The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout
Authors' conclusion
SEL-212 efficacy and tolerability were comparable to pegloticase in refractory gout.
Study context
- Population
- Adults with refractory gout
- Comparison
- SEL-212 monthly vs pegloticase twice monthly for 6 months
- Primary endpoint
- Proportion of participants with serum urate (SU) <6 mg/dl for ≥80% of the time during months 3 and 6
- Follow-up
- Months 3 and 6
Methodological detailsphase 2, open-label, head-to-head
- Phase 2
- Open-label
- Head-to-head
Primary result
As reported in the abstract
SU <6 mg/dl for ≥80% of the time, months 3 and 6 combined
P = 0.181
Secondary outcomes
| Outcome | SEL-212 | Pegloticase | P value |
|---|---|---|---|
| Percentage reduction in SU levels · months 3 and 6 | −73.79% | −47.96% | P = 0.0161 |
Gout flare incidence and number of tender and/or swollen joints
- Reductions comparable between treatments
Safety
Treatment-related gout flares
Treatment-related infections
Treatment-related infusion-related reactions
| Outcome | SEL-212 | Pegloticase |
|---|---|---|
| Stomatitis (and related terms)Associated with ImmTOR only | 9.6% | 0 events |
Original publication
The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR™) versus pegloticase for refractory gout. Rheumatology (Oxford). Published 14 July 2023. doi:10.
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