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 | ⑧ | ||
| 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).