Through week 112, the incidences of adverse events, serious adverse events, adverse reactions leading to drug discontinuation, infections and injection site reactions were generally consistent with the placebo-controlled period through one year of the study. Serious adverse events occurred in 8% of guselkumab-treated patients, and 3% had at least one serious infection. Infections included disseminated herpes zoster, listeria meningitis and fungal esophagitis. One of the placebo-switch patients died in a road traffic incident, one placebo-switch patient had inflammatory bowel disease, and no patients had anaphylactic reactions, serum sickness reactions or active tuberculosis. No new safety signals were identified.
Overall, the use of guselkumab to treat patients with PsA who are biologic naive led to improvements in joint and skin symptoms, as well as improvements in physical functioning, with low rates of radiographic progression throughout two years of treatment.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
Reference
- McInnes I, Rahman P, Gottlieb A, 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-naive patients with active psoriatic arthritis [abstract: 1336]. Arthritis Rheumatol. 2021 Oct; 73(suppl 10).
