Skip to main content
. 2025 Aug 22;18:11539–11549. doi: 10.2147/JIR.S516825

Table 1.

General Information of the Included Studies

Study Country Center Sample Size(T/Ca) Intervention Control Measures Follow-Up Duration Efficacy Outcomes Safety Outcomes
Klein,4 2020 The United States Multi-center 25/0 Rilonacept 2x160mg loading dose, followed by 160mg per week (2.2 mg/kg in pediatric patients); None 6-24weeks Active pericarditis patients: ①②③④⑤⑥Corticosteroid-dependent patients: ③④⑤⑥⑦ ⑧⑨⑩
Lin,17 2021 ①②⑤ /
Klein,18 2021 The United States, Australia, Israel, Italy Multi-center Run-in period: 86/0
Randomized trial period: 30/31
Run-in period: Rilonacept 320mg (4.4mg/kg in pediatric patients) loading dose, followed by 160mg per week (2.2mg/kg in pediatric patients);
Randomized-withdrawal period: Rilonacept 160mg per week (2.2mg/kg in pediatric patients);
Placebo Averaged 36 weeksb Run-in period: ⑪ ⑫ ⑬ ⑭Randomized-withdrawal period: ⑮ ⑯ ⑧⑨⑩
Brucato,19 2022 ①⑰ ⑱ ⑲ ⑳ /
Imazio,20 2024 74/0 Within 18 months from the most recent pericarditis event: Rilonacept 160mg weekly;
18 months after the most recent pericarditis event: Options include continuing with rilonacept open-label, suspending rilonacept for observation, or discontinuing from the study;
None 24 months Within 18 months from the most recent pericarditis event: ①②③⑥⑮
18 months after the most recent pericarditis event: ①②③⑥⑮

Notes: aT/C: treatment and control. bIncludes a 12-week run-in period. ① Pericardial pain numeric rating scale (NRS) scores; ② C-reactive protein (CRP) levels; ③ Other pericarditis symptoms; ④ Health-related quality of life (physical and mental aspects); ⑤ Concomitant use of corticosteroids or not; ⑥ Changes in the use of other concomitant medications for pericarditis; ⑦ Disease activity after the tapering and discontinuation of corticosteroids; ⑧ Treatment-emergent adverse events; ⑨ Safety clinical laboratory testing included local haematology, chemistry, urinalysis and central laboratory lipid panel; ⑩ Physical examinations included vital signs, weight and height; ⑪ The time to pain response (rolling mean numerical rating scale score of ≤ 2 on 3 consecutive days); ⑫ The time to normalization of the CRP level; ⑬ The time to prespecified treatment response; ⑭ The time by which the patients discontinued standard therapy and were receiving rilonacept monotherapy; ⑮ Recurrence events; ⑯ The percentage of patients who had a persistent clinical response at the week-16 assessment, the percentage of days with no or minimal pericarditis pain (numerical rating scale score ≤ 2) through week 16, and the percentage of patients with absent or minimal pericarditis symptoms (score of 0 or 1), according to the patient’s global impression of pericarditis severity rating scale (scores range from 0 to 6, with higher scores indicating greater severity of symptoms), at the week-16 assessment; ⑰ Health-related quality of life assessed with the SF‐36v2; ⑱ General health status score assessed using the EQ‐5D Visual Analogue Scale (EQ VAS); ⑲ Sleep impact assessed by the Insomnia Severity Index (ISI); ⑳ Global pericarditis symptom severity assessed by the Patient Global Impression of Pericarditis Symptom Severity (PGIPS).