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  • Open Access

Efficacy and safety of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (SJIA): tender 52-week data

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Pediatric Rheumatology20119 (Suppl 1) :P164

https://doi.org/10.1186/1546-0096-9-S1-P164

  • Published:

Keywords

  • Otitis Medium
  • Pneumothorax
  • Gastroenteritis
  • Septic Arthritis
  • Tocilizumab

Background

sJIA refractory to immunosuppressants including methotrexate and TNF-α inhibitors can lead to severe disabilities. Excessive IL-6 production has been implicated in the pathoetiology of sJIA.

Aim

To determine the efficacy and safety of TCZ, an IL-6 receptor inhibitor, in patients (pts) with sJIA treated for 52 weeks (wks) in the ongoing, 3-part, 5-year, phase 3 TENDER study.

Methods

Pts (N=112) 2–17 years with active sJIA for ≥6 months were randomized 2:1 to TCZ (8 mg/kg if body weight ≥30 kg; 12 mg/kg if <30 kg) or placebo every 2 wks for 12 wks in part 1; all pts received open-label (OL) TCZ in part 2. Pts who escaped to OL TCZ in part 1 also entered part 2. Oral corticosteroid (CS) tapering was permitted at wks 6 and 8 in part 1 and in the OL extension in the presence of ACR70 response, ESR <20 mm/h, and absence of fever. Efficacy data included pts who reached wk 52 of TCZ treatment (n=88); safety data considered all pts (N=112).

Results

Proportions of TCZ pts who achieved JIA ACR30 + absence of fever or JIA ACR70/90 increased to wk 52 (Table). Number of joints with active arthritis or with limitation of movement decreased from 19.8±15.7 and 19.8±15.6, respectively, to 3.0±7.0 and 7.5±11.7 at wk 52 (45% of pts had 0 active joints). CHAQ-DI score improved from 1.7±0.9 to 0.7±0.8 at wk 52. Physician global assessment VAS and pt/parent global assessment VAS improved from 64.9±22.3 and 58.7±24.4, respectively, to 9.7±12.8 and 12.6±18.5 at wk 52. CS dose decreased from 0.30±0.20 mg/kg/d to 0.06±0.08 at wk 52; 48% discontinued CSs. 33 serious AEs (SAEs) occurred in 25 pts; 12 SAEs were considered related (remotely, possibly, or probably) to TCZ (rate: 0.23/pt year [PY] in part 1, 0.25/PY in part 2). 15 serious infections occurred; 6 (gastroenteritis, varicella, septic arthritis, otitis media, pharyngotonsillitis, upper respiratory tract infection) were considered related to TCZ; all resolved and none led to discontinuation. 12 pts withdrew (4, AEs; 4, insufficient response). One pt died of a suspected tension pneumothorax considered unrelated to treatment.

Conclusions

TENDER 1-year results demonstrate that TCZ is highly effective and generally well tolerated in pts with sJIA.
 

Wk 12

Wk 52

Responses

Placebo (n=37)

TCZ (n=75)

TCZ (n=88)

JIA ACR30 + absence of fever, n (%)

9 (24)

64 (85)

77 (88)

JIA ACR70, n (%)

3 (8)

53 (71)

78 (89)

JIA ACR90, n (%)

2 (5)

28 (37)

57 (65)

Authors’ Affiliations

(1)
Ospedale Bambino Gesù, Rome, Italy
(2)
PRCSG, Cincinnati, USA
(3)
PRINTO, Genoa, Italy
(4)
Roche, Welwyn, UK

Copyright

© De Benedetti et al; licensee BioMed Central Ltd. 2011

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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