Publications

Burmester et al. provide insights into the benefit–risk profiles of UPA and adalimumab in patients with varying cardiovascular (CV) risks, suggesting that UPA may offer efficacy advantages over adalimumab irrespective of baseline CV risk, with generally similar rates of AEs. To better understand the benefits and risks of RA treatments in patients with different background CV risk, Burmester et al. assessed the short-term and long-term benefit–risk profiles of UPA and adalimumab in patients enrolled in SELECT-COMPARE.

Schaefer et al. showed that treatment with JAKis (predominantly BARI and TOF) was associated with an increased HR of malignancies compared to treatment with bDMARDs in the overall study cohort, consistent with results from the ORAL surveillance trial. To better understand the complex role of JAKis in cancer development in RA patients, Schaefer et al. estimated the effects of JAKis compared to bDMARDs on the risk of malignancy (excluding NMSC) in patients with RA.

Wieczorek et al. present the first evidence supporting the use of a dual JAK and ROCK inhibitor as a potential treatment option for patients with RA who have inadequate response to MTX. Wieczorek et al. conducted a randomised, Phase 2 study of CPL’116 in patients with RA with inadequate response to MTX, to evaluate dose-dependent effects on disease control and pharmacokinetics, and its effect on laboratory abnormalities among other safety assessments.

Heiting et al. investigated whether the initiation of IL-17 blockade with secukinumab improves bone turnover, bone mineral density, and microarchitecture in axSpA patients. Despite symptomatic benefits of therapy with secukinumab, with improvements in pain and function, there were few biochemical, densitometric, or microarchitectural changes in skeletal health over two years of treatment with secukinumab. Larger, longer-term controlled studies using sensitive metrics such as HR-pQCT to follow bone quality are needed to improve our understanding of bone health in axSpA and the relation to disease activity and therapy.

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.

In more than 1500 patients from 13 European countries, Pons et al. demonstrated that secukinumab retention rates after four years were approximately 50% in both axSpA and PsA patients. Pons et al. aimed to assess retention rates and proportions of patients achieving remission and LDA, according to disease activity measures and patient-reported outcomes at 24 and 48 months, in axSpA and PsA patients initiating secukinumab. In this large real-world study, Pons et al., for the first time, report 48-month retention rates as well as rates of remission and LDA. Importantly, b/tsDMARD naïve patients demonstrated higher retention, remission and LDA rates than patients with prior b/tsDMARDs exposure, particularly in axSpA.