secukinumab in polymyalgia rheumatica (PMR)

Secukinumab is a fully human monoclonal antibody that selectively inhibits interleukin-17A.

The REPLENISH trial evaluated the efficacy and safety of in patients with relapsing polymyalgia rheumatica (PMR) (1):

• 381 patients aged 50 or older (mean age 70; 70% women) with active, recently relapsed PMR
• patients were randomized equally (1:1:1) into three groups for a 52-week period:
  • secukinumab 300 mg, or,
  • secukinumab 150 mg, or,
  • placebo
• secukinumab was given via subcutaneous injection using a standard biologic schedule:
  • loading phase:
    • once a week for the first 4 weeks (Weeks 0, 1, 2, and 3)
  • maintenance phase:
    • once every 4 weeks thereafter (starting at Week 4) through Week 48
• all three arms (including the placebo group) received a background protocol-specified daily prednisone taper designed to last exactly 24 weeks, gradually stepping patients down to zero milligrams by the half-year mark
• primary end-point:
  • proportion of patients achieving sustained remission at Week 52 (defined as no symptom recurrence or need for rescue medication from Week 12 through Week 52)
• study results showed that secukinumab doubled the chances of keeping PMR in check compared to standard tapering alone.
  • sustained remission rate:
    • secukinumab 300 mg: 41.2%
    • secukinumab 150 mg: 40.6%
    • placebo: 20.4%
  • sustained complete remission (clinical remission plus completely normal inflammatory blood markers such as ESR/CRP):
    • secukinumab 300 mg: 28.2%
    • secukinumab 150 mg: 24.5%
    • placebo: 4.7%
  • time to flare / rescue rherapy:
    • patients on the active drug went significantly longer before needing a rescue steroid escalation
    • median time to treatment escalation was 337 days (300 mg dose) and 282 days (150 mg dose) compared to just 157 days in the placebo arm
  • serious adverse events occurred in 13.5% of the patients in the secukinumab 300 group, in 15.9% in the secukinumab 150 group, and in 14.2% in the placebo group
  • nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain were more common in the secukinumab groups than in the placebo group
• study authors concluded:
  • “..Among patients with relapsed polymyalgia rheumatica, treatment with secukinumab plus a 24-week glucocorticoid taper resulted in a higher percentage of patients with remission and in lower cumulative glucocorticoid doses than a glucocorticoid taper alone..”

Reference:

1. Stone JH et al. REPLENISH Investigators. Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica. N Engl J Med. 2026 Jun 3.