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

A. Ravelli, S. Davì, G. Bracciolini, A. Pistorio, A. Consolaro, E.H.P. van Dijkhuizen, B. Lattanzi, G. Filocamo, S. Verazza, V. Gerloni, M. Gattinara, I. Pontikaki, A. Insalaco, F. De Benedetti, A. Civino, G. Presta, L. Breda, V. Marzetti, S. Pastore, S. Magni-ManzoniM.C. Maggio, F. Garofalo, D. Rigante, M. Gattorno, C. Malattia, P. Picco, S. Viola, S. Lanni, N. Ruperto, A. Martini

Research output: Contribution to journalArticle

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. © 2017 Elsevier Ltd
Original languageEnglish
Pages (from-to)909-916
Number of pages8
JournalThe Lancet
Volume389
Issue number10072
DOIs
Publication statusPublished - 2017

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Juvenile Arthritis
Methotrexate
Adrenal Cortex Hormones
Joints
Therapeutics
Arthritis
Tarsal Joints
Subtalar Joint
Drug Evaluation
European Union
Masks
Elbow
Knee Joint
Transaminases
Wrist
Italy
Research Personnel
Clinical Trials
Liver

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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, A.; Davì, S.; Bracciolini, G.; Pistorio, A.; Consolaro, A.; van Dijkhuizen, E.H.P.; Lattanzi, B.; Filocamo, G.; Verazza, S.; Gerloni, V.; Gattinara, M.; Pontikaki, I.; Insalaco, A.; De Benedetti, F.; Civino, A.; Presta, G.; Breda, L.; Marzetti, V.; Pastore, S.; Magni-Manzoni, S.; Maggio, M.C.; Garofalo, F.; Rigante, D.; Gattorno, M.; Malattia, C.; Picco, P.; Viola, S.; Lanni, S.; Ruperto, N.; Martini, A.

In: The Lancet, Vol. 389, No. 10072, 2017, p. 909-916.

Research output: Contribution to journalArticle

Ravelli, A. ; Davì, S. ; Bracciolini, G. ; Pistorio, A. ; Consolaro, A. ; van Dijkhuizen, E.H.P. ; Lattanzi, B. ; Filocamo, G. ; Verazza, S. ; Gerloni, V. ; Gattinara, M. ; Pontikaki, I. ; Insalaco, A. ; De Benedetti, F. ; Civino, A. ; Presta, G. ; Breda, L. ; Marzetti, V. ; Pastore, S. ; Magni-Manzoni, S. ; Maggio, M.C. ; Garofalo, F. ; Rigante, D. ; Gattorno, M. ; Malattia, C. ; Picco, P. ; Viola, S. ; Lanni, S. ; Ruperto, N. ; Martini, A. / Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial. In: The Lancet. 2017 ; Vol. 389, No. 10072. pp. 909-916.
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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. {\circledC} 2017 Elsevier Ltd",
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T1 - Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial

AU - Ravelli, A.

AU - Davì, S.

AU - Bracciolini, G.

AU - Pistorio, A.

AU - Consolaro, A.

AU - van Dijkhuizen, E.H.P.

AU - Lattanzi, B.

AU - Filocamo, G.

AU - Verazza, S.

AU - Gerloni, V.

AU - Gattinara, M.

AU - Pontikaki, I.

AU - Insalaco, A.

AU - De Benedetti, F.

AU - Civino, A.

AU - Presta, G.

AU - Breda, L.

AU - Marzetti, V.

AU - Pastore, S.

AU - Magni-Manzoni, S.

AU - Maggio, M.C.

AU - Garofalo, F.

AU - Rigante, D.

AU - Gattorno, M.

AU - Malattia, C.

AU - Picco, P.

AU - Viola, S.

AU - Lanni, S.

AU - Ruperto, N.

AU - Martini, A.

N1 - Cited By :3 Export Date: 30 October 2017 CODEN: LANCA Correspondence Address: Ravelli, A.; Pediatria II-Reumatologia, Istituto Giannina GasliniItaly; email: angeloravelli@gaslini.org

PY - 2017

Y1 - 2017

N2 - 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. © 2017 Elsevier Ltd

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/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. © 2017 Elsevier Ltd

U2 - 10.1016/S0140-6736(17)30065-X

DO - 10.1016/S0140-6736(17)30065-X

M3 - Article

VL - 389

SP - 909

EP - 916

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 10072

ER -