Solid Malignancies Among Etanercept-Treated Patients With Granulomatosis With Polyangiitis (Wegener's) Long-Term Followup of a Multicenter Longitudinal Cohort
link https://doi.org/10.1002/art.30394account_box Silva, Franciscoaccount_box Seo, Philipaccount_box Schroeder, Darrell R.account_box Stone, John H.account_box Merkel, Peter A.account_box Hoffman, Gary S.account_box Spiera, Robertaccount_box Sebastian, Jodi K.account_box Davis, John C., Jr.account_box St Clair, E. Williamaccount_box Allen, Nancy B.account_box McCune, W. Josephaccount_box Ytterberg, Steven R.account_box Specks, Ulrichaccount_box Wegener's Granulomatosis
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Objective. An association between therapeutic inhibition of tumor necrosis factor (TNF) and solid malignancies was observed during the Wegener's Granulomatosis Etanercept Trial (WGET), which included 180 patients with granulomatosis with polyangiitis (Wegener's) (GPA). The present study was conducted to determine the malignancy risk beyond the time of exposure to study therapy.
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| Autor | Silva, Francisco Seo, Philip Schroeder, Darrell R. Stone, John H. Merkel, Peter A. Hoffman, Gary S. Spiera, Robert Sebastian, Jodi K. Davis, John C., Jr. St Clair, E. William Allen, Nancy B. McCune, W. Joseph Ytterberg, Steven R. Specks, Ulrich Wegener's Granulomatosis |
| Título | Solid Malignancies Among Etanercept-Treated Patients With Granulomatosis With Polyangiitis (Wegener's) Long-Term Followup of a Multicenter Longitudinal Cohort |
| Revista | ARTHRITIS AND RHEUMATISM |
| ISSN | 0004-3591 |
| ISSN electrónico | 1529-0131 |
| Volumen | 63 |
| Número de publicación | 8 |
| Página inicio | 2495 |
| Página final | 2503 |
| Fecha de publicación | 2011 |
| Resumen | Objective. An association between therapeutic inhibition of tumor necrosis factor (TNF) and solid malignancies was observed during the Wegener's Granulomatosis Etanercept Trial (WGET), which included 180 patients with granulomatosis with polyangiitis (Wegener's) (GPA). The present study was conducted to determine the malignancy risk beyond the time of exposure to study therapy. Methods. The occurrence and type of solid malignancies were ascertained using a standardized data form. Data collected included vital status, histologic findings, and therapeutic interventions. The Surveillance, Epidemiology, and End- Results database was used to estimate a standardized incidence rate (SIR) for solid malignancies. Results. Post-trial followup data were available for 153 patients (85% of the original cohort), with a median followup time of 43 months. Fifty percent of these patients had received etanercept. There were no differences in demographic characteristics between the etanercept and placebo groups. Thirteen new solid malignancies were detected, 8 in the etanercept group and 5 in the placebo group. Compared to the general population, the risk of solid malignancies in the etanercept group was increased (SIR 3.92 [95% confidence interval 1.69-7.72]), but was not different from the risk in the placebo group compared to the general population (SIR 2.89 [95% confidence interval 0.94-6.73]). All solid malignancies occurred in patients who had been exposed to cyclophosphamide. The overall duration of disease and a history of malignancy before trial enrollment were associated with the development of malignancy during post-trial followup. Conclusion. The incidence of solid malignancy remained increased during long-term followup of the WGET cohort. However, this could not be attributed solely to etanercept exposure during the trial. Anti-TNF therapy with etanercept appears to further increase the risk of malignancy observed in patients with GPA treated with cytotoxic agents and should be avoided in these patients. |
| Derechos | acceso restringido |
| Agencia financiadora | NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases) FDA (Office of Orphan Products Development) Vasculitis Clinical Research Consortium through the NIH (National Center for Research Resources and National Institute of Arthritis and Musculoskeletal and Skin Diseases) Mayo Foundation for Medical Education and Research Vasculitis Clinical Research Consortium NATIONAL CENTER FOR RESEARCH RESOURCES NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES |
| DOI | 10.1002/art.30394 |
| Editorial | WILEY |
| Enlace | |
| Id de publicación en Pubmed | MEDLINE:21484770 |
| Id de publicación en WoS | WOS:000293840200039 |
| Paginación | 9 páginas |
| Palabra clave | TUMOR-NECROSIS-FACTOR SQUAMOUS-CELL CARCINOMA POPULATION-BASED COHORT RHEUMATOID-ARTHRITIS FACTOR-ALPHA CANCER MORBIDITY INCREASED RISK LYMPHOMA THERAPY DISEASE |
| Tema ODS | 03 Good Health and Well-being |
| Tema ODS español | 03 Salud y bienestar |
| Tipo de documento | artículo |