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Abstract Number: 1657

The Effect of Guselkumab on Enthesitis: Results from a Phase 2 Study in Patients with Active Psoriatic Arthritis

Philip Helliwell1, Alice B Gottlieb2, Atul A. Deodhar3, Wolf-Henning Boehncke4, Dennis McGonagle1, Xie L. Xu5, Stephen Xu5, Yuhua Wang5, Elizabeth C Hsia5,6, Chetan S Karyekar5 and Philip J. Mease7, 1U of Leeds, Leeds, United Kingdom, 2NY Medical College, Metropolitan Hospital, NY, NY, 3Oregon Health & Science U, Portland, OR, 4U of Geneva, Geneva, Switzerland, 5Janssen Research & Development, LLC, Spring House, PA, 6U Penn School of Medicine, Phila, PA, 7Swedish Medical Center & U of Wash, Seattle, WA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Effective, Enthesitis, Psoriatic arthritis and safety

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Session Information

Date: Monday, October 22, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Clinical/Epidemiology Studies

Session Type: ACR Poster Session B

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

Background/Purpose: In a Phase 2 study, Guselkumab (GUS) was shown to be safe & effective in pts w/active PsA w/meaningful improvements in enthesitis. To evaluate the effect of GUS on enthesitis in a subset of pts w/enthesitis at baseline (BL) from the Phase 2 PsA study of GUS.

Methods: Pts w/active PsA & ≥3% BSA of plaque PsO, despite current or previous treatment, were randomized 2:1 to 100mg SC GUS or PBO at wks 0,4, →q8w during a 24-wk double-blind treatment period. At wk16, pts w/<5% improvement in swollen & tender joint counts(SJC&TJC) early escaped(EE) to open-label ustekinumab. At wk24, the PBO group crossed over to GUS at wks24,28 →q8w(PBO→GUS) & the GUS group continued receiving GUS(GUS→GUS) through wk44. Enthesitis was assessed using the Leeds enthesitis index(LEI). Enthesitis scores during the 24wk double-blind treatment was analyzed using LOCF imputation for missing data & EE. Enthesitis after wk24 was analyzed using observed data.

Results: Of 149 total pts w active PsA,107(72%) presented w/enthesitis at BL(PBO N=31,mean[SD] LEI=2.6[1.48], median[range]=2.0[1, 6]; GUS N=76,mean(SD) LEI=2.7[1.54], median[range]=2.0[1, 6])& 85 continued at Wk24(PBO→GUS N=18;GUS→GUS N=67). Except for higher TJC/SJC & CRP, BL characteristics of enthesitis subset was similar to overall population. GUS significantly reduced the LEI by wk8(mean[SD]] change from BL, PBO:-0.4[1.59]; GUS:-1.2[1.65];p=0.037),& through wk24(mean[SD] change from BL, PBO:-0.7[1.53]; GUS:-1.5[1.81];p=0.045). GUS also significantly increased the % of pts w/enthesitis resolution(Figure). After wk24, PBO→GUS group achieved rapid, sustained resolution(wk56: mean[SD] change from BL=-2.1[1.65];62.5% of pts w/resolution), similar to GUS→GUS group(wk56:mean[SD] change from BL=-1.9[1.59],70.8% of pts w/resolution). Improvement in enthesitis was observed at each enthesitis site assessed, & was greater in ACR20(Table) responders vs non-responders in GUS-treated pts & was correlated w/improvement in TJC (R=0.37, p=0.001) & SJC (R=0.27,p=0.020), physician’s(R=0.47,p<0.0001) & pts global assessment of disease activity(R=0.32,p=0.005), & SF36 PCS(R=0.27,p=0.02) & MCS(R=0.35,p=0.002).

Conclusion: GUS treatment produces rapid & sustained improvement of enthesitis in pts w/active PsA, which correlates w/improvement in joint symptoms & pt-reported outcomes.

Table. Change in LEI in ACR20/50 and PASI75 Responders and Non-responders

Mean (SD) change from BL in LEI at Wk24

Non-responders

Responders

p-value

ACR 20

-0.93(2.054), n=28

-2.06(1.660), n=47

0.002

ACR 50

-1.55(2.190), n=49

-1.81(1.132), n=26

0.057

PASI 75

-1.25(1.138), n=12

-1.71(1.995), n=63

0.524


Disclosure: P. Helliwell, Janssen Research & Development, LLC., 2; A. B. Gottlieb, Janssen Research & Development, LLC., 2; A. A. Deodhar, Janssen Research & Development, LLC, 2; W. H. Boehncke, Janssen Research & Development, LLC, 2; D. McGonagle, Janssen Research & Development, LLC, 2; X. L. Xu, Janssen Research & Development, LLC, 3; S. Xu, Janssen Research & Development, LLC, 3; Y. Wang, Janssen Research & Development, LLC, 3; E. C. Hsia, Janssen Research & Development, LLC, 3; C. S. Karyekar, Janssen Research & Development, LLC, 3; P. J. Mease, Janssen Research & Development, LLC, 2.

To cite this abstract in AMA style:

Helliwell P, Gottlieb AB, Deodhar AA, Boehncke WH, McGonagle D, Xu XL, Xu S, Wang Y, Hsia EC, Karyekar CS, Mease PJ. The Effect of Guselkumab on Enthesitis: Results from a Phase 2 Study in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/the-effect-of-guselkumab-on-enthesitis-results-from-a-phase-2-study-in-patients-with-active-psoriatic-arthritis/. Accessed .
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