New Data Highlight Effectiveness of Guselkumab for Patients with PsA

ACR CONVERGENCE 2021—A phase 3, randomized study demonstrated that guselkumab (Tremfya) improves joint and skin symptoms in patients with psoriatic arthritis (PsA) through two years. These data were presented by Iain McInnes, MD, professor of medicine at the Institute of Infection, Immunity and Inflammation, University of Glasgow School of Medicine, Glasgow, Scotland, during ACR Convergence 2021.

Researchers enrolled 739 adult patients with PsA in this double-blind, randomized controlled trial. The patients were biologic-naive and had active disease, defined as having at least five swollen joints plus at least five tender joints and a C-reactive protein (CRP) of at least 0.6 mg/dL. Patients were randomized to receive either 100 mg of guselkumab every four weeks, 100 mg of guselkumab at weeks 0 and 5 and every eight weeks thereafter, or placebo with a switch at week 24 to 100 mg of guselkumab every four weeks.

Efficacy end points included ACR 20/50/70 responses, Health Assessment Questionnaire Disability Index (HAQ-DI) scores, Psoriasis Area and Severity Index (PASI) 75/90/100 response and an Investigator’s Global Assessment (IGA). Clinical efficacy was assessed in the modified intention to treat population through week 100, with missing data imputation. Changes in PsA-modified van der Heijde-Sharpe (vdH-S) radiographic scores and safety assessments were observed through week 112.

The Results

At week 24, 96% (n=712) of patients continued with guselkumab, with 93% (n=687) continuing to week 52 and 88% (n=652) continuing to week 100. At week 100, the ACR 20 results ranged from 68–78%, the ACR50 results ranged from 48–56% and the ACR 70 results ranged from 30–36%. The ACR 20 response rates in the modified intention to treat population continued to increase after week 24. At week 100, the ACR 20 response was 76% for patients who received guselkumab every four weeks and 74% for those who received guselkumab every eight weeks.

For patients who switched from placebo to guselkumab after week 24, the ACR 20 response at week 100 was 68%. Similar patterns and rates of response occurred for the other efficacy measures (e.g., ACR 50/70, HAQ-DI, PASI 90/100). The IGA and PASI 75 response rates were consistent through week 100 in patients who received guselkumab every four weeks and every eight weeks. The week 100 efficacy data for patients who switched from placebo to guselkumab at week 24 were similar to the data for patients treated with guselkumab every four weeks and every eight weeks. Low rates of radiographic progression were observed during the study.

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.

Reference

1. 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).