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SAT0423 Patient-Reported Quality of Life in Patients with Baseline Objective Signs of Inflammation and Active Nonradiographic Axial Spondyloarthritis Treated with Golimumab: Results of The Open-Label Extension of A Randomized, Double-Blind Study
  1. W.P. Maksymowych1,
  2. M. Dougados2,
  3. J. Sieper3,
  4. J. Braun4,
  5. G. Bergman5,
  6. S.P. Curtis5,
  7. A. Tzontcheva5,
  8. G. Philip5,
  9. S. Huyck5,
  10. D. van der Heijde6
  1. 1University of Alberta, Edmonton, Canada
  2. 2Paris-Descartes University, Paris, France
  3. 3University Clinic Benjamin Franklin, Berlin
  4. 4Rheumazentrum Ruhrgebiet, Herne, Germany
  5. 5Merck & Co., Inc., Kenilworth, United States
  6. 6Leiden University Medical Center, Leiden, Netherlands

Abstract

Background In a randomized, double-blind (DB), placebo (PBO)-controlled, phase 3 study (GO-AHEAD; NCT01453725), patients (pts) with nonradiographic axial spondyloarthritis (nr-axSpA) had significantly greater improvement in quality of life (QoL) after 16 weeks of treatment with golimumab (GLM) compared with PBO.1

Objectives To assess QoL during the open-label extension (OLE) of GO-AHEAD in pts who had objective signs of inflammation (MRI sacroiliitis+ and/or C-reactive protein >upper limit of normal) at baseline of the DB phase.

Methods Pts completing the 16-week DB study (GLM or PBO) received GLM 50mg Q4W during the 44-week OLE (36-week efficacy period; 8-week safety follow-up). QoL evaluations in pts with objective inflammation included Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL), 36-item Short Form Health Survey (SF-36), and EuroQol Group 5 Dimensions Health Questionnaire (EQ-5D) Index and Health State (0–10cm VAS), and Work Productivity and Activity Impairment (WPAI) at weeks 16 and 52 and the Patient's Global Disease Assessment (PGDA; 0–10cm VAS) at weeks 16, 20, 24, 32, 40, and 52. Data were summarized descriptively.

Results In total, 153 pts with objective inflammation at baseline of the DB study were treated in the OLE (GLM=76; PBO=77). Pts who received GLM during the DB phase and continued GLM in the OLE (the GLM/GLM group) had continued improvement in QoL at week 52 as measured by the EQ-5D, SF-36, ASQoL, and PGDA VAS scales (Figure). Pts who received PBO during the DB phase and switched to GLM during the OLE (the PBO/GLM group) had notable improvements in these QoL scales at week 52 (Figure). Likewise, pts in the GLM/GLM group had continued benefits in work productivity and impairment, and those in the PBO/GLM1 group had notably improved benefits in work productivity and impairment (Table).

Table 1.

Mean (SD) change from baseline in WPAI scores

Conclusions Among pts with objective inflammation before treatment in the DB phase of GO-AHEAD, those who continued GLM in the OLE had continued benefits in QoL and work productivity, and those who switched to GLM in the OLE from PBO in the DB phase had notable improvement in QoL and work productivity.

  1. Sieper J, et al. Arthritis Rheum. 2015;67(10):2702–2712.

Disclosure of Interest W. Maksymowych Grant/research support from: AbbVie, Janssen, Pfizer, Consultant for: AbbVie, Amgen, UCB, Pfizer, Merck, Janssen, Eli Lilly, Celgene, Synarc, Boehringer, M. Dougados Grant/research support from: AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, J. Sieper Consultant for: AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, J. Braun Grant/research support from: Abbvie (Abbott), Amgen, Biogen, Boehringer, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, Consultant for: Abbvie (Abbott), Amgen, Biogen, Boehringer, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, G. Bergman Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, S. Curtis Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, A. Tzontcheva Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, G. Philip Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, S. Huyck Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB, Vertex, Employee of: Imaging Rheumatology BV

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