ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1204

Improvements in Health-Related Quality of Life in Psoriatic Arthritis Patients Treated with Intravenous Golimumab, an Anti-TNFα Monoclonal Antibody: 1-Year Results of a Phase III Trial

M. Elaine Husni1, Diane Harrison 2, Elizabeth Hsia 3, Eric K H Chan 2, Chenglong Han 2, Shelly Kafka 4, Kim Hung Lo 2, Lilianne Kim 2 and Arthur Kavanaugh 5, 1Department of Rheumatologic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, 2Janssen Research & Development, LLC, Spring House, PA, 3Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, PA, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5University of California, San Diego School of Medicine, La Jolla, CA

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Monday, November 11, 2019

Title: Measures Of Healthcare Quality Poster II: Improving Care

Session Type: Poster Session (Monday)

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

Background/Purpose: In the randomized, phase 3, GO-VIBRANT study, more patients with psoriatic arthritis (PsA) achieved ACR 20/50/70 after 24 weeks IV treatment with the anti-TNFa monoclonal antibody golimumab (GLM-IV) than placebo (PBO) (p< 0.001). After cross-over from PBO to GLM-IV at week 24, 52-week achievement of ACR responses was similar between the two treatment groups.1 Here we examine effects on measures of health-related quality of life (HRQoL) for up to 52 weeks of treatment.

Methods: Adult patients with active PsA who met CASPAR criteria (N=480) were randomized (1:1) to GLM-IV 2 mg/kg at weeks 0, 4, then every 8 weeks or matching PBO through week 20 then cross-over to GLM-IV at weeks 24, 28, then every 8 weeks. Physical function was assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). Measures of HRQoL included Short-Form-36 Physical and Mental Component Summaries (SF-36 PCS/MCS), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, EuroQol-5D visual analog scale (EQ-VAS), and Dermatology Life Quality Index (DLQI), assessed at weeks 0, 8, 14, 24, 36, and 52.

Results: GLM- IV and PBO groups had comparable HRQoL characteristics at baseline (Table 1). At 24 weeks, changes from baseline were greater for GLM-IV vs PBO, respectively (HAQ-DI, -0.63 vs -0.14; SF-36 PCS, 9.4 vs 2.4; SF-36 MCS, 5.3 vs 0.8; FACIT-Fatigue, 9.2 vs 2.3; EQ-VAS, 20.2 vs 5.5; and DLQI, -8.1 vs -1.9). At week 24 more patients receiving GLM-IV than PBO achieved minimal clinically important improvements from baseline in HAQ (≥0.35 points),2 SF-36 (≥5points),3 and FACIT-fatigue (≥4 points).4 Among patients randomized to GLM-IV, changes in HRQoL measures were maintained from week 24 to week 52. Among patients randomized to PBO, after switching to GLM-IV at week 24, improvements in HRQoL measures from week 36 to week 52 were comparable to those of patients originally randomized to GLM-IV (Tables 1 and 2).

Conclusion: Improvements in HRQoL among patients with PsA after 24 weeks’ GLM-IV treatment were greater than PBO and were maintained through week 52 of treatment. Patients switching from PBO to GLM-IV at week 24 experienced improvements in HRQoL by week 36, which were maintained through week 52 and were similar to those achieved by patients originally randomized to GLM-IV.

  1. Husni et al. Arthritis Care Res. 2019 DOI:10.1002/acr.23905.
  2. Mease et al. J Rheumatol. 2011;38:2461.et al.
  3. Lubeck et al. 2004;22:27.
  4. Cella et al. J Rheumatol. 2005;32:811.

Disclosure: M. Husni, Abbvie, 5, AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, UCB, 5, Abbvie, Amgen, Janssen, Novartis, Lilly, Regeneron, Pfizer and UCB, 5, Bristol-Myers Squibb, 5, Eli Lilly, 5, Genentech, 5, Janssen, 5, Janssen Research & Development, LLC, 2, 3, Novartis, 5, PASE questionnaires, 7, Pfizer, 5, Sanofi-Genzyme, 5, UCB, 5; D. Harrison, Janssen Research & Development, LLC, 3; E. Hsia, Janssen Research & Development, LLC, 3; E. Chan, Janssen Research & Development, LLC, 3; C. Han, Janssen Research & Development, LLC, 3, 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; A. Kavanaugh, Abbott, 2, Abbott, Amgen, AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, UCB, 2, Amgen, 2, Bristol-Myers Squibb, 2, Eli Lilly, 5, Eli Lilly and Company, 5, Gilead Sciences, Inc., 2, Janssen, 2, Janssen Research & Development, LLC, 2, Novartis, 2, 5, Pfizer, 2, Pfizer Inc, 2, Roche, 2, UCB Pharma, 2.

To cite this abstract in AMA style:

Husni M, Harrison D, Hsia E, Chan E, Han C, Kafka S, Lo K, Kim L, Kavanaugh A. Improvements in Health-Related Quality of Life in Psoriatic Arthritis Patients Treated with Intravenous Golimumab, an Anti-TNFα Monoclonal Antibody: 1-Year Results of a Phase III Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/improvements-in-health-related-quality-of-life-in-psoriatic-arthritis-patients-treated-with-intravenous-golimumab-an-anti-tnf%ce%b1-monoclonal-antibody-1-year-results-of-a-phase-iii-trial/. Accessed .

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