For the entire cohort, patients were predominantly women (60.2%) and white (56.1%), with a mean age of 73 years. The demographic characteristics were similar in the patients new to rheumatology practice: 55.8% were women; 46.7% were white, with a mean age of 72 years. The most common comorbidities were hypertension (81.2%), congestive heart failure (52.4%), hyperlipidemia (41.3%) and ischemic heart disease (36%). On average, patients received medications for six to seven comorbidity categories. At baseline, 92.3% of the patients were on glucocorticoids and 13.1% were on a steroid-sparing agent, of which methotrexate (6.9%) and hydroxychloroquine (4.4%) were the most frequently used. At 13 to 24 months, 63.8% of the patients remained on glucocorticoids. The use of steroid-sparing agents increased to 39%, but this remained primarily conventional immunomodulatory drugs, such as methotrexate (19.5%) and hydroxychloroquine (11.1%). The use of IL-6 inhibitors and rituximab past one year was reported in 2.5% and 0.3% of patients, respectively.
Persistent glucocorticoid use was associated with female sex, a higher number of comorbidities and use of a steroid-sparing agent at 24 months. The use of a steroid-sparing agent was associated with obesity and a higher number of comorbidities. In contrast, a lower use of steroid-sparing agents was associated with older age and private insurance.
“At the 13- to 24-month follow-up, close to two-thirds of patients remained on glucocorticoids, while less than half of patients were receiving a glucocorticoid-sparing agent,” Dr. Sattui says. “Even low doses of glucocorticoids are associated with toxicity—more so in this population (e.g., older age, higher burden of comorbidities).
“Methotrexate, as one would expect given the 2015 existing recommendations, was the most frequent choice of glucocorticoid-sparing agent, followed by hydroxychloroquine, leflunomide, and then IL-6 inhibitors.6 Although trials do exist for methotrexate, there are no rigorous studies (until recent IL-6 inhibitor trials) that support their use,” Dr. Sattui says.
With the FDA approval of a biologic for the treatment of PMR, adds Dr. Sattui, “I would expect to see changes in the treatment practices. However, this will most likely take some time given the usual delay in uptake of new treatments and because as promising as the results of the recently published SAPHYR trial are, these only apply to a select population.”4
Future Research
Dr. Sattui notes that we need to better understand the benefits of glucocorticoid-sparing agents, including glucocorticoid-free and drug-free remission. Efforts should also focus on identifying patients who could benefit from these agents and for whom earlier consideration is needed. He also recommends prospective analyses that include treatments used and patient-reported outcomes relevant to these individuals and this age group, such as physical function and mobility.
