Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial

The Lancet

Volumn 371, Issue 9617, 2008, Pages 998-1006

  Yokota, Shumpei ^a   Imagawa, Tomoyuki ^a   Mori, Masaaki ^a   Miyamae, Takako ^a   Aihara, Yukoh ^a   Takei, Shuji ^b   Iwata, Naomi ^c   Umebayashi, Hiroaki ^d   Murata, Takuji ^e   Miyoshi, Mari ^f   Tomiita, Minako ^g   Nishimoto, Norihiro ^h   Kishimoto, Tadamitsu ^h  

^a YOKOHAMA CITY UNIVERSITY   (Japan)

^b KAGOSHIMA UNIVERSITY   (Japan)

^c AICHI CHILDREN'S HEALTH AND MEDICAL CENTER   (Japan)

^d MIYAGI CHILDREN S HOSPITAL   (Japan)

^e OSAKA MEDICAL COLLEGE   (Japan)

^f KOBE CHILDREN S HOSPITAL   (Japan)

^g CHIBA UNIVERSITY   (Japan)

^h OSAKA UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ATLIZUMAB; C REACTIVE PROTEIN; PLACEBO;

ADOLESCENT; ADULT; ANAPHYLAXIS; ARTICLE; BRONCHITIS; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; GASTROENTERITIS; GASTROINTESTINAL HEMORRHAGE; HUMAN; INFECTIOUS MONONUCLEOSIS; JUVENILE RHEUMATOID ARTHRITIS; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION;

EID: 40749152243     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(08)60454-7     Document Type: Article

References (27)

1. Cassidy J., and Petty R. Juvenile idiopathic arthritis. In: Cassidy J., and Petty R. (Eds). Textbook of pediatric rheumatology. 5th edn. (2005), WB Saunders, Philadelphia 291-303
2. Billiau A., Roskams T., Van Damme-Lombaerts R., Matthys P., and Wouters C. Macrophage activation syndrome: characteristic findings on liver biopsy illustrating the key role of activated, IFN-gamma-producing lymphocytes and IL-6- and TNF-alpha-producing macrophages. Blood 105 (2005) 1648-1651
3. Kelly A., and Ramanan A. Recognition and management of macrophage activation syndrome in juvenile arthritis. Curr Opin Rheumatol 19 (2007) 477-481
4. Cortis E., and Insalaco A. Macrophage activation syndrome in juvenile idiopathic arthritis. Acta Paediatr Suppl 95 (2006) 38-41
5. Grom A., Murray K., Luyrink L., et al. Patterns of expression of tumor necrosis factor alpha, tumor necrosis factor beta, and their receptors in synovia of patients with juvenile rheumatoid arthritis and juvenile spondylarthropathy. Arthritis Rheum 39 (1996) 1703-1710
6. Lovell D., Giannini E., Reiff A., et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl J Med 342 (2000) 763-769
7. Genovese M., Bathon J., Martin R., et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 46 (2002) 1443-1450
8. Quartier P., Taupin P., Bourdeaut F., et al. Efficacy of etanercept for the treatment of juvenile idiopathic arthritis according to the onset type. Arthritis Rheum 48 (2003) 1093-1101
9. Ramanan A., and Schneider R. Macrophage activation syndrome following initiation of etanercept in a child with systemic onset juvenile rheumatoid arthritis. J Rheumatol 30 (2003) 401-403
10. Pascual V., Allantaz F., Arce E., et al. Role of interleukin-1 (IL-1) in the pathogenesis of systemic onset juvenile idiopathic arthritis and clinical response to Il-1 blockade. J Exp Med 201 (2005) 1479-1486
11. Irigoyen P., Olsen J., Hom C., et al. Treatment of systemic juvenile rheumatoid arthritis with anakinra (abstract). Arthritis Rheum 50 suppl (2004) S437
12. Henrickson M. Efficacy of anakinra in refractory systemic arthritis (abstract). Arhtiritis Rheum 50 suppl (2004) S438
13. Verbsky J., and White A. Effective use of the recombinant interleukin-1 receptor antagonist anakinra in therapy-resistant systemic onset juvenile rheumatoid arthritis. J Rheumatol 31 (2004) 2071-2075
14. Lurati A., Teruzzi B., Salmaso A., et al. Macrophage activation syndrome during anti-IL1 receptor therapy (anakinra) in a patient affected by systemic onset idiopathic juvenile arthritis. Paed Rheumatol Online J 3 (2005) 79-85
15. Buoncompagni A., Loy A., Sala I., et al. Editorial: The paradox of macrophage activation syndrome triggered by biologic medications. Paed Rheumatol Online J 3 (2005) 70-73
16. Rose-John S., Scheller J., Elson G., et al. Interleukin-6 biology is coordinated by membrane-bound and soluble receptors: role in inflammation and cancer. J Leukoc Biol 80 (2006) 227-236
17. de Benedetti F., Massa M., Robbioni P., et al. Correlation of interleukin-6 levels with joint involvement and thrombocytosis in patients with systemic juvenile rheumatoid arthritis. Arthritis Rheum 34 (1991) 1158-1163
18. de Benedetti F., and Martini A. Targeting the interleukin-6 receptor: a new treatment for systemic juvenile idiopathic arthritis. Arthritis Rheum 52 (2005) 687-693
19. Lieskovska J., Guo D., and Derman E. Growth impairment in IL-6-overexpressing transgenic mice is associated with induction of SOCS3 mRNA. Growth Horm IGF Res 13 (2003) 26-35
20. Woo P., Wilkinson N., Prieur A.-M., et al. Open label phase II trial of single, ascending doses of MRA in Caucasian children with severe systemic juvenile idiopathic arthritis: proof of principle of the efficacy of IL-6 receptor blockade in this type of arthritis and demonstration of prolonged clinical improvement. Arthritis Res Ther 7 (2005) R1281-R1288
21. Yokota S., Miyamae T., Imagawa T., et al. Therapeutic efficacy of humanized recombinant anti-interleukin-6 receptor antibody in children with systemic-onset juvenile idiopathic arthritis. Arthritis Rheum 52 (2005) 818-825
22. Petty R., Southwood T., Manners P., et al., International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol 31 (2004) 390-392
23. Giannini E., Ruperto N., Ravelli A., Lovell D., Felson D., and Martini A. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum 40 (1997) 1202-1209
24. Woo P., Southwood T., Prieur A., et al. Randomized, placebo-controlled, crossover trial of low-dose oral methotrexate in children with extended oligoarticular or systemic arthritis. Arthritis Rheum 43 (2000) 1849-1857
25. NCI. Cancer Therapy Evaluation Program, common terminology criteria for adverse events, version 3·0, DCTD, NCI, NIH, DHHS (2006), National Cancer Institute, Bethesda
26. Yokota S., Imagawa T., Miyamae T., et al. Long-term therapeutic experience of humanized anti-IL-6 receptor monoclonal antibody (aIL-6R Mab) in systemic-onset juvenile idiopathic arthritis (So-JIA). Arthritis Rheum 50 (2004) S438
27. Stephan J., Zeller J., Hubert P., et al. Macrophage activation and rheumatic disease in childhood: a report of four new cases. Clin Exp Rheumatol 11 (1993) 451-456