November 2023

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

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October 2023

Janus Kinase Inhibitor—Tofacitinib Associated with Pemphigus: An Analysis of the FDA Adverse Event Reporting System Data

ExpExpert Opin Drug Saf. 2023;22(12):1317–1320 doi: 10.1080/14740338.2023.2248872

This study presents initial data suggesting an association between the use of JAK inhibitors and pemphigus. This research used the FAERS database to investigate connections between JAK inhibitor usage and the occurrence of pemphigus as an adverse event.

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Anti-gm-csf Otilimab versus Sarilumab or Placebo in Patients with Rheumatoid Arthritis and Inadequate Response to Targeted Therapies: A Phase III Randomised Trial (contRAst 3)

Ann Rheum Dis. 2023;82(12):1527–1537 doi 10.1136/ard-2023-224449

The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

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Prevention of Radiographic Progression in Higher-Risk Patients with Rheumatoid Arthritis Using Filgotinib in Phase III Studies: Narrative Review of Post Hoc Analyses

Rheumatol Ther. 2023;10(6):1399–1415 doi: 10.1007/s40744-023-00590-w

Findings from post hoc analyses extend the knowledge base for radiographic benefits of filgotinib in patients with RA.

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A Real-World Effectiveness Study Using a Mobile Application to Evaluate Early Outcomes with Upadacitinib in Rheumatoid Arthritis

Rheumatol Ther. 2023;10(6):1519–1533 doi 10.1007/s40744-023-00594-6

This study by Harrold, et al. showed that RA patients initiating upadacitinib reported improvements in RAPID3, pain, stiffness, and fatigue as early as Week 1, with 37.5% achieving RAPID3 LDA at Week 12. TNFi-experienced patients had similar outcomes.

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Anti-GM-CSF Otilimab Versus Tofacitinib or Placebo in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Conventional or Biologic DMARDs: Two Phase 3 Randomised Trials (contRAst 1 and contRAst 2)

Ann Rheum Dis 2023;0:1–11 doi 10.1136/ard-2023-224482

Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.

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Incidence, Prevalence, and Co-occurrence of Autoimmune Disorders Over Time and by Age, Sex, and Socioeconomic Status: A Population-based Cohort Study of 22 Million Individuals in the UK

Lancet. 2023; 401(10391):1878–1890 doi 10.1016/S0140-6736(23)00457-9

Incidence rates for autoimmune diseases increased between 2000 and 2019 in the UK, notably in coeliac disease, Sjogren's syndrome, and Graves' disease. Pernicious anaemia and Hashimoto's thyroiditis had the greatest decrease in incidence. These disorders affected about 10% of the population, with socioeconomic, seasonal, and regional variations observed.

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Global, Regional, and National Burden of Rheumatoid Arthritis, 1990–2020, and Projections to 2050: a Systematic Analysis of the Global Burden of Disease Study 2021

Lancet Rheumatol 2023;5(10):e594–610 doi 10.1016/S2665-9913(23)00211-4

As part of the GBD 2021, the authors provide updated estimates for the global burden of RA. In 2020, approximately 17.6 million people worldwide had RA, with a 14.1% increase in prevalence since 1990. Mortality decreased by 23.8% from 1990 to 2020. The study forecasts an increase in cases to 31.7 million by 2050.

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Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from the Phase III, Randomised, Placebo-Controlled, Active Reference BE OPTIMAL Study

Ann Rheum Dis. 2023;82(11):1404–1414 doi: 10.1136/ard-2023-224431

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

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Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety Data of the First 192 Patients from the UPJOINT Study, a Multicentre, Observational Study in Clinical Practice

Rheumatol Ther. 2023;10(6):1503–1508 doi: 10.1007/s40744-023-00589-3

In the UPJOINT open label study, the proportion of patients with PsA, and an inadequate response to csDMARDs or bDMARDs, who achieved minimal disease activity with upadacitinib was in line with the results of previous studies at 24 weeks. No new safety signals were identified.

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