Publications

Mease et al. found that bimekizumab demonstrated a favourable long-term safety profile in patients with axSpA and PsA.

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.

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.

Zhao et al. found that among patients with PsA or axSpA, JAKi were not associated with increased risk of CVD or common cancers compared to TNFi or IL-17i.

Zavoriti and Miossec explored the impact of tofacitinib on inflammation and coagulation in RA. Tofacitinib reduced synovial and vascular inflammation by inhibiting IFNɣ, IL-17A, and IL-6 production but failed to prevent the prothrombotic effects of inflammatory cytokines on endothelial cells. These findings suggest that while tofacitinib reduces inflammation, it does not mitigate associated thrombotic risk.

Deodhar et al. conducted a pooled analysis of Phase 2 and 3 RCT data to assess the safety of tofacitinib in AS. The results showed that tofacitinib 5 mg BID had a tolerable safety profile over 48 weeks, consistent with its use in other inflammatory conditions such as RA and PsA.

Haraoui et al. conducted a subgroup analysis of the CANTORAL study, showing that tofacitinib effectiveness was similar in patients with or without CV risk enrichment. However, AEs, particularly in older patients (≥65 years), were more frequent in the CV+ cohort. These findings highlight the need for tailored CV risk management when treating RA with tofacitinib.

Goldman, et al. conducted a pharmacovigilance study to evaluate the cardiovascular safety of JAK inhibitors in RA patients. The study demonstrated an increase in the reporting of VTE, stroke, and ischemic heart disease in patients treated with JAK inhibitor compared to bDMARDs, especially within the first year of treatment. This suggests a class effect of JAK inhibitors on cardiovascular risk, emphasising the need for ongoing surveillance and proactive cardiovascular risk management.

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.