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Abstract Number: 1258

Effects of Intravenous Golimumab, an Anti-TNFα Monoclonal Antibody, on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 1-Year Results of a Phase III Trial

John Reveille1, Atul Deodhar 2, Diane Harrison 3, Elizabeth Hsia 4, Eric K H Chan 3, Shelly Kafka 5, Kim Hung Lo 3, Lilianne Kim 3 and Chenglong Han 3, 1University of Texas McGovern Medical School, Houston, 2Oregon Health & Science University, Portland, OR, 3Janssen Research & Development, LLC, Spring House, PA, 4Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, PA, 5Janssen Scientific Affairs, LLC, Horsham, PA

Meeting: ACR/ARP Annual Meeting 2019

Keywords: ,

Session Information

Date: Monday, November 11, 2019

Title: Miscellaneous Rheumatic & Inflammatory Disease Poster II: Autoinflammation Related Diseases & Therapies

Session Type: Poster Session (Monday)

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

Background/Purpose: In patients with ankylosing spondylitis (AS), IV administration of the anti-TNFa antibody golimumab (GLM-IV) resulted in improvements in composite measures of various aspects of the disease (eg, ASAS percent response, BASDAI, and BASFI) that were greater than placebo (PBO) at week 16 or earlier in the GO-ALIVE study.1 The improvements were maintained for up to 1 year of treatment.2 Here we examine treatment effects on health-related quality of life (HRQoL).

Methods: Adult patients with definite AS (per modified NY criteria), BASDAI ≥4, total back pain VAS ≥4, CRP ≥0.3 mg/dL, and inadequate response to NSAIDs were randomized to GLM-IV 2mg/kg at weeks 0 and 4 then every 8 weeks, or to PBO at weeks 0 and 4 and GLM-IV at weeks 16 and 20, then every 8 weeks. Stable doses of methotrexate (≤ 25 mg/week), sulfasalazine, hydroxychloroquine, NSAIDs, other analgesics, and low dose oral corticosteroids were permitted for patients who were receiving these medications at baseline.  Measures of HRQoL included the Ankylosing Spondylitis Quality of Life questionnaire (ASQoL), Short Form-36 physical and mental component summary scores (SF-36 PCS/MCS), Medical Outcomes Study Sleep Scale (MOS-SS), and EuroQoL visual analog scale (EQ VAS), each measured at weeks 16, 28, and 52. P values provided are nominal, not adjusted for multiplicity.

Results: At week 16, patients with AS receiving GLM-IV had greater improvements from baseline in HRQoL than those receiving PBO in each measure, respectively (ASQoL, -5.4 vs -1.8; SF-36 PCS, 8.5 vs 2.9; SF-36 MCS, 6.5 vs 0.78; MOS-SS, 6.6 vs 2.5; and EQ VAS, 20.3 vs 4.8; all p< 0.001), see Table. Changes from baseline were maintained through week 52 in patients randomized to GLM-IV. Patients switched from PBO to GLM IV at week 16 demonstrated improvement from baseline by week 28, which was maintained through week 52 and was similar to that of patients who received GLM IV at baseline (Table).

Conclusion: Improvements in HRQoL among patients with active AS treated with GLM-IV were greater than PBO at week 16 and were maintained through week 52. Patients switching from PBO to GLM-IV at week 16 experienced improvements in HRQoL by week 28 and maintained the improvement through week 52 at levels similar to those of the patients originally randomized to GLM-IV.

  1. Deodhar et al. J Rheum. 2018;45:341
  2. Reveille et al. J Rheum. 2019. DOI: 10.3899/jrheum.180718.

Disclosure: J. Reveille, Abbvie, 2, CB, 5, Eli Lilly, 2, 5, 8, Janssen, 2, Janssen Research & Development, LLC, 2, Novartis, 5, Pfizer, 2, 5, UCB, 5; A. Deodhar, AbbVie, 2, 5, 9, Abbvie, 5, 8, Abbvie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, and UCB Pharma, 5, 8, AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer and UCB, 5, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer, UCB, 5, Amgen, 5, 8, 9, BMS, 2, 5, 8, BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, 2, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, UCB Pharma, 2, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, 8, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, 9, Eli Lilly and Company, 2, 5, Eli Lilly,, 5, Eli Lilly, GSK, Novartis, Pfizer and UCB, 2, Galagagos, 5, Galapagos, 5, 8, 9, Glaxo Smith & Klein, 2, Glaxo Smith & Kline, 2, 5, 8, Glaxo Smith Klein, 5, Glaxo SmithKlein, 2, 5, GlaxoSmithKlein, 2, 5, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, Janssen, 2, 5, 8, 9, Janssen Pharmaceutica, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9; D. Harrison, Janssen Research & Development, LLC, 3; E. Hsia, Janssen Research & Development, LLC, 3; E. Chan, Janssen Research & Development, LLC, 3; S. Kafka, Janssen Research & Development, LLC, 3, Janssen Scientific Affairs, LLC, 1, 3; K. Lo, Janssen Research & Development, LLC, 3; L. Kim, 3anssen Research & Development, LLC, 3, Janssen Research & Development, LLC, 3; C. Han, Janssen Research & Development, LLC, 3, Janssen Research & Development, LLC,, 3.

To cite this abstract in AMA style:

Reveille J, Deodhar A, Harrison D, Hsia E, Chan E, Kafka S, Lo K, Kim L, Han C. Effects of Intravenous Golimumab, an Anti-TNFα Monoclonal Antibody, on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 1-Year Results of a Phase III Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/effects-of-intravenous-golimumab-an-anti-tnf%ce%b1-monoclonal-antibody-on-health-related-quality-of-life-in-patients-with-ankylosing-spondylitis-1-year-results-of-a-phase-iii-trial/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-intravenous-golimumab-an-anti-tnf%ce%b1-monoclonal-antibody-on-health-related-quality-of-life-in-patients-with-ankylosing-spondylitis-1-year-results-of-a-phase-iii-trial/