Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial.

Abstract

BACKGROUND:

Little evidence-based information is available to guide the treatment of oligoarticular juvenile idiopathic arthritis. We aimed to investigate whether oral methotrexate increases the efficacy of intra-articular corticosteroid therapy.

METHODS:

We did this prospective, open-label, randomised trial at ten hospitals in Italy. Using a concealed computer-generated list, children younger than 18 years with oligoarticular-onset disease were randomly assigned (1:1) to intra-articular corticosteroids alone or in combination with oral methotrexate (15 mg/m2; maximum 20 mg). Corticosteroids used were triamcinolone hexacetonide (shoulder, elbow, wrist, knee, and tibiotalar joints) or methylprednisolone acetate (ie, subtalar and tarsal joints). We did not mask patients or investigators to treatment assignments. Our primary outcome was the proportion of patients in the intention-to-treat population who had remission of arthritis in all injected joints at 12 months. This trial is registered with European Union Clinical Trials Register, EudraCT number 2008-006741-70.

FINDINGS:

Between July 7, 2009, and March 31, 2013, we screened 226 participants and randomly assigned 102 to intra-articular corticosteroids alone and 105 to intra-articular corticosteroids plus methotrexate. 33 (32%) patients assigned to intra-articular corticosteroids alone and 39 (37%) assigned to intra-articular corticosteroids and methotrexate therapy had remission of arthritis in all injected joints (p=0·48). Adverse events were recorded for 20 (17%) patients who received methotrexate, which led to permanent treatment discontinuation in two patients (one due to increased liver transaminases and one due to gastrointestinal discomfort). No patient had a serious adverse event.

INTERPRETATION:

Concomitant administration of methotrexate did not augment the effectiveness of intra-articular corticosteroid therapy. Future studies are needed to define the optimal therapeutic strategies for oligoarticular juvenile idiopathic arthritis.

FUNDING:

Italian Agency of Drug Evaluation.

• Authors: Angelo Ravelli, Sergio Davì, Giulia Bracciolini, Angela Pistorio, Alessandro Consolaro, Evert Hendrik Pieter van Dijkhuizen, Bianca Lattanzi, Giovanni Filocamo, Sara Verazza, Valeria Gerloni, Maurizio Gattinara, Irene Pontikaki, Antonella Insalaco, Fabrizio De Benedetti, Adele Civino, Giuseppe Presta, Luciana Breda, Valentina Marzetti, Serena Pastore, Silvia Magni-Manzoni, Maria Cristina Maggio, Franco Garofalo, Donato Rigante, Marco Gattorno, Clara Malattia, Paolo Picco, Stefania Viola, Stefano Lanni, Nicolino Ruperto, Alberto Martini, Italian Pediatric Rheumatology Study Group
• Journal: Lancet (London, England) (Lancet) Vol. 389 Issue 10072 Pg. 909-916 (03 04 2017) ISSN: 1474-547X [Electronic] England
• PMID: 28162781 (Publication Type: Journal Article)
• Copyright: Copyright © 2017 Elsevier Ltd. All rights reserved.

Chemical References

• Adrenal Cortex Hormones
• Methotrexate

Topics

• Adrenal Cortex Hormones
• Arthritis, Juvenile
• Humans
• Injections, Intra-Articular
• Italy
• Methotrexate
• Prospective Studies
• Treatment Outcome