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Adverse events reporting | Prescribing information ( This product is under additional monitoring)

PsA clinical publications

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McInnes IB, et al. Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19-Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis. Presented at Innovations in Dermatology Conference, March 16-20, 2021. Online

McInnes IB, et al. Efficacy and safety of guselkumab, an interleukin-23p19-specific monoclonal antibody, through 1 year in biologic-naive psoriatic arthritis patients. Arthritis Rheumatol 2021. Apr;73(4):604-616.

Ritchlin CT, et al. Guselkumab, an inhibitor of the IL- 23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic- naïve or TNFα inhibitor- experienced. RMD Open 2021;7:e001457.

Coates LC, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who demonstrated inadequate response to tumor necrosis factor inhibition: week 24 results of a phase 3b, randomized, controlled study. Presentation at EULAR 2–5 June 2021. Online. #OP0230.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance Website: www.hpra.ie. Adverse events should also be reported to Janssen Sciences Ireland UC on 1800 709 122 or at dsafety@its.jnj.com.
CP-310758 - July 2022