) was linked to stable adverse events (AEs) and mortality rates.

These findings were published in Immunity, Inflammation and Disease, where the study authors also found a good safety profile for the treatment after being introduced.

To come to these results, the authors used the Taiwan National Health Insurance Database to identify 41,821 patients who had incident RA between 2000 and 2017.

The study was broken down into phases, with phase 1 between 2000 and 2002, phase 2 between 2003 and 2012, and phase 3 between 2013 and 2017.

All 41,821 patients were prescribed conventional DMARDs (cDMARDs) in phase 1. Later, between 1% and 3% of patients were prescribed either a TNF inhibitor (TNFi) in phase 2 or ortho-methoxyamphetamine (OMA) in phase 3. Levels and trends from phases 2 and 3 were compared with those of phase 1 using interrupted time series (ITS) analysis.

In the study sample, the authors found a cancer incidence rate of 1.9% with a mortality rate of 4.19%.

Additionally, 1‐year incident rate of gastrointestinal (GI) bleeding and 3‐year incident rates of other AEs and mortality were calculated and adjusted using propensity score‐based stabilized weights.

AEs of interest included acute myocardial infarction, congestive heart failure, ischemic stroke or transient ischemic attack, overall thromboembolism, tuberculosis, total hip replacement, total knee replacement (TKR), cancer, and all‐cause mortality.

After starting cDMARD treatment, 1‐year GI bleeding rate started to decrease among patients with RA, and remained stable after using biologic DMARDs (bDMARDs).

Additionally, after initiating TNFi use, there was a steady or mild decrease in all 3-year AE trends except for TKR. According to ITS analysis, the trend of TKR incidence mildly increased by 0.13% during phase 2 compared with phase 1 (P = .0322), and trends became steady in phase 3.

“However, TKR started to decrease among patients with RA after cDMARD treatment became available and the slope significantly increased after TNFi introduction, whereas the incidence rate of THR exhibited a steady trend after both cDMARDs and bDMARDs treatment,” the authors explained.

While there are multiple limitations to this research, the authors determined that trends in most measured AEs and mortality were generally steady and mildly decreased after patients with RA began use of cDMARDs and bDMARDs, and risk of AEs and mortality did not increase after treatment.

Reference

Fang YF, Liu JR, Chang SH, Kuo CF, See LC. Trends of adverse events and mortality after DMARDs in patients with rheumatoid arthritis: Interrupted time-series analysis. Immun Inflamm Dis. 2022;10(7):e630. doi:10.1002/iid3.630