ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 595

Cinical Responses and Improvements in Patient-Reported Outcomes Are Associated with Increased Productivity in the Workplace and at Home in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol

Vivian P. Bykerk1, Paul Emery2, Michael Weinblatt3, Gerd-Rüdiger Burmester4, Daniel E. Furst5, Xavier Mariette6, Ronald van Vollenhoven7, Oana Purcaru8, Pauline Ralston9 and Clifton Bingham III10, 1Divison of Rheumatology, Hospital for Special Surgery, New York, NY, 2University of Leeds, Midlothian, United Kingdom, 3Brigham and Women’s Hospital, Boston, MA, 4Charité – University Medicine Berlin, Berlin, Germany, 5David Geffen School of Medicine at UCLA, Los Angeles, CA, 6Université Paris-Sud, Paris, France, 7Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, 8UCB Pharma, Slough, United Kingdom, 9Hays Pharma, London, United Kingdom, 10Johns Hopkins University, Baltimore, MD

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Sunday, November 13, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Rheumatoid arthritis (RA) is associated with work disability, loss of productivity and reduced quality of life. In established and early RA, compared with MTX alone, certolizumab pegol (CZP)+MTX significantly improves the signs and symptoms of RA,1 inhibits radiographic progression and improves workplace/household productivity.2,3 In early RA, the association between reaching clinical targets and patient (pt) treatment targets, in terms of workplace and household productivity, has not been assessed. We evaluated the association between CZP-mediated stringent clinical targets and improvements in workplace/household productivity.

Methods: C-EARLY (NCT01519791) was a double-blind, randomized controlled trial, which enrolled DMARD-naïve pts with active, moderate to severe, progressive, early RA (<1 yr from diagnosis).2 Pts were randomized 3:1 to CZP+MTX or placebo (PBO)+MTX. MTX was titrated to 15–25 mg/wk by Wk 8; maximum tolerated dose (optimized dose) was maintained to Wk 52. Associations between clinical responses and workplace/household productivity outcomes were evaluated at Wk 52 in CZP pts. Clinical response criteria included sustained remission (sREM: DAS28[ESR] <2.6 at Wks 40 and 52), sustained low disease activity (sLDA: DAS28[ESR] ≤3.2 at Wks 40 and 52), radiographic non-progression (mTSS change ≤0.5), and normative physical function (HAQ-DI ≤0.5). Changes from baseline (BL) at Wk 52 in workplace/household productivity (Work Productivity Survey [WPS]4) were compared in responders/non-responders, using a non-parametric bootstrap-t method. Missing data were imputed using LOCF for WPS outcomes and NRI for clinical responses.

Results: 879 pts were enrolled; 655 pts in the CZP+MTX group were included in the full analysis set. At BL, 52.3% pts were employed; similar burden at BL was seen between groups, except in absenteeism/presenteeism for pts in sREM/sLDA. Overall, pts achieving sREM/sLDA and normative function reported greater improvements in workplace/household productivity at Wk 52 vs non-responders (Table). An association was not seen between radiographic non-progression and workplace/household productivity (Table). Responders also reported greater improvements in family and social leisure activity participation (data not shown).

Conclusion: Achieving stringent clinical targets, such as sREM/sLDA and normative physical function, were associated with numerically greater improvements in workplace and household productivity after 1 yr in DMARD-naïve pts with early, moderate to severe, progressive RA treated with CZP. The ability to return to maximum levels of participation early in the disease course is an important goal for pts with RA. References: 1. Strand V. Arthritis Res Ther 2009;11:R170; 2. Emery P. Ann Rheum Dis 2016 doi:10.1136/annrheumdis-2015-209057; 3. Kavanaugh A. Arthritis Care Res 2009;61(11);1592–1600; 4. Osterhaus J. Arthritis Res Ther 2009;11:R73

Disclosure: V. P. Bykerk, AbbVie, Bristol-Myers Squibb, Pfizer, Genentech, Regeneron, UCB Pharma, 5; P. Emery, Pfizer, MSD, AbbVie, UCB, Roche, Brisol-Myers Squibb, Schering Plough, Novartis, Samsung, 5,Pfizer, MSD, AbbVie, UCB Pharma, Roche, Bristol-Myers Squibb, Schering Plough, Novartis, Samsung, 9; M. Weinblatt, Bristol Myers Squibb, Crescendo Bioscience, UCB Pharma, 2,Amgen, AbbVie, Bristol Myers Squibb, Crescendo Bioscience, UCB Pharma, Roche, 5; G. R. Burmester, AbbVie, MSD, Pfizer, Roche, UCB Pharma, 5; D. E. Furst, Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, 2,Abbott, Actelion, Amgen, Bristol-Myers Squibb, BiogenIdec, Janssen, Gilead, GlaxoSmithKline, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, 5,Abbott, Actelion, Amgen, Bristol-Myers Squibb, BiogenIdec, Janssen, Gilead, NIH, Roche/Genentech, 9,Abbott, Actelion, UCB Pharma, 9; X. Mariette, Pfizer, GlaxoSmithKline, and Roche, 2,Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Roche, UCB Pharma and Sanofi-Aventis, 5; R. van Vollenhoven, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Roche, UCB Pharma, 2,AbbVie, Biotest, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Pfizer, Roche, UCB Pharma, Vertex, 5; O. Purcaru, UCB Pharma, 3; P. Ralston, Hays Pharma, 3; C. Bingham III, UCB Pharma, 5.

To cite this abstract in AMA style:

Bykerk VP, Emery P, Weinblatt M, Burmester GR, Furst DE, Mariette X, van Vollenhoven R, Purcaru O, Ralston P, Bingham C III. Cinical Responses and Improvements in Patient-Reported Outcomes Are Associated with Increased Productivity in the Workplace and at Home in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/cinical-responses-and-improvements-in-patient-reported-outcomes-are-associated-with-increased-productivity-in-the-workplace-and-at-home-in-rheumatoid-arthritis-patients-treated-with-certolizumab-pegol/. Accessed .

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