August 2024

Pregnancy outcomes in patients treated with upadacitinib: Analysis of data from clinical trials and postmarketing reports

Drug Saf 2024 doi: 10.1007/s40264-024-01454-0 Epub ahead of print

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.

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July 2024

Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of Phase 2/3 randomized trials

J Am Acad Dermatol 2024;91:72–81 doi: 10.1016/j.jaad.2024.02.039

Results of this analysis by Blauvelt, et al. showed a low adjudicated suicidal ideation and behaviour (SIB) rate of 0.13/100 patient-years for bimekizumab, consistent with general psoriasis population ranges. Bimekizumab did not increase the risk of SIB compared to other anti-IL-17A/anti-IL-23 therapies.

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Durable Control of Psoriatic Arthritis with Guselkumab Across Domains and Patient Characteristics: Post Hoc Analysis of a Phase 3 study

Clin Rheumatol 2024 doi: 10.1007/s10067-024-06991-8 Epub ahead of print

Ritchlin et al. conducted a post hoc analysis of the DISCOVER-2 trial, evaluating the efficacy of guselkumab in biologic-naïve patients with PsA. Guselkumab provided durable disease control across key PsA domains and PROs over 2 years, regardless of baseline characteristics. A significant proportion of patients achieved stringent endpoints such as ACR50/70, complete skin clearance, and resolution of dactylitis/enthesitis.

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Efficacy and safety of filgotinib for the treatment of perianal fistulising Crohn’s disease [DIVERGENCE 2]: A Phase 2, randomised, placebo-controlled trial

J Crohns Colitis 2024;18:864–74 doi: 10.1093/ecco-jcc/jjae003

Filgotinib (FIL) 200mg was associated with numerical reductions in the number of draining perianal fistulas based on combined clinical and MRI findings compared with placebo. Reinisch et al. reported a numerically higher proportion of patients achieving the primary endpoint of a combined fistula response and/or remission at Week 24 with FIL 200mg compared with placebo.

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Risankizumab induction therapy achieves early symptom improvements that are associated with future clinical and endoscopic outcomes in Crohn's disease: Post hoc analysis of the ADVANCE, MOTIVATE, and FORTIFY Phase 3 studies

J Crohns Colitis 2024;18:818–27 doi: 10.1093/ecco-jcc/jjad206

This post hoc analysis provides additional support for the utility of risankizumab therapy in patients with moderately to severely active CD. Investigators examined the efficacy of risankizumab for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints.

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June 2024

A disease-associated gene desert directs macrophage inflammation through ETS2

Nature 2024 doi: 10.1038/s41586-024-07501-1 Epub ahead of print

Stankey, et al. used functional genomics to show that the ETS2 gene is a central regulator of human inflammatory macrophages. They also found that ETS2 was disrupted by JAK inhibitors and MEK inhibitors, with multiple MEK inhibitors being shown to downregulate ETS2-target genes.

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Phase 2 trial of deucravacitinib in psoriatic arthritis: Biomarkers associated with disease activity, pharmacodynamics, and clinical responses

Arthritis Rheumatol 2024 doi: 10.1002/art.42921 Epub ahead of print

FitzGerald, et al. found that Deucravacitinib significantly impacted biomarkers associated with TYK2 signalling pathways of key inflammatory cytokines, including IL-23 and Type I IFN, and those related to collagen matrix turnover.

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May 2024

Adverse events with risankizumab in the real world: Postmarketing pharmacovigilance assessment of the FDA adverse event reporting system

Front Immunol 2023;14:1169735 DOI 10.3389/fimmu.2023.1169735 Epub ahead of print

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.

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Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT)

J Rheumatol. 2024 Apr 15:jrheum.2023-1062 doi: 10.3899/jrheum.2023-1062 Epub ahead of print

The 5-year benefit-risk profile for upadacitinib in RA remains favourable, with clinical outcomes improved or maintained through Week 260. No new safety findings were identified during the LTE. Results remained consistent with earlier analyses of SELECT-NEXT.

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Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease

N Engl J Med 2023; 388:1966–1980 doi: 10.1056/NEJMoa2212728

Upadacitinib was associated with higher percentages of remission and endoscopic response regardless of previous failure of biologic therapy. This paper reports the Phase 3 efficacy and safety results of upadacitinib in patients with moderate-to-severe Crohn’s disease.

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