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Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial.
Ravelli, Angelo; Davì, Sergio; Bracciolini, Giulia; Pistorio, Angela; Consolaro, Alessandro; van Dijkhuizen, Evert Hendrik Pieter; Lattanzi, Bianca; Filocamo, Giovanni; Verazza, Sara; Gerloni, Valeria; Gattinara, Maurizio; Pontikaki, Irene; Insalaco, Antonella; De Benedetti, Fabrizio; Civino, Adele; Presta, Giuseppe; Breda, Luciana; Marzetti, Valentina; Pastore, Serena; Magni-Manzoni, Silvia; Maggio, Maria Cristina; Garofalo, Franco; Rigante, Donato; Gattorno, Marco; Malattia, Clara; Picco, Paolo; Viola, Stefania; Lanni, Stefano; Ruperto, Nicolino; Martini, Alberto.
Afiliação
  • Ravelli A; Istituto Giannina Gaslini, Genoa, Italy; Università degli Studi di Genova, Genoa, Italy. Electronic address: angeloravelli@gaslini.org.
  • Davì S; Istituto Giannina Gaslini, Genoa, Italy.
  • Bracciolini G; Università degli Studi di Genova, Genoa, Italy.
  • Pistorio A; Istituto Giannina Gaslini, Genoa, Italy.
  • Consolaro A; Istituto Giannina Gaslini, Genoa, Italy; Università degli Studi di Genova, Genoa, Italy.
  • van Dijkhuizen EHP; Istituto Giannina Gaslini, Genoa, Italy.
  • Lattanzi B; Azienda Ospedaliera Universitaria Ospedali Riuniti Salesi Children's Hospital, Ancona, Italy.
  • Filocamo G; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Verazza S; Università degli Studi di Genova, Genoa, Italy.
  • Gerloni V; Istituto Gaetano Pini, Milan, Italy.
  • Gattinara M; Istituto Gaetano Pini, Milan, Italy.
  • Pontikaki I; Istituto Gaetano Pini, Milan, Italy.
  • Insalaco A; Ospedale Pediatrico Bambino Gesù, Rome, Italy.
  • De Benedetti F; Ospedale Pediatrico Bambino Gesù, Rome, Italy.
  • Civino A; Azienda Ospedaliera Cardinale G Panico, Tricase, Italy.
  • Presta G; Azienda Ospedaliera Cardinale G Panico, Tricase, Italy.
  • Breda L; Ospedale Policlinico, Chieti, Italy.
  • Marzetti V; Ospedale Policlinico, Chieti, Italy.
  • Pastore S; IRCCS Burlo Garofolo, Trieste, Italy.
  • Magni-Manzoni S; Ospedale Pediatrico Bambino Gesù, Rome, Italy.
  • Maggio MC; Università degli Studi di Palermo, Palermo, Italy.
  • Garofalo F; Ospedale degli Infermi, Biella, Italy.
  • Rigante D; Università Cattolica Sacro Cuore e Fondazione Policlinico Universitario A Gemelli, Rome, Italy.
  • Gattorno M; Istituto Giannina Gaslini, Genoa, Italy.
  • Malattia C; Istituto Giannina Gaslini, Genoa, Italy; Università degli Studi di Genova, Genoa, Italy.
  • Picco P; Istituto Giannina Gaslini, Genoa, Italy.
  • Viola S; Istituto Giannina Gaslini, Genoa, Italy.
  • Lanni S; Istituto Giannina Gaslini, Genoa, Italy.
  • Ruperto N; Istituto Giannina Gaslini, Genoa, Italy.
  • Martini A; Istituto Giannina Gaslini, Genoa, Italy; Università degli Studi di Genova, Genoa, Italy.
Lancet ; 389(10072): 909-916, 2017 03 04.
Article em En | MEDLINE | ID: mdl-28162781
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 (11) 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.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Artrite Juvenil / Metotrexato Tipo de estudo: Clinical_trials / Observational_studies Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Artrite Juvenil / Metotrexato Tipo de estudo: Clinical_trials / Observational_studies Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2017 Tipo de documento: Article