SAT0268 Tocilizumab Therapy in Children with Polyarthicular Course Juvenile Idiopathic Arthritis
Authors: E. Alexeeva, R. Denisova, S. Valieva, T. Bzarova, K. Isayeva, T. Sleptsova, E. Chistyakova, A. Chomahidze, O. Lomakina, M. Soloshenko, A. Fetisova, E. Kashchenko
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Patients with polyarticular-course Juvenile idiopathic arthritis (pcJIA) have risk for profound disability.Although these patients may respond to methotrexate (MTX) or biological agents approved for pcJIA, up to 30% continue to have active disease.Interleukin-6 (IL-6) is concentrations are positively correlated with the severity of joint involvement and with C-reactive protein (CRP) levels. Tocilizumab is effective drug for the treatment of JIA refractory to immunosuppressive drugs. <h3>Objectives</h3> To evaluate safety and efficacy of tocilizumab treatment in children with pcJIA <h3>Methods</h3> Analysis of efficacy and safety tocilizumab therapy was performed in 46 patients (4 - RF+, 3-enthesitis related arthritis, 1-psoriatic JIA) and in 24 patients, whom follow up period was 6 and 12 m. Median age was 9,8 y (range; 1,9 to 17,2 y) and median disease duration was 5,1y (range; 0.4 to 13,7 y). Tocilizumab was administrated intravenously at a dose of 8or 10 mg/kg every 4 weeks. 29 patients were treated by biologics previously. The majority of patients received concomitantDMARDs, 31 patients received methotrexate, 1-leflunomid, 1-sulfasalazin,5-cyclosporin and 8- prednisolone at dose 0.4 (0.2; 1) mg/kg/day. 14 patients had uveitis: 6-not active,1-subactive and 7-active. Efficacy end points included the American College of Rheumatology (ACR)for improvement 30 (ACR30), ACR50, ACR70, ACR90 and criteria of inactive disease andindex JADAS10. During the follow-up period, significant side-effects were sought. <h3>Results</h3> The ACR Pedi 30, 50, 70, 90 and 100 improvement were achieved by 92% (n=36), 82% (n=32), 56% (n=22), 23% (n=9),and 12% (n=5) of patients at Week 24 (n=39), by 100% (n=24), 87% (n=21), 83% (n=20), 54% (n=13), and 20% (n=5) of patients at Week 48 (n=24)respectively. Inactive disease was achieved by 14/39 (36%) of patients at week 24 and by 12/24 (50%) of patients at week 48. The JADAS10 decreased from 23,4 (14,8; 27,8) to 6,2 (1,6; 11,8) at week 24 (p&lt;0.001) and to 2,0 (0,5; 4,9) at week 48 (p&lt;0.001). The number of platelets decreased from 383 x109/l (302; 488) to 250 (220; 282) at week 24 (p&lt;0.001) and to 258 (216; 284) at week 48 (p&lt;0.001), number of leucocytes – from 8,8 x109/l (7,6; 9,9) to 6,5 (5,3; 7,3) at week 24 (p&lt;0.001) and to 6,4 (4,7; 6,8)) at week 48 (p&lt;0.001); level of hemoglobin increased from 112 (100; 123) g/l to 126 (118; 132) at week 24 (p&lt;0.01) and to 129 (122; 136)) at week 48 (p&lt;0.001).The frequently observed non-severe adverse events were nasopharyngitis, upper respiratory tract infections and gastroenteritis. No cases of opportunistic infections, malignancies or death were reported. 12 patients had incidences of neutropenia, 2 – thrombocytopenia,7-increased level of ALT and AST. Tocilizumab treatment was discontinued in 7 patients during the follow-up 48 weeks period. The causes for cancellation were lack of efficacy (n=6), infusion reaction (n=1), flare (n=1). 5patients were switched to antiTNF blockers and 2 – to abatacept. <h3>Conclusions</h3> Tocilizumab treatment provided clinically meaningful improvement for patients with pcJIA. Tocilizumab induced remission of the disease The safety profile of tocilizumab was consistent that seen in other studies <h3>Disclosure of Interest</h3> E. Alexeeva Grant/research support from: Roche, Novartis, UCB, R. Denisova Grant/research support from: Roche, Novartis, Pfizer, UCB, S. Valieva Grant/research support from: Roche, T. Bzarova Grant/research support from: Pfizer, K. Isayeva Grant/research support from: Roche, Novartis, T. Sleptsova Grant/research support from: Novartis, UCB, E. Chistyakova: None declared, A. Chomahidze: None declared, O. Lomakina: None declared, M. Soloshenko: None declared, A. Fetisova: None declared, E. Kashchenko: None declared