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

Dafna D Gladman¹, Wolf-Henning Boehncke², Alice B Gottlieb³, Philip Helliwell⁴, Peter Nash⁵, Xie L. Xu⁶, Stephen Xu⁶, Yuhua Wang⁶, Elizabeth C Hsia^6,7, Chetan S Karyekar⁶ and Atul A. Deodhar⁸, ¹Krembil Research Institute, U of Toronto, Toronto, ON, Canada, ²U of Geneva, Geneva, Switzerland, ³NY Medical College, Metropolitan Hospital, NY, NY, ⁴U of Leeds, Leeds, United Kingdom, ⁵U of Queensland, Brisbane, Australia, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷U Penn School of Medicine, Phila, PA, ⁸Oregon Health & Science University, Portland, OR

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Effective, Physical function and psoriatic arthritis

Session Information

Date: Sunday, October 21, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster I: Imaging, Clinical Studies, and Treatment

Session Type: ACR Poster Session A

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

Background/Purpose: In a Ph2 study, GUS was shown to be safe&effective in pts w/active PsA. We evaluated effect of GUS on dactylitis in subset of pts w/dactylitis at baseline (BL) from Ph2 GUS PsA study.

Methods: Pts w/active PsA & ≥3% BSA of plaque PsO, despite current or previous treatment, were randomized 2:1 to 100mg SC GUS at wks0,4 then q8w or PBO during a 24wk double-blind treatment (tx) period. At wk16, pts w/<5% improvement in swollen&tender joint counts(SJC/TJC) early escaped(EE). At wk24, PBO group(grp) crossed over to GUS (wks24, 28→ q8w)(PBO→GUS) & GUS grp continued GUS (GUS→GUS)) thru wk44. Dactylitis was assessed by scoring each digit from 0-3(0=absent,1=mild,2=mod, 3=sev), for combined score of 0-60. Sensitivity analysis of change from BL thru wk24 in dactylitic digits was performed(combined score 20). Dactylitis scores during 24wk double-blind tx was analyzed using LOCF imputation for missing data & EE. Dactylitis after wk24 was evaluated using observed data.

Results: Of 149 pts,81 presented w/dactylitis at BL(PBO N=23,mean[SD]=3.9[3.01];GUS N=58, mean[SD]=6.5[6.15]) & 66 continued to active tx period(PBO→GUS N=16;GUS→GUS N=50).The dactylitis subset was similar to overall population in BL characteristics except for higher median values for # of SJC, # of TJC,&CRP. At wks16&24, GUS grp had significantly greater reduction in dactylitis score(wk24 mean[SD] change from BL,PBO:-0.4[6.06];GUS:-3.8[4.93];p=0.006)&a greater % of pts w/dactylitis resolution vs PBO grp(Figure). Consistent results were obtained w/# digits w/dactylitis(wk24 mean[SD] change from BL, PBO:-0.2[3.04];GUS:-2.1[2.21];p=0.003). Improvement in dactylitis seen at wk24 was maintained in GUS→GUS grp(wk56:mean[SD] change from BL=-5.5[4.84],75% of pts w/resolution)& the values for the PBO→GUS grp(wk56:mean[SD]change from BL=-4.4[3.50],93.7% of pts w/resolution)approached those of GUS→GUS grp. Improvement in dactylitis was greater in ACR20/ACR50 responders vs non-responders in GUS-txd pts(Table)&was significantly correlated with improvement in TJC(R=0.38,p=0.004),SJC(R=0.50,p<0.0001),&HAQ-DI score(R=0.33,p=0.013).

Conclusion: GUS is efficacious in resolving symptoms of dactylitis in pts w/active PsA. This effect on dactylitis is correlated with improvement in joint symptoms & physical function.

Table 1. Change in Dactylitis Score in ACR20/50 and PASI75 Responders and Non-responders
	Mean (SD) change from BL in Dactylitis Score at Wk24
	Non-responders	Responders	p-value
ACR 20	-1.76(7.595), n=21	-4.94(4.666), n=36	0.044
ACR 50	-2.44(6.213), n=36	-6.05(5.133), n=21	0.027
PASI 75	-4.00(2.858), n=13	-3.70(6.736), n=44	0.924

Disclosure: D. D. Gladman, Janssen Research & Development, LLC, 2; W. H. Boehncke, Janssen Research & Development, LLC, 2; A. B. Gottlieb, Janssen Research & Development, LLC, 2; P. Helliwell, Janssen Research & Development, LLC, 2; P. Nash, 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; A. A. Deodhar, Janssen Research & Development, LLC, 2.

To cite this abstract in AMA style:

Gladman DD, Boehncke WH, Gottlieb AB, Helliwell P, Nash P, Xu XL, Xu S, Wang Y, Hsia EC, Karyekar CS, Deodhar AA. The Effect of Guselkumab on Dactylitis: 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-dactylitis-results-from-a-phase-2-study-in-patients-with-active-psoriatic-arthritis/. Accessed .

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