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

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Arthritis Rheum. 2008 Jan 15;59(1):32-41.

Clinical remission and/or minimal disease activity in patients

receiving adalimumab treatment in a multinational, open-label,

twelve-week study.

Burmester GR, Ferraccioli G, Flipo RM, Monteagudo-Sáez I, Unnebrink K,

Kary S, Kupper H.

Charité University Medicine Berlin, Berlin, Germany.

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<or=3.3, or Clinical Disease Activity Index

(CDAI) score<or=2.8. MDA required absence of tender and swollen joints

plus erythrocyte sedimentation rate (ESR)<or=10 mm/hour; DAS28

score<or=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<or=3.3, and CDAI<or=2.8, respectively. MDA was

observed in 45% of patients by DAS28<or=2.85, in 43% by the core set

of criteria, and in 13% by absence of tender/swollen joints plus

ESR<or=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<or=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; <or=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.

PMID: 18163417

http://www.ncbi.nlm.nih.gov/pubmed/18163417

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