Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Efficacy, Safety, and Improvements in Work Productivity and Daily Activities with Certolizumab Pegol After Incomplete Response to Disease-Modifying Anti-Rheumatic Drugs in Patients with Low to Moderate Disease Activity.
Smolen1, Josef, Emery2, Paul, Ferraccioli3, Gianfranco, Berenbaum4, Francis, Davies5, Owen, Purcaru5, Oana, Ambrugeat5, Johann
Medical University of Vienna and Hietzing Hospital, Vienna, Austria
Leeds Institute of Molecular Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK, Leeds, United Kingdom
Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy
Pierre and Marie Curie University, AP-HP St-Antoine Hospital, Paris, France
UCB, Brussels, Belgium
UCB, Smyrna, GA
Johan Wolfgang Goethe University, Frankfurt am Main, Germany
We evaluated the efficacy, safety, and effects on work productivity and daily activity of certolizumab pegol (CZP) in combination with nonbiologic DMARDs in RA patients (pts) with low to moderate disease activity (DA).
CERTAIN (CERTolizumab pegol in the treatment of RA: remission INduction and maintenance in pts with low DA) was a 52-wk, double-blind, Phase IIIb trial that enrolled pts with low to moderate DA (CDAI >6 and <=16). Pts were randomized (1:1) to CZP (400 mg at Wks 0, 2, and 4, then 200 mg every other wk) or placebo (PBO) + existing DMARDs for an initial 24-wk phase (NCT00674362). Primary efficacy end point was % of pts in CDAI remission (<=2.8) at both Wks 20 and 24. CDAI/SDAI/DAS remission was assessed using NRI. Pts with CDAI remission at Wks 20 and 24 stopped CZP and were followed until Wk 52. Work productivity and daily activities were assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI:RA). We report data for efficacy, safety, and WPAI:RA up to Wk 24.
A total of 194 pts were randomized (mean age 54 y; 80% female) and 164 (84.5%) completed 24 wks. At BL, mean RA duration was 4.6 y and >90% of pts had moderate DA. Mean BL scores were SJC = 3.3, TJC = 3.8, CDAI = 13.4, HAQ-DI = 1.1, and DAS28(ESR) = 4.5. Significantly more CZP pts had CDAI remission at both Wks 20 and 24 than PBO pts (18.8% vs 6.1%, p=0.013 by logistic regression). At Wk 24, more CZP pts had CDAI remission/low DA (63.1% vs 29.7%) (Figure). CZP was associated with prevention of disease worsening; fewer CZP pts had moderate/high DA (37.0% vs 70.4%). Most of the effect of treatment with CZP was already seen at Wk 12, with similar numbers of pts in CDAI remission/low DA as at Wk 24. Mean CDAI/SDAI/DAS28 scores worsened in PBO pts (mean change from BL at Wk 24 CZP vs PBO: 4.01/4.4/1.12 vs 3.38/3.4/0.07). Safety results at Wk 24 indicated that CZP was well tolerated with AE, serious AE, and serious infection rates comparable between CZP and PBO (68.8% vs 67.3%; 5.2% vs 7.1%; 2.1% vs 1.0%). At BL, 32.4% pts were employed (29% in PBO vs 35.9% in CZP). Increased WPAI:RA mean scores at BL indicated an economic burden of low to moderate RA, especially in terms of overall work and daily activities (Table). Over the 24 wks, CZP pts reported on average greater improvements in absenteeism, presenteeism, overall work impairment, and daily activity, than PBO (Table).
In RA pts with longstanding low to moderate DA, the addition of CZP to nonbiologic DMARDs was well tolerated and associated with increased rates of remission, prevention of disease worsening, and improved work productivity and daily activity.
To cite this abstract, please use the following information:
Smolen, Josef, Emery, Paul, Ferraccioli, Gianfranco, Berenbaum, Francis, Davies, Owen, Purcaru, Oana, et al; Efficacy, Safety, and Improvements in Work Productivity and Daily Activities with Certolizumab Pegol After Incomplete Response to Disease-Modifying Anti-Rheumatic Drugs in Patients with Low to Moderate Disease Activity. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :2214