At week 24, 44% of patients treated with guselkumab experienced an ACR20 response compared with 19.8% of patients treated with placebo. At all the time points measured, the ACR20 response was higher in patients who received guselkumab than those who received placebo, as well as statistically significant (P<0.001).
For all major secondary end points, treatment with guselkumab was superior to treatment with placebo, but the statistical significance was not reported. At week 24, the secondary end points included:
- A change from baseline in the Health Assessment Questionnaire-Disability Index score;
- The percentage of participants who achieved an ACR50 response; and
- The change from baseline in 36-Item Short form Health Survey Physical Component Summary score.
For patients who discontinued prior TNFi use due to lack of benefit, guselkumab was an effective in treatment. Adverse events were similar between both treatment groups and included infections and injection-site reactions.
This study showed that taking 100 mg of subcutaneous guselkumab every eight weeks in patients with PsA for whom at least one TNFi was not tolerated or had not elicited a response had a durable and consistently higher ACR20 compared with patients who received placebo. Additionally, these patients had a favorable safety profile with guselkumab 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.
References
- Coates LC, Gossec L Thender E 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, randomize, controlled study [abstract OP0230]. Ann Rheum Dis. 2021;80(suppl 1):140–141.
- Janssen Pharmaceutica N.V. A study of guselkumab in participants with active psoriatic arthritis and an inadequate response to anti-tumor necrosis factor alpha therapy (COSMOS). ClinicalTrials.gov. 2021 Jan 20.
- Guselkumab label. U.S. Food & Drug Administration. 2017 Jul 13.
- Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): A double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1126–1136.
