Premium
A66: Assessment of Radiographic Progression in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Tocilizumab: 2‐Year Results From the TENDER Trial
Author(s) -
Malattia Clara,
Ruperto Nicolino,
Palmisani Elena,
Pederzoli Silvia,
Pistorio Angela,
Brunner Hermine,
Cuttica Rubén J.,
Calvo Inmaculada,
Garay Stella Maris,
Eleftheriou Despina,
Wouters Carine,
Wang Jianmei,
Devlin Clare,
Lovell Daniel J.,
Martini Alberto,
Benedetti Fabrizio,
Ravelli Angelo
Publication year - 2014
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.38482
Subject(s) - tocilizumab , medicine , juvenile , arthritis , radiography , surgery , rheumatoid arthritis , genetics , biology
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][De Benedetti F, 2012], [2][De Benedetti F, 2012]). The aim of this study was to investigate the 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 to 17 years old with active, refractory sJIA of ≥6 months' duration and inadequate response to previous nonsteroidal anti‐inflammatory drugs and oral corticosteroids were enrolled in TENDER. Patients were randomly assigned 2:1 to receive TCZ according to body weight (12 mg/kg <30 kg or 8 mg/kg ≥30 kg) or placebo intravenously 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 a negative Poznanski score change. Clinical efficacy end points 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 in 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 53.9/59.2 mm/h erythrocyte sedimentation rate. At weeks 52 and 104, 20 and 19 patients, respectively, had aSH progression, and 8 and 8 patients, respectively, had Poznanski score progression. Median changes in aSH score from baseline to weeks 52 and 104 were 0 and 0.5, respectively ( ). Median changes in Poznanski score from baseline to weeks 52 and 104 were 0.29 and 0.16, respectively ( ).Week 52 Week 104aSH score (n = 47), median (IQR) 0.00 (−8.70: 4.00) 0.50 (−7.50: 12.00) Poznanski score (n = 33), median (IQR) 0.29 (−0.05: 1.05) 0.16 (−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.Conclusion: Although 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.