Publications

Mease et al. conducted a post-hoc analysis of the phase 3 DISCOVER-2 trial to assess the persistence of clinically relevant improvements with guselkumab in biologic-naïve patients with PsA. The analysis showed that guselkumab maintained clinical improvements in joint and skin domains at consecutive dosing visits (Q8W) and over time.

Mease et al. assessed the comparative effectiveness of bimekizumab and risankizumab in patients with PsA over 52 weeks using a matching-adjusted indirect comparison (MAIC). The study included patients who were biologic disease-modifying anti-rheumatic drug (bDMARD) naïve or had a prior inadequate response or intolerance to tumour necrosis factor inhibitors (TNFi-IR).

McInnes et al. reported that bimekizumab demonstrated sustained efficacy and safety over 52 weeks in patients with psoriatic arthritis (PsA), regardless of concomitant methotrexate (MTX) use. Both bimekizumab groups (with and without MTX) showed similar improvements in achieving ACR50 and PASI100 responses.

van Vollenhoven et al. compared the efficacy and safety of upadacitinib monotherapy to methotrexate monotherapy over five years in methotrexate-naïve patients with rheumatoid arthritis. The study found that upadacitinib provided better long-term efficacy and higher rates of disease activity remission than methotrexate; however, it was associated with higher incidences of adverse events, particularly at the higher dose of 30 mg.

Fleischmann et al. evaluated the long-term efficacy and safety of upadacitinib in rheumatoid arthritis patients with inadequate response or intolerance to bDMARDs over five years. The study demonstrated that upadacitinib 15 mg and 30 mg were effective in maintaining disease control, with >75% of patients achieving CDAI LDA by week 260. The safety profile remained consistent with no new issues identified.

This study by Mahadevan, et al. evaluated pregnancy outcomes in patients exposed to upadacitinib during pregnancy. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases not receiving upadacitinib. The data were limited for in utero exposure to upadacitinib, so definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes.

More RA patients on upadacitinib versus adalimumab achieved clinical remission, LDA, and DAS28 (CRP) <2.6. Radiographic progression was less with continuous upadacitinib versus continuous adalimumab. Upadacitinib showed similar safety to adalimumab, with higher incidences of HZ, lymphopenia, CPK elevation, hepatic disorder and nonmelanoma skin cancer.

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.

Crude gastrointestinal perforation (GIP) incidence rate was higher for the JAKi group compared with those receiving adalimumab, however rates of GIP did not differ between JAKi and adalimumab groups in the weighted and adjusted model. Hoisnard et al compared the risk of GIP in patients initiating treatment with JAKis or adalimumab among real-world patients with rheumatic disease.

The 5-year benefit-risk profile for upadacitinib in RA remains favourable, with clinical outcomes improved or maintained through Week 260. No new safety findings were identified during the LTE. Results remained consistent with earlier analyses of SELECT-NEXT.