Also patient/parent's global assessment of overall well-being on a 21 circle VAS greatly improved over time, being 5.8 at day 0 and 1.6 at day 60 (where 10 is the worst quality).Īll patients successfully discontinued corticosteroids within 6 weeks and proceeded to part 2. Pain VAS quickly dropped, and was 0.4 on average at day 60. Eighteen patients displayed a pericardial effusion, mild in all cases (<10mm).Īll patients had a complete response to open-label anakinra treatment at day 8, according to the protocol definition, that was maintained until randomization (day 60).ĬRP was normalized in all the patients at day 8, and remained normal at day 60. Median duration of follow up was 14 months.Īt the time of study enrollment, all 21 patients were experiencing a recurrence of pericarditis with a mean VAS of pain of 7.7 mean CRP level was 4.2 mg/dL. Mean number of recurrences before the study was 6.8, with a clinical history of recurrent pericarditis lasting 27.8 months on average.One patient was in the pediatric age-range (15 years old), and the remaining 20 patients were adults (age >18 years). Out of 25 patients screened for entry in the study from 3 centers in Italy, 21 were enrolled.All the patients were then followed for other 4 months to assess safety. Patients who had another pericarditis recurrence could have the option to be re-treated with anakinra. The end of the study was the end of part 2 (8 months after enrollment) or the time of relapse, whichever occurred first. It consisted of two parts: (1) an open-label treatment period in which anakinra was administered daily for 60 days followed by (2) a double-blind withdrawal period in which patients who had a sustained complete response in part 1 were randomized to anakinra or to placebo daily for up to 6 months. SOBI is currently evaluating the outcomes of this study and potential next steps.
SOBI provided anakinra and placebo as part of unrestricted institutional grant and had no role in the design and conduct of the study and in preparation of the The study was an investigator initiated, 8-month, multicenter, randomized, double-blind, placebo-controlled, medication-withdrawal study to evaluate the efficacy and tolerability of anakinra in adults and children with idiopathic recurrent pericarditis. To evaluate the efficacy and tolerability of anakinra in adults and children with recurrent idiopathic pericarditis that was corticosteroid-dependent and colchicine-resistant. Anakinra was used first in pediatric patients and then evaluated in adults.6,7 Anakinra administered daily subcutaneously for several months showed in both children and adults a rapid response with corticosteroid withdrawal.7,8 Current evidence with anakinra is based entirely on case reports and retrospective series,9 and to our knowledge, no randomized controlled trials have been conducted. Quality of life may be severely affected in frequently relapsing cases, and patients with frequent recurrences can develop corticosteroid-dependence.Īnakinra is an interleukin (IL)-1 beta recombinant receptor antagonist that has been proposed as a potential treatment for recurrent pericarditis.
Treatment modalities in recurrent pericarditis include non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, colchicine, immunosuppressive agents, and pericardiectomy. The cookie is used to store the user consent for the cookies in the category "Other.Recurrent pericarditis is a difficult clinical problem1,2 that affects up to 30% of patients after a first episode of acute pericarditis, and up to 50% of those with a first recurrence, if not treated with colchicine.3-5 The optimal regimen for avoiding recurrences has not been clearly established. This cookie is set by GDPR Cookie Consent plugin. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly.