RESEARCH - Clinical remission and/or minimal disease activity in RA patients receiving Humira

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Arthritis Care & Research

Volume 59, Issue 1, Pages 32-41

Published Online: 28 Dec 2007

Rheumatoid Arthritis

Clinical remission and/or minimal disease activity in patients

receiving adalimumab treatment in a multinational, open-label,

twelve-week study

Gerd R. Burmester 1 *, Gianfranco Ferraccioli 2, René-Marc Flipo 3,

Indalecio Monteagudo-Sáez 4, a Unnebrink 5, Sonja Kary 5,

Hartmut Kupper 5

1Charité University Medicine Berlin, Berlin, Germany

2Catholic University of Rome, Rome, Italy

3University Hospital, Lille, France

4Hospital General Universitario Gregorio Marañón, Madrid, Spain

5Abbott GmbH & Co. KG, Ludwigshafen, Germany

Abstract

Objective

To 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.

Methods

Clinical 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 proportional hazards regression analysis,

respectively.

Results

A 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.

Conclusion

During 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.

Read the entire article here:

http://www3.interscience.wiley.com/cgi-bin/fulltext/117870784/HTMLSTART

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