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Abstract Number: 1531

Effects of Intravenous Golimumab on Patient-Reported Outcomes in Active Ankylosing Spondylitis: 28-Week Results of the Phase 3 Trial

John D. Reveille1, Atul A. Deodhar2, Eric K.H. Chan3, Steven Peterson4, Nan Li4, Elizabeth C. Hsia5, Lilianne Kim4, Kim Hung Lo4, Diane D. Harrison4 and Chenglong Han6, 1University of Texas McGovern Medical School, Houston, TX, 2Division of Arthritis & Rheumatic Diseases OP09, Oregon Health & Science University, Portland, OR, 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: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Ankylosing spondylitis (AS), anti-TNF therapy, physical function and quality of life, PRO

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Session Information

Date: Monday, November 6, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster II

Session Type: ACR Poster Session B

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

 

Background/Purpose: To evaluate patient-reported outcomes (PRO) of physical functioning, mental health functioning, health state, and health-related quality of life (HRQoL) in patients (pts) with active AS treated with intravenous (IV) golimumab (GLM), an anti-TNFα monoclonal antibody.

Methods: GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo(PBO)-controlled trial. Pts (≥18 years) had a diagnosis of definite AS (modified New York criteria) and BASDAI ≥4, total back pain visual analog scale (VAS) ≥4, and CRP ≥0.3mg/dL.  At baseline, 208 pts were randomized to IV GLM 2mg/kg (N=105) at Wks0, 4, and every 8 wks or PBO (N=103) at Wks0, 4, and 12, with crossover to IV GLM at Wk16. PRO instruments included: SF-36, a generic instrument designed to measure physical & mental health functioning; EQ-5D VAS, a generic measure of current health state; and AS Quality of Life (ASQoL), a disease-specific instrument designed to measure impact of AS on HRQoL.  SF-36 scores range from 0-100; higher scores indicate better functioning.  It has Physical (PCS) and Mental Component Summary (MCS) and 8 subscales (physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional, & mental health).  EQ-5D has a scale of 0-100 (0=worst health you can imagine; 100=best health you can imagine).  ASQoL assesses sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, & social life in pts with AS; range: 0-18, higher scores indicating worse HRQoL.  Unadjusted p-values of least square mean differences between treatment groups were based on analysis of covariance controlling for prior anti-TNF therapy.

Results: Table summarizes mean changes from baseline at Wks8, 16, and 28. Mean improvements in SF-36 PCS/MCS were greater in the IV GLM group than PBO at Wk8 (6.83 vs 2.07, p<0.001; 5.56 vs 1.67, p=0.006, respectively) and maintained through Wk16 (8.52 vs 2.87, p<0.001; 6.47 vs 0.84, p<0.001, respectively). Greater mean improvements in all SF-36 subscales were observed in the IV GLM group at Wks8 & 16 compared to PBO (p<0.01, with the exception of the role-emotional subscale [p=0.058]). Proportion of pts achieving clinically meaningful change (≥5) in SF-36 PCS/MCS was higher in IV GLM than PBO at Wks8 & 16 (PCS: 58.1 vs 27.2, 67.6 vs 35.9, respectively; MCS: 48.6 vs 34.0, 54.3 vs 29.1, respectively; p<0.05 for all). Mean EQ-5D VAS improvements were greater (p<0.001) in IV GLM than PBO at Wks8 & 16 (17.61 vs 6.63, 20.32 vs 4.79, respectively). Greater mean improvements in ASQoL observed in IV GLM compared to PBO at Wks8 & 16 (-4.5 vs -1.5, p<0.001, -5.4 vs -1.8, p<0.001, respectively). By Wk28, after PBO crossover to IV GLM, mean improvement in PCS, MCS, EQ-5D VAS, and ASQoL was similar between the two treatment arms.

Conclusion: Adult pts with active AS treated with IV GLM showed marked improvements in physical functioning, mental health functioning, health state, and HRQoL.

 

Table Summary of mean (standard deviation) changes in SF-36, EQ-5D, and ASQoL

 

 

IV GOLIMUMAB 2mg/kg

PLACEBO

Patients

 

105

103

Mean (SD) change from baseline in SF-36 PCS:

Week 8

6.83 (6.90)

(p<0.001)

2.07 (5.66)

 

Week 16

8.52 (7.54)

(p<0.001)

2.87 (6.11)

 

Week 28

9.08 (8.02)

9.29 (7.09)

Mean (SD) change from baseline in SF-36 MCS:

Week 8

5.56 (9.26)

(p=0.006)

1.67 (8.80)

 

Week 16

6.47 (9.12)

(p<0.001)

0.84 (9.82)

 

Week 28

6.16 (10.91)

5.60 (9.70)

Mean (SD) change from baseline in EQ-5D VAS:

Week 8

17.61 (24.02)

(p<0.001)

6.63 (19.88)

 

Week 16

20.32 (24.59)

(p<0.001)

4.79 (23.47)

 

Week 28

20.52 (27.86)

22.45 (23.08)

Mean (SD) change from baseline in ASQoL:

Week 8

-4.5 (4.71)

(p<0.001)

-1.5 (3.90)

 

Week 16

-5.4 (5.01)

(p<0.001)

-1.8 (4.50)

 

Week 28

-5.3 (5.24)

-5.3 (4.84)

 


Disclosure: J. D. Reveille, Janssen, 5; A. A. Deodhar, Amgen, Abbvie, GSK, Elli Lilly, Janssen, Novartis, Pfizer, UCB, 2,Elli Lilly, Janssen, Novartis, Pfizer, UCB, 6; E. K. H. Chan, Johnson & Johnson, LLC, 1,Janssen Global Services, LLC, 3; S. Peterson, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; N. Li, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; E. C. Hsia, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; L. Kim, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; K. H. Lo, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; D. D. Harrison, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; C. Han, Janssen Global Services, LLC, 3,Johnson & Johnson, LLC, 1.

To cite this abstract in AMA style:

Reveille JD, Deodhar AA, Chan EKH, Peterson S, Li N, Hsia EC, Kim L, Lo KH, Harrison DD, Han C. Effects of Intravenous Golimumab on Patient-Reported Outcomes in Active Ankylosing Spondylitis: 28-Week Results of the Phase 3 Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/effects-of-intravenous-golimumab-on-patient-reported-outcomes-in-active-ankylosing-spondylitis-28-week-results-of-the-phase-3-trial/. Accessed .
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