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Abstract Number: 630

Effects of Intravenous Golimumab, an Anti-Tnfα Monoclonal Antibody, on Mental and Physical Functioning and Health-Related Quality of Life in Active Psoriatic Arthritis: 24-Week Results of a Phase 3 Trial

M. Elaine Husni1, Arthur Kavanaugh2, Eric K. H. Chan3, Nan Li4, Steven Peterson4, Elizabeth C. Hsia5, Lilianne Kim4, Kim Hung Lo4 and Diane D. Harrison4, 1Rheumatology, Cleveland Clinic, Cleveland, OH, 2Medicine, University of California, San Diego, La Jolla, CA, 3Janssen Global Services, LLC, Raritan, NJ, 4Janssen Research & Development, LLC, Spring House, PA, 5Janssen Research & Development, LLC/University of Pennsylvania, Spring House/Philadelphia, PA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: anti-TNF therapy, mental health, physical function, psoriatic arthritis and quality of life

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Session Information

Date: Sunday, November 5, 2017

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

Session Type: ACR Poster Session A

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

Background/Purpose: To evaluate physical and mental health functioning, health state, and health-related quality of life (HRQoL) in patients with active psoriatic arthritis (PsA) treated with intravenously administered (IV) golimumab (GLM), an anti-TNFα monoclonal antibody.

Methods: In this Phase 3, multicenter, randomized, double-blind, placebo-controlled trial, adult patients (N=480) with active PsA naïve to anti-TNFa therapy (mean age=46 yr) received IV GLM 2 mg/kg (N=241) at Weeks 0 and 4 and every 8 weeks thereafter or placebo (N=239) at Weeks 0, 4, 12, and 20 with crossover to IV GLM at Week 24. Three self-report instruments were included: 1) Short Form Health Survey (SF-36), a generic instrument of physical and mental health functioning: scores for its Physical (PCS) and Mental Component Summary (MCS) and 8 subscales (physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional, and mental health) each range from 0 to 100 with higher scores indicating better function; 2) EuroQol visual analog scale (EQ-VAS), a generic measure of current health state (0=worst health you can imagine to 100=best health you can imagine); 3) Dermatology Life Quality Index (DLQI), a disease-specific HRQoL instrument measuring impact of skin disorders on daily living (scores range from 0-30 with lower scores indicating lesser impact). SF-36 PCS and MCS at Week 14 were controlled secondary endpoints. Least square mean differences between the treatment groups were estimated using analysis of covariance controlling for methotrexate use and baseline score.

Results: Mean improvements from baseline with IV GLM vs placebo occurred as early as Week 8 in SF-36 PCS (8.0 vs 1.7) and MCS (5.0 vs 1.2) scores (Table 1). Greater mean improvements from baseline in PCS (p<0.001) and MCS (p<0.001) scores were seen with IV GLM vs placebo at Weeks 14 and 24. Greater mean improvements in all 8 SF-36 subscales at Weeks 14 and 24 were also observed with IV GLM vs placebo (p<0.001 for all). The percentages of patients achieving clinically meaningful change (5 points or greater) in PCS and MCS scores were higher in IV GLM vs placebo at Weeks 14 and 24 (PCS: 67.6% vs 29.7%, 69.7% vs 29.3%; MCS: 51.5% vs 26.4%, 46.9% vs 29.3%; p<0.001 for all). Mean EQ-VAS improvements were observed as early as Week 8 with IV GLM vs placebo (17.2 vs 3.7) and remained greater with IV GLM vs placebo at Weeks 14 and 24 (both p<0.001; Table 1). Mean changes in DLQI were observed with IV GLM as early as Week 8 (-7.2 vs -1.7; Table 1). Higher percentages of patients in the IV GLM cohort achieved DLQI scores of 0 or 1 at Weeks 14 (35.3% vs 9.8%; p<0.001) and 24 (40.7% vs 9.8%; p<0.001) vs placebo.

Conclusion: Adult patients with active PsA treated with IV GLM showed marked improvements from baseline vs. placebo in physical and mental health function, health state, and HRQoL as early as Week 8; improvements were maintained through Weeks 14 and 24.

 

Table 1: Summary of mean (standard deviation) changes in SF-36, EQ-VAS, and DLQI

 

 

Golimumab 2 mg/kg

Placebo

Patient self-report instruments

 

N=241

N=239

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

Week 8

8.0 (7.30)

(n=237)

1.7 (5.40)

(n=236)

 

Week 14

8.6 (7.59)

(n=237)

p<0.001

2.6 (5.84)

(n=236)

 

Week 24

9.4 (8.07)

(n=237)
p<0.001*

2.4 (6.07)

(n=236)

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

Week 8

5.0 (9.85)

(n=237)

1.2 (7.60)

(n=236)

 

Week 14

5.3 (9.88)

(n=237)

p<0.001

 0.9 (7.58)

(n=236)

 

Week 24

 5.3 (10.20)

(n=237)
p<0.001*

 0.8 (7.45)

(n=236)

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

Week 8

17.2 (22.70)

(n=232)

3.7 (21.81)

(n=225)

 

Week 14

18.7 (24.29)

(n=233)
p<0.001*

5.3 (21.02)

(n=222)

 

Week 24

20.2 (24.23)

(n=231)
p<0.001*

5.5 (23.09)

(n=221)

Mean (SD) change from baseline in DLQI:

Week 8

-7.2 (7.24)

(n=194)

-1.7 (4.91)

(n=195)

 

Week 14

-7.7 (7.18)

(n=194) p<0.001*

-1.8 (5.70)

(n=195)

 

Week 24

-8.1 (7.72)

(n=194) p<0.001*

-1.9 (5.90)

(n=195)

*presented p values are nominal


Disclosure: M. E. Husni, AbbVie, Amgen, Janssen Research and Development, LLC, BMS, Novartis, Eli Lilly, 5; A. Kavanaugh, Janssen Research Development, LLC, 2,Janssen Research Development, LLC, 5; E. K. H. Chan, Janssen Global Services, LLC, 3,Johnson & Johnson, 1; N. Li, Janssen Research & Development, LLC, 3,Johnson & Johnson, LLC, 1; S. Peterson, 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.

To cite this abstract in AMA style:

Husni ME, Kavanaugh A, Chan EKH, Li N, Peterson S, Hsia EC, Kim L, Lo KH, Harrison DD. Effects of Intravenous Golimumab, an Anti-Tnfα Monoclonal Antibody, on Mental and Physical Functioning and Health-Related Quality of Life in Active Psoriatic Arthritis: 24-Week Results of a Phase 3 Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/effects-of-intravenous-golimumab-an-anti-tnf%ce%b1-monoclonal-antibody-on-mental-and-physical-functioning-and-health-related-quality-of-life-in-active-psoriatic-arthritis-24-week-results-of-a/. Accessed .
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