No deaths or opportunistic infections occurred.
The authors note that self-administration was permitted during the COVID-19 pandemic, when site visits were restricted, resulting in some major protocol deviations. However, they state, “These were classified mostly as drug administration or study visit missed or outside of the prespecified window, and most were considered to have no effect on efficacy assessments.”
Dr. Coates says, “This drug has now been licensed for treatment of patients with PsA and this study supports use in those who have previously been treated with other biologics.”
“Next steps would include observational ‘real-world’ data in patients in the clinic,” she adds. “This would support data on efficacy/safety in a wider population, as not all patients are eligible or willing to join clinical trials,” she adds. “The efficacy seen in arthritis, enthesitis and dactylitis, as well as skin disease also leads to a significant benefit in terms of functional ability and quality of life.”
Dr. Soumya Chakravarty, Senior Director, Strategic Lead, Rheumatology Therapeutic Area at Janssen Scientific Affairs, LLC, commented in an email to Reuters Health, “Results from this study provide further evidence that [guselkumab] is effective in treating patients with various manifestations of active psoriatic arthritis even when TNF inhibitor treatment has failed.”
The study was sponsored by Janssen Research and Development, LLC. Four coauthors are employees and Dr. Coates and other coauthors have received funds from the company.
Reference
- Coates LC, Gossec L, Theander E, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase 3b, randomised, controlled study (COSMOS). Ann Rheum Dis. 2021 Nov 24;annrheumdis-2021-220991. Online ahead of print.
