If the patient experiences a relapse, the prednisone dose can be increased to the pre-relapse level and then decreased gradually over four to eight weeks to the dose at which relapse occurred. Dr. Buttgereit noted that, within the context of these recommendations, it’s important for physicians and patients to participate in shared decision making and routinely discuss the goals of care, which most commonly focus on maximizing health-related quality of life.5,6
Next, Dr. Buttgereit discussed recent clinical trials demonstrating the effectiveness of interleukin (IL) 6 receptor inhibition in the treatment of PMR. These studies include the PMR-SPARE trial of tocilizumab, the SEMAPHORE trial of tocilizumab and the SAPHYR trial of sarilumab.7–9 Although the PMR-SPARE and SEMAPOHORE trials demonstrated positive results for tocilizumab, the SAPHYR trial may be more familiar to rheumatologists in the U.S. because its findings influenced the 2023 U.S. Food & Drug Administration’s approval of sarilumab for the treatment of patients with PMR for whom glucocorticoids have proved inadequate or who cannot tolerate glucocorticoid tapering.10
The SAPHYR trial enrolled 118 patients with PMR, all of whom had:9 1) at least one episode of disease flare during glucocorticoid tapering (at a dose of ≥7.5 mg of prednisone per day) within 12 weeks of screening, and 2) a history of at least eight weeks of glucocorticoid treatment. the investigators randomly assigned patients to receive 200 mg of sarilumab twice per month over 52 weeks plus a 14-week prednisone taper or placebo plus a 52-week prednisone taper. The primary outcome at 52 weeks was sustained remission, defined as the absence of PMR signs/symptoms by week 12, sustained C-reactive protein (CRP) normalization, absence of disease flare and adherence to the prednisone taper from weeks 12 through 52. At week 52, sustained remission occurred in 28% of participants in the sarilumab group and in 10% in the placebo group; this significant difference held true even when ESR and CRP were removed from the analysis. The cumulative glucocorticoid dose at week 52 was lower in the sarilumab group than in the placebo group (777 mg vs. 2,044 mg, respectively). Fewer disease flares occurred after clinical remission at week 12 in the sarilumab group than in the placebo group (24% vs. 57%, respectively). Finally, patients treated with sarilumab had lower glucocorticoid toxicity index scores during 52 weeks (52.32 vs. 57.22) and larger mean improvement in disease activity score from baseline to week 52 (−15.57 vs. −10.27) than those receiving placebo.
