Frequency of Symptomatic Adverse Events in Rheumatoid Arthritis: An Exploratory Online Survey

Abstract

Objective To generate initial data on the frequency and impact of symptomatic adverse events (AEs) associated with rheumatoid arthritis (RA) drug therapy from the patients' perspective. Methods We conducted an exploratory online survey asking patients with RA to indicate whether they currently or had ever experienced the 80 different symptomatic AEs included in the Patient-Reported Outcomes version of The Common Terminology Criteria For Adverse Events (PRO-CTCAE™). Results were summarized to report their frequency and regression models were used to estimate their associations with RA medication use and overall bother. Results The 560 patients who completed the survey and reported taking at least one RA medication (DMARD, steroids, NSAIDs), had a mean disease duration of 8 years, and were on a wide range of DMARDs. The number of symptomatic AEs experienced in the past 7 days was none (6%), 1-10 (28%), 11-20 (28%), and >20 (38%). Overall, most participants reported that side effects bothered them somewhat (28%), quite a bit (24%) or very much (15%). In multivariable regression analyses, current prednisone and NSAID use were associated with the greatest number of current side effects (26 and 22 respectively). Many of the strongest associations between current symptomatic AEs and medication use aligned with known side effect profiles. Conclusion In this exploratory online survey, patients with RA reported frequent symptomatic AEs with their medications that are bothersome. Further work is needed to develop and validate a measure for use in patients with rheumatic disease.

Mitochondrial Dysfunction and Oxidative Stress in Rheumatoid Arthritis

“…Although the past decade has undoubtedly constituted a great revolution in treatment strategies for RA, some patients do no reach low disease activity or become non-responders, and most of the treatments cause long-term adverse side effects [ 28 , 29 ]. In this scenario, dietary bioactive compounds that exhibit anti-oxidant and anti-inflammatory properties have been proposed as potential candidates for the development of new therapeutic interventions [ 30 , 31 , 32 , 33 ].…”

Taking the Long View: Patients Perceive Benefits and Risks of Treatment as Multidimensional

“…Lifelong therapy requires patients with RA to continuously assess and reassess the benefits vs risks of each treatment. The study by Hazlewood and colleagues, "Frequency of Symptomatic Adverse Events in Rheumatoid Arthritis: An Exploratory Online Survey, " 1 is an important contribution in advancing scientific understanding of the risk side of this balancing act. The study identifies and quantifies how patients perceive symptomatic adverse events (AEs)-a term the authors use interchangeably with "side effects"-when participating in clinical trials to develop new therapeutic options.…”

“…Hazlewood et al have parsed 3 dimensions: which side effect(s), how frequently side effects are experienced, and which medications are potentially implicated. 1 Patients take note of other dimensions as well; temporality and severity of side effects are important factors not addressed by the study. 1 It is important to distinguish between long-term effects that may emerge after years of therapy vs more immediate side effects.…”

“…1 Patients take note of other dimensions as well; temporality and severity of side effects are important factors not addressed by the study. 1 It is important to distinguish between long-term effects that may emerge after years of therapy vs more immediate side effects. Further, some side effects may subside between doses, 2 while others may be ongoing or recurring.…”

“…Hazlewood et al chose a different approach by focusing specifically on symptomatic AEs (side effects) and drawing from the preexisting list of such side effects from cancer medications from the Patient-Reported Outcomes of the Common Terminology Criteria For Adverse Events (PRO-CTCAE). 1 Future efforts to generate data on the frequency, severity, and duration of side effects from a patient perspective must take into account the perceived and experienced heterogeneity of their impact on QOL within a hierarchical ordering of side effects. Grading systems need to take this into account because people living with RA make benefit-risk assessments based on these nuances.…”