Key result
Goflikicept cuts pericarditis recurrence by ~100% vs placebo over a 24-week withdrawal period.
Why the study?
Idiopathic recurrent pericarditis is a rare autoinflammatory disease driven by IL-1alpha and IL-1beta, prompting evaluation of the efficacy and safety of the new IL-1 inhibitor goflikicept.
RCT (n=22)
Open-label
1:1
Yes
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Although the sample size is small and the duration of follow-up is limited, the safety profile for goflikicept was similar to that of prior IL-1 blocker studies.”
“In a small industry-sponsored and industry-authored phase II/III study performed at two sites in Russia, treatment with the IL-1 inhibitor goflikicept in one of two different dosing regimens was associated with treatment response for idiopathic recurrent pericarditis (IRP). Of 20 patients in a randomized withdrawal period, goflikicept was superior to placebo in preventing recurrences of IRP through 24 weeks of therapy.”
“These results have been further confirmed with a different IL-1 trap receptor, goflikicept.”
Supports goflikicept to reduce recurrences and enable steroid discontinuation; extends IL-1 inhibition evidence in idiopathic recurrent pericarditis.
BACKGROUND Idiopathic recurrent pericarditis (IRP) is a rare autoinflammatory disease. Interleukin (IL)-1α and IL-1β are the pivotal cytokines in the pathophysiology of acute pericarditis and its recurrence. We created a phase II/III study with a new IL-1 inhibitor-goflikicept in IRP. OBJECTIVES This study sought to evaluate the efficacy and safety of goflikicept treatment in patients with IRP. METHODS We conducted a 2-center open-label study of goflikicept in patients with IRP with and without recurrence at time of enrollment. The study consisted of 4 periods: screening, run-in (open-label treatment period), randomized withdrawal, and follow-up. Patients with clinical response to goflikicept in the run-in period were randomized (1:1) to a placebo-controlled withdrawal period, where the time to first pericarditis recurrence (primary endpoint) was evaluated. RESULTS We enrolled 22 patients, and 20 of these patients were randomized. Reduction of C-reactive protein level accompanied by reduction of chest pain and pericardial effusion compared to baseline was demonstrated during the run-in period. Recurrence of pericarditis occurred in 9 of 10 patients in the placebo group, and there were no recurrence events in goflikicept group within 24 weeks after randomization (P < 0.001). A total of 122 adverse events were reported in 21 patients (95.5%), with no deaths and no new safety signals identified for goflikicept. CONCLUSIONS 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 to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis; NCT04692766).
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Myachikova et al. (2023) conducted an RCT in Idiopathic recurrent pericarditis (n=22). Goflikicept vs. Placebo was evaluated on time to first pericarditis recurrence (p=<0.001). Goflikicept reduced the risk of pericarditis recurrence compared with placebo during a 24-week withdrawal period.
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