Rituximab in routine care of severe active rheumatoid arthritis
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...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2019
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| In: |
Zeitschrift für Rheumatologie
Year: 2019, Jahrgang: 78, Heft: 9, Pages: 881-888 |
| ISSN: | 1435-1250 |
| DOI: | 10.1007/s00393-018-0552-0 |
| Online-Zugang: | Verlag, Volltext: https://doi.org/10.1007/s00393-018-0552-0
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| Verfasserangaben: | 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 |
MARC
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| 245 | 1 | 0 | |a Rituximab in routine care of severe active rheumatoid arthritis |c 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 |
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| 520 | |a 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. | ||
| 650 | 4 | |a Beobachtungsstudie | |
| 650 | 4 | |a Effectiveness | |
| 650 | 4 | |a Observational study | |
| 650 | 4 | |a Response latency | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a Sicherheit | |
| 650 | 4 | |a Therapie | |
| 650 | 4 | |a Therapy | |
| 650 | 4 | |a Wirklatenz | |
| 650 | 4 | |a Wirksamkeit | |
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| 700 | 1 | |a Berger, S. |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Kellner, H. |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Müller, G. A. |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Peters, M. A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wendler, J. |e VerfasserIn |4 aut | |
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