Sarilumab helps improve patient-reported outcomes in relapsing polymyalgia rheumatica

In the treatment of patients with relapsing polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper, the use of sarilumab appears to produce clinically important improvements in health-related quality of life and patient-reported outcomes, according to the results of a phase III study.

The study included 118 adult patients (mean age 68.9 years, 69 percent female, 83 percent White) who were at least 50 years of age, who had at least one episode of disease flare during a glucocorticoid taper (at a dose of ≥7.5 mg/day or prednisone dose equivalent) within 12 weeks before screening and had a history of at least 8 weeks of glucocorticoid treatment (≥10 mg/day or prednisone dose equivalent). These patients were randomly assigned to receive either subcutaneous sarilumab 200 mg once every 2 weeks with a 14-week glucocorticoid taper (n=60) or matching placebo with a 52-week glucocorticoid taper (n=58).

The patient-reported outcomes included Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment of Health Visual Analog Scale (VAS), Pain VAS, Short Form Health Survey (SF-36 v2), EuroQoL 5-Dimensions 3-Levels (EQ-5D), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). These outcomes were assessed until week 52.

At week 52, patients in the sarilumab group reported significantly greater improvements in SF-36 Physical Component Summary (PCS) (mean change, 7.65 vs 2.87; p=0.020) and Mental Component Summary (MCS) scores (mean change, 3.04 vs –1.71; p=0.030) and in scores for five of eight domains, as well as in EQ-5D utility index (mean change, 0.11 vs –0.02; p=0.034) and Pain VAS (mean change, –20.57 vs –12.04; p=0.20) compared with those in the placebo group.

Sarilumab was associated with more than threefold greater odds of having improvements of minimum clinically important difference or greater in SF-36 PCS scores compared with placebo (odds ratio, 3.46, 95 percent confidence interval, 1.16–10.62; p=0.020).

Finally, more than 50 percent of patients achieved scores at or above normative values for SF-36 MCS and four domains, whereas those in the placebo group did not achieve this for any domain.