Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: A phase 3 trial (TENDER) demonstrated the efficacy of the interleukin-6 receptor inhibitor tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA).1,2 The purpose of this analysis was to investigate progression of radiographic joint damage in patients with sJIA treated with TCZ for up to 2 years in TENDER.
Methods: One hundred twelve patients 2-17 years old with active, refractory sJIA of ≥6 months’ duration and an inadequate response to previous non-steroidal anti-inflammatory drugs and oral corticosteroids were enrolled in TENDER. Patients were randomized 2:1 to receive TCZ according to body weight (12 mg/kg <30 kg or 8 mg/kg ≥30 kg) or placebo IV every 2 weeks for 12 weeks. Patients then received open-label TCZ in the ongoing long-term extension. Radiographic progression was calculated as change in adapted Sharp/van der Heijde score (aSH) score and/or Poznanski score, assessed on hand and wrist radiographs, from baseline to weeks 52 and 104. Radiographic progression was indicated by a positive aSH score change or negative Poznanski score change. Clinical efficacy endpoints included American College of Rheumatology (ACR) Pediatric (Pedi) 70/90 responses.
Results: Baseline and ≥1 postbaseline aSH and Poznanski scores were available for 47 and 33 patients, respectively (reasons for missing x-rays: early withdrawal, no consent, unreadable x-rays). Baseline characteristics for patients with radiographic data were similar to the whole TCZ population.1 Patients with assessable aSH/Poznanski scores had 5.2/4.8-year disease duration, 21.3/19.2 active joints, 20.0/18.2 joints with limitation of movement, and erythrocyte sedimentation rates of 53.9/59.2 mm/h. At weeks 52 and 104, 20 and 19 patients, respectively, had aSH progression, and 8 and 6 patients, respectively, had Poznanski score progression. Median change in aSH score from baseline to weeks 52 and 104 were 0 and 0.5, respectively (Table). Median change in Poznanski score from baseline to weeks 52 and 104 were 0.3 and 0.17, respectively (Table).
Conclusion: Though changes in radiographic scores over time were seen in many patients, on average, patients with sJIA did not experience noticeable progression of radiographic damage over 2 years of treatment with TCZ.
References: 1. De Benedetti F et al. N Engl J Med 2012;367:2385. 2. De Benedetti F et al. Ann Rheum Dis 2012;71(Suppl 3):425.
|
|
Week 52 |
Week 104 |
|
aSH score (n = 47), median (IQR) |
0.00 (-8.70: 4.00) |
0.50 (-7.50: 12.00) |
|
Poznanski score (n = 33), median (IQR) |
0.30 (-0.02: 1.03) |
0.17 (0.01: 1.04) |
|
ACR Pedi 70 (n = 112), n/N (%) |
92/106 (86.8) |
57/65 (87.7) |
|
ACR Pedi 90 (n = 112), n/N (%) |
67/106 (63.2) |
46/65 (70.8) |
|
IQR, interquartile range. |
|
|
Disclosure:
C. Malattia,
None;
N. Ruperto,
To Gaslini Hospital: Abbott, Astrazeneca, BMS, Centocor Research & Development, Eli Lilly and Company, “Francesco Angelini”, Glaxo Smith & Kline, Italfarmaco, Novartis, Pfizer Inc., Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, Wyeth Pharmaceuti,
2,
Astrazeneca, Bristol Myers and Squibb, Janssen Biologics B.V., Roche, Wyeth, Pfizer,
8;
E. Palmisani,
None;
S. Pederzoli,
None;
A. Pistorio,
None;
H. Brunner,
Novartis, Genentech, Medimmune, EMD Serono, AMS, Pfizer, UCB, Jannsen,
5,
Genentech ,
8;
R. J. Cuttica,
Roche, Abbott, Pfizer, Novartis, BMS,
8;
I. Calvo,
None;
S. M. Garay,
None;
D. Eleftheriou,
None;
C. Wouters,
None;
J. Wang,
Roche Pharmaceuticals,
3;
C. Devlin,
Roche Pharmaceuticals,
3;
D. J. Lovell,
NIH,
2,
AstraZeneca, Centocor, Janssen, Wyeth, Amgen, Bristol-Meyers Squibb, Abbott, Pfizer, Regeneron, Hoffmann-La Roche, Novartis, Genentech,
5,
Roche, Genentech,
8;
A. Martini,
Abbott, AstraZeneca, BMS, Centocor, Lilly, Francesco Angelini, GSK, Italfarmaco, MerckSerono, Novartis, Pfizer, Regeneron, Roche, Sanofi Aventis, Schwarz Biosciences, Xoma, Wyeth,
2,
Abbott, AstraZeneca, BMS, Centocor, Lilly, Francesco Angelini, GSK, Italfarmaco, MerckSerono, Novartis, Pfizer, Regeneron, Roche, Sanofi Aventis, Schwarz Biosciences, Xoma, Wyeth,
5,
Abbott, Boehringer, BMS, Novartis, Astellas, Italfarmaco, MedImmune, Pfizer, Roche,
8;
F. De Benedetti,
Abbott, Pfizer, BMS, Roche, Novimmune, Novartis, SOBI,
2;
A. Ravelli,
None.
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