Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open‐label, twelve‐week study

Wiley - Tập 59 Số 1 - Trang 32-41 - 2008
Gerd R Burmester1, Gianfranco Ferraccioli2, René‐Marc Flipo3, Indalecio Monteagudo-Sáez4, Kristina Unnebrink5, S. Kary5, H. Küpper5
1Charité-Univ Medicine Berlin, Berlin, Germany
2Catholic University of Rome, Rome, Italy
3University Hospital, Lille, France
4Hospital General Universitario Gregorio Marañon, Madrid, Spain
5Abbott GmbH & Co. KG, Ludwigshafen, Germany

Tóm tắt

AbstractObjectiveTo evaluate the effect of adalimumab treatment on clinical remission and/or minimal disease activity (MDA) in 6,610 patients with active rheumatoid arthritis (RA) who were enrolled in the Research in Active RA trial, a multinational, open‐label, 12‐week study with an optional extension period.MethodsClinical remission was defined as a Disease Activity Score in 28 joints (DAS28) <2.6, Simplified Disease Activity Index (SDAI) score ≤3.3, or Clinical Disease Activity Index (CDAI) score ≤2.8. MDA required absence of tender and swollen joints plus erythrocyte sedimentation rate (ESR) ≤10 mm/hour; DAS28 score ≤2.85; or achievement of 5 of 7 core criteria for pain, swollen/tender joints, physical function, physician/patient global assessment, and ESR. Time to and time in remission/MDA and response predictors were analyzed using Kaplan‐Meier estimates and Cox proportional hazards regression analysis, respectively.ResultsA total of 38%, 24%, and 27% of patients achieved remission defined as DAS28 <2.6, SDAI ≤3.3, and CDAI ≤2.8, respectively. MDA was observed in 45% of patients by DAS28 ≤2.85, in 43% by the core set of criteria, and in 13% by absence of tender/swollen joints plus ESR ≤10 mm/hour. Median times in continuous remission and MDA were 3.4 and 4.4 months, respectively. Predictors for remission (DAS28 <2.6) and MDA (DAS28 ≤2.85) were male sex; younger age; concomitant disease‐modifying antirheumatic drug use; lower baseline DAS28, CRP concentration, and Health Assessment Questionnaire disease index score; ≤1 comorbidity; and tumor necrosis factor antagonist naivety.ConclusionDuring adalimumab treatment, 25% of patients experienced clinical remission and nearly half achieved MDA. To our knowledge, this analysis represents the largest prospective clinical trial data set to be assessed using Outcome Measures in Rheumatology Clinical Trials MDA criteria.

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Tài liệu tham khảo

10.1002/14651858.CD005113.pub2

Genovese MC, 2005, Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis, J Rheumatol, 32, 1232

Liang GC, 2005, Current tumor necrosis factor‐alpha inhibitor use is associated with a higher probability of remissions in patients with rheumatoid arthritis, J Rheumatol, 32, 1662

10.1002/art.20568

Balsa A, 2004, Value of Disease Activity Score 28 (DAS28) and DAS28–3 compared to American College of Rheumatology‐defined remission in rheumatoid arthritis, J Rheumatol, 31, 40

10.1136/ard.2003.011395

10.1002/art.22003

Pincus T, 2004, Relative versus absolute goals of therapies for RA: ACR 20 or ACR 50 responses versus target values for “near remission” of DAS or single measures, Clin Exp Rheumatol, 22, S50

Dougados M, 2005, It's good to feel better but it's better to feel good, J Rheumatol, 32, 1

10.1002/art.1780241012

10.1093/rheumatology/35.11.1101

Pincus T, 2006, Complexities in defining remission in rheumatic diseases, Clin Exp Rheumatol, 24, S1

Aletaha D, 2006, Remission of rheumatoid arthritis: should we care about definitions?, Clin Exp Rheumatol, 24, S45

Fransen J, 2006, DAS remission cut points, Clin Exp Rheumatol, 24, S29

Makinen H, 2006, Definitions of remission for rheumatoid arthritis and review of selected clinical cohorts and randomised clinical trials for the rate of remission, Clin Exp Rheumatol, 24, S22

Ranganath VK, 2006, ACR remission criteria and response criteria, Clin Exp Rheumatol, 24, S14

10.1002/art.21235

10.1136/ard.2005.037333

10.1016/j.semarthrit.2005.06.003

10.1002/art.1780380107

10.1093/rheumatology/keh297

Aletaha D, 2005, The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis, Clin Exp Rheumatol, 23, S100

Geborek P, 2006, New and established criteria for remission and disease activity in an observational RA cohort treated with etanercept, Arthritis Rheum, 54, S203

Lissiane K, 2006, The new indexes Sdai and Cdai in early arthritis: similar performance to Das 28 index, Arthritis Rheum, 54, S206

Smolen J, 2006, A clinical score that does not require an acute phase response measure, the Clinical Disease Activity Index (CDAI), is of similar value as DAS and DAS28 as an indicator of low disease activity in rheumatoid arthritis, Arthritis Rheum, 54, S199

Wells GA, 2005, Minimal disease activity for rheumatoid arthritis: a preliminary definition, J Rheumatol, 32, 2016

10.1136/ard.2006.066761

10.1093/rheumatology/kem091

10.1002/art.1780310302

10.1002/art.1780390105

10.1136/ard.2005.037903

10.1002/art.21830

10.1093/rheumatology/kel149

10.1186/ar1933

10.1136/ard.2003.014928

Wells GA, 2006, Validation of minimal disease activity for rheumatoid arthritis patients treated with the biologic therapy abatacept, Arthritis Rheum, 54, S384

10.1002/art.10697

10.1002/art.20217

10.2165/00003495-200666140-00001

10.1186/ar1005

10.1016/S0140-6736(04)15640-7

10.1136/ard.2004.034371

10.1136/ard.2006.056937

10.1002/art.1780380602