TY - JOUR T1 - Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial. JF - Lancet Y1 - 2017 A1 - Ravelli, Angelo A1 - Davì, Sergio A1 - Bracciolini, Giulia A1 - Pistorio, Angela A1 - Consolaro, Alessandro A1 - van Dijkhuizen, Evert Hendrik Pieter A1 - Lattanzi, Bianca A1 - Filocamo, Giovanni A1 - Verazza, Sara A1 - Gerloni, Valeria A1 - Gattinara, Maurizio A1 - Pontikaki, Irene A1 - Insalaco, Antonella A1 - De Benedetti, Fabrizio A1 - Civino, Adele A1 - Presta, Giuseppe A1 - Breda, Luciana A1 - Marzetti, Valentina A1 - Pastore, Serena A1 - Magni-Manzoni, Silvia A1 - Maggio, Maria Cristina A1 - Garofalo, Franco A1 - Rigante, Donato A1 - Gattorno, Marco A1 - Malattia, Clara A1 - Picco, Paolo A1 - Viola, Stefania A1 - Lanni, Stefano A1 - Ruperto, Nicolino A1 - Martini, Alberto KW - Adrenal Cortex Hormones KW - Arthritis, Juvenile KW - Humans KW - Injections, Intra-Articular KW - Italy KW - Methotrexate KW - Prospective Studies KW - Treatment Outcome AB -

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/m; 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.

VL - 389 IS - 10072 U1 - http://www.ncbi.nlm.nih.gov/pubmed/28162781?dopt=Abstract ER -