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P277 Assessment of disease activity using RAPID3 and evaluation of treatment effect of guselkumab in patients with PsA: results from a randomised placebo-controlled Phase 2 clinical trial

  • Deodhar, Atul School of Medicine, Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA
  • Kirkham, Bruce Department of Rheumatology, Guy’s and St. Thomas NHS Foundation Trust, London, UNITED KINGDOM
  • Rahman, Proton Faculty of Medicine, Memorial University of Newfoundland, St. Johns, NL, CANADA
  • Helliwell, Philip School of Medicine, University of Leeds, Leeds, UNITED KINGDOM
  • Gottlieb, Alice B Icahn School of Medicine, Mount Sinai, New York, NY, USA
  • Boehncke, Wolf-Henning Departement de Medecine, Geneva University Hospitals, Geneva, SWITZERLAND
  • Xu, Xie L Janssen Research & Development, Janssen-Cilag Ltd, Spring House, PA, USA
  • Gorecki, Patricia C Janssen Medical Affairs, Janssen-Cilag Ltd, High Wycombe, UNITED KINGDOM
  • Han, Chenglong Janssen Research & Development, Janssen-Cilag Ltd, Spring House, PA, USA
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  • 2020-4-20
Published in:
  • Rheumatology. - Oxford University Press (OUP). - 2020, vol. 59, no. Supplement_2
Pharmacology (medical)
Rheumatology
English Abstract

Background
To evaluate the effect of guselkumab (GUS) on Routine Assessment of Patient Index Data 3 (RAPID3) in patients with psoriatic arthritis (PsA).


Methods
In a Phase 2 trial, patients with active PsA and ≥3% body surface area of plaque psoriasis despite current or previous treatment with standard-of-care therapies, including anti-TNFα agents, were randomized 2:1 to receive GUS 100 mg (n = 100) or placebo (PBO, n = 49) subcutaneously at weeks 0, 4, and every 8 weeks (q8w) thereafter through W44. At W16, patients from either group with <5% improvement from baseline in both swollen and tender joint counts were eligible for early escape to open label ustekinumab. At W24, all remaining PBO patients crossed over to receive GUS 100 mg, and then received GUS at W28 and q8w thereafter through W44. RAPID3 (0-30) is derived from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) and numerical rating scales (0-10) for pain and patient global assessment. A change of 5.1 in RAPID3 score was identified as the minimally important difference (MID) in PsA, and RAPID3 ≤3.0 was used to define PsA remission. Change in RAPID3 and proportion of patients achieving MID were compared between treatments. Correlations of RAPID3 scores with the PsA Disease Activity Score (PASDAS), GRACE index, Disease Activity in Psoriatic Arthritis (DAPSA), and Modified Composite Psoriatic Disease Activity Index (mCPDAI) were evaluated using Spearman correlation.


Results
The mean (SD) RAPID3 score at baseline was 16.9 (5.19). At W24, patients in the GUS group (n = 100) achieved statistically significantly greater decrease from baseline (improvement) in RAPID3 (-5.81 ± 6.0) than the PBO group (n = 49) (-0.57 ± 5.1, p < 0.001), and 50% of patients in the GUS group vs 20.4% in the PBO group achieved an MID (p < 0.001). Higher RAPID3 remission rate in the GUS than the PBO group (14.0% vs 2.4%, p = 0.022) was observed. The mean ± SD decrease from baseline in RAPID3 was -6.36 ± 6.2 at W24, and -7.48 ± 6.3 at W44 in those who continued GUS (n = 86). Among patients who switched from PBO to GUS at W24 (n = 28), mean ± SD change from baseline (improvement) in RAPID3 was -2.28 ± 5.2 at W24 while on placebo and -7.60 ± 6.6 at W44 after switching to GUS. The RAPID3 score was highly correlated with PASDAS (r = 0.84, p < 0.001), GRACE index (r = 0.89, p < 0.001), DAPSA (r = 0.77 p < 0.001) and mCPDAI (r = 0.65, p < 0.001) at W16.


Conclusion
GUS-treated PsA patients demonstrated significant improvement in RAPID3 compared to PBO. RAPID3 is simple and feasible to use in routine clinical care, and it correlates well with other comprehensive PsA-specific disease activity measures.


Disclosures
A. Deodhar: Other; A.D. has been a study investigator for Janssen. B. Kirkham: Other; B.K. has been a study investigator for Janssen. P. Rahman: Other; P.R. has been a study investigator for Janssen. P. Helliwell: Other; P.H. has been a study investigator for Janssen. A.B. Gottlieb: Other; A.G. has been a study investigator for Janssen. W. Boehncke: Other; W.B. has been a study investigator for Janssen. X.L. Xu: Other; X.X. is a Janssen employee. P.C. Gorecki: Other; P.G. is a Janssen employee. C. Han: Other; C.H. is a Janssen employee.
Language
  • English
Open access status
bronze
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Persistent URL
https://sonar.ch/global/documents/269471
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