Abstract: Current Status of Outcome Measures in Vasculitis: Focus on Wegener's Granulomatosis and Microscopic Polyangiitis. Report from OMERACT 7

Current Status of Outcome Measures in Vasculitis: Focus on Wegener's Granulomatosis and Microscopic Polyangiitis. Report from OMERACT 7

PETER A. MERKEL, PHILIP SEO, PETER ARIES, TUHINA NEOGI, ALEXANDRA VILLA-FORTE, MAARTEN BOERS, DAVID CUTHBERTSON, DAVID T. FELSON, BERNHARD HELLMICH, GARY S. HOFFMAN, DAVID R. JAYNE, CEES G.M. KALLENBERG, JEFFREY KRISCHER, ALFRED MAHR, ERIC L. MATTESON, ULRICH SPECKS, RAASHID LUQMANI, and JOHN H. STONE; for the Vasculitis Clinical Research Consortium

ABSTRACT.

The complexity of assessing disease activity, disease status, and damage in the vasculitides reflects the multisystemic pathologic manifestations of these often chronic illnesses. Major progress has been made in the past decade in the development of validated and widely accepted outcome measures for use in clinical trials. Over time, these tools have been regularly revised, expanded, and supplemented with new measures of disease prognosis and damage. As a result clinical research in this area has become increasingly complex. This article critically reviews the current status of tools for assessing disease activity and damage in "ANCA-associated" vasculitides (Wegener's granulomatosis and microscopic polyangiitis), summarizes the current level of validation of each measure, addresses central problems and controversies to be considered during development of new vasculitis assessment tools, and proposes a series of research agendas for consideration by the vasculitis research community. (J Rheumatol 2005;32:2488-95)

Key Indexing Terms:

VASCULITIS
OUTCOME MEASURES
WEGENER'S GRANULOMATOSIS
MICROSCOPIC POLYANGIITIS

From the Boston University School of Medicine, Boston, MA; Johns Hopkins University, Baltimore, MD, USA; University Schleswig-Holstein, Lubeck, Germany; Cleveland Clinic, Cleveland, OH, USA; VU University Medical Center, Amsterdam, The Netherlands; Moffitt Cancer Center, Tampa, FL, USA; Addenbrookes Hospital, Cambridge, UK; University Hospital, Groningen, The Netherlands; Hôpital Cochin, Paris, France; Mayo Clinic College of Medicine, Rochester, MN, USA; and University of Edinburgh, Edinburgh, UK.

P.A. Merkel, MD, MPH, Boston University School of Medicine; P. Seo, MD, Johns Hopkins University; P. Aries, MD, University Schleswig-Holstein; T. Neogi, MD, Boston University School of Medicine; A. Villa-Forte, MD, Cleveland Clinic; M. Boers, MD, PhD; D. Cuthbertson, MD, VU University Medical Center; D.T. Felson, Boston University School of Medicine; B. Hellmich, MD, Johns Hopkins University; G.S. Hoffman, MD, Cleveland Clinic; D. Jayne, MD, Addenbrookes Hospital; J. Krischer, MD, Moffitt Cancer Center; A. Mahr, MD, Hôpital Cochin; E.L. Matteson, MD; U. Specks, MD, Mayo Clinic College of Medicine; R. Luqmani, MD, Boston University School of Medicine; J.H. Stone, MD, Johns Hopkins University; for the Vasculitis Clinical Research Consortium.

Supported by The National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Center for Research Resources/NIH. The Vasculitis Clinical Research Consortium is part of the NIH Rare Diseases Clinical Research Network (http://rarediseasesnetwork.org/vcrc).

Drs. Merkel, Matteson, and Stone are supported by Mid-Career Development Awards in Clinical Investigation (NIH-NIAMS: K24 AR02224, AR47578-01A1, and AR049185).

Address reprint requests to Dr. P.A. Merkel, Vasculitis Center, E5, Boston University School of Medicine, 715 Albany Street, Boston, MA 02118. E-mail: pmerkel@bu.edu