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Arthritis Res Ther. 2015 Apr 9;17:97. doi: 10.1186/s13075-015-0611-8.

Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial.

Author information

1
Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. patrick.verschueren@uzleuven.be.
2
Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. patrick.verschueren@uzleuven.be.
3
Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. diederik.decock@med.kuleuven.be.
4
Reuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. luk.corluy@skynet.be.
5
Jessa Ziekenhuis Hasselt, Stadsomvaart 11, 3500, Hasselt, Belgium. luk.corluy@skynet.be.
6
ZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. rik.joos@zna.be.
7
Reuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. c.langenaken@skynet.be.
8
Jessa Ziekenhuis Hasselt, Stadsomvaart 11, 3500, Hasselt, Belgium. c.langenaken@skynet.be.
9
Heilig Hart Ziekenhuis Leuven, Naamsestraat 105, 3000, Leuven, Belgium. veerle.taelman@uz.kuleuven.be.
10
ZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. frank.raeman@zna.be.
11
Department of Rheumatology, Onze-Lieve-Vrouw Ziekenhuis Aalst, Bloklaan 5, 1730 Asse, Aalst, Belgium. isabelle.ravelingien@olvz-aalst.be.
12
AZ Groeninge Hospital Kortrijk, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. klaas.vandevyvere@azgroeninge.be.
13
Reuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. jan.lenaerts@skynet.be.
14
Jessa Ziekenhuis Hasselt, Stadsomvaart 11, 3500, Hasselt, Belgium. jan.lenaerts@skynet.be.
15
ZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. elke.geens@zna.be.
16
ReumaClinic Genk & UHasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. piet.geusens@scarlet.be.
17
Maastricht UMC, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands. piet.geusens@scarlet.be.
18
ReumaClinic Genk & UHasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. johanvanhoof@skynet.be.
19
AZ Groeninge Hospital Kortrijk, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. annedurnez@hotmail.com.
20
Reuma-Instituut Genk, Weg naar As 123, 3600, Genk, Belgium. remans.jan@pandora.be.
21
Department of Rheumatology, Onze-Lieve-Vrouw Ziekenhuis Aalst, Bloklaan 5, 1730 Asse, Aalst, Belgium. bvcruyssen@hotmail.com.
22
Imeldaziekenhuis Bonheiden, Imeldalaan 9, 2820, Bonheiden, Belgium. elsvanessche@hotmail.com.
23
ReumaClinic Hasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. annasileghem@gmail.com.
24
AZ Sint Lucas Brugge, Sint-Lucaslaan 29, 8310, Brugge, Belgium. griet.de.brabanter@telenet.be.
25
Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. johan.joly@uzleuven.be.
26
Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. kristien.vanderelst@uzleuven.be.
27
Skeletal Biology and Engineering Research Center, KU Leuven Department of Public Health and Primary Care, Herestraat 49, 3000, Leuven, Belgium. kristien.vanderelst@uzleuven.be.
28
Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. sabrina.meyfroidt@med.kuleuven.be.
29
Skeletal Biology and Engineering Research Center, KU Leuven Department of Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. rene.westhovens@uzleuven.be.
30
Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. rene.westhovens@uzleuven.be.

Abstract

INTRODUCTION:

Considering a lack of efficacy data in patients with early rheumatoid arthritis (eRA) presenting without classical markers of poor prognosis, we compared methotrexate (MTX) with or without step-down glucocorticoids in the CareRA trial.

METHODS:

Disease-modifying antirheumatic drug-naïve patients with eRA were stratified into a low-risk group based on prognostic markers that included non-erosiveness, anti-citrullinated protein antibodies and rheumatoid factor negativity and low disease activity (Disease Activity Score in 28 joints based on C-reactive protein (DAS28(CRP)) ≤3.2). Patients were randomized to 15 mg of MTX weekly (MTX with tight step-up (MTX-TSU)) or 15 mg of MTX weekly with prednisone bridging, starting at 30 mg and tapered to 5 mg daily from week 6 (COmbinatie therapie bij Reumatoïde Artritis (COBRA Slim)). A TSU approach was applied. Outcomes assessed were DAS28(CRP)-determined remission, cumulative disease activity, Health Assessment Questionnaire (HAQ) scores and adverse events (AEs) after 16 treatment weeks.

RESULTS:

We analyzed 43 COBRA Slim and 47 MTX-TSU patients and found that 65.1% in the COBRA Slim group and 46.8% in the MTX-TSU group reached remission (P = 0.081). Mean ± standard deviation area under the curve values of DAS28(CRP) were 13.84 ± 4.58 and 11.18 ± 4.25 for the MTX-TSU and COBRA Slim patients, respectively (P = 0.006). More COBRA Slim patients had an HAQ score of 0 (51.2% versus 23.4%, P = 0.006) at week 16. Therapy-related AEs between groups did not differ.

CONCLUSION:

In patients with low-risk eRA, MTX with step-down glucocorticoid bridging seems more efficacious than MTX step-up monotherapy, with a comparable number of AEs observed over the first 16 treatment weeks.

TRIAL REGISTRATION:

EU Clinical Trials Register Identifier: EudraCT number 2008-007225-39 . Registered 5 November 2008.

PMID:
25889222
PMCID:
PMC4422551
DOI:
10.1186/s13075-015-0611-8
[Indexed for MEDLINE]
Free PMC Article
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