Publications

In this first global clinical study of a nanobody in inflammatory arthritis, sonelokimab, an
IL-17A- and IL-17F-inhibiting nanobody demonstrated strong efficacy across multiple domains including high-hurdle composite joint and skin responses. McInnes et al. reported on the Phase 2, randomized, double-blind, PBO-controlled ARGO trial which evaluated the efficacy and safety of sonelokimab in patients with active PsA.

Mease et al. report that patients without radiographic progression through 2 years of secukinumab treatment had greater achievement of LDA states at Week 104 than patients with radiographic progression. This post hoc analysis by Mease et al. of the FUTURE 5 study evaluated the relationship between radiographic progression status at Week 104 and achievement of LDA or remission and identified demographics and clinical characteristics that were associated with radiographic progression status at Week 104.

Mease et al. showed that guselkumab provided significantly higher rates of clinical improvement and significant inhibition of structural damage progression versus PBO, with no new safety signals, at Week 24 in biologic-naïve participants with active and erosive PsA. Mease et al. report primary efficacy and safety results for the double-blind PBO-controlled phase (Weeks 0-24) of the 3-year APEX study.

Ritchlin et al. conducted a post hoc analysis of the DISCOVER-2 trial, evaluating the efficacy of guselkumab in biologic-naïve patients with PsA. Guselkumab provided durable disease control across key PsA domains and PROs over 2 years, regardless of baseline characteristics. A significant proportion of patients achieved stringent endpoints such as ACR50/70, complete skin clearance, and resolution of dactylitis/enthesitis.

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

Whole blood transcriptome profiling reveals differential gene expression in patients with active PsA from the DISCOVER-1 and DISCOVER-2 clinical studies in comparison with healthy controls.

Post hoc analysis of guselkumab, Phase 3 DISCOVER-1 and -2 studies finds that 75% of guselkumab-randomised patients have complete resolution of dactylitis through one year.

TNF inhibitors (TNFi) are one main mode of therapy in patients with PsA who fail to respond to csDMARDs. However, they have a primary treatment failure rate of 40% and only a modest target of ≥20% ACR20 response. The objective of this study was to evaluate efficacy and safety of guselkumab, interleukin-23 inhibitor in the DISCOVER-1 study with active PsA patients by prior use of TNFi.

Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.

This study highlighted that the safety of bimekizumab in patients with PsA over 3 years of treatment was consistent with the previous 48-week results, as well as other recently published studies of IL-17 inhibitors in PsA patients.