Publications

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.

Goldman, et al. conducted a pharmacovigilance study to evaluate the cardiovascular safety of JAK inhibitors in RA patients. The study demonstrated an increase in the reporting of VTE, stroke, and ischemic heart disease in patients treated with JAK inhibitor compared to bDMARDs, especially within the first year of treatment. This suggests a class effect of JAK inhibitors on cardiovascular risk, emphasising the need for ongoing surveillance and proactive cardiovascular risk management.

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.

Fleischmann, et al. found that patients who switched from adalimumab to upadacitinib and vice versa following lack of improvement showed improvements in disease activity measures and functional outcomes through 228 weeks.