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Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort.

Publication ,  Journal Article
Silva, F; Seo, P; Schroeder, DR; Stone, JH; Merkel, PA; Hoffman, GS; Spiera, R; Sebastian, JK; Davis, JC; St Clair, EW; Allen, NB; McCune, WJ ...
Published in: Arthritis Rheum
August 2011

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.

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Published In

Arthritis Rheum

DOI

EISSN

1529-0131

Publication Date

August 2011

Volume

63

Issue

8

Start / End Page

2495 / 2503

Location

United States

Related Subject Headings

  • SEER Program
  • Receptors, Tumor Necrosis Factor
  • Randomized Controlled Trials as Topic
  • Neoplasms
  • Middle Aged
  • Male
  • Longitudinal Studies
  • Incidence
  • Immunoglobulin G
  • Humans
 

Citation

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Silva, F., Seo, P., Schroeder, D. R., Stone, J. H., Merkel, P. A., Hoffman, G. S., … Wegener’s Granulomatosis Etanercept Trial Research Group, . (2011). Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort. Arthritis Rheum, 63(8), 2495–2503. https://doi.org/10.1002/art.30394
Silva, Francisco, Philip Seo, Darrell R. Schroeder, John H. Stone, Peter A. Merkel, Gary S. Hoffman, Robert Spiera, et al. “Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort.Arthritis Rheum 63, no. 8 (August 2011): 2495–2503. https://doi.org/10.1002/art.30394.
Silva F, Seo P, Schroeder DR, Stone JH, Merkel PA, Hoffman GS, et al. Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort. Arthritis Rheum. 2011 Aug;63(8):2495–503.
Silva, Francisco, et al. “Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort.Arthritis Rheum, vol. 63, no. 8, Aug. 2011, pp. 2495–503. Pubmed, doi:10.1002/art.30394.
Silva F, Seo P, Schroeder DR, Stone JH, Merkel PA, Hoffman GS, Spiera R, Sebastian JK, Davis JC, St Clair EW, Allen NB, McCune WJ, Ytterberg SR, Specks U, Wegener’s Granulomatosis Etanercept Trial Research Group. Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener's): long-term followup of a multicenter longitudinal cohort. Arthritis Rheum. 2011 Aug;63(8):2495–2503.
Journal cover image

Published In

Arthritis Rheum

DOI

EISSN

1529-0131

Publication Date

August 2011

Volume

63

Issue

8

Start / End Page

2495 / 2503

Location

United States

Related Subject Headings

  • SEER Program
  • Receptors, Tumor Necrosis Factor
  • Randomized Controlled Trials as Topic
  • Neoplasms
  • Middle Aged
  • Male
  • Longitudinal Studies
  • Incidence
  • Immunoglobulin G
  • Humans