Patients upset by frequent side effects of RA drugs

Symptomatic adverse events (AEs) are common and troublesome for many patients with rheumatoid arthritis (RA) who are taking medications for their condition, results of an exploratory study have shown.

“[P]atients with RA reported frequent symptomatic AEs with their medications that are bothersome,” said the researchers, led by Glen Hazlewood, associate professor at Cumming School of Medicine, University of Calgary, Alberta, and Arthritis Research Canada, British Columbia, Canada.

Hazlewood and colleagues carried out an exploratory online survey on RA patients to determine whether they currently or had ever experienced the 80 different symptomatic AEs included in the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events.

The research team summarized the results to report the frequency and used regression models to estimate the associations of AEs with RA medication use and overall bother.

A total of 560 patients completed the survey and reported taking at least one RA medication (disease-modifying antirheumatic drugs [DMARDs], steroids, nonsteroidal anti-inflammatory drugs [NSAIDs]). They had a mean disease duration of 8 years and were taking a wide range of DMARDs. [J Rheumatol 2022;49:998-1005]

Majority of the respondents reported >20 symptomatic AEs experienced in the past 7 days, while 28 percent reported 11‒20 AEs, and another 28 percent reported 1‒10 side effects. Only 6 percent of RA patients did not have any symptomatic AEs in the past week. Most of the respondents said that these side effects bothered them somewhat (28 percent), quite a bit (24 percent), or very much (15 percent).

Multivariable regression analyses revealed that current use of prednisone and NSAID contributed to the highest number of current side effects (26 and 22, respectively). Several of these robust associations between current symptomatic AEs and medication use were consistent with known side effect profiles.

“Our study suggests that real-world patients using common RA treatment regimens report many symptomatic AEs that they attribute to their RA medications,” the researchers said. “Collectively, these side effects are substantially bothersome to many patients.”

Some of the side effects associated with prednisone and NSAID use likely indicate the true burden of AEs that are common with both drugs in rheumatic diseases. [J Rheumatol 2017;44:1754-1758; Arthritis Res Ther 2013;15(Suppl 3):S2]

In previous studies, patients and physicians placed different importance on AEs from glucocorticoid use. Thus, a patient-reported collection of side effects could complement routine AE monitoring, which has been suggested for those taking the said drug even at low doses. [Ann Rheum Dis 2010;69:1015-1021; Ann Rheum Dis 2010;69:1913-1919]

However, a few of these AEs could be attributed to active RA, since patients on NSAIDs or prednisone had a higher probability of having active or recently active disease.

“While we asked patients to indicate which side effects they had experienced ‘as a result of taking your RA medications’, assigning attribution of symptoms is challenging,” the researchers said. “Understanding attribution would need to occur through longitudinal and/or interventional studies.” [Mayo Clin Proc Innov Qual Outcomes 2019;3:176-182; J Clin Oncol 2010;28:3002-3007]