Rheumatology Advance Access originally published online on September 9, 2009
Rheumatology 2009 48(11):1429-1434; doi:10.1093/rheumatology/kep261
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Evaluation of two strategies (initial methotrexate monotherapy vs its combination with adalimumab) in management of early active rheumatoid arthritis: data from the GUEPARD trial
1Department of Rheumatology, Hôpital G Montpied, Clermont-Ferrand, 2Department of Rheumatology, Centre Hospitalier, Le Mans, 3Department of Rheumatology, Hôpital Hautepierre, Strasbourg, 4Department of Rheumatology, Hôpital Bicêtre, Le KremlinBicêtre, 5Department of Rheumatology, Hôpital Bichat, Paris, 6Department of Rheumatology, Hôpital Lapeyronie, Montpellier, 7Department of Rheumatology, Hôpital R Salengro, Lille, 8Department of Rheumatology, Hôpital Trousseau, Tours, 9Department of Rheumatology, Hôpital Saint Antoine, Paris, 10Department of Rheumatology, Hôpital Monod, Montivilliers, 11Department of Rheumatology, Hôpital Pellegrin, Bordeaux, 12Department of Rheumatology, Amiens and 13Department of Rheumatology B, Hôpital Cochin, Paris, France.
Correspondence to: Martin Soubrier, Hôpital G Montpied, 63003 Clermont-Ferrand, France. E-mail: msoubrier{at}chu-clermontferrand.fr
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Abstract |
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Objectives. In early and active RA despite MTX, continuous treatment with TNF blockers in combination with MTX is recommended. To compare this strategy with an initial combination of MTX and adalimumab (ADA) given for 3 months and then adjusted based on the disease activity status.
Methods. Prospective unblinded randomized multicentre controlled 1-year trial in which 65 patients with early (<6 months) and active [disease activity score (DAS28ESR) >5.1] RA were assigned to Group 1 (32 patients): MTX (0.3 mg/kg/week, maximum of 20 mg/week, without escalating dose regimen) or to Group 2 (33 patients): initial combination therapy with MTX (as in Group 1) and ADA (40 mg eow). In both groups, treatment was adjusted every 3 months. The aim was to achieve a low DAS (DAS28ESR <3.2).
Results. From Week 12 until Week 52, seven patients in Group 1 and 11 patients in Group 2 remained in low disease activity state while receiving MTX monotherapy (P = 0.28). The 1-year area under the curve (AUC) of DAS28 was lower in Group 2 owing to an initial better response. The total intake of anti-TNF-
and the mean increase in total modified Sharp score was similar in the two groups.
Conclusions. Initial combination of MTX and ADA and then an adjusted based on the disease activity status achieved a faster control of disease activity but did not increase the number of patients for whom anti-TNF- treatment was not needed after 12 weeks nor a better subsequent clinical or radiological outcome than a 3-month delayed initiation of anti-TNF in patients with still active disease despite MTX.
KEY WORDS: Rheumatoid arthritis, Anti-TNF, Tight contol
Present address: Denis Mulleman, Department of Rheumatology, Université François Rabelais de Tours, Tours, France.
Submitted 27 January 2009;
revised version accepted 22 July 2009.
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