TY  - JOUR
A1  - Wendler, Jörg
A1  - Burmester, Gerd R.
A1  - Sörensen, Helmut
A1  - Krause, Andreas
A1  - Richter, Constanze
A1  - Tony, Hans-Peter
A1  - Rubbert-Roth, Andrea
A1  - Bartz-Bazzanella, Peter
A1  - Wassenberg, Siegfried
A1  - Haug-Rost, Iris
A1  - Dörner, Thomas
T1  - Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients
JF  - Arthritis Research & Therapy
N2  - 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.
KW  - Rituximab
Y1  - 2014
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-121184
VL  - 16
IS  - 2
ER  - 
TY  - JOUR
A1  - Stephan, Marlene
A1  - Tascilar, Koray
A1  - Yalcin-Mutlu, Melek
A1  - Hagen, Melanie
A1  - Haschka, Judith
A1  - Reiser, Michaela
A1  - Hartmann, Fabian
A1  - Kleyer, Arnd
A1  - Hueber, Axel J.
A1  - Manger, Bernhard
A1  - Figueiredo, Camille
A1  - Cobra, Jayme Fogagnolo
A1  - Tony, Hans-Peter
A1  - Finzel, Stephanie
A1  - Kleinert, Stefan
A1  - Wendler, Jörg
A1  - Schuch, Florian
A1  - Ronneberger, Monika
A1  - Feuchtenberger, Martin
A1  - Fleck, Martin
A1  - Manger, Karin
A1  - Ochs, Wolfgang
A1  - Schmitt-Haendle, Matthias
A1  - Lorenz, Hannes Martin
A1  - Nüsslein, Hubert
A1  - Alten, Rieke
A1  - Henes, Joerg
A1  - Krüger, Klaus
A1  - Schett, Georg
A1  - Rech, Jürgen
T1  - Physical function of RA patients tapering treatment — a post hoc analysis of the randomized controlled RETRO trial
JF  - Journal of Clinical Medicine
N2  - Several studies have shown that tapering or stopping disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients in sustained remission is feasible. However, tapering/stopping bears the risk of decline in physical function as some patients may relapse and face increased disease activity. Here, we analyzed the impact of tapering or stopping DMARD treatment on the physical function of RA patients. The study was a post hoc analysis of physical functional worsening for 282 patients with RA in sustained remission tapering and stopping DMARD treatment in the prospective randomized RETRO study. HAQ and DAS-28 scores were determined in baseline samples of patients continuing DMARD (arm 1), tapering their dose by 50% (arm 2), or stopping after tapering (arm 3). Patients were followed over 1 year, and HAQ and DAS-28 scores were evaluated every 3 months. The effect of treatment reduction strategy on functional worsening was assessed in a recurrent-event Cox regression model with a study-group (control, taper, and taper/stop) as the predictor. Two-hundred and eighty-two patients were analyzed. In 58 patients, functional worsening was observed. The incidences suggest a higher probability of functional worsening in patients tapering and/or stopping DMARDs, which is likely due to higher relapse rates in these individuals. At the end of the study, however, functional worsening was similar among the groups. Point estimates and survival curves show that the decline in functionality according to HAQ after tapering or discontinuation of DMARDs in RA patients with stable remission is associated with recurrence, but not with an overall functional decline.
KW  - HAQ
KW  - Rheumatoid Arthritis
KW  - PROM’s
KW  - DMARD
KW  - DAS28
Y1  - 2023
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-319349
SN  - 2077-0383
VL  - 12
IS  - 11
ER  -