Phase 3 Trial Confirms Sarilumab Improves Polymyalgia Rheumatica Outcomes

New phase 3 data supported the effectiveness of sarilumab 200 mg every 2 weeks, combined with a 14-week glucocorticoid taper, for the treatment of polymyalgia rheumatica.¹

“Improvements were highest in patients with most severe disease,” wrote investigators, led by Vibeke Strand, MD, from the division of immunology/rheumatology at Stanford University.¹

On March 1, 2023, the US Food and Drug Administration (FDA) approved sarilumab (Kevzara), an injectable interleukin-6 (IL-6) receptor blocker, as the first biologic treatment for adults with polymyalgia rheumatica.² The FDA based its decision on the phase 3 SAPHYR published in October 2023, finding that patients with polymyalgia rheumatica who took sarilumab were significantly more likely to achieve sustained remission and have lower steroid exposure compared with those on placebo.³ SAPHYR was a multicenter, double-blind trial assessing the safety and efficacy of twice-monthly sarilumab in patients who experienced a disease flare while tapering glucocorticoids (≥ 7.5 mg/day).

Strand and colleagues’ recent study, another phase 3, double-blind, randomized controlled trial, sought to assess the effect of sarilumab on patient-reported outcomes among adults aged ≥ 50 years with polymyalgia rheumatica.¹ The primary endpoint was changes in patient-reported outcomes from baseline to week 52. Patient-reported outcomes included the 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 including the descriptive system and the VAS), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).

The study recruited 118 patients between October 9, 2018, and July 15, 2020, with a mean age of 68.9 years. The sample had a high proportion of females (69%) and White participants (83%).¹

Participants had a history of ≥ 8 weeks of glucocorticoid treatment (≥ 10 mg per day or prednisone dose equivalent). Within 12 weeks before screening, participants had ≥ 1 episode of disease flare during a glucocorticoid taper (≥ 7.5 mg per day), symptoms of polymyalgia rheumatica, and an erythrocyte sedimentation rate > 30 mm/h or a C-reactive protein concentration of ≥ 10 mg/L.

Patients were randomized 1:1 to receive either subcutaneous sarilumab 200 mg once every 2 weeks with a 14-week glucocorticoid taper (n = 60) or a placebo with a 52-week glucocorticoid taper (n = 58). Investigators noted that 1 patient randomized to the sarilumab arm did not receive treatment. The treatment allocation was blinded to both patients and investigators.

At baseline, 73% of participants assigned to sarilumab and 74% assigned to placebo reported moderate-to-severe fatigue. At week 52, patients on sarilumab reported greater improvement in SF-36 Physical Component Summary (least-squares mean [LSM] change 7.65 vs 2.87; P =.020) and Mental Component Summary (MCS; 3.04 vs –1.71; P =.030) scores compared to those on placebo. Participants on sarilumab also showed greater improvements in EQ-5D utility index (0.11 vs –0.02, P =.034) and VAS scores (8.37 vs –0.46, P =.084), FACIT-F (7.91 vs 4.17, P =.060), HAQ-DI (–.39 vs –0.15, P =.054), Pain VAS (–20.57 vs –12.04, P =.20), and Patient Global Assessment VAS (–15.01 vs –6.08, P =.13).¹

A greater proportion of patients on sarilumab vs placebo reported improvements of minimum clinically important difference or greater SF-36 PCS scores (odds ratio [OR], 3.46; 95% confidence interval [CI], 1.16 to 10.62; P = .020).¹

More than 50% of patients receiving sarilumab reported scores at or above normative values for SF-36 MCS and 4 domain scores. This was not the case for scores in the placebo group.

“The use of sarilumab 200 mg once every 2 weeks with a 14-week glucocorticoid taper led to clinically important improvements in health-related quality of life and patient-reported outcomes versus placebo with a 52-week glucocorticoid taper,” investigators concluded.¹ “These findings provide support for the use of sarilumab in patients with polymyalgia rheumatica whose disease activity and health-related quality of life is not adequately managed by glucocorticoid monotherapy according to treat-to-target principles.”

References

1. Strand V, Msihid J, Sloane J, et al. Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial. Lancet Rheumatol. 2025;7(8):e544-e553. doi:10.1016/S2665-9913(25)00041-4

2. Pine, L. FDA Approves Sarilumab as First, Only Biologic Treatment for Polymyalgia Rheumatica. HCPLive. March 1, 2025. https://www.hcplive.com/view/fda-approves-sarilumab-as-first-only-biologic-treatment-for-polymyalgia-rheumatica. Accessed August 15, 2025.

3. Pine, L. Sarilumab Demonstrates Sustained Remission in Patients with Polymyalgia Rheumatica. HCPLive. October 5, 2025. https://www.hcplive.com/view/sarilumab-demonstrates-sustained-remission-in-patients-with-polymyalgia-rheumatica. Accessed August 15, 2025