Publications

Hernández-Hernández et al. showed that in a real-world clinical settings, UPA persistence is lower among RA patients who have received prior IL-6i treatment; and that treatment strategies to avoid UPA in patients with cardiovascular risk (CVR) appear to be primarily driven by pivotal safety studies rather than regulatory guidance.

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.

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.

Buch et al. demonstrated that filgotinib sustained its efficacy in rheumatoid arthritis patients through Wk156 in the FINCH 4 long-term extension study, showing stable safety profiles. The study reported high ACR response rates and remission based on Boolean criteria, underlining filgotinib's potential for extended clinical benefits.

Buch et al. evaluated the efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and inadequate response to methotrexate in the FINCH 1 study. At     Wk 12, ACR20 response rates were significantly higher with filgotinib 200 mg (77.9%) and 100 mg (67.8%) compared to placebo (43.8%). Safety profiles for both filgotinib doses were similar to adalimumab.

Patients classified as having a high neutrophil-to-lymphocyte ratio (NLR-High) who received filgotinib 200mg + MTX/csDMARDs exhibited consistently better responses after 12 weeks across clinical trials, clinical endpoints, and PROs, compared with NLR-Low patients. Taylor et al. analysed data from the 3 FINCH trials to investigate the potential association of baseline NLR with improved clinical response to filgotinib in MTX-naïve or MTX-experienced RA populations.

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

Crude gastrointestinal perforation (GIP) incidence rate was higher for the JAKi group compared with those receiving adalimumab, however rates of GIP did not differ between JAKi and adalimumab groups in the weighted and adjusted model. Hoisnard et al compared the risk of GIP in patients initiating treatment with JAKis or adalimumab among real-world patients with rheumatic disease.