Background/Purpose: Systemic Juvenile Idiopathic Arthritis (sJIA) is classified as an acquired autoinflammatory disease. The interleukin-1 and interleukin-6 play a pivotal role in pathogenesis of this disease. The systemic manifestations as well as arthritis in sJIA are related to interleukin-6 action. Tocilizumab is promising drug for the treatment of systemic arthritis refractory to immunosuppressive drugs.

Objectives: To evaluate safety and efficacy of tocilizumab treatment in children with systemic juvenile idiopathic arthritis.

Methods:

A prospective observational study in patients with sJIA taking tocilizumab. A total of 94 patients (49 boys and 45 girls) were included in this study. Median age was 5,5 years (range; 2 to 15 years) and median disease duration was 3,5 years (range; 0.5 to 12 years). Tocilizumab was administrated intravenously at a dose of 8-10 mg/kg every 2 weeks during 2 months then every 4 weeks. All patients received DMARDs. Efficacy end points included the American College of Rheumatology (ACR) Pediatric criteria for improvement 30 (ACR30), ACR50, ACR70 and criteria of inactive disease and remission.

Results:

39 of 94 patients (41%) entered 52 weeks and 69 patients – 24 weeks of continuous tocilizumab treatment. Tocilizumab treatment was discontinued in 15 patients. 40 patients continue to receive Tocilizumab therapy and have not entered 52 weeks yet. The ACR Pedi 30, 50 and 70 improvement were achieved by 100%, 100% and 75% of patients at Week 24 (n=69) and by 100%, 100% and 87% of patients at Week 52 (n=39), respectively. Inactive disease was achieved by 55% of patients at week 24 (n=69) and by 65% of patients at week 52 (n=39). Remission was achieved by 59% of patients (n=39). The mean dose of oral glucocorticoid was decreased from 0,6 (0,4; 0,5) mg/kg (n=45) to 0,2 (0,1-0,3) mg/kg (n=20) at week 52. 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. There were three cases of pneumonia and cellulitis. 30 patients had incidences of neutropenia. Tocilizumab treatment was discontinued in 15 patients. The causes for cancellation were relapse of disease (n=7), inefficacy (n=3), remission (n=1), parent’s refusal (n=1), infusion reaction (n=2) and Crohn’s disease (n=1).

Dynamics in systemic features

	Background	1 m	6 m	12 m
Number of systemic features per patient	3,1	1,1	0,5	0,2

Conclusion:

The results of the annual prospective observational study have shown the high efficiency of tocilizumab in patients with the severe sJIA. Drug induced remission of extra-articular manifestations, arthritis and normalized laboratory parameters of the disease activity without initiation of treatment with oral prednisolone and increase its dose, thus avoiding severe irreversible complications of glucocorticoid therapy. Tocilizumab induced disease remission in 59% of patients at Week 52.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/tocilizumab-therapy-in-children-with-systemic-onset-juvenile-idiopathic-arthritis-russian-experience/