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.

Heutz et al. found that patients requiring bDMARDs rarely achieved DMARD-free remission, while 15–37% of those on non-bDMARDs reached this milestone, underscoring significant differences based on treatment type. This suggests the EULAR recommendation against DMARD cessation may be too generalised.

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December 2024

Alarfaj et al. demonstrate fenofibrate significantly improved clinical outcomes, inflammatory biomarkers, and quality of life in patients with mild-to-moderate UC when added to mesalamine therapy.

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Baraliakos et al. assessed the long-term efficacy and safety of upadacitinib in patients with active ankylosing spondylitis who were refractory to biologic therapy. At week 104, the treatment sustained improvements in disease activity and functional outcomes with low rates of radiographic progression and no new safety signals.

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.

Baricitinib as monotherapy for treatment of rheumatoid arthritis: analysis of real-world data

Current Medical Research and Opinion 2024;40:1993–2002 doi: 10.1080/03007995.2024.2416979.

Edwards et al. report on real-world data for baricitinib monotherapy in rheumatoid arthritis, showing significant disease activity reduction across multiple registries and observational studies. These findings reinforce the viability of baricitinib monotherapy in clinical practice for RA patients, complementing existing guidelines.

November 2024

Choy et al. investigated the efficacy and safety of intensified versus standard infliximab dosing for steroid-refractory acute severe ulcerative colitis (ASUC). The study found that a first dose of 10mg/kg infliximab was not superior to the standard 5mg/kg dose in achieving clinical response by Day 7. Earlier responses were noted with dose intensification, but no significant differences were observed in remission, colectomy rates, or safety profiles by Month 3.

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Mease et al. conducted a post-hoc analysis of the phase 3 DISCOVER-2 trial to assess the persistence of clinically relevant improvements with guselkumab in biologic-naïve patients with PsA. The analysis showed that guselkumab maintained clinical improvements in joint and skin domains at consecutive dosing visits (Q8W) and over time.

Tanaka et al. observed that in Japanese patients with rheumatoid arthritis treated with tofacitinib, those with absolute lymphocyte counts (ALCs) <0.5x10³ cells/mm³ had a higher risk of serious infections and herpes zoster events compared to patients with higher ALC levels. This threshold may help identify increased infection risk in this population