Open Access Highly Accessed Research article

Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study

Gerd R Burmester1*, Marco Matucci-Cerinic2, Xavier Mariette3, Francisco Navarro-Blasco4, Sonja Kary5, Kristina Unnebrink5 and Hartmut Kupper5

Author Affiliations

1 Department of Rheumatology and Clinical Immunology, Charité – University Medicine, Charitéplatz 1, 10117 Berlin, Germany

2 Azienda Ospedaliera Careggi, Largo Giovanni Alessandro Brambilla, 3, Firenze, Italy

3 Université Paris-Sud, AP-HP, Hôpital Bicêtre, INSERM U1012, 63, rue Gabriel Péri, Le Kremlin Bicêtre 94276, France

4 Hospital General, Universitario de Elche, Cami de L'Almassera, 11, 03203 Elche, Alicante, Spain

5 AbbVie Deutschland GmbH & Co KG, Knollstraße 50, 67061 Ludwigshafen, Germany

For all author emails, please log on.

Arthritis Research & Therapy 2014, 16:R24  doi:10.1186/ar4452

Published: 27 January 2014

Additional files

Additional file 1:

Name and address of the Independent Ethics Committee/Institutional Review Board (IEC/IRB) from the ReAlise Study (NCT00234884).

Format: DOCX Size: 65KB Download file

Open Data

Additional file 2:

Name and address of the Independent Ethics Committee/Institutional Review Board (IEC/IRB) from the ReAct Study (NCT00448383).

Format: DOCX Size: 197KB Download file

Open Data

Additional file 3: Table S1-S6:

Overview of serious adverse events and adverse events of interest (E (E/100 PYs)) in patients who recieved no concomitant disease-modifying anti-rheumatic drugs (DMARDs), at least 1 concomitant DMARD, no concomitant corticosteriods, concomitant corticosteriods, no prior infliximab or etanercept, and prior infliximab or etanercept, respectively. E, events; PYs, patient-years.

Format: DOCX Size: 31KB Download file

Open Data

Additional file 4: Figure S1:

Percentages of patients with American College of Rheumatology (ACR) (A) 20%, (B) 50%, or (C) 70% improvement for those patients with prior use of TNF antagonists and TNF antagonist-naive patients. Data are shown as observed values for all evaluable patients at each time point during long-term treatment with adalimumab (ADA). LO, last observation.

Format: PDF Size: 30KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data

Additional file 5: Figure S2:

European League Against Rheumatism (EULAR) responses of at least ‘moderate’ and ‘good’ for those patients with prior use of TNF antagonists and TNF antagonist-naive patients. Data are shown as observed values for all evaluable patients at each time point during long-term treatment with adalimumab (ADA). LO, last observation.

Format: PDF Size: 29KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data

Additional file 6: Figure S3:

(A) Low disease activity (LDA) and (B) disease remission (REM) defined as Simplified Disease Activity Index (SDAI) ≤11 and SDAI ≤3.3, respectively, for those patients with prior use of TNF antagonists and TNF antagonist-naive patients. Percentages of patients with (C) minimal important difference ≥0.22 on the Health Assessment Questionnaire Disability Index (HAQ DI) and (D) normal function defined as HAQ DI ≤0.5. Data are shown as observed values for all evaluable patients at each time point during long-term treatment with adalimumab (ADA). LO, last observation.

Format: PDF Size: 82KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data