Universität zu Köln

Wendler, Joerg, Burmester, Gerd R., Soerensen, Helmut, Krause, Andreas, Richter, Constanze, Tony, Hans-Peter, Rubbert-Roth, Andrea, Bartz-Bazzanella, Peter, Wassenberg, Siegfried, Haug-Rost, Iris and Doerner, Thomas (2014). Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients. Arthritis Res. Ther., 16 (2). LONDON: BMC. ISSN 1478-6362

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Wendler, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Burmester, Gerd R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Soerensen, Helmut UNSPECIFIED UNSPECIFIED UNSPECIFIED Krause, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Richter, Constanze UNSPECIFIED UNSPECIFIED UNSPECIFIED Tony, Hans-Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartz-Bazzanella, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Wassenberg, Siegfried UNSPECIFIED UNSPECIFIED UNSPECIFIED Haug-Rost, Iris UNSPECIFIED UNSPECIFIED UNSPECIFIED Doerner, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-449929
DOI:	10.1186/ar4521
Journal or Publication Title:	Arthritis Res. Ther.
Volume:	16
Number:	2
Date:	2014
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1478-6362
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NECROSIS-FACTOR INHIBITORS; RECEIVING RITUXIMAB; EFFICACY; SAFETY; RECOMMENDATIONS; METHOTREXATE; THERAPY; COURSES Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/44992