Publications

The SELECT-MONOTHERAPY study evaluated the safety and efficacy of UPA monotherapy through 260 weeks of treatment, in patients with RA who had prior inadequate response to MTX. No new safety signals were observed with long-term exposure to UPA, and results were consistent with prior findings and the established safety profile of UPA across indications. These data support the potential of UPA as a treatment option for patients with moderate to severe active RA who have responded inadequately to MTX.

Silvagni et al. aimed to comparatively assess the risk of cardiovascular events (CVE) in RA patients treated with JAKis or TNFis and to explore the interactions with patient profiles [including age, baseline cardio-cerebrovascular (CV) risk, and frailty, which is a state of decreased physiological reserve, assessed using a validated frailty index for Administrative Heathcare Databases (AHD)]. This AHD-based study highlighted no significantly increased risk of CVEs or MACEs for JAKis with respect to TNFis. The CV risk remains mainly driven by the patient profiles. The frailty, in parallel with baseline CV risk, emerged as an important determinant of CVEs, MACEs, and thromboembolic events (TEs). Frailty and baseline CV risk are key predictors of CVEs, MACEs, and TEs, and should be considered in both clinical assessment and trial design for RA patients on ts/b-DMARDs.

Poddubnyy et al. identified no apparent increase in the risk of developing extramusculoskeletal manifestations (EMMs) in patients with PsA, r-axSpA, and nr-axSpA receiving 15mg UPA in the SELECT trials. Majority of patients did not report a history of EMMs at baseline, regardless of disease indication or study treatment.

Haddad et al. used real-world data from Israel’s largest health maintenance organisation to investigate predictors and patterns of biologic therapy switching in PsA, reporting that nearly half of biologic users switched therapy at least once. Cross-class switching, particularly from anti-TNF to IL-17 therapies, was frequent and consistent across two decades of treatment data.

Mariette et al. investigated the long-term safety of filgotinib with regard to MACE, VTE and malignancy across RA and UC clinical trial populations. Rates of these events remained low overall, with some increases observed in patients aged 65 years and older.

Phase 2 study data show that zimlovisertib + tofacitinib was more effective than tofacitinib alone, in patients with moderate-to-severe RA and an inadequate response to MTX.

Di Napoli et al. conducted a global pharmacovigilance analysis comparing MACE between JAKis and anti-TNFα therapies in patients with RA. JAKis were more frequently associated with reported MACE, particularly stroke, and had a shorter median time to onset than
anti-TNFα therapy.

Kanda et al. investigated the efficacy of second-line b/tsDMARDs in RA patients unresponsive to first-line b/tsDMARDs. Using data from the FIRST registry, the study assessed 687 patients with RA treated with TNFis, IL-6 receptor inhibitors, cytotoxic T-lymphocyte-associated protein 4 immunoglobulin, or JAKis. After propensity score-based adjustment, JAKi showed the highest persistence rate, greatest improvement in CDAI, and highest remission rates at 24 weeks. Among JAKi, UPA was most effective in achieving remission, with a safety profile comparable to other b/tsDMARDs.

Eberhard et al. investigated the effectiveness of JAKi versus bDMARDs on pain reduction in RA patients, using Swedish national register data. JAKi treatment resulted in a significantly greater reduction in pain at three months compared with TNFis, with a higher proportion achieving low pain at 12 months, particularly in those previously treated with multiple bDMARDs.