ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2552

Fatigue in Psoriatic Arthritis Patients Treated with Intravenous Golimumab: Early Improvement Is Associated with Week 24 Outcomes in Acr 20, 50, and Health-Related Quality of Life

Arthur Kavanaugh1, M. Elaine Husni2, Eric K. H. Chan3, Diane D. Harrison4, Lilianne Kim4, Kim Hung Lo4, Elizabeth C Hsia5 and Chenglong Han6, 1University of California, San Diego, School of Medicine, La Jolla, CA, 2Orthopedic and Rheumatologic Institute, Cleveland Clinic, Cleveland, OH, 3Janssen Global Services, LLC, Raritan, NJ, 4Janssen Research & Development, LLC, Spring House, PA, 5Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, PA, 6Janssen Global Services, LLC, Malvern, PA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

      Background/Purpose: To investigate improvement in fatigue in adult patients with active psoriatic arthritis (PsA) treated with intravenously administered (IV) golimumab, an anti-TNFα monoclonal antibody, and to evaluate improvement in fatigue at Week 8 in predicting ACR 20, 50, minimal disease activity (MDA), and health-related quality of life (HRQoL) outcomes at Week 24.   

Methods: GO-VIBRANT is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled trial.  Adults with active PsA who were biologic-naïve (n=480; aged ≥18 years) were randomized to IV golimumab 2 mg/kg at Weeks 0 and 4 and every 8 weeks thereafter (n=241), or placebo at Weeks 0, 4, 12, and 20 with crossover to IV golimumab at Week 24 (n=239). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and HRQoL and physical function were measured by the Short-Form 36 (SF-36) and Health Assessment Questionnaire Disability Index (HAQ-DI).  ANCOVA, T-test, CMH test, and Chi-square test were used for various analyses.   Results: There was greater mean improvement in the FACIT-F score from baseline with IV golimumab than placebo at Weeks 8, 14, and 24 (7.9 vs 2.0; 8.4 vs 2.2; 9.2 vs 2.3, respectively, all p<0.0001) (Table 1a).  A larger proportion of golimumab-treated patients achieved a ≥4-point improvement in FACIT-F as early as Week 8 vs placebo (p<0.0001) (Table 1b). Similar results were found after adjusting for ACR 20 and 50 response. General linear models suggested patients with clinically meaningful improvement in fatigue (≥4 points) at Week 8 (on average) achieved improvements in HAQ-DI and (SF-36) Mental Component Summery (MCS) and Physical Component Summary (PCS) at Week 24 (Table 2b). Logistic regressions suggested that clinically meaningful improvement in fatigue at Week 8 was associated with ACR 20 and ACR 50 responses, as well as clinically meaningful improvements in SF-36 MCS, PCS (≥5 points), and HAQ-DI (≥.30) at Week 24, but not MDA responses (OR 1.54 [95% CI 0.89-2.67, p-value 0.1184) (Table 2a).  Fatigue improvements at Week 8 did not predict normal SF-36 MCS and PCS scores (≥50) at Week 24.   Conclusion: Adult patients with active PsA treated with IV golimumab showed larger mean improvement in fatigue vs placebo.  Early improvement in fatigue is associated with 24-week outcomes in ACR 20, 50, and HRQoL.    

Table 1a.  Summary of Change from Baseline in FACIT-Fatigue Through Week 24
Without ACR 20 and 50 adjustments
  Time point Golimumab (N is between 231 – 233) Placebo (N=between 221-225) P-value*
Mean ± SD change from baseline in FACIT-F score Week 8 7.9 ± 9.53 (n=232) 2.0 ± 7.89 (n=225) <0.0001
  Week 14 8.4 ± 9.86) (n=233) 2.2 ± 7.60 (n=222) <0.0001
  Week 24 9.2 ± 9.77 (n=231) 2.3 ±7.80 (n=221) <0.0001
*p-value is based on ANCOVA controlling for baseline MTX usage (Yes, No) and baseline FACIT-fatigue score.
 
1b. Number of Subjects Who Achieved at Least a 4-Unit Improvement from Baseline in FACIT-Fatigue Through Week 24
Number (%) of patients who achieved ≥4-unit improvement from baseline in FACIT-F score Week 8 161 (69.4) (n=232) 91 (40.4) (n=225) <0.0001**
  Week 14 159 (68.2) (n=233) 92 (41.4) (n=222) <0.0001**
  Week 24 162 (70.1) (n=231) 95 (43.0) (n=221) <0.0001**
**p-value is based on CMH test controlling for baseline MTX usage (Yes, No)
 

Table 2a. Logistic regression of ACR 20, 50, Minimal Disease Activity, and HRQoL at Week 24 (dependent variable) on FACIT-fatigue improvement of ≥4 at Week 8 (independent variable)
  Odds ratio 95% CI P-value*
Week 24      
    ACR 20 (N=457) 1.98 1.28-3.07 0.0022
   ACR 50 (N=457) 2.19 1.33-3.60 0.0020
       
    HAQ-DI (≥30) (N=449) 2.31 1.53-3.51 <.0001
   Minimal Disease Activity (N=449) 1.54 0.89-2.67 0.1184
       
   SF-36MCS (≥50) (N=457) 0.94 0.63-1.41 0.7615
   SF-36PCS (≥50) (N=457) 1.14 0.63-2.07 0.6634
   SF-36MCS improvement (≥5 points) (N=457) 2.22 1.48-3.34 0.0001
   SF-36PCS improvement (≥5 points) (N=457) 2.20 1.45-3.33 0.0002

*p-value is based on Chi-Square test controlling for treatment

 

2b. General linear model of quality of life parameters at Week 24 (dependent variable) on FACIT-fatigue improvement of ≥4 at Week 8 (independent variable)
Week 24 Estimate** P-value*
   HAQ-DI (N=449) 0.229 <.0001
   SF-36 MCS (N=457) -2.842 0.0003
   SF-36 PCS (N=457) -3.340 <.0001

*p-value is based on t-test controlling for baseline value of quality of life parameters.

All variables are based on observed score, **estimate represents the average impact of having a 4-point FACIT-F improvement (compared to not having a 4- point FACIT-F improvement) on the quality of life parameters


Disclosure: A. Kavanaugh, Janssen Research & Development, LLC, 2; M. E. Husni, Janssen Research and Development, LLC, 2; E. K. H. Chan, Janssen Global Services, LLC, 3; D. D. Harrison, Janssen Research & Development, LLC, 3; L. Kim, Janssen Research & Development, LLC, 3; K. H. Lo, Janssen Research and Development, LLC, 3; E. C. Hsia, Janssen Research & Development, LLC, 3; C. Han, Janssen Research & Development, LLC, 3.

To cite this abstract in AMA style:

Kavanaugh A, Husni ME, Chan EKH, Harrison DD, Kim L, Lo KH, Hsia EC, Han C. Fatigue in Psoriatic Arthritis Patients Treated with Intravenous Golimumab: Early Improvement Is Associated with Week 24 Outcomes in Acr 20, 50, and Health-Related Quality of Life [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/fatigue-in-psoriatic-arthritis-patients-treated-with-intravenous-golimumab-early-improvement-is-associated-with-week-24-outcomes-in-acr-20-50-and-health-related-quality-of-life/. Accessed .

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