Background: Idiopathic recurrent pericarditis (IRP) is a rare autoinflammatory pericardial disease associated with aberrant activation of the NLRP3 inflammasome and overproduction of interleukin-1. In some patients, conventional anti-inflammatory therapy, including nonsteroidal anti-inflammatory drugs, colchicine, and corticosteroids is ineffective. Goflikicept, a novel IL-1 inhibitor, may be a promising treatment option.

Aim: To evaluate the efficacy and safety of goflikicept in patients with IRP in real-world clinical practice.

Materials and methods: This ongoing observational study includes patients with IRP, refractory to standard anti-inflammatory therapy, both during recurrence and remission. Goflikicept is administered subcutaneously on a loading regimen (Week 0 – 160 mg; Week 1 – 80 mg; Week 3 – 80 mg; followed by 80 mg every 2 weeks). The planned treatment duration is 77 weeks. IRP recurrence rate, leukocyte count, C-reactive protein (CRP) level, pericardial effusion volume and adverse events are being monitored. 

Results: We enrolled 7 patients, including 2 patients with steroid-dependent pericarditis. During the course of therapy, concomitant therapy was discontinued in 5 patients. Only 1 patient developed IRP recurrence, which occurred in the early stage of goflikicept therapy (at Week 3). In patients without recurrence pericardial effusion decreased over time (pericardial layers separation: (Median [IQR]), mm; Week 0 – 1.2 [0;2.3] vs Week 4 – 0.5 [0;1.9] vs Week 14 – 0 [0;1]). We also observed a reduction in CRP level (mg/L; Week 0 – 0.50 [0.20;1.30] vs Week 4 – 0.10 [0.03;0.20] vs Week 14 – 0.15 [0.10;0.28]) and leukocyte count (10*9/L; Week 0 – 8.71 [8.33;9.01] vs Week 4 – 6.04 [5.08;7.84] vs Week 14 – 5.49 [5.25;5.80]). There were 2 episodes of upper respiratory tract infection and 1 episode of outpatient-treated pneumonia. No serious adverse events or deaths occurred.

Conclusion: Goflikicept may be a reasonable treatment option in refractory IRP patients. Upon completion, this study will determine efficacy and safety profile of goflikicept in routine clinical practice.

To be updated