AB0467 Rapid achievement of remission with certolizumab pegol was maintained for one year: interim results from fast, a german non-interventional study in rheumatoid arthritis real life patients

Abstract

Background Certolizumab pegol (CZP) demonstrated a fast response and acceptable safety profile in clinical studies in rheumatoid arthritis (RA).1-3 Objectives To assess use of CZP in daily clinical practice in Germany. Methods The efficacy and tolerability of CZP (approved dosage: 400 mg at Weeks [Wks] 0, 2, and 4, then 200 mg every other Wk) is being assessed among 1068 patients (pts) with RA from 160 sites in the ongoing FαsT trial. Primary endpoint is DAS28(CRP) remission at Wk 104. At the cut-off date for this interim analysis (July 2011) 665 pts were enrolled. Wk 12 efficacy and safety data is reported in 160 pts with an available DAS28(CRP) value at baseline (BL) and Wk 12 (±1). Wk 52 (±8) efficacy is reported in 56 pts who completed up to 1 year and have non-missing observations (NMO). Results Of the 160 pts, 73% were female, mean age 54 years (yrs). At BL, 81% pts were RF positive and 79% ACPA positive. 50%/16% had received prior TNF inhibitors/other biologics, 90% had prior synthetic DMARDs. Mean RA duration was 10.7 yrs; mean CRP was 19.4 mg/L. Mean (SD) BL scores were: TJC 9.5 (6.8), SJC 7.6 (5.9), CDAI 29.9 (12.6), DAS28(CRP) 4.9 (1.0), DAS28(ESR) 5.4 (1.1) HAQ-DI 1.3 (0.7). Of the 160 pts, mean change from BL was -1.42 (1.3) in DAS28(CRP) at Wk 12 and 30.6%/16.3% were in DAS28(CRP) remission (REM)/low disease activity (LDA). Disposition of the 160 pts at Wk 52 is divided into pts with available DAS28(CRP) values (36.3%), pts who did not reach Wk 52 yet (38.3%) and pts who discontinued between Wk 12 and 52 (25%). 56 pts with NMO at Wk 52 reported mean (SD) changes from BL in DAS28(CRP) of -1.61 (1.1) at Wk 12 and -1.77 (1.3) at Wk 52. Of these 56 pts, at Wk 12 33.9%/28.6% and at Wk 52 44.6%/19.6% were in REM/LDA. The sum of the categories LDA/REM was similar (∼60%) at Wk 12 and 52 (Figure). Incidence rate (IR) of adverse events (AE) was 90 cases/100 pt-yrs (38 infections) and the IR of serious AE was 10.5 cases/100 pt-yrs. No deaths or cases of TB were reported. Conclusions In the FαsT non-interventional study, “real-life” RA pts treated with CZP achieved a fast reduction of disease activity by Wk12 which further improved for pts with available DAS28(CRP) values at Wk 52. Incidence and severity of AE was consistent with previous CZP experience and in line with the summary of product characteristics. References Arthritis Rheum 2008;58:3319–3329. Ann Rheum Dis 2009;68:797–804. Ann Rheum Dis 2009;68:805–811. Disclosure of Interest G. Burmester Grant/Research support from: UCB Pharma, Consultant for: UCB Pharma, Speakers Bureau: UCB Pharma, U. Müller-Ladner Consultant for: UCB Pharma, Speakers Bureau: UCB Pharma, H. Nüsslein Consultant for: UCB Pharma, Speakers Bureau: UCB Pharma, U. von Hinuber Consultant for: UCB Pharma, Speakers Bureau: UCB Pharma, E. Edelmann Consultant for: UCB Pharma, Speakers Bureau: UCB Pharma, J. Detert Consultant for: UCB Pharma, M. Höhle: None Declared, C. Richter Consultant for: UCB Pharma, Speakers Bureau: UCB Pharma, T. Klopsch: None Declared, T. Kumke Employee of...

Two Dosing Regimens of Certolizumab Pegol in Patients With Active Rheumatoid Arthritis

“…Post hoc analyses demonstrated that response to CZP during the run-in phase and the response for the 2 different dosing regimens were similar regardless of prior anti-TNF exposure at baseline. This supports emerging data on the efficacy of CZP in patients with prior anti-TNF exposure from clinical trials ( 21 , 22 ), observational studies ( 23 , 24 ), and registries ( 25 ). These studies have shown robust clinical responses to CZP, irrespective of previous anti-TNF therapy.…”

Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland

“…For example, patients treated with CZP in the RAPID 1 study experienced improvements in clinical and patient-reported outcomes after 1 week, which were maintained over 1 year [ 7 ]. Similar outcomes have been observed in a German non-interventional study (NCT01069419) [ 10 ], in which patients treated with CZP during routine clinical practice achieved a rapid reduction of disease activity by week 12, which was maintained to week 52. However, there are currently limited real-world data describing these outcomes in the UK and Ireland.…”

Effectiveness and safety of certolizumab pegol in rheumatoid arthritis patients in Canadian practice: 2-year results from the observational FαsT-CAN study

“…5,6,16 The proportion of patients in the FAS who completed the study to Week 104 was 42%, which is similar to the retention rate (36.2%) observed in the German FαST non-interventional study at Week 52. 17 While, the PROACTIVE non-interventional study in the United Kingdom and Ireland had a higher retention rate, with 68.5% of patients completing the study to Week 88. 18 Within the present study, it was observed that similar proportions of patients achieved DAS28 < 2.6 at Week 104, whether they had <2 years or ⩾2 years RA duration.…”