Efficacy and Safety of Nanoencapsulated Sirolimus Plus Pegadricase: Results From the Randomized, Placebo‐Controlled Phase 3 Trials
Authors' conclusion
NASP treatment resulted in a significantly higher proportion of patients with complete SU response during weeks 21 to 24 compared with placebo and was generally well tolerated.
Study context
- Population
- Patients with uncontrolled gout
- Participants
- 265 patients
- Comparison
- High-dose or low-dose nanoencapsulated sirolimus (NAS) plus pegadricase vs placebo, infusions every 4 weeks for 6 doses
- Primary endpoint
- Proportion of patients with serum urate <6 mg/dL for ≥80% of the time during weeks 21-24
- Follow-up
- Weeks 21-24
Methodological detailsdouble-blind, placebo-controlled, Phase 3, two trials (DISSOLVE I and II), 1:1:1 randomisation
- Double-blind
- Placebo-controlled
- Phase 3
- Two trials (DISSOLVE I and II)
- 1:1:1 randomisation
Primary result
As reported in the abstract
Serum urate (SU) response (SU <6 mg/dL ≥80% of time)
High-dose (HD) NASP vs Placebo: P < 0.0001 for both doses vs placebo · low-dose (LD) NASP vs Placebo: P < 0.0001 for both doses vs placebo
Secondary outcomes
Proportion of patients with gout flares over time
- Weeks 1-12: similar between NASP and placebo; thereafter decreased with NASP but unchanged with placebo
Safety
Gout flares (adverse event)
Infections
Stomatitis
Infusion reactions within 1 hour
- Infrequent in NASP-treated patients
- 4%
Original publication
Efficacy and Safety of Nanoencapsulated Sirolimus Plus Pegadricase: Results From the Randomized, Placebo‐Controlled Phase 3 Trials. Arthritis Rheumatol. Published 25 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →