Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results
Authors' conclusion
Treatment with goflikicept prevented recurrences and maintained IRP remission with a favorable risk-benefit ratio. Goflikicept reduced the risk of recurrence compared with placebo.
Study context
- Population
- Patients with idiopathic recurrent pericarditis (IRP), with and without recurrence at enrollment, responding to goflikicept in run-in20 randomized
- Participants
- 22 patients
- Comparison
- Goflikicept vs placebo in randomized withdrawal
- Primary endpoint
- Time to first pericarditis recurrence
Methodological detailsphase II/III, 2-center, open-label run-in, randomized withdrawal, placebo-controlled
- Phase II/III
- 2-center
- Open-label run-in
- Randomized withdrawal
- Placebo-controlled
Primary result
As reported in the abstract
Pericarditis recurrence · within 24 weeks after randomization
| Group | Value | Patients |
|---|---|---|
| Placebo | 9 events | 9 of 10 |
| Goflikicept | 0 events |
Value
Placebo9 events
Goflikicept0 events
Patients
Placebo9 of 10
Goflikicept— not stated in the abstract
- Goflikicept vs Placebo: P < 0.001
Further findings
CRP, chest pain and pericardial effusion vs baseline (run-in) · run-in period
- Reduction of CRP with reduction of chest pain and pericardial effusion vs baseline
Safety
- Adverse events reported
- 122
- Patients with adverse events
- 21 (95.5%)
- Deaths
- 0
- No new safety signals for goflikicept
Original publication
Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results. J Am Coll Cardiol. Published 4 July 2023. doi:10.
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