Peter A. Merkel, MD, MPH; Grace H. Lo, MD; Janet T. Holbrook, PhD, MPH; Andrea K. Tibbs, BS; Nancy B. Allen, MD; John C. Davis Jr, MD, MPH; Gary S. Hoffman, MD; W. Joseph McCune, MD; E. William St. Clair, MD; Ulrich Specks, MD; Robert Spiera, MD; Michelle Petri, MD, MPH; John H. Stone, MD, MPH; and for The Wegener's Granulomatosis Etanercept Trial Research Group*
Grant Support: By the National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases (contract no. N01-AR-9-2240 and center grant AR47785); U.S. Food and Drug Administration, Office of Orphan Products (grant no. FD-R-001652-01); General Clinical Research Center grants M01-RRO-00533 (Boston University), M01-RRO-0042 (The University of Michigan), M01-RR-30 (Duke University), and M01-RRO-2719 (Johns Hopkins University School of Medicine), from the National Center for Research Resources, National Institutes of Health (NIAMS-NIH AR2224); and Amgen Corporation, Thousand Oaks, California. Drs. Merkel, St. Clair, and Stone are partly supported by a Mid-Career Development Awards in Clinical Investigation (NIH-NIAMS K24 AR2224-01A1, K24 AR049185-01, and K24 AR049185-01).
Potential Financial Conflicts of Interest: Grants received: E.W. St. Clair (Amgen Corp.).
Requests for Single Reprints: Peter A. Merkel, MD, MPH, Boston University School of Medicine, Vasculitis Center, E-5, 715 Albany Street, Boston, MA 02118; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Merkel and Lo: Boston University School of Medicine, Vasculitis Center, E-5, 715 Albany Street, Boston, MA 02118.
Dr. Holbrook and Ms. Tibbs: Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD 21205.
Dr. Allen: Duke University Medical Center, Box 3440, Durham, NC 27710.
Dr. Davis: University of California, San Francisco, 533 Parnassus Avenue, Box 0633, San Francisco, CA 94143.
Dr. Hoffman: The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195.
Dr. McCune: University of Michigan, Taubman Center, Room 3918-0358, Ann Arbor, MI 48109.
Dr. St. Clair: Duke University Medical Center, Box 3874, Durham, NC 27710.
Dr. Specks: Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Dr. Spiera: Beth Israel Medical Center, 170 East End Avenue, New York, NY 10128.
Dr. Petri: Johns Hopkins Unversity School of Medicine, 1830 East Monument Street, #7500, Baltimore, MD 21205.
Dr. Stone: Johns Hopkins Vasculitis Center, 5501 Hopkins Bayview Circle, Baltimore, MD 21224.
Author Contributions: Conception and design: P.A. Merkel, G.H. Lo, J.T. Holbrook, G.S. Hoffman, E.W. St. Clair, U. Specks, R. Spiera, J.H. Stone.
Analysis and interpretation of the data: P.A. Merkel, G.H. Lo, J.T. Holbrook, A.K. Tibbs, J.C. Davis Jr., G.S. Hoffman, W.J. McCune, E.W. St. Clair, J.H. Stone.
Drafting of the article: P.A. Merkel, G.H. Lo, J.T. Holbrook, J.C. Davis Jr., M. Petri, J.H. Stone.
Critical revision of the article for important intellectual content: P.A. Merkel, G.H. Lo, J.T. Holbrook, N.B. Allen, J.C. Davis Jr., G.S. Hoffman, W.J. McCune, E.W. St. Clair, U. Specks, R. Spiera, J.H. Stone.
Final approval of the article: P.A. Merkel, G.H. Lo, J.T. Holbrook, N.B. Allen, J.C. Davis Jr., G.S. Hoffman, W.J. McCune, E.W. St. Clair, U. Specks, R. Spiera, J.H. Stone.
Provision of study materials or patients: P.A. Merkel, N.B. Allen, J.C. Davis Jr., G.S. Hoffman, W.J. McCune, E.W. St. Clair, U. Specks, R. Spiera, M. Petri, J.H. Stone.
Statistical expertise: P.A. Merkel, J.T. Holbrook.
Obtaining of funding: P.A. Merkel, J.T. Holbrook, J.H. Stone.
Administrative, technical, or logistic support: P.A. Merkel, J.T. Holbrook, J.C. Davis Jr., G.S. Hoffman.
Collection and assembly of data: P.A. Merkel, J.C. Davis Jr., G.S. Hoffman, W.J. McCune, E.W. St. Clair, U. Specks, R. Spiera, M. Petri, J.H. Stone.
Venous thrombotic events (VTEs) have been observed in Wegener granulomatosis, but the incidence rate is not known.
To measure the incidence of VTEs in patients with Wegener granulomatosis.
Prospective, observational cohort study.
A multicenter, randomized, double-blind, placebo-controlled treatment trial for Wegener granulomatosis.
180 patients with Wegener granulomatosis enrolled during periods of active disease.
Venous thrombotic events (deep venous thromboses or pulmonary emboli) were documented and confirmed prospectively. Incidence rates were calculated on the basis of time to first VTE.
Thirteen patients had VTEs before enrollment. During 228 person-years of prospective follow-up, 16 VTEs occurred in 167 patients with no history of VTE. Median time from enrollment to VTE for patients with an event was 2.1 months. The incidence of VTE among patients with Wegener granulomatosis was 7.0 per 100 person-years (95% CI, 4.0 to 11.4).
Although prospectively recorded, screening for VTEs did not occur.
The incidence rate of VTEs in Wegener granulomatosis is high when compared with available rates in the general population, patients with lupus, and patients with rheumatoid arthritis. These results have important implications for clinical care of patients with Wegener granulomatosis.
*For a list of members of The Wegener's Granulomatosis Etanercept Trial Research Group, see the Appendix.
Merkel PA, Lo GH, Holbrook JT, Tibbs AK, Allen NB, Davis JC, et al. Brief Communication: High Incidence of Venous Thrombotic Events among Patients with Wegener Granulomatosis: The Wegener's Clinical Occurrence of Thrombosis (WeCLOT) Study. Ann Intern Med. ;142:620–626. doi: 10.7326/0003-4819-142-8-200505030-00011
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Published: Ann Intern Med. 2005;142(8):620-626.
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