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.

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.

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

Tsai et al. observed no significant difference in the incidence of psoriatic arthritis among psoriasis patients treated with IL-23 inhibitors compared to IL-12/23 inhibitors, although there was a numerically lower PsA risk with IL-23 inhibitors. Results indicate both therapies are similarly effective for PsO management.

October 2024

Kristensen et al. compared 14 PsA drugs across five treatment classes, evaluating their real-world effectiveness over three months. Ixekizumab showed rapid effectiveness on joint disease activity and skin outcomes, performing better than IL-12/23i and IL-23i, and comparable to TNFi and JAKi. More patients with active psoriasis achieved minimal disease activity with Ixekizumab than other therapies.

September 2024

Adami et al. conducted a retrospective analysis to evaluate the GC sparing effects of JAKi versus bDMARDs in rheumatoid arthritis patients. They found that JAKi therapy was associated with a significant reduction in GC dose compared with bDMARDs. This suggests that JAKi could be more effective in reducing long-term GC exposure in RA patients.

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August 2024

This study by Mahadevan, et al. evaluated pregnancy outcomes in patients exposed to upadacitinib during pregnancy. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases not receiving upadacitinib. The data were limited for in utero exposure to upadacitinib, so definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes.

May 2024

Shu, et al. identified 37 preferred terms as unexpected AEs following risankizumab treatment, and found 48 AEs with an increased risk of risankizumab-induced AE severity. They also identified that risankizumab signal strengths were significantly higher in eight system organ classes.

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.

Results of this analysis by Hernández-Cruz, et al. show that infections, herpes zoster and gastrointestinal AEs in patients with RA tended to be more frequent with JAKi treatment versus TNFi. They also found that treatment persistence was similar with JAKi and TNFi in patients with RA and axSpA, and only slightly higher for TNFi in patients with PsA.