Catch‐Up Growth During Tocilizumab Therapy for Systemic Juvenile Idiopathic Arthritis: Results From a Phase III Trial1. Issue 3 (March 2015)

• Record Type: Journal Article
• Authors: De Benedetti, Fabrizio; Brunner, Hermine; Ruperto, Nicolino; Schneider, Rayfel; Xavier, Ricardo; Allen, Roger; Brown, Diane E.; Chaitow, Jeffrey; Pardeo, Manuela; Espada, Graciela; Gerloni, Valeria; Myones, Barry L.; Frane, James W.; Wang, Jianmei; Lipman, Terri H.; Bharucha, Kamal N.; Martini, Alberto; Lovell, Daniel; for the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group
• Is Part Of: Arthritis & rheumatology. Volume 67:Issue 3(2015)
• Page Start: 840
• Page End: 848
• Publication Date: 2015-03
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/art.38984
• Languages: English
• ISSNs: 2326-5191

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="art38984-sec-0001" sec-type="section"> <title>Objective</title> <p>To investigate the impact of tocilizumab treatment on growth and growth‐related laboratory parameters in patients with systemic juvenile idiopathic arthritis (JIA) enrolled in a phase III clinical trial.</p> </sec> <sec id="art38984-sec-0002" sec-type="section"> <title>Methods</title> <p>Patients with systemic JIA ages 2–17 years (n = 112) received tocilizumab in a 12‐week, randomized, placebo‐controlled period and a long‐term open‐label extension. Height velocity and standard deviation (SD) score; levels of insulin‐like growth factor 1 (IGF‐1), osteocalcin (OC), and C‐telopeptide of type I collagen (CTX‐I); and Juvenile Arthritis Disease Activity Score in 71 joints (JADAS‐71) were measured in a post hoc analysis of 83 patients who never received growth hormone and did not reach Tanner stage 5 by the end of the first year of treatment.</p> </sec> <sec id="art38984-sec-0003" sec-type="section"> <title>Results</title> <p>Patients had stunted growth at baseline (mean height SD score −2.2). During tocilizumab treatment, males (73%) and females (83%) experienced above‐normal mean height velocities of 6.6 cm/year (<italic>P</italic> < 0.0001 versus World Health Organization norms). Mean height SD score increases during year 1 (0.29) and year 2 (0.31) were significant (both <italic>P</italic> < 0.0001). The mean SD score for IGF‐1 levels increased significantly (−0.2 for year 1 and −0.1 for year 2 versus −1.0 at baseline; both <italic>P</italic> < 0.0001). Mean OC and CTX‐I levels (both <italic>P</italic> < 0.0001) and the OC:CTX‐I ratio (<italic>P</italic> = 0.014) significantly increased from baseline to year 2. In multiple regression analysis, first‐year height velocity had a significant inverse relationship to JADAS‐71 at year 1, age, mean glucocorticoid dosage during the year, and height SD score at baseline.</p> </sec> <sec id="art38984-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Our findings indicate that during treatment with tocilizumab, patients with systemic JIA experience significant catch‐up growth, normalization of IGF‐1 levels, and bone balance improvement favoring bone formation.</p> </sec> </abstract>