Publications

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.

Van den Bosch et al. reported that upadacitinib 15 mg once daily led to sustained improvement in nr-axSpA over two years, including disease activity, pain, and quality of life. The study reports that 57.1% achieved ASAS40 response at week 104, with no new safety signals identified.

Deodhar et al. assessed the long-term safety, tolerability and efficacy of bimekizumab in patients with r-axSpA over five years. The study found that bimekizumab maintained disease control achieved at Wk48 through Wk256, with no new safety signals observed. Adverse events were consistent with previous reports, and clinical benefits, including improvements in disease activity and patient-reported outcomes, were sustained.

Baraliakos et al. evaluated the long-term safety and efficacy of bimekizumab in axSpA through a 2-year analysis of the BE MOBILE 1 and BE MOBILE 2 studies. Bimekizumab was well tolerated, with a consistent safety profile and no new safety signals. Clinical improvements, including ASAS40 response and MRI remission, were sustained through Wk104.

Baraliakos et al. assessed the long-term efficacy and safety of upadacitinib in patients with active ankylosing spondylitis who were refractory to biologic therapy. At week 104, the treatment sustained improvements in disease activity and functional outcomes with low rates of radiographic progression and no new safety signals.

The 1-year results of the SELECT-AXIS 2 study showed significant improvements in ASAS40 achievement in patients with nr-axSpA that were treated with upadacitinib 15mg QD versus placebo. Improvements in ASDAS endpoints, back pain, BASFI, and hsCRP from baseline were also observed.

The 2023 EULAR recommendations provided an updated consensus on the pharmacological management of PsA with a new overarching principle and recommendation for 2023. Recent MOA safety data emphasised the importance of patient-specific benefit-risk profiling in JAKi therapy, and extra-musculoskeletal (MSK) manifestations related to PsA should be considered during drug selection.

Baraliakos, et al. present data from two Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, that investigated the clinical efficacy and safety of bimekizumab in axSpA patients. They found that bimekizumab had sustained and consistent efficacy in patients with nr-axSpA and r-axSpA.

The efficacy and safety of updacitinib in bDMARD-IR patients with AS were sustained through to one year in an open-label extension of the SELECT-AXIS 2 study.

Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.