PMID- 25889222
OWN - NLM
STAT- MEDLINE
DCOM- 20160119
LR  - 20181113
IS  - 1478-6362 (Electronic)
IS  - 1478-6354 (Print)
IS  - 1478-6354 (Linking)
VI  - 17
IP  - 1
DP  - 2015 Apr 9
TI  - 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.
PG  - 97
LID - 10.1186/s13075-015-0611-8 [doi]
LID - 97
AB  - 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-naive 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 Reumatoide 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.
FAU - Verschueren, Patrick
AU  - Verschueren P
AD  - Skeletal Biology and Engineering Research Center, KU Leuven Department of 
      Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. 
      patrick.verschueren@uzleuven.be.
AD  - Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, 
      Leuven, Belgium. patrick.verschueren@uzleuven.be.
FAU - De Cock, Diederik
AU  - De Cock D
AD  - Skeletal Biology and Engineering Research Center, KU Leuven Department of 
      Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. 
      diederik.decock@med.kuleuven.be.
FAU - Corluy, Luk
AU  - Corluy L
AD  - Reuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. 
      luk.corluy@skynet.be.
AD  - Jessa Ziekenhuis Hasselt, Stadsomvaart 11, 3500, Hasselt, Belgium. 
      luk.corluy@skynet.be.
FAU - Joos, Rik
AU  - Joos R
AD  - ZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. 
      rik.joos@zna.be.
FAU - Langenaken, Christine
AU  - Langenaken C
AD  - Reuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. 
      c.langenaken@skynet.be.
AD  - Jessa Ziekenhuis Hasselt, Stadsomvaart 11, 3500, Hasselt, Belgium. 
      c.langenaken@skynet.be.
FAU - Taelman, Veerle
AU  - Taelman V
AD  - Heilig Hart Ziekenhuis Leuven, Naamsestraat 105, 3000, Leuven, Belgium. 
      veerle.taelman@uz.kuleuven.be.
FAU - Raeman, Frank
AU  - Raeman F
AD  - ZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. 
      frank.raeman@zna.be.
FAU - Ravelingien, Isabelle
AU  - Ravelingien I
AD  - Department of Rheumatology, Onze-Lieve-Vrouw Ziekenhuis Aalst, Bloklaan 5, 1730 
      Asse, Aalst, Belgium. isabelle.ravelingien@olvz-aalst.be.
FAU - Vandevyvere, Klaas
AU  - Vandevyvere K
AD  - AZ Groeninge Hospital Kortrijk, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. 
      klaas.vandevyvere@azgroeninge.be.
FAU - Lenaerts, Jan
AU  - Lenaerts J
AD  - Reuma-Instituut Hasselt, Anne Frankplein 17, 3500, Hasselt, Belgium. 
      jan.lenaerts@skynet.be.
AD  - Jessa Ziekenhuis Hasselt, Stadsomvaart 11, 3500, Hasselt, Belgium. 
      jan.lenaerts@skynet.be.
FAU - Geens, Elke
AU  - Geens E
AD  - ZNA Jan Palfijn Antwerpen, Lange Bremstraat 70, 2170, Merksem, Belgium. 
      elke.geens@zna.be.
FAU - Geusens, Piet
AU  - Geusens P
AD  - ReumaClinic Genk & UHasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. 
      piet.geusens@scarlet.be.
AD  - Maastricht UMC, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands. 
      piet.geusens@scarlet.be.
FAU - Vanhoof, Johan
AU  - Vanhoof J
AD  - ReumaClinic Genk & UHasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. 
      johanvanhoof@skynet.be.
FAU - Durnez, Anne
AU  - Durnez A
AD  - AZ Groeninge Hospital Kortrijk, Pres. Kennedylaan 4, 8500, Kortrijk, Belgium. 
      annedurnez@hotmail.com.
FAU - Remans, Jan
AU  - Remans J
AD  - Reuma-Instituut Genk, Weg naar As 123, 3600, Genk, Belgium. 
      remans.jan@pandora.be.
FAU - Vander Cruyssen, Bert
AU  - Vander Cruyssen B
AD  - Department of Rheumatology, Onze-Lieve-Vrouw Ziekenhuis Aalst, Bloklaan 5, 1730 
      Asse, Aalst, Belgium. bvcruyssen@hotmail.com.
FAU - Van Essche, Els
AU  - Van Essche E
AD  - Imeldaziekenhuis Bonheiden, Imeldalaan 9, 2820, Bonheiden, Belgium. 
      elsvanessche@hotmail.com.
FAU - Sileghem, An
AU  - Sileghem A
AD  - ReumaClinic Hasselt, Jaarbeurslaan 21, 3600, Genk, Belgium. 
      annasileghem@gmail.com.
FAU - De Brabanter, Griet
AU  - De Brabanter G
AD  - AZ Sint Lucas Brugge, Sint-Lucaslaan 29, 8310, Brugge, Belgium. 
      griet.de.brabanter@telenet.be.
FAU - Joly, Johan
AU  - Joly J
AD  - Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, 
      Leuven, Belgium. johan.joly@uzleuven.be.
FAU - Van der Elst, Kristien
AU  - Van der Elst K
AD  - Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, 
      Leuven, Belgium. kristien.vanderelst@uzleuven.be.
AD  - Skeletal Biology and Engineering Research Center, KU Leuven Department of Public 
      Health and Primary Care, Herestraat 49, 3000, Leuven, Belgium. 
      kristien.vanderelst@uzleuven.be.
FAU - Meyfroidt, Sabrina
AU  - Meyfroidt S
AD  - Skeletal Biology and Engineering Research Center, KU Leuven Department of 
      Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. 
      sabrina.meyfroidt@med.kuleuven.be.
FAU - Westhovens, Rene
AU  - Westhovens R
AD  - Skeletal Biology and Engineering Research Center, KU Leuven Department of 
      Development and Regeneration, Herestraat 49, 3000, Leuven, Belgium. 
      rene.westhovens@uzleuven.be.
AD  - Department of Rheumatology, University Hospitals Leuven, Herestraat 49, 3000, 
      Leuven, Belgium. rene.westhovens@uzleuven.be.
CN  - CareRA study group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150409
PL  - England
TA  - Arthritis Res Ther
JT  - Arthritis research & therapy
JID - 101154438
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Glucocorticoids)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*therapeutic use
MH  - Area Under Curve
MH  - Arthritis, Rheumatoid/blood/*diagnosis/*drug therapy
MH  - Biomarkers/blood
MH  - C-Reactive Protein/*analysis
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Glucocorticoids/*therapeutic use
MH  - Humans
MH  - Male
MH  - Methotrexate/*therapeutic use
MH  - Middle Aged
MH  - Prognosis
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC4422551
EDAT- 2015/04/19 06:00
MHDA- 2016/01/20 06:00
PMCR- 2015/04/09
CRDT- 2015/04/19 06:00
PHST- 2014/11/04 00:00 [received]
PHST- 2015/03/26 00:00 [accepted]
PHST- 2015/04/19 06:00 [entrez]
PHST- 2015/04/19 06:00 [pubmed]
PHST- 2016/01/20 06:00 [medline]
PHST- 2015/04/09 00:00 [pmc-release]
AID - 10.1186/s13075-015-0611-8 [pii]
AID - 611 [pii]
AID - 10.1186/s13075-015-0611-8 [doi]
PST - epublish
SO  - Arthritis Res Ther. 2015 Apr 9;17(1):97. doi: 10.1186/s13075-015-0611-8.