| Abstract | OBJECTIVES: There is little established information regarding the safety of antitumor necrosis factor therapies used outside the setting of clinical trials. This study evaluated the long-term safety and tolerability of open-label use of etanercept when used to treat patients with a variety of systemic rheumatic diseases. Reduction of concomitant corticosteroid and disease-modifying antirheumatic drug was also assessed. METHODS: Retrospective medical record review of 180 patients who were started on etanercept between December 1998 and April 2000 at an academic medical center. RESULTS: Most patients (81%) remained on therapy for longer than 6 months, and a significant number (43%) of patients for longer than 12 months. Etanercept was prescribed for rheumatoid arthritis (RA) in 144 patients and for diseases other than RA, including ankylosing spondylitis, psoriatic arthritis, and polymyositis, in 36 patients. Fifty-six percent of patients taking corticosteroids were able to reduce their dose and 51% of patients were able to taper their methotrexate dosages. Forty-three patients (26%) discontinued etanercept. Reasons for discontinuing therapy included serious adverse events (2.9%), of which infection was most common. These included a psoas abscess secondary to Mycobacterium avium-intracellulare, septic wrist, bacteremia, and septic total hip replacement. Two deaths associated with infection were seen. CONCLUSIONS: The majority of the studied patients tolerated etanercept for longer than 6 months. Many of these patients were able to subsequently taper or even discontinue corticosteroid and methotrexate therapy. Serious infections occurred in this patient population. Our results underscore the value of long-term observation under the conditions of clinical practice beyond controlled clinical trials. |
| Authors | Kristine Phillips, M Elaine Husni, Elizabeth W Karlson, Jonathan S Coblyn
(Affiliation: Robert B. Brigham Multipurpose Arthritis and Musculoskeletal Diseases Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.)
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| Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 47
Issue 1
Pg. 17-21
(Feb 2002)
ISSN: 0004-3591 United States |
| PMID | 11932873
(Publication Type: Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.)
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| Chemical References |
- Antirheumatic Agents
- Immunoglobulin G
- Immunologic Factors
- Receptors, Tumor Necrosis Factor
- TNFR-Fc fusion protein
- Prednisone
- Methotrexate
|
| Topics |
- Academic Medical Centers
- Antirheumatic Agents
(therapeutic use)
- Female
- Humans
- Immunoglobulin G
(adverse effects, therapeutic use)
- Immunologic Factors
(adverse effects, therapeutic use)
- Infection
(etiology)
- Male
- Massachusetts
- Methotrexate
(therapeutic use)
- Middle Aged
- Prednisone
(therapeutic use)
- Receptors, Tumor Necrosis Factor
(therapeutic use)
- Rheumatic Diseases
(complications, drug therapy)
|
