RESEARCH - Evaluation of two strategies (initial MTX monotherapy vs its combination with Humira): GUEPARD

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Rheumatology Advance Access originally published online on September 9, 2009

Rheumatology 2009 48(11):1429-1434; doi:10.1093/rheumatology/kep261

Evaluation of two strategies (initial methotrexate monotherapy vs its

combination with adalimumab) in management of early active rheumatoid

arthritis: data from the GUEPARD trial

Soubrier1, Xavier Puéchal2, Sibilia3, Xavier Mariette4,

Olivier Meyer5, Bernarde Combe6, René Marc Flipo7, Denis Mulleman8,

Francis Berenbaum9, Zarnitsky10, Thierry Schaeverbeke11,

Patrice Fardellone12 and Maxime Dougados13

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.

Abstract

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.

http://rheumatology.oxfordjournals.org/cgi/content/abstract/48/11/1429?etoc

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