Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone

Edward C. Keystone, Ferdinand C. Breedveld, Désireé Van Der Heijde, Ronald F. Van Vollenhoven, Paul Emery, Josef S. Smolen, Iain Sainsbury, Stefan Florentinus, Hartmut Kupper, Kun Chen, Arthur Kavanaugh

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective To evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA). Methods Post hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression (Î "mTSS≤0.5). Results Regardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (∼25%) versus established RA (14%) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (∼50% of patients with early RA and 39% with established RA). Conclusion Treatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52. Trial registration number DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.

Original languageEnglish
Article numbere000445
JournalRMD Open
Volume3
Issue number2
DOIs
Publication statusPublished - 1 Sep 2017

Cite this

Keystone, Edward C. ; Breedveld, Ferdinand C. ; Heijde, Désireé Van Der ; Van Vollenhoven, Ronald F. ; Emery, Paul ; Smolen, Josef S. ; Sainsbury, Iain ; Florentinus, Stefan ; Kupper, Hartmut ; Chen, Kun ; Kavanaugh, Arthur. / Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. In: RMD Open. 2017 ; Vol. 3, No. 2.
@article{9dd5f07c973c47a5a61a081907cf5169,
title = "Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone",
abstract = "Objective To evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA). Methods Post hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression ({\^I} {"}mTSS≤0.5). Results Regardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (∼25{\%}) versus established RA (14{\%}) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (∼50{\%} of patients with early RA and 39{\%} with established RA). Conclusion Treatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52. Trial registration number DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.",
keywords = "anti-TNF, methotrexate, rheumatoid arthritis, treatment",
author = "Keystone, {Edward C.} and Breedveld, {Ferdinand C.} and Heijde, {D{\'e}sire{\'e} Van Der} and {Van Vollenhoven}, {Ronald F.} and Paul Emery and Smolen, {Josef S.} and Iain Sainsbury and Stefan Florentinus and Hartmut Kupper and Kun Chen and Arthur Kavanaugh",
year = "2017",
month = "9",
day = "1",
doi = "10.1136/rmdopen-2017-000445",
language = "English",
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Keystone, EC, Breedveld, FC, Heijde, DVD, Van Vollenhoven, RF, Emery, P, Smolen, JS, Sainsbury, I, Florentinus, S, Kupper, H, Chen, K & Kavanaugh, A 2017, 'Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone' RMD Open, vol. 3, no. 2, e000445. https://doi.org/10.1136/rmdopen-2017-000445

Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. / Keystone, Edward C.; Breedveld, Ferdinand C.; Heijde, Désireé Van Der; Van Vollenhoven, Ronald F.; Emery, Paul; Smolen, Josef S.; Sainsbury, Iain; Florentinus, Stefan; Kupper, Hartmut; Chen, Kun; Kavanaugh, Arthur.

In: RMD Open, Vol. 3, No. 2, e000445, 01.09.2017.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone

AU - Keystone, Edward C.

AU - Breedveld, Ferdinand C.

AU - Heijde, Désireé Van Der

AU - Van Vollenhoven, Ronald F.

AU - Emery, Paul

AU - Smolen, Josef S.

AU - Sainsbury, Iain

AU - Florentinus, Stefan

AU - Kupper, Hartmut

AU - Chen, Kun

AU - Kavanaugh, Arthur

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Objective To evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA). Methods Post hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression (Î "mTSS≤0.5). Results Regardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (∼25%) versus established RA (14%) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (∼50% of patients with early RA and 39% with established RA). Conclusion Treatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52. Trial registration number DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.

AB - Objective To evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA). Methods Post hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression (Î "mTSS≤0.5). Results Regardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (∼25%) versus established RA (14%) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (∼50% of patients with early RA and 39% with established RA). Conclusion Treatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52. Trial registration number DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.

KW - anti-TNF

KW - methotrexate

KW - rheumatoid arthritis

KW - treatment

UR - http://www.scopus.com/inward/record.url?scp=85030330093&partnerID=8YFLogxK

U2 - 10.1136/rmdopen-2017-000445

DO - 10.1136/rmdopen-2017-000445

M3 - Article

VL - 3

JO - RMD Open

JF - RMD Open

SN - 2056-5933

IS - 2

M1 - e000445

ER -