Armstrong et al. evaluated the long-term safety and efficacy of deucravacitinib in patients with moderate to severe plaque psoriasis over a three-year period. The study found that exposure-adjusted incidence rates of AEs remained stable or declined over time, with no new safety signals emerging. Clinical response rates, including PASI75/90, were maintained, supporting the drug’s long-term efficacy.

Sands et al. evaluated tamuzimod, a selective sphingosine 1-phosphate receptor 1 modulator, in patients with moderately-to-severely active UC. At Week 13, clinical remission (defined as an MMS stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore ≤1, excluding friability) was achieved by 28% and 24% of patients receiving tamuzimod 60 mg and 30 mg, respectively, compared with 11% in the placebo group. The treatment was well tolerated; most AEs were mild or moderate.

Deodhar et al. assessed the long-term safety, tolerability and efficacy of bimekizumab in patients with r-axSpA over five years. The study found that bimekizumab maintained disease control achieved at Wk48 through Wk256, with no new safety signals observed. Adverse events were consistent with previous reports, and clinical benefits, including improvements in disease activity and patient-reported outcomes, were sustained.

Baraliakos et al. evaluated the long-term safety and efficacy of bimekizumab in axSpA through a 2-year analysis of the BE MOBILE 1 and BE MOBILE 2 studies. Bimekizumab was well tolerated, with a consistent safety profile and no new safety signals. Clinical improvements, including ASAS40 response and MRI remission, were sustained through Wk104.

Gladman et al. assessed the impact of bimekizumab over 1 year on patient-reported symptoms, HRQoL, and work productivity in patients with PsA who were bDMARD-naïve or TNF-IR. The study showed that bimekizumab treatment resulted in sustained improvements across multiple domains, including pain, fatigue, physical function, and work impairment.

January 2025

Ferrante et al. conducted a phase 3 trial evaluating the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease. The study demonstrated that mirikizumab significantly improved clinical and endoscopic outcomes compared with placebo at week 52, with a favourable safety profile and tolerable adverse events.

McInnes et al. assessed the efficacy of guselkumab over 48 weeks in patients with psoriatic arthritis who had an inadequate response to TNF inhibitors. The results demonstrated consistent improvements in joint, skin, and patient-reported outcomes across all baseline-defined subgroups. Guselkumab showed greater efficacy compared with placebo at Week 24, with responses maintained or improved through Week 48.

Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis

Journal Reference: Adv Rheumatol. 2024 Dec 18;64:87 doi: 10.1186/s42358-024-00402-x

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.

Barriers to CAR T-cell therapy in rheumatology

Lancet Rheumatol 2024 doi: 10.1016/S2665-9913(24)00240-6

Lungova et al. explored the potential of CAR T-cell therapy in autoimmune conditions such as SLE, myopathies, and systemic sclerosis. While clinical cases show promise, adoption is limited by high costs, narrow patient eligibility, and safety concerns, including cytokine release syndrome. Future targeted CAR T-cell approaches may enhance efficacy and safety.

December 2024

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.