Publications

Wollenhaupt et al. undertook a post-hoc analysis of data from eight Phase 3 and 3b/4 clinical trials to assess change from baseline (Δ) weight and BMI in patients with moderate to severe RA receiving TOF through 12 months. Additionally, Wollenhaupt et al. evaluated correlations between baseline/changes in disease activity, baseline CRP, and changes in lipids with Δweight and BMI. Wollenhaupt et al. showed that mean Δweight and BMI increased over time and were greater with TOF (all doses) versus placebo at Months 3 and 6, and with TOF monotherapy versus combination therapy, at Months 3, 6, and 12. The correlation and sensitivity analyses showed weak correlation between Δweight or BMI with TOF and DAS28-4(ESR), baseline CRP or lipid changes.

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.

Maksymowych et al. evaluated the effect of ixekizumab and adalimumab versus placebo over 52 weeks on structural lesions in sacroiliac joints assessed by MRI in patients naive to biological DMARDs with radiographic axSpA from the COAST-V study. The authors reported a decrease in erosion and increase in backfill at Week 16 with further reductions in erosion and increases in backfill occurring at Week 52 in patients receiving ixekizumab.

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.

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.