SAT0511 CANAKINUMAB IN SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: CLINICAL INACTIVE DISEASE RATE AND SAFETY IN ITALIAN PATIENTS
Authors: Manuela Pardeo, Claudia Bracaglia, Anna Lucia Piscitelli, Arianna De Matteis, Jessica Tibaldi, Maria Alessio, Achille Marino, Giovanni Conti, Maria Cristina Maggio, Clotilde Alizzi, Francesco Licciardi, Alma Nunzia Olivieri, Giovanni Filocamo, Francesca Orlando, Silvana Martino, Rolando Cimaz, Angelo Ravelli, Fabrizio De Benedetti
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Systemic juvenile idiopathic arthritis (sJIA) is a polygenic autoinflammatory disease. The innate immune mechanisms play a central role with overproduction of inflammatory cytokines. The increased knowledge on the role of these cytokines has provided a change in the natural history of the disease with the introduction of the targeted treatments. Remarkable results has been observed with canakinumab, an anti-interleukin-1β monoclonal antibody, in two clinical trials but little information are available in real life. <h3>Objectives:</h3> To evaluate clinical inactive disease rate and safety of canakinumab in Italian patients with sJIA. <h3>Methods:</h3> We have collected retrospectively clinical and laboratory data of patients with sJIA treated with canakinumab in 9 Italian Pediatric Rheumatology centers. Clinically inactive disease (CID) at 6 months was defined according to Wallace criteria. We analyzed the effect of canakinumab on fever, rash, number of actives joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and physician's global assessment of disease activity score. <h3>Results:</h3> Forty seven patients (26 F) were included in the analyses. The median age (range) at the diagnosis and at the beginning of treatment with canakinumab was 7.6 (1-14.7) and 10.2 (1.7-22.2) years, respectively. Twenty seven patients (57.4%) had been previously treated with other biologic agents (18 with anakinra, 1 with tocilizumab, 6 with both and 2 with etanercept), withdrawn for inefficacy in 15/27 (55.5%). Thirty patients (63.8%) were receiving concomitant treatment with glucocorticoids at the median dose (range) of 0.69 (0.02-2.75) mg/kg/die. Thirtynine out of 47 patients had &gt; 6 months of follow-up. Among these 39 patients, 27 (69.2%) achieved CID at 6 months and 5/27 (18.5%) were still on glucocorticoids. Of the 30 patients who received concomitant glucocorticoids at baseline, 24 achieved 6 months of follow-up and 12 (50%) of these were able to withdraw glucocorticoids. Minor adverse events were reported in 5/30 (16.6%) patients: upper respiratory tract infections in 4 and transient injection site reaction in 1. No cases of macrophage activation syndrome was reported. <h3>Conclusion:</h3> Our results provide initial real world evidence of the efficacy of treatment with canakinumab in patients with sJIA. In our study the percentage of patients who reached CID at 6 months is slightly higher (69.2%) than reported at the end (from 3 months to one year) of the 2 published randomized trials (60%). No serious adverse events were recorded in our population. <h3>Disclosure of Interests:</h3> Manuela Pardeo: None declared, Claudia Bracaglia: None declared, Anna Lucia Piscitelli: None declared, Arianna De Matteis: None declared, Jessica Tibaldi: None declared, Maria Alessio: None declared, Achille Marino: None declared, Giovanni Conti: None declared, Maria Cristina Maggio: None declared, Clotilde Alizzi: None declared, Francesco Licciardi: None declared, Alma Nunzia Olivieri: None declared, Giovanni Filocamo: None declared, Francesca Orlando: None declared, Silvana Martino: None declared, Rolando Cimaz: None declared, Angelo Ravelli Grant/research support from: Angelini, AbbVie, Bristol-Myers Squibb, Johnson &amp; Johnson, Novartis, Pfizer, Reckitt Benkiser, and Roche, Consultant for: Angelini, AbbVie, Bristol-Myers Squibb, Johnson &amp; Johnson, Novartis, Pfizer, Reckitt Benkiser, and Roche, Speakers bureau: Angelini, AbbVie, Bristol-Myers Squibb, Johnson &amp; Johnson, Novartis, Pfizer, Reckitt Benkiser, and Roche, Fabrizio De Benedetti Grant/research support from: Abbvie, SOBI, Novimmune, Roche, Novartis, Sanofi, Pfizer