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) |
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Format: | Artikel |
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 |
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ISSN: | 1462-0324 1462-0332 |
DOI: | 10.1093/rheumatology/keaa111.255 |