Publications

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.

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.

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.

This post hoc analysis of ORAL Surveillance showed that incidence of venous thromboembolism (VTE) events was higher in patients with RA treated with tofacitinib (10>5mg BID) versus TNFi. Across treatments, VTE risk factors (age, BMI, and VTE history) were aligned with previous studies in the general RA population.

The observed benefit:risk ratio strongly favours JAKi use in the majority of patients, and HCPs should consider and adhere to guidance on high-risk patients where applicable. Szekanecz et al summarised the safety and efficacy of approved JAKis tofacitinib, baricitinib, upadacitinib, and filgotinib to aid in clinical decision making.

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.

The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

This post hoc analysis of data from the ORAL Shift study, concludes that DAS28-4(ESR), CDAI remission and SDAI remission are the metrics most likely to reflect actual disease activity, in the context of tofacitinib in a randomised withdrawal of MTX.

Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.