RECOMMENDATIONS

Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

D Aletaha¹, R Landewe², T Karonitsch¹, J Bathon³, M Boers⁴, C Bombardier⁵, S Bombardieri⁶, H Choi⁷, B Combe⁸, M Dougados⁹, P Emery¹⁰, J Gomez-Reino¹¹, E Keystone¹², G Koch¹³, T K Kvien¹⁴, E Martin-Mola¹⁵, M Matucci-Cerinic¹⁶, K Michaud¹⁷, J O’Dell¹⁷, H Paulus¹⁸, T Pincus¹⁹, P Richards²⁰, L Simon²¹, J Siegel²², J S Smolen^1,23, T Sokka²⁴, V Strand²⁵, P Tugwell²⁶, D van der Heijde²⁷, P van Riel²⁸, S Vlad²⁹, R van Vollenhoven³⁰, M Ward³¹, M Weinblatt³², G Wells³³, B White³⁴, F Wolfe³⁵, B Zhang²⁹, A Zink³⁶, D Felson²⁹

¹ Medical University of Vienna, Vienna, Austria
² University Hospital Maastricht, Maastricht, The Netherlands
³ Johns Hopkins University, Baltimore, Maryland, USA
⁴ VU University Medical Center, Amsterdam, The Netherlands
⁵ Institute for Work and Health, Toronto, Ontario, Canada
⁶ University of Pisa, Pisa, Italy
⁷ University of British Columbia, Vancouver, British Columbia, Canada
⁸ CHU de Montpellier, Montpellier, France
⁹ Paris-Descartes University, Paris, France
¹⁰ University of Leeds, Leeds, UK
¹¹ University of Santiago de Compostela School of Medicine, Santiago, Spain
¹² University of Toronto, Ontario, Canada
¹³ University of North Carolina, Chapel Hill, North Carolina, USA
¹⁴ Diakonhjemmet Hospital, Oslo, Norway
¹⁵ Hospital Universitario La Paz, Madrid, Spain
¹⁶ University of Florence, Florence, Italy
¹⁷ University of Nebraska, Omaha, Nebraska, USA
¹⁸ University of California, Los Angeles, California, USA
¹⁹ New York University Hospital for Joint Diseases, New York, USA
²⁰ University of Bristol, Bristol, UK
²¹ Beth Israel Deaconess Medical, Boston, Massachusetts, USA
²² Food and Drug Administration, Rockville, Maryland, USA
²³ Hietzing Hospital, Vienna, Austria
²⁴ Jyvaskyla Central Hospital, Jyvaskyla, Finland
²⁵ Stanford University, Portola Valley, California, USA
²⁶ Institute of Population Health, Ottawa, Ontario, Canada
²⁷ Leiden University Medical Center, Leiden, The Netherlands
²⁸ Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
²⁹ Boston University School of Medicine, Boston, Massachusetts, USA
³⁰ Karolinska University Hospital, Stockholm, Sweden
³¹ National Institutes of Health, Bethesda, Maryland, USA
³² Brigham & Women’s Hospital, Boston, Massachusetts, USA
³³ University of Ottawa, Ottawa, Ontario, Canada
³⁴ Medimmune, Gaithersburg, Maryland, USA
³⁵ National Data Bank for Rheumatic Diseases, Wichita, Kansas, USA
³⁶ Charité Medical School, Berlin, Germany

Correspondence to:
D Aletaha, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria; daniel.aletaha{at}meduniwien.ac.at

Objective: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).

Methods: The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).

Results: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue.

Conclusions: These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

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