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Open Access Highly Accessed Research article

Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients

Joerg Wendler1*, Gerd R Burmester2, Helmut Sörensen3, Andreas Krause4, Constanze Richter5, Hans-Peter Tony6, Andrea Rubbert-Roth7, Peter Bartz-Bazzanella8, Siegfried Wassenberg9, Iris Haug-Rost10 and Thomas Dörner11

Author Affiliations

1 Rheumatologische Schwerpunktpraxis, Moehrendorfer Strasse 1c, D-91056 Erlangen, Germany

2 Department of Rheumatology and Clinical Immunology, Charité – University Medicine Berlin, Free University and Humboldt University Berlin, Schumannstr 20-21, 10098 Berlin, Germany

3 Rheumaprojekt Berlin-Brandenburg, Argentinische Allee 42, 14163 Berlin, Germany

4 Immanuel Krankenhaus, Lindenberger Weg 19, D-13125 Berlin, Germany

5 Rheumatology Medical Centre, Stuttgart, Germany

6 Medizinische Klinik und Poliklinik II, Rheumatology/Clinical Immunology, Klinikstr 6-8, 97070 Würzburg, Germany

7 Medical Clinic I, University of Cologne, Josef-Stelzmann-Str 9, 50931 Cologne, Germany

8 Klinik für Internistische Rheumatologie, Mauerfeldchen 25, 52146 Würselen, Germany

9 Ev. Fachkrankenhaus Ratingen, Rosenstraße 2, D-40882 Ratingen, Germany

10 Department of Rheumatology, Specialty Care/Medical Affairs Roche Pharma AG, Emil-Barell-Straße 1, D-79639 Grenzach-Wyhlen, Germany

11 CC12, Department of Medicine Rheumatology and Clinical Immunology and DRFZ Berlin, Schumannstr 20/21, 10098 Berlin, Germany

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Arthritis Research & Therapy 2014, 16:R80  doi:10.1186/ar4521

Published: 26 March 2014

Abstract

Introduction

The aim of this study was to evaluate the safety and efficacy of rituximab (RTX) in a large cohort of patients with rheumatoid arthritis in routine care, and to monitor changes in daily practice since the introduction of RTX therapy.

Methods

This was a multicentre, prospective, non-interventional study conducted under routine practice conditions in Germany. Efficacy was evaluated using Disease Activity Score in 28 joints (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Safety was assessed by recording adverse drug reactions (ADRs). Physician and patient global efficacy and tolerability assessments were also evaluated.

Results

Overall, 2,484 patients (76.7% female, mean age 56.4 years, mean disease duration 11.7 years) received RTX treatment (22.7% monotherapy). The total observation period was approximately six-years (median follow-up 14.7 months). RTX treatment led to improvements in DAS28 and HAQ-DI that were sustained over multiple courses. DAS28 improvements positively correlated with higher rheumatoid factor levels up to 50 IU/ml. Response and tolerability were rated good/very good by the majority of physicians and patients. Mean treatment intervals were 10.5 and 6.8 months for the first and last 400 enrolled patients, respectively. Infections were the most frequently reported ADRs (9.1%; 11.39/100 patient-years); approximately 1% of patients per course discontinued therapy due to ADRs.

Conclusions

Prolonged RTX treatment in routine care is associated with good efficacy and tolerability, as measured by conventional parameters and by physicians’ and patients’ global assessments. Rheumatoid factor status served as a distinct and quantitative biomarker of RTX responsiveness. With growing experience, physicians repeated treatments earlier in patients with less severe disease activity.