Female sex predictive of nausea, alopecia in patients with RA starting methotrexate
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Female sex was identified as a baseline predictor of increased odds of both nausea and alopecia in patients with rheumatoid arthritis beginning methotrexate treatment, according to data presented at ACR Convergence 2021.
“Methotrexate is the first-line treatment for the management of patients diagnosed with rheumatoid arthritis. However, the concerns about adverse events may reduce adherence to the treatment, and this could lead to delay in achieving a state of disease remission,” Ahmad Sherbini, MD, MSC, of the University of Manchester, U.K., told Healio. “Therefore, we wanted to know how common adverse events, such as nausea and alopecia, occurred in patients starting methotrexate for the first time and which characteristics could predict later development of these adverse events.”
In one previous study, pooled prevalence of nausea in randomized controlled trials was 19.2% in patients with RA taking methotrexate. Another study in a cohort of 762 patients with RA showed that nausea accounted for 20.6% of methotrexate withdrawal because of adverse events, according to the presentation.
“Alopecia, on the other hand, has a lower prevalence. Pooled estimate was around 7% in randomized controlled trials, but it’s often a major cause of worry and hesitancy for patients when starting the treatment,” Sherbini said in the presentation.
In a multicenter prospective cohort study, Sherbini and colleagues evaluated 1,069 patients with early RA beginning methotrexate treatment. Patients reported any adverse events at 6- and 12-month follow-ups. Of these patients, 333 reported nausea and 98 reported alopecia.
“In our findings, women were twofold more likely to report nausea compared to men, and patients who were more concerned about the treatment were more likely to report nausea,” Sherbini told Healio. “Higher disease activity was associated with increased odds of nausea in the first year of treatment. For alopecia, being a woman and higher disability at the start of treatment were associated with later development of alopecia.”
As baseline predictors of nausea in the first year of treatment, female sex vs. male sex had an odds ratio of 2.09 (95% CI, 1.5-2.91), and increased disease activity as measured by Disease Activity Score-28 with CRP also raised the odds (OR = 1.16; 95% CI, 1.02-1.31), according to the presentation. Female sex (OR = 4.87; 95% CI, 2.52-9.44) and higher Health Assessment Questionnaire – Disability Index score (OR = 1.62; 95% CI,1.09-2.41) were found to be predictive of alopecia.
“We also found that alcohol consumption was associated with later development of nausea and alopecia,” Sherbini told Healio. “This was surprising because alcohol was shown to be associated with elevated liver enzymes in previous studies.”
Besides nausea, other reported gastrointestinal adverse events reported in the first year were anorexia, vomiting, stomach pain and diarrhea. Mucocutaneous adverse events other than alopecia were oral ulcers and itching.
“These are our first steps toward understanding the complex causal mechanisms leading to nausea and alopecia in people taking methotrexate for rheumatoid arthritis. Therefore, the findings should be interpreted with caution and require further investigation in the future,” Sherbini told Healio. “The knowledge about rates of adverse events occurrence should be communicated to patients to help them make informed decisions regarding whether to start treatment, and to address their concerns, which could potentially increase adherence to the treatment.”
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Sherbini A. Abstract 1444. Presented at: ACR Convergence 2021; November 3-10, 2021 (virtual meeting).
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