Cardio-oncology & otherRandomised controlled trial
Treatment of Idiopathic Recurrent Pericarditis With Goflikicept
- Randomised controlled trial
- phase II/III
- 2-center
- open-label run-in
- randomized withdrawal
- placebo-controlled
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
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 |
- 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
- 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. J Am Coll Cardiol. Published 4 July 2023. doi:10.1016/j.jacc.2023.04.046
Summarised from the published abstract; every number is checked against it