Article (Scientific journals)
Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial
Burmester, G. R.; Mariette, X.; Montecucco, C. et al.
2007In Annals of the Rheumatic Diseases, 66 (6), p. 732-739
Peer Reviewed verified by ORBi
 

Files


Full Text
Malaise_2007_AnnRheumDis_732-739.pdf
Publisher postprint (290.19 kB)
Download

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
Antibodies, Monoclonal; Antirheumatic Agents; Tumor Necrosis Factor-alpha; adalimumab; Arthritis, Rheumatoid
Abstract :
[en] Objective: To evaluate the safety and effectiveness of adalimumab alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA). Methods: Patients with active RA despite treatment with DMARDs or prior treatment with a tumour necrosis factor antagonist participated in a multicentre, open-label clinical study of adalimumab 40 mg every other week for 12 weeks with an optional extension phase. Patients were allowed to continue with pre-existing traditional DMARDs. Long- term safety results are reported for all patients (4210 patient-years (PYs) of adalimumab exposure). The observed effectiveness results at week 12 are reported using American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria. Results: Among the 6610 treated patients, adalimumab was generally well tolerated. Serious infections occurred in 3.1% of patients (5.5/100 PYs, including active tuberculosis, 0.5/100 PYs). Demyelinating disease (0.06%) and systemic lupus erythematosus (0.03%) were rare serious adverse events. The standardised incidence ratio of malignancy was 0.71 (95% CI 0.49 to 1.01). The standardised mortality ratio was 1.07 ( 95% CI 0.75 to 1.49). At week 12, 69% of patients achieved an ACR20 response, 83% a moderate, and 33% a good EULAR response. Adalimumab was effective in combination with a variety of DMARDs. The addition of adalimumab to antimalarials was comparably effective to the combination of adalimumab and methotrexate. Conclusions: Considering the limitations of an open- label study, adalimumab alone or in combination with standard DMARDs appeared to be well tolerated and effective in 6610 difficult- to- treat patients with active RA treated in clinical practice.
Disciplines :
Rheumatology
Author, co-author :
Burmester, G. R.
Mariette, X.
Montecucco, C.
Monteagudo-Saez, I.
Malaise, Michel ;  Université de Liège - ULiège > Département des sciences cliniques > Rhumatologie
Tzioufas, A. G.
Bijlsma, J. W. J.
Unnebrink, K.
Kary, S.
Kupper, H.
Language :
English
Title :
Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial
Publication date :
June 2007
Journal title :
Annals of the Rheumatic Diseases
ISSN :
0003-4967
eISSN :
1468-2060
Publisher :
BMJ Group, London, United Kingdom
Volume :
66
Issue :
6
Pages :
732-739
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 19 September 2010

Statistics


Number of views
156 (2 by ULiège)
Number of downloads
233 (1 by ULiège)

Scopus citations®
 
180
Scopus citations®
without self-citations
156
OpenCitations
 
141

Bibliography


Similar publications



Contact ORBi