P262 Guselkumab, an anti-interleukin-23p19 monoclonal antibody, in patients with active PsA who were biologic-naïve or prior TNFα inhibitor-treated: week 24 results of a Phase 3, randomised, double-blind, placebo-controlled study

Abstract Background Guselkumab (GUS), an anti-interleukin-23p19 monoclonal antibody, is approved to treat psoriasis (PsO). We evaluated GUS efficacy and safety in a Phase 3, double-blind, placebo (PBO)-controlled trial in patients with active PsA who were biologic-naïve or prior TNFα inhibitor (TNFi...

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Veröffentlicht in:Rheumatology (Oxford, England) England), 2020-04, Vol.59 (Supplement_2)
Hauptverfasser: Deodhar, Atul, Helliwell, Philip, Boehncke, Wolf-Henning, Hsia, Elizabeth C, Kollmeier, Alexa P, Subramanian, Ramanand A, Xu, Xie L, Sheng, Shihong, Zhou, Bei, Gorecki, Patricia C, Ritchlin, Christopher
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Sprache:eng
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Zusammenfassung:Abstract Background Guselkumab (GUS), an anti-interleukin-23p19 monoclonal antibody, is approved to treat psoriasis (PsO). We evaluated GUS efficacy and safety in a Phase 3, double-blind, placebo (PBO)-controlled trial in patients with active PsA who were biologic-naïve or prior TNFα inhibitor (TNFi)-treated (DISCOVER-1). Methods Adults with active PsA (≥3 swollen + ≥3 tender joints; CRP ≥0.3mg/dL) despite standard therapies (eg, non-biologic DMARDs, apremilast, or NSAIDs) were eligible. ∼30% of patients previously could have received or have had inadequate response to 1-2 TNFi. Patients were randomised 1:1:1, stratified by Week [W]0 DMARD use and prior TNFi use, to GUS 100mg Q4W; GUS 100mg at W0, W4, Q8W (Q8W); or PBO. Concomitant stable use of select non-biologic DMARDs, oral corticosteroids, and NSAIDs was allowed. At W16, patients with
ISSN:1462-0324
1462-0332
DOI:10.1093/rheumatology/keaa111.255