Document Detail

A pilot study: use of fludarabine for refractory dermatomyositis and polymyositis, and examination of endpoint measures.
MedLine Citation:
PMID:  9972969     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To study the effects of the adenine analog, fludarabine, on patients with refractory dermatomyositis and polymyositis, and to assess variables used in following myositis patients during medical intervention. METHODS: Patients whose myositis was not controlled by prednisone and at least one other immunosuppressive medication were entered into a pilot study during which they received 6 monthly cycles of intravenous fludarabine. Patients were assessed at baseline, every other month, and at month 7 for primary outcome measures of strength and function. Other measurements including peripheral blood cell subsets, muscle enzymes, and various assessments of disease activity were followed monthly during the fludarabine infusion period and for up to 6 months post therapy. RESULTS: Of 16 patients who entered the study, 4 patients were classified as improved, and 7 patients were classified as unchanged. Five patients who withdrew before month 7 were classified as treatment failures. Fludarabine caused a significant and prolonged lymphopenia without an increase in infectious complications over that seen with other immunosuppressive agents used for myositis. A sudden death of one patient at the end of the study was not thought to be drug related. Variables followed during the study emphasized the distinction between patient functional improvement and disease remission. CONCLUSION: A subset of patients with refractory myositis may benefit from fludarabine therapy and controlled trials are indicated. Refinement and validation of variables useful for following myositis patients await larger studies.
E M Adams; F Pucino; C Yarboro; J E Hicks; B Thornton; C McGarvey; B C Sonies; M L Bartlett; M L Villalba; T Fleisher; P H Plotz
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  The Journal of rheumatology     Volume:  26     ISSN:  0315-162X     ISO Abbreviation:  J. Rheumatol.     Publication Date:  1999 Feb 
Date Detail:
Created Date:  1999-06-30     Completed Date:  1999-06-30     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7501984     Medline TA:  J Rheumatol     Country:  CANADA    
Other Details:
Languages:  eng     Pagination:  352-60     Citation Subset:  IM    
Arthritis Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD 20892, USA.
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MeSH Terms
Anti-Inflammatory Agents / therapeutic use
Dermatomyositis / drug therapy*
Edema / drug therapy,  pathology
Flow Cytometry
Hematologic Tests
Immunosuppressive Agents / adverse effects,  therapeutic use*
Magnetic Resonance Imaging
Middle Aged
Muscle, Skeletal / pathology
Pilot Projects
Polymyositis / drug therapy*
Prednisone / therapeutic use
Treatment Outcome
Vidarabine / adverse effects,  analogs & derivatives*,  therapeutic use
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Immunosuppressive Agents; 21679-14-1/fludarabine; 53-03-2/Prednisone; 5536-17-4/Vidarabine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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