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
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...
Ausführliche Beschreibung
Autor*in: |
Verschueren, Patrick [verfasserIn] |
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Englisch |
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2015 |
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Anmerkung: |
© Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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Übergeordnetes Werk: |
Enthalten in: Arthritis Research & Therapy - London : BioMed Central, 1999, 17(2015), 1 vom: 09. Apr. |
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Übergeordnetes Werk: |
volume:17 ; year:2015 ; number:1 ; day:09 ; month:04 |
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DOI / URN: |
10.1186/s13075-015-0611-8 |
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SPR030216575 |
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245 | 1 | 0 | |a 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 |
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520 | |a 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. | ||
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10.1186/s13075-015-0611-8 doi (DE-627)SPR030216575 (SPR)s13075-015-0611-8-e DE-627 ger DE-627 rakwb eng Verschueren, Patrick verfasserin aut 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 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Health Assessment Questionnaire Score (dpeaa)DE-He213 Treatment Adjustment (dpeaa)DE-He213 Body Mass Index Gain (dpeaa)DE-He213 Early Intensive Treatment (dpeaa)DE-He213 Intensive Treatment Strategy (dpeaa)DE-He213 De Cock, Diederik aut Corluy, Luk aut Joos, Rik aut Langenaken, Christine aut Taelman, Veerle aut Raeman, Frank aut Ravelingien, Isabelle aut Vandevyvere, Klaas aut Lenaerts, Jan aut Geens, Elke aut Geusens, Piet aut Vanhoof, Johan aut Durnez, Anne aut Remans, Jan aut Vander Cruyssen, Bert aut Van Essche, Els aut Sileghem, An aut De Brabanter, Griet aut Joly, Johan aut Van der Elst, Kristien aut Meyfroidt, Sabrina aut Westhovens, Rene aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 17(2015), 1 vom: 09. Apr. (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:17 year:2015 number:1 day:09 month:04 https://dx.doi.org/10.1186/s13075-015-0611-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2015 1 09 04 |
spelling |
10.1186/s13075-015-0611-8 doi (DE-627)SPR030216575 (SPR)s13075-015-0611-8-e DE-627 ger DE-627 rakwb eng Verschueren, Patrick verfasserin aut 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 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Health Assessment Questionnaire Score (dpeaa)DE-He213 Treatment Adjustment (dpeaa)DE-He213 Body Mass Index Gain (dpeaa)DE-He213 Early Intensive Treatment (dpeaa)DE-He213 Intensive Treatment Strategy (dpeaa)DE-He213 De Cock, Diederik aut Corluy, Luk aut Joos, Rik aut Langenaken, Christine aut Taelman, Veerle aut Raeman, Frank aut Ravelingien, Isabelle aut Vandevyvere, Klaas aut Lenaerts, Jan aut Geens, Elke aut Geusens, Piet aut Vanhoof, Johan aut Durnez, Anne aut Remans, Jan aut Vander Cruyssen, Bert aut Van Essche, Els aut Sileghem, An aut De Brabanter, Griet aut Joly, Johan aut Van der Elst, Kristien aut Meyfroidt, Sabrina aut Westhovens, Rene aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 17(2015), 1 vom: 09. Apr. (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:17 year:2015 number:1 day:09 month:04 https://dx.doi.org/10.1186/s13075-015-0611-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2015 1 09 04 |
allfields_unstemmed |
10.1186/s13075-015-0611-8 doi (DE-627)SPR030216575 (SPR)s13075-015-0611-8-e DE-627 ger DE-627 rakwb eng Verschueren, Patrick verfasserin aut 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 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Health Assessment Questionnaire Score (dpeaa)DE-He213 Treatment Adjustment (dpeaa)DE-He213 Body Mass Index Gain (dpeaa)DE-He213 Early Intensive Treatment (dpeaa)DE-He213 Intensive Treatment Strategy (dpeaa)DE-He213 De Cock, Diederik aut Corluy, Luk aut Joos, Rik aut Langenaken, Christine aut Taelman, Veerle aut Raeman, Frank aut Ravelingien, Isabelle aut Vandevyvere, Klaas aut Lenaerts, Jan aut Geens, Elke aut Geusens, Piet aut Vanhoof, Johan aut Durnez, Anne aut Remans, Jan aut Vander Cruyssen, Bert aut Van Essche, Els aut Sileghem, An aut De Brabanter, Griet aut Joly, Johan aut Van der Elst, Kristien aut Meyfroidt, Sabrina aut Westhovens, Rene aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 17(2015), 1 vom: 09. Apr. (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:17 year:2015 number:1 day:09 month:04 https://dx.doi.org/10.1186/s13075-015-0611-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2015 1 09 04 |
allfieldsGer |
10.1186/s13075-015-0611-8 doi (DE-627)SPR030216575 (SPR)s13075-015-0611-8-e DE-627 ger DE-627 rakwb eng Verschueren, Patrick verfasserin aut 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 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Health Assessment Questionnaire Score (dpeaa)DE-He213 Treatment Adjustment (dpeaa)DE-He213 Body Mass Index Gain (dpeaa)DE-He213 Early Intensive Treatment (dpeaa)DE-He213 Intensive Treatment Strategy (dpeaa)DE-He213 De Cock, Diederik aut Corluy, Luk aut Joos, Rik aut Langenaken, Christine aut Taelman, Veerle aut Raeman, Frank aut Ravelingien, Isabelle aut Vandevyvere, Klaas aut Lenaerts, Jan aut Geens, Elke aut Geusens, Piet aut Vanhoof, Johan aut Durnez, Anne aut Remans, Jan aut Vander Cruyssen, Bert aut Van Essche, Els aut Sileghem, An aut De Brabanter, Griet aut Joly, Johan aut Van der Elst, Kristien aut Meyfroidt, Sabrina aut Westhovens, Rene aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 17(2015), 1 vom: 09. Apr. (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:17 year:2015 number:1 day:09 month:04 https://dx.doi.org/10.1186/s13075-015-0611-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2015 1 09 04 |
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10.1186/s13075-015-0611-8 doi (DE-627)SPR030216575 (SPR)s13075-015-0611-8-e DE-627 ger DE-627 rakwb eng Verschueren, Patrick verfasserin aut 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 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Health Assessment Questionnaire Score (dpeaa)DE-He213 Treatment Adjustment (dpeaa)DE-He213 Body Mass Index Gain (dpeaa)DE-He213 Early Intensive Treatment (dpeaa)DE-He213 Intensive Treatment Strategy (dpeaa)DE-He213 De Cock, Diederik aut Corluy, Luk aut Joos, Rik aut Langenaken, Christine aut Taelman, Veerle aut Raeman, Frank aut Ravelingien, Isabelle aut Vandevyvere, Klaas aut Lenaerts, Jan aut Geens, Elke aut Geusens, Piet aut Vanhoof, Johan aut Durnez, Anne aut Remans, Jan aut Vander Cruyssen, Bert aut Van Essche, Els aut Sileghem, An aut De Brabanter, Griet aut Joly, Johan aut Van der Elst, Kristien aut Meyfroidt, Sabrina aut Westhovens, Rene aut Enthalten in Arthritis Research & Therapy London : BioMed Central, 1999 17(2015), 1 vom: 09. Apr. (DE-627)326646418 (DE-600)2041668-4 1478-6354 nnns volume:17 year:2015 number:1 day:09 month:04 https://dx.doi.org/10.1186/s13075-015-0611-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2015 1 09 04 |
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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. 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Verschueren, Patrick misc Health Assessment Questionnaire Score misc Treatment Adjustment misc Body Mass Index Gain misc Early Intensive Treatment misc Intensive Treatment Strategy 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 |
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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 Health Assessment Questionnaire Score (dpeaa)DE-He213 Treatment Adjustment (dpeaa)DE-He213 Body Mass Index Gain (dpeaa)DE-He213 Early Intensive Treatment (dpeaa)DE-He213 Intensive Treatment Strategy (dpeaa)DE-He213 |
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misc Health Assessment Questionnaire Score misc Treatment Adjustment misc Body Mass Index Gain misc Early Intensive Treatment misc Intensive Treatment Strategy |
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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 |
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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 |
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Verschueren, Patrick |
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Verschueren, Patrick De Cock, Diederik Corluy, Luk Joos, Rik Langenaken, Christine Taelman, Veerle Raeman, Frank Ravelingien, Isabelle Vandevyvere, Klaas Lenaerts, Jan Geens, Elke Geusens, Piet Vanhoof, Johan Durnez, Anne Remans, Jan Vander Cruyssen, Bert Van Essche, Els Sileghem, An De Brabanter, Griet Joly, Johan Van der Elst, Kristien Meyfroidt, Sabrina Westhovens, Rene |
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Elektronische Aufsätze |
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Verschueren, Patrick |
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10.1186/s13075-015-0611-8 |
title_sort |
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 |
title_auth |
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 |
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. © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
abstractGer |
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. © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
abstract_unstemmed |
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. © Verschueren et al.; licensee BioMed Central. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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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 |
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De Cock, Diederik Corluy, Luk Joos, Rik Langenaken, Christine Taelman, Veerle Raeman, Frank Ravelingien, Isabelle Vandevyvere, Klaas Lenaerts, Jan Geens, Elke Geusens, Piet Vanhoof, Johan Durnez, Anne Remans, Jan Vander Cruyssen, Bert Van Essche, Els Sileghem, An De Brabanter, Griet Joly, Johan Van der Elst, Kristien Meyfroidt, Sabrina Westhovens, Rene |
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