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SAT0165 Improvements in Patient-Reported Outcomes and Workplace and Household Productivity Following 52 Weeks of Treatment with Certolizumab Pegol in Combination with Methotrexate in Dmard-Naïve Early Rheumatoid Arthritis Patients: Results from the C-Early Randomized, Double-Blind, Controlled Phase 3 Study
  1. P. Emery1,
  2. C.O. Bingham2,
  3. G.-R. Burmester3,
  4. V.P. Bykerk4,
  5. D.E. Furst5,
  6. X. Mariette6,
  7. O. Purcaru7,
  8. G. Coteur7,
  9. B. VanLunen8,
  10. M. Weinblatt9
  1. 1University of Leeds, Leeds, United Kingdom
  2. 2John Hopkins University, Baltimore, United States
  3. 3Charité - University Medicine Berlin, Berlin, Germany
  4. 4Weill Cornell Medical College, Hospital for Special Surgery, New York
  5. 5University of California, Los Angeles, California, United States
  6. 6Université Paris-Sud, AP-HP, Hôpitaux universitaires Paris-Sud, Paris, France
  7. 7UCB Pharma, Brussels, Belgium
  8. 8UCB Pharma, Raleigh
  9. 9Brigham and Women's Hospital, Boston, United States

Abstract

Background Rheumatoid arthritis (RA) leads to high burden on patient (pt) physical function, quality of life (QoL) and work disability. Improvements in pt-reported outcomes (PROs)1 and workplace and household productivity2 with certolizumab pegol (CZP)+MTX were reported in established RA. Here we report results from C-EARLY, a phase 3 study of CZP+MTX in DMARD-naïve pts with early active RA.

Objectives To assess the effect of CZP+MTX vs placebo (PBO)+MTX on PROs, workplace and household productivity, and need for help with daily activities in DMARD-naïve pts with early active RA.

Methods Pts in this multicenter, double-blind, randomized study (NCT01519791) were DMARD-naïve, had early, active RA: <1yr diagnosis at baseline (BL), fulfilling 2010 ACR/EULAR criteria; ≥4 swollen and ≥4 tender joints; DAS28[ESR]≥3.2; CRP≥10mg/L and/or ESR≥28mm/hr, rheumatoid factor or ACPA positive. Pts were randomized 3:1 to CZP (400mg Wks 0, 2, 4 then 200mg Q2W to Wk52)+MTX or PBO+MTX. MTX was initiated at 10mg/wk and increased up to 25mg/wk by Wk8, maximum tolerated dose was maintained to Wk52. Changes from BL in HAQ-DI, PtGADA, Pain VAS, % pts achieving normative physical function (HAQ-DI≤0.5), health-related QoL (SF-36, EQ-5D-3L) and workplace and household productivity (Work Productivity Survey [WPS]3) were assessed. At Wk52 changes from BL were analyzed using ANCOVA (LOCF imputation); categorical variables were analyzed using logistic regression (non-responder imputation); WPS responses (LOCF imputation) were compared using a non-parametric bootstrap-t method. Need for regular assistance in usual activities was summarized descriptively.

Results 660 (CZP+MTX) and 219 (PBO+MTX) pts were randomized; 655 vs 213 in the full analysis set (pts with BL and post-BL DAS28[ESR]). BL characteristics were balanced between study arms. BL disease severity was high: mean (SD) HAQ-DI 1.6 (0.6), Pain VAS 66.1 (22.4), PtGADA 65.3 (22.0) (Table A), DAS28[ESR] 6.7 (0.9), months since diagnosis 2.9 (4.3). 52% of pts were employed at BL (Table B). At Wk52, greater PRO improvements were observed with CZP+MTX vs PBO+MTX (Table A). CZP+MTX pts reported greater improvements vs PBO+MTX in household productivity, and lower need for assistance in usual activities. Employed CZP+MTX pts reported reductions in absenteeism and presenteeism vs PBO+MTX (Table B).

Conclusions In DMARD-naïve early RA pts, CZP+MTX showed greater improvements at 1yr in physical function, pain, disease activity, fatigue and health-related QoL, improved workplace and household productivity, and reduced need for assistance with regular activities compared to PBO+MTX.

References

  1. Strand V. Arthritis Res Ther 2009;11:R170;

  2. Kavanaugh A. Arthritis Care Res 2009;61(11):1592–1600;

  3. Osterhaus J. Arthritis Res Ther 2009;11:R73

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.

Disclosure of Interest P. Emery Consultant for: Pfizer, MSD, AbbVie, UCB Pharma, Roche and BMS, Speakers bureau: Pfizer, MSD, AbbVie, UCB Pharma, Roche and BMS, C. Bingham: None declared, G.-R. Burmester: None declared, V. Bykerk: None declared, D. Furst Grant/research support from: Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, Consultant for: Abbott, Actelion, Amgen, Bristol-Myers Squibb, BiogenIdec, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, Speakers bureau: Abbott, Actelion, UCB Pharma, X. Mariette Grant/research support from: Pfizer, Roche, Consultant for: BMS, GSK, Pfizer, Roche, UCB Pharma, O. Purcaru Employee of: UCB Pharma, G. Coteur Employee of: UCB Pharma, B. VanLunen Employee of: UCB Pharma, M. Weinblatt Grant/research support from: Bristol Myers Squibb, Crescendo Bioscience, UCB Pharma, Consultant for: Amgen, Abbvie, Bristol Myers Squibb, Crescendo Bioscience, UCB Pharma, Roche

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