Format

Send to

Choose Destination
Arthritis Care Res (Hoboken). 2019 Aug 17. doi: 10.1002/acr.24046. [Epub ahead of print]

Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase 2 Trial.

Author information

1
FRCP: University of Leeds, Leeds, UK.
2
Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA.
3
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
4
Division of Dermatology and Venereology, Geneva University Hospitals, and Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland.
5
Immunology, Janssen Research & Development, LLC, San Diego, CA, USA.
6
Clinical Biostatistics, Janssen Research & Development, LLC, Spring House, PA, USA.
7
Immunology, Janssen Research & Development, LLC, Spring House and University of Pennsylvania Medical Center, Philadelphia, PA, USA.
8
Division of Rheumatology, University of Toronto, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario Canada.
9
Immunology & Rheumatology, University of Rochester Medical Center, Rochester, NY, USA.

Abstract

OBJECTIVE:

Assess performance of psoriatic arthritis (PsA) composite indices and evaluate guselkumab's effect on achieving low disease activity or remission.

METHODS:

In this Phase 2 trial, patients with active PsA (≥3 tender and ≥3 swollen joints, C-reactive protein ≥0.3 mg/dL, ≥3% body-surface-area psoriasis involvement) were randomized 2:1 to subcutaneous guselkumab 100 mg (N=100) or placebo (N=49) at Week 0, Week 4 and q8w through Week44. At Week 16, patients with <5% improvement in swollen and tender joints could early escape (EE) to open-label ustekinumab. Patients continuing placebo crossed-over to receive guselkumab 100 mg at Weeks 24, 28, 36, and 44 (placebo→guselkumab). PsA composite indices (Psoriatic ArthritiS Disease Activity Score [PASDAS], GRAppa Composite scorE [GRACE], modified Composite Psoriatic Disease Activity Index [mCPDAI], Disease Activity index for PSoriatic Arthritis [DAPSA]) were analyzed as secondary outcomes (last-observation-carried-forward for missing/post-EE data through Week 24; observed data post-Week 24). Instrument performance was assessed.

RESULTS:

Baseline PASDAS, GRACE, mCPDAI, and DAPSA scores indicated moderate-to-high disease activity. At Week 24, mean changes in each of these composite indices demonstrated significant improvement with guselkumab (-2.50, -2.73, -3.8, -23.08, respectively) vs. placebo (-0.49, 0.35, -0.8, -4.98; all p<0.001). Significantly more guselkumab-treated patients achieved low (or very-low/remission) disease activity state(s) per PASDAS (very-low+low 35.0% vs. 4.1%; p<0.001), GRACE (29.6% vs. 2.1%; p<0.001), mCPDAI (45.9% vs. 10.4%, p<0.001), and DAPSA (remission+low 40.0% vs. 12.2%; p<0.001); 12% of guselkumab-treated vs. no placebo-treated patients achieved DAPSA remission (p<0.01). The PASDAS and GRACE instruments were more sensitive than the mCPDAI and DAPSA tools in detecting treatment effect. Residual skin disease and enthesitis were marginally more prominent in patients achieving DAPSA low disease activity versus other indices.

CONCLUSION:

Guselkumab demonstrated efficacy in achieving low disease activity/remission based on all PsA composite indices assessed. Composite index use in PsA trials and the clinic requires careful consideration to optimize feasibility and instrument performance.

PMID:
31421033
DOI:
10.1002/acr.24046

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center