SAT0322 The effect of guselkumab on dactylitis: results from a phase 2 study in patients with active psoriatic arthritis
Authors: D. Gladman, W.-H. Boehncke, A.B. Gottlieb, P. Helliwell, P. Nash, X.L. Xu, S. Xu, Y. Wang, E.C. Hsia, C.S. Karyekar, A. Deodhar
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> In a Phase 2 study, Guselkumab (GUS) was shown to be safe and effective in patients (pts) w/active psoriatic arthritis (PsA). <h3>Objectives</h3> To evaluate the effect of GUS on dactylitis in a subset of pts w/dactylitis at baseline (BL) in the phase 2 PsA study of GUS. <h3>Methods</h3> Pts w/active PsA and ≥3% body surface area of plaque psoriasis, despite current or previous treatment, were randomised 2:1 to receive 100 mg subcutaneous GUS at wks 0, 4 then every 8 weeks (wks, q8w) or placebo (PBO) during a 24wk double-blind treatment period. At wk16, pts w/&lt;5% improvement in swollen and tender joint counts early escaped (EE). At wk24, the PBO group crossed over to receive GUS (wks 24, 28 then q8w) (PBO→GUS) and the GUS group continued receiving GUS (GUS→GUS)) through wk44. Dactylitis was assessed by scoring each digit from 0–3 (0=absent, 1=mild, 2=moderate, 3=severe), for a combined score of 0–60. Sensitivity analysis of change from BL through wk24 in dactylitic digits was performed (combined score 20). Dactylitis scores during the 24-wk double-blind treatment was analysed using LOCF imputation for missing data and EE. Dactylitis after wk24 was evaluated using observed data. <h3>Results</h3> 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]) and 66 continued to the active treatment period (PBO→GUS n=16; GUS→GUS n=50). The dactylitis subset was similar to the overall population in BL characteristics except for higher median values for # of swollen joints, # of tender joints, and CRP. At wks 16 and 24, the GUS group had a significantly greater reduction in the dactylitis score (wk24 mean [SD] change from BL, PBO: −0.4 [6.06]; GUS: −3.8 [4.93]; p=0.006) and a greater% of pts w/dactylitis resolution, compared to the PBO group (figure 1). Consistent results were obtained w/the # 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 the GUS→GUS group (wk56: mean[SD] change from BL=−5.5 [4.84], 75% of pts w/resolution) and the values for the PBO→GUS group (wk56: mean[SD] change from BL=−4.4 [3.50], 93.7% of pts w/resolution) approached those of the GUS→GUS group. Improvement in dactylitis was greater in ACR20/ACR50 responders vs non-responders in GUS-treated patients (Table 1) and was significantly correlated with improvement in TJC (R=0.38, p=0.004), SJC (R=0.50, p&lt;0.0001), and HAQ-DI score (R=0.33, p=0.013). <h3>Conclusions</h3> GUS is efficacious in resolving symptoms of dactylitis in pts w/active PsA. This effect on dactylitis is correlated with improvement in joint symptoms and physical function. <h3>Disclosure of Interest</h3> D. Gladman Grant/research support from: Janssen Research and Development, LLC, W.-H. Boehncke Grant/research support from: Janssen Research and Development, LLC, A. Gottlieb Grant/research support from: Janssen Research and Development, LLC, P. Helliwell Grant/research support from: Janssen Research and Development, LLC, P. Nash Grant/research support from: Janssen Research and Development, LLC, X. Xu Employee of: Janssen Research and Development, LLC, S. Xu Employee of: Janssen Research and Development, LLC, Y. Wang Employee of: Janssen Research and Development, LLC, E. Hsia Employee of: Janssen Research and Development, LLC, C. Karyekar Employee of: Janssen Research and Development, LLC, A. Deodhar Grant/research support from: Janssen Research and Development, LLC