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Effectiveness and safety of anti-tumour necrosis factor therapy with certolizumab pegol observed in real-life rheumatoid arthritis patients in Germany: results from the non-interventional FαsT study
G. Burmester1, H. Nüsslein2, U. Von Hinüber3, J. Detert4, C. Richter5, T. Kumke6, I. Leunikava7, U. Lendl8, D. Fricke9, U. Müller-Ladner10
- Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany. gerd.burmester@charite.de
- Rheumatology Practice, University of Erlangen-Nürnberg, Germany.
- Private Practice, Hildesheim, Germany.
- Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Germany.
- Private Practice, Stuttgart, Germany.
- UCB Pharma, Monheim, Germany.
- UCB Pharma, Monheim, Germany.
- UCB Pharma, Monheim, Germany.
- UCB Pharma, Monheim, Germany.
- Department of Rheumatology and Clinical Immunology, Justus-Liebig University Giessen, Campus Kerckhoff Bad Nauheim, Germany.
CER11453
2019 Vol.37, N°5
PI 0842, PF 0851
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PMID: 30873942 [PubMed]
Received: 11/06/2018
Accepted : 10/12/2018
In Press: 07/03/2019
Published: 29/08/2019
Abstract
OBJECTIVES:
To report the tolerability and effectiveness of certolizumab pegol (CZP) for the treatment of patients with active rheumatoid arthritis (RA) in a routine clinical practice setting.
METHODS:
FαsT (NCT01069419) was a non-interventional, observational 104-week (wk) study performed at 163 sites in Germany. RA patients were treated according to the treating physician’s discretion. Clinical remission (DAS28-CRP<2.6) at wk 104 was the primary endpoint of the study. Remission data based on ESR (DAS28-ESR<2.6) were also assessed. Secondary endpoints included the effect of CZP treatment on pain, physical function and disease activity. Safety data were collected at all study visits.
RESULTS:
1,117 patients were enrolled in the FαsT study (78% female, mean age: 55 years). Rapid responses were observed at wk 6 (18.7% and 12.9% patients in DAS28-CRP and DAS28-ESR remission, respectively) with improvements sustained over 2 years (20.0% and 13.9% patients achieved DAS28-CRP and DAS28-ESR remission, respectively at wk 104). Anti-TNF naïve patients exhibited greater improvements than anti-TNF experienced patients (mean DAS28-ESR change from baseline [CfB] -1.3, -1.5 and -1.7 for patients with ≥2, 1 and no anti-TNFs, respectively at wk104). Improvements were reported in all secondary endpoint measures. 1,111 patients were exposed to CZP for a total of 1,538 patient-years during the study. 2,000 treatment-emergent adverse events (TEAEs) were reported in 745 patients (67.1%); 9 (0.8%) experienced TEAEs with fatal outcome.
CONCLUSIONS:
CZP demonstrated efficacy and safety outcomes reflective of those observed in trial settings. Rapid reductions in disease activity and improvements in physical function were maintained up to wk 104.
