The cumulative corticosteroid dose was also higher in patients in the placebo group. Dr. Spiera pointed out that some of that was due to 52-week taper in this group, but the difference between the anticipated steroid use and actual steroid use, the difference in rescue steroids, was statistically significantly lower in the sarilumab group (P=0.02) A higher proportion of patients in the comparator arm also required additional glucocorticoids as rescue therapy compared to the sarilumab arm (59% vs. 32%; P=0.0053).
A variety of patient-reported quality of life and function measures, including the Short Form-36 Mental Component and Physical Component Scores, the Functional Assessment of Chronic Illness, the EuroQol-5 Dimension (EQ-5D) and the Health Assessment Questionnaire-Disability Index (HAQ-DI), favored sarilumab in a statistically significant manner, as did some of the physician assessments like the PMR-Activity Scale (PMR-AS).
Adverse events were as expected with sarilumab, and the frequency of serious adverse events was similar in both arms. In the sarilumab arm, 15% of patients had neutropenia, and another 15% had arthralgias. The comparator arm had more effects related to glucocorticoids, such as insomnia (16%). Dr. Spiera also pointed out that no patients in the sarilumab group had diverticulitis that required medical intervention from gastrointestinal perforation; this was a potential concern given the older patient age group and this rare potential adverse effect of IL-6 inhibitors.
When asked when he might use sarilumab in clinical practice, Dr. Spiera noted that for a patient not flaring on very low glucocorticoid doses, it might not be needed. “But that’s not the group of patients that’s our challenge,” he added. “I think I’d be interested in giving it to any patient who has previously flared or any patient at very high risk of glucocorticoid side effects.”
Diet & Exercise Interventions
Stephen Messier, PhD, director of the J.B. Snow Biomechanics Laboratory at Wake Forest University, Winston-Salem, N.C., presented findings from the WE-CAN trial, a study of the impact of a community-level diet and exercise program on knee pain in patients with knee osteoarthritis and overweight and obesity.6
The incidence of both osteoarthritis and obesity has been increasing in recent years, particularly in older adults. Osteoarthritis is the leading cause of chronic disability in older adults, one that significantly impacts patients’ function and quality of life. Obesity is a major risk factor for the development of osteoarthritis and for its progression, and individuals with more severe obesity tend to have more severe joint degradation compared with individuals of normal weight or underweight with osteoarthritis.7