Document Detail

Immunogenicity, efficacy and adverse events of adalimumab in RA patients.
MedLine Citation:
PMID:  17006705     Owner:  NLM     Status:  MEDLINE    
To assess the immunogenicity of adalimumab, a human anti-TNF-alpha mAb, we evaluated the formation of antibodies to adalimumab, efficacy and adverse events among 15 patients with highly active rheumatoid arthritis. Four patients were treated with adalimumab as monotherapy, and 11 patients with concomitant DMARDs. Disease activity was measured by DAS28. The antibodies were detected by ELISA. Thirteen (87%) patients withdrew from therapy within 45 weeks and overall 13 (87%) patients showed antibodies to adalimumab including 11 patients who withdrew from therapy. In four patients without concomitant DMARDs and in nine patients with concomitant DMARDs, we detected anti-adalimumab antibodies. Overall, five of seven patients with adverse drug reactions and all nine patients with lack of efficacy were associated with the formation of antibodies. Two antibody-positive patients developed an exantheme. The results indicate that adalimumab is, in spite of its fully human sequences, immunogenic and induces antibodies in a high rate of adalimumab-treated patients.
Niko K Bender; Christoph E Heilig; Benjamin Dröll; Jessica Wohlgemuth; Franz-Paul Armbruster; Bernhard Heilig
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Publication Detail:
Type:  Clinical Trial; Journal Article     Date:  2006-09-28
Journal Detail:
Title:  Rheumatology international     Volume:  27     ISSN:  0172-8172     ISO Abbreviation:  Rheumatol. Int.     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-01-09     Completed Date:  2007-10-16     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  8206885     Medline TA:  Rheumatol Int     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  269-74     Citation Subset:  IM    
Rheumapraxis Heidelberg, Wielandstr. 20, 69120, Heidelberg, Germany.
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MeSH Terms
Antibodies, Anti-Idiotypic / immunology*
Antibodies, Monoclonal / adverse effects,  immunology*
Antibodies, Monoclonal, Humanized
Arthritis, Rheumatoid / drug therapy*
Middle Aged
Treatment Failure
Reg. No./Substance:
0/Antibodies, Anti-Idiotypic; 0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; FYS6T7F842/adalimumab

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