Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial

P H de Jong; J M Hazes; H K Han; M Huisman; D van Zeben; P A van der Lubbe; A H Gerards; B van Schaeybroeck; P B de Sonnaville; M V van Krugten; J J Luime; A E Weel

doi:10.1136/annrheumdis-2013-204788

Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial

P H de Jong^*, J M Hazes, H K Han, M Huisman, D van Zeben, P A van der Lubbe, A H Gerards, B van Schaeybroeck, P B de Sonnaville, M V van Krugten, J J Luime, A E Weel

^*Corresponding author for this work

Rheumatology

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

OBJECTIVES: To compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis.

METHODS: In a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression.

RESULTS: 281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively -2.39 (95% CI -4.77 to -0.00) and -1.67 (95% CI -3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM.

CONCLUSIONS: Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.

TRIAL REGISTRATION NUMBER: ISRCTN26791028.

Original language	English
Pages (from-to)	1331-1339
Number of pages	9
Journal	Annals of the Rheumatic Diseases
Volume	73
Issue number	7
DOIs	https://doi.org/10.1136/annrheumdis-2013-204788
Publication status	Published - Jul 2014

Bibliographical note

Funding:
This work was supported by an unrestricted grant from Pfizer bv. [0881–
102217]. Pfizer had no involvement in the study design; in collection, analysis and
interpretation of data; writing of the report; and decision to submit for publication.
The corresponding author had full access to all data and had final responsibility for
the decision to submit for publication. Data management was sponsored by the
Dutch Arthritis Foundation.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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Cite this

de Jong, P. H., Hazes, J. M., Han, H. K., Huisman, M., van Zeben, D., van der Lubbe, P. A., Gerards, A. H., van Schaeybroeck, B., de Sonnaville, P. B., van Krugten, M. V., Luime, J. J., & Weel, A. E. (2014). Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial. Annals of the Rheumatic Diseases, 73(7), 1331-1339. https://doi.org/10.1136/annrheumdis-2013-204788

@article{032d5189c9444d388bd3e266b74490b5,

title = "Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial",

abstract = "OBJECTIVES: To compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis.METHODS: In a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression.RESULTS: 281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively -2.39 (95% CI -4.77 to -0.00) and -1.67 (95% CI -3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM.CONCLUSIONS: Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.TRIAL REGISTRATION NUMBER: ISRCTN26791028.",

author = "{de Jong}, {P H} and Hazes, {J M} and Han, {H K} and M Huisman and {van Zeben}, D and {van der Lubbe}, {P A} and Gerards, {A H} and {van Schaeybroeck}, B and {de Sonnaville}, {P B} and {van Krugten}, {M V} and Luime, {J J} and Weel, {A E}",

note = "Funding: This work was supported by an unrestricted grant from Pfizer bv. [0881– 102217]. Pfizer had no involvement in the study design; in collection, analysis and interpretation of data; writing of the report; and decision to submit for publication. The corresponding author had full access to all data and had final responsibility for the decision to submit for publication. Data management was sponsored by the Dutch Arthritis Foundation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",

year = "2014",

month = jul,

doi = "10.1136/annrheumdis-2013-204788",

language = "English",

volume = "73",

pages = "1331--1339",

journal = "Annals of the Rheumatic Diseases",

issn = "0003-4967",

publisher = "Elsevier",

number = "7",

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de Jong, PH , Hazes, JM, Han, HK, Huisman, M, van Zeben, D, van der Lubbe, PA, Gerards, AH, van Schaeybroeck, B, de Sonnaville, PB, van Krugten, MV, Luime, JJ & Weel, AE 2014, 'Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial', Annals of the Rheumatic Diseases, vol. 73, no. 7, pp. 1331-1339. https://doi.org/10.1136/annrheumdis-2013-204788

Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial. / de Jong, P H ; Hazes, J M; Han, H K et al.
In: Annals of the Rheumatic Diseases, Vol. 73, No. 7, 07.2014, p. 1331-1339.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial

AU - de Jong, P H

AU - Hazes, J M

AU - Han, H K

AU - Huisman, M

AU - van Zeben, D

AU - van der Lubbe, P A

AU - Gerards, A H

AU - van Schaeybroeck, B

AU - de Sonnaville, P B

AU - van Krugten, M V

AU - Luime, J J

AU - Weel, A E

N1 - Funding: This work was supported by an unrestricted grant from Pfizer bv. [0881– 102217]. Pfizer had no involvement in the study design; in collection, analysis and interpretation of data; writing of the report; and decision to submit for publication. The corresponding author had full access to all data and had final responsibility for the decision to submit for publication. Data management was sponsored by the Dutch Arthritis Foundation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2014/7

Y1 - 2014/7

N2 - OBJECTIVES: To compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis.METHODS: In a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression.RESULTS: 281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively -2.39 (95% CI -4.77 to -0.00) and -1.67 (95% CI -3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM.CONCLUSIONS: Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.TRIAL REGISTRATION NUMBER: ISRCTN26791028.

AB - OBJECTIVES: To compare 1-year clinical efficacy of (1) initial triple disease-modifying antirheumatic drug therapy (iTDT) with initial methotrexate (MTX) monotherapy (iMM) and (2) different glucocorticoid (GC) bridging therapies: oral versus a single intramuscular injection in early rheumatoid arthritis.METHODS: In a single-blinded randomised clinical trial patients were randomised into three arms: (A) iTDT (methotrexate+sulfasalazine+hydroxychloroquine) with GCs intramuscularly; (B) iTDT with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. Primary outcomes were (1) area under the curve (AUC) of Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS) and (2) the proportion of patients with radiographic progression.RESULTS: 281 patients were randomly assigned to arms A (n=91), B (n=93) or C (n=97). The AUC DAS and HAQ were respectively -2.39 (95% CI -4.77 to -0.00) and -1.67 (95% CI -3.35 to 0.02) lower in patients receiving iTDT than in those receiving iMM. After 3 months, treatment failure occurred less often in the iTDT group, resulting in 40% fewer treatment intensifications. The difference in treatment intensifications between the arms required to maintain the predefined treatment goal remained over time. No differences were seen between the two GC bridging therapies. Respectively 21%, 24% and 23% of patients in arms A, B and C had radiographic progression after 1 year. Patients receiving iTDT had more adjustments of their medication owing to adverse events than those receiving iMM.CONCLUSIONS: Treatment goals are attained more quickly and maintained with fewer treatment intensifications with iTDT than with iMM. However, no difference in radiographic progression is seen. Both GC bridging therapies are equally effective and, therefore, both can be used.TRIAL REGISTRATION NUMBER: ISRCTN26791028.

U2 - 10.1136/annrheumdis-2013-204788

DO - 10.1136/annrheumdis-2013-204788

M3 - Article

C2 - 24788619

SN - 0003-4967

VL - 73

SP - 1331

EP - 1339

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 7

ER -

Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial

Abstract

Bibliographical note

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