ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 710

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

Walter Maksymowych1, Maxime Dougados2, Joachim Sieper3, Jürgen Braun4, G Bergman5, Sean P. Curtis6, Anjela Tzontcheva6, George Philip6, Susan Huyck6 and Désirée van der Heijde7, 1Medicine, University of Alberta,, Edmonton, AB, Canada, 2Paris-Descartes University, Paris, France, 3Rheumatology Department, Charité – University Medicine Berlin, Berlin, Germany, 4Rheumazentrum Ruhrgebiet, Herne, Germany, 5Merck & Co., Inc., Whitehouse Station, NJ, 6Merck & Co., Inc., Kenilworth, NJ, 7Rheumatology, Leiden University Medical Center, Leiden, Netherlands

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords:

Session Information

Date: Sunday, November 13, 2016

Session Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster I: Axial and Peripheral Spondyloarthritis – Clinical Aspects, Imaging and Treatment

Session Type: ACR Poster Session A

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

Background/Purpose: In an open-label extension (OLE) of a 16-week, randomized, double blind (DB), placebo (PBO)-controlled, phase 3 study (GO-AHEAD; NCT1453725) in patients with nonradiographic axial spondyloarthritis (nr-axSpA)1, we assessed quality of life (QoL) in patients with objective signs of inflammation at baseline.   

Methods: Patients received GLM 50mg Q4W during the 44-week OLE (36-week efficacy period; 8-week safety follow-up). QoL evaluations were specified in patients with objective inflammation (MRI sacroiliitis+ and/or C-reactive protein >upper limit of normal) and 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.

Results: There were 153 patients with objective inflammation at baseline (of the DB period:  GLM=76; PBO=77) who were then treated in the OLE. At week 52, patients continuing GLM and those switched from PBO to GLM in the OLE demonstrated improvement in QoL parameters (Figure) Mean (SD) change from baseline in Overall Work Impairment scores were -21.2 (24.7) (GLM) and -8.4 (28.5) (PBO) at week 16; at week 52, mean (SD) changes were  -31.1 (GLM/GLM) and -26.5 (27.2) (PBO/GLM). 

Conclusion: Among patients with objective inflammation before treatment in the DB phase, 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.   Reference: 1. Sieper J, et al. Arthritis Rheum. 2015;67(10):2702-2712.  

Disclosure: W. Maksymowych, Merck & Co., Inc., 5; M. Dougados, AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma, 2,AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma, 5; J. Sieper, Abbott, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 8,Abbott, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB Pharma, 5; J. Braun, Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 5,Abbott, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, 2; G. Bergman, Merck & Co., Inc., 3; S. P. Curtis, Merck & Co., Inc., 3; A. Tzontcheva, Merck & Co., Inc., 3; G. Philip, Merck & Co., Inc., 3; S. Huyck, Merck & Co., Inc., 3; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5,Director of Imaging Rheumatology bv, 3.

To cite this abstract in AMA style:

Maksymowych W, Dougados M, Sieper J, Braun J, Bergman G, Curtis SP, Tzontcheva A, Philip G, Huyck S, van der Heijde D. 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 [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/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-extensio/. Accessed July 4, 2020.

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