ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2566

Impact of Guselkumab Versus Placebo and Adalimumab on Patient Reported Outcomes in Patients with and without Psoriatic Arthritis in a Phase 3 Pivotal Psoriasis Study

Luis Puig1, Chenglong Han2, Ronald Vender3, Michael Song2, Yin You2, Yaung-Kaung Shen2 and Peter Foley4, 1Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona Medical School, Barcelona, Spain, 2Janssen Research & Development, LLC, Spring House, PA, 3McMaster University, Hamilton, ON, Canada, 4University of Melbourne, St. Vincent’s Hospital, Melbourne and Skin & Cancer Foundation Inc., Carlton, Australia

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: VOYAGE 2 is a phase 3 double-blind, placebo/active comparator-controlled trial comparing guselkumab (GUS) with placebo (PBO) and adalimumab (ADA) in patients (pts) with moderate-to-severe PsO. The impact of treatment on patient-reported outcomes (PROs) was evaluated.

Methods: Pts were randomized to GUS 100mg (wks 0 & 4, then q8wks), ADA (80 mg wk 0, 40 mg wk 1, then 40 mg q2 wks), or PBO (wks 0, 4, & 12, then GUS 100mg wks 16 & 20). We evaluated PROs using the Work Limitations Questionnaire [WLQ; work productivity], the Hospital Anxiety & Depression Scale [HADS], and the Medical Outcomes Study 36-Item Short Form (SF-36; health related quality of life) at wk16 (GUS vs PBO) and wk24 (GUS vs ADA) in pts with and without PsA.

Results: In all, 18% of pts reported a history of PsA. At wk16, GUS pts had numerically greater improvements vs PBO in work productivity, anxiety and depression, and SF-36 PCS & MCS scores regardless of PsA status. The least square (LS) mean differences (95% CI; adjusted for baseline value) for GUS vs PBO for all PROs were generally similar between pts with and without PsA. At wk24, GUS pts had numerically greater improvements vs ADA in all PROs regardless of PsA status. The LS mean differences for GUS vs ADA were generally greater for pts with PsA vs pts without PsA (Table).

Conclusion: GUS showed better improvements in all PROs vs PBO at wk16 and vs ADA at wk24. Improvements vs PBO were similar regardless of PsA status, while improvements vs ADA were greater for pts with PsA.

 

Table: Summary of Change from Baseline in WLQ, HADS and SF-36 Scores from VOYAGE 2

 

Week 16 GUS vs PBO

Week 24 GUS vs ADA

 

w/ PSA

w/out PSA

w/ PSA

w/out PSA

 

N, LSMean Diff (95% CI)

p-value

N, LSMean Diff

(95% CI)

p-value

N, LSMean Diff (95% CI)

p-value

N, LSMean Diff (95% CI)

p-value

WLQ Physical Demands

86, -7.1

(-13.21, -0.92)

0.0249

446, -7.7

(-10.56, -4.88)

<0.0001

79, -1.6

(-10.58, 7.29)

0.7152

445, -2.6

(-5.39, 0.28)

0.0769

WLQ Time Management

85, -6.6

(-15.35, 2.06)

0.1326

419, -7.0

(-10.31, -3.79)

<0.0001

79, -4.3

(-14.40, 5.81)

0.3996

420, -0.6

(-3.46, 2.30)

0.6931

WLQ Mental-Interpersonal

83, -3.8

(-11.03, 3.35)

0.2913

439, -4.9

(-7.54, -2.35)

0.0002

78, -11.4

(-19.37, -3.34)

0.0061

436, -1.5

(-4.16, 1.11)

0.2569

WLQ Ouput Demands

84, -7.9

(-14.51, -1.21)

0.0211

440, -3.5

(-6.11, -0.88)

0.0089

79, -14.7

(-24.29, -5.17)

0.0030

437, -1.2

(-3.94, 1.62)

0.4136

Anxiety Score

135, -1.2

(-2.45, 0.04)

0.0584

608, -1.6

(-2.05, -1.07)

<0.0001

133, -2.1

(-3.33, -0.83)

0.0012

608, -0.8

(-1.29, -0.28)

0.0025

Depression Score

135, -1.2

(-2.55, 0.06)

0.0611

608, -1.5

(-1.96, -0.98)

<0.0001

133, -1.5

(-2.85, -0.09)

0.0374

608, -0.4

(-0.91, 0.10)

0.1158

SF-36 Physical Score

135, 5.7

(2.94, 8.43)

<0.0001

607, 4.4

(3.31, 5.39)

<0.0001

132, 2.9

(0.21, 5.57)

0.0346

608, 1.0

(-0.10, 2.04)

0.0753

SF-36 Mental Score

135, 4.5

(1.61, 7.48)

0.0026

607, 4.8

(3.53, 6.15)

<0.0001

132, 3.2

(-0.12, 6.53)

0.0591

608, 1.8

(0.45, 3.15)

0.0092

N is the sample size across two groups

 

Disclosure: L. Puig, Janssen Research & Development, LLC, 2; C. Han, Janssen Research & Development, LLC, 3; R. Vender, Janssen Research & Development, LLC, 2; M. Song, Janssen Research & Development, LLC, 3; Y. You, Janssen Research & Development, LLC, 3; Y. K. Shen, Janssen Research & Development, LLC, 3; P. Foley, Janssen Research & Development, LLC, 2.

To cite this abstract in AMA style:

Puig L, Han C, Vender R, Song M, You Y, Shen YK, Foley P. Impact of Guselkumab Versus Placebo and Adalimumab on Patient Reported Outcomes in Patients with and without Psoriatic Arthritis in a Phase 3 Pivotal Psoriasis Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/impact-of-guselkumab-versus-placebo-and-adalimumab-on-patient-reported-outcomes-in-patients-with-and-without-psoriatic-arthritis-in-a-phase-3-pivotal-psoriasis-study/. Accessed .

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