Rituximab in routine care of severe active rheumatoid arthritis

• Verfasst von: Krause, Andreas [VerfasserIn]
• Verfasst von: Aries, P. M. [VerfasserIn]
• Verfasst von: Berger, S. [VerfasserIn]
• Verfasst von: Fiehn, C. [VerfasserIn]
• Verfasst von: Kellner, H. [VerfasserIn]
• Verfasst von: Lorenz, Hanns-Martin [VerfasserIn]
• Verfasst von: Meier, L. [VerfasserIn]
• Verfasst von: Müller, G. A. [VerfasserIn]
• Verfasst von: Müller-Ladner, U. [VerfasserIn]
• Verfasst von: Schwarting, A. [VerfasserIn]
• Verfasst von: Tony, H.-P. [VerfasserIn]
• Verfasst von: Peters, M. A. [VerfasserIn]
• Verfasst von: Wendler, J. [VerfasserIn]
• Titel: Rituximab in routine care of severe active rheumatoid arthritis
• Verf.angabe: A. Krause, P.M. Aries, S. Berger, C. Fiehn, H. Kellner, H.-M. Lorenz, L. Meier, G. A. Müller, U. Müller-Ladner, A. Schwarting, H.-P. Tony, M.A. Peters, J. Wendler
• Jahr: 2019
• Jahr des Originals: 2018
• Umfang: 8 S.
• Fussnoten: Published online: 1 October 2018 ; Gesehen am 09.12.2019
• Titel Quelle: Enthalten in: Zeitschrift für Rheumatologie
• Ort Quelle: Darmstadt : Steinkopff, 1997
• Jahr Quelle: 2019
• Band/Heft Quelle: 78(2019), 9, Seite 881-888
• ISSN Quelle: 1435-1250
• DOI: doi:10.1007/s00393-018-0552-0
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Beobachtungsstudie
• Sach-SW: Effectiveness
• Sach-SW: Observational study
• Sach-SW: Response latency
• Sach-SW: Safety
• Sach-SW: Sicherheit
• Sach-SW: Therapie
• Sach-SW: Therapy
• Sach-SW: Wirklatenz
• Sach-SW: Wirksamkeit
• K10plus-PPN: 1684849985

Abstract

ObjectiveTo assess safety, effectiveness and onset of effect of rituximab (RTX) in routine clinical treatment of severe, active rheumatoid arthritis (RA).MethodsProspective, multi-centre, non-interventional study in rheumatological outpatient clinics or private practices in Germany. RTX-naïve adult patients were to receive RTX according to marketing authorisation and at their physician’s discretion. Also according to their physician’s discretion, patients could receive a second cycle of RTX (re-treatment = treatment continuation). Major outcome was the change in Disease Activity Score based on 28-joints count and erythrocyte sedimentation rate (DAS28-ESR) over 24 weeks and during 6 months of re-treatment.ResultsOverall, 1653 patients received at least one cycle RTX; 99.2% of these had received disease-modifying antirheumatic drugs (DMARD) pre-treatment and 75.5% anti-tumor necrosis factor(TNF)‑α pre-treatment. After a mean interval of 8.0 months, 820 patients received RTX re-treatment. Mean DAS28-ESR decreased from 5.3 at baseline to 3.8 after 24 weeks (−1.5 [95% confidence interval, CI: −1.6; −1.4]), and from 4.1 at start of cycle 2 to 3.5 at study end (change from baseline: −1.8 [95% CI: −2.0; −1.7]). Improvements in DAS28-ESR and Health Assessment Questionnaire (HAQ) score occurred mainly during the first 12 weeks of RTX treatment, with further DAS28-ESR improvement until week 24 or month 6 of re-treatment. Improvements in DAS28-ESR and EULAR responses were more pronounced in seropositive patients. RF was a predictor of DAS28-ESR change to study end. Safety analysis showed the established profile of RTX.ConclusionRTX was safe and effective in a real-life setting with rapid and sustained improvement in RA signs and symptoms.