Document Detail

Responses to adalimumab in patients with active psoriatic arthritis who have not adequately responded to prior therapy: effectiveness and safety results from an open-label study.
MedLine Citation:
PMID:  20595284     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the effectiveness and safety of adalimumab in patients with active psoriatic arthritis (PsA) and an inadequate response to prior therapy.
METHODS: Patients were treated with subcutaneous injections of adalimumab 40 mg every other week in addition to their standard antirheumatic therapies in a 12-week, open-label study. Effectiveness evaluations at Week 12 included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index (PASI) response rates, Psoriatic Arthritis Response Criteria (PsARC), active dactylitis, enthesitis, and target lesion assessment. Physical function was evaluated using the Health Assessment Questionnaire Disability Index (HAQ-DI).
RESULTS: A total of 127 patients were enrolled. At Week 12, patients achieved ACR20, ACR50, and ACR70 response rates of 78.0%, 55.9%, and 21.3%, respectively. PASI50 and PASI75 response rates were 64.7% and 47.1%. A PsARC response was experienced by 70.1% of patients. Between baseline and Week 12, clinically and statistically significant reductions occurred in the mean total plaque score of the target lesion as well as in the percentages of patients with active dactylitis and enthesitis. A mean improvement in HAQ-DI was also observed (-0.44; p < 0.001). Three serious adverse events were reported, but none was considered related to adalimumab therapy.
CONCLUSION: Adalimumab-treated patients achieved significant improvements in both skin and joint manifestations of PsA, as well as in physical function. Adalimumab was well tolerated and had a safety profile similar to that observed in other clinical trials of adalimumab for the treatment of PsA. identifier: NCT00427362.
Dafna D Gladman; ; John S Sampalis; Olivier Illouz; Benoît Guérette
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-07-01
Journal Detail:
Title:  The Journal of rheumatology     Volume:  37     ISSN:  0315-162X     ISO Abbreviation:  J. Rheumatol.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-02     Completed Date:  2011-02-14     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  7501984     Medline TA:  J Rheumatol     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  1898-906     Citation Subset:  IM    
Toronto Western Research Institute, 399 Bathurst Street, Room 1E-410B, Toronto, Ontario M5T 2S8, Canada.
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MeSH Terms
Antibodies, Monoclonal / therapeutic use*
Antibodies, Monoclonal, Humanized
Antirheumatic Agents / therapeutic use*
Arthritis, Psoriatic / drug therapy*,  pathology,  physiopathology
Disability Evaluation
Joints / pathology
Middle Aged
Severity of Illness Index
Skin / pathology
Treatment Outcome
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/Antirheumatic Agents; FYS6T7F842/adalimumab

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