July 2024

The outcomes of children born to mothers with autoimmune rheumatic diseases

Lancet Rheumatol 2024:S2665-9913(24)00096-1 doi: 10.1016/S2665-9913(24)00096-1 Epub ahead of print

This Series paper by Andreoli, et al. provides a comprehensive overview of the literature for pregnancy outcomes for mothers with autoimmune rheumatic disease, and provides guidance on discussing these topics with patients. They also provide a list of frequently asked questions related to pregnancy and children by women with autoimmune rheumatic diseases.

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April 2024

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal Phase 3 trial

https://pubmed.ncbi.nlm.nih.gov/33549192/

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

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Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a Phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1)

J Am Acad Dermatol 2015;73:37-49. doi: 10.1016/j.jaad.2015.03.049

Here, investigators reported that efficacy measures for skin and scalp were significantly greater for apremilast than for placebo in patients with PsO at baseline. Previously, clinical study data has highlighted that the use of apremilast leads to a reduction in the expression within the epidermis of numerous inflammatory cytokines relevant to PsO. As a result, ESTEEM 1 evaluated the efficacy/safety of apremilast at 30 mg BID for moderate to severe PsO.

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March 2024

Long term safety of ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: A post hoc analysis of final safety data from 25 randomized clinical trials

Arthritis Res Ther 2024;26(1):49 doi: 10.1186/s13075-023-03257-7

Incident rates of TEAEs were comparable for patients with PsO, PsA, and axSpA and did not increase with prolonged ixekizumab (IXE) treatment. Deodhar, et al. presented the final update on the long-term safety of IXE up to 6 years in PsO patients and up to 3 years in PsA and axSpA patients. Exposure-adjusted incident rates were calculated using patient data (TEAEs, SAEs, selected AEs) from 25 clinical trials.

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February 2024

Efficacy of Baricitinib in Patients with Moderate-To-Severe Rheumatoid Arthritis up to 6.5 Years of Treatment: Results of a Long-Term Study

Rheumatology 2024 doi 10.1093/rheumatology/keae012 Epub ahead of print

This pooled analysis of four Phase 3 RCTs investigated the long-term efficacy baricitinib in patients with active RA who were MTX-IR, csDMARD-IR, or bDMARD-IR. They found that baricitinib demonstrated efficacy up to 6.5 years and was well tolerated.

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November 2023

Risk of Major Adverse Cardiovascular Events in Immune-Mediated Inflammatory Disorders on Biologics and Small Molecules: Network Meta-Analysis

CClin Gastroenterol Hepatol 2023;22:961-970.e12

The results of this study show that anti-IL-12/23, JAK inhibitors, and anti-TNF-α were associated with slightly higher risk of MACE compared with placebo. The risk was no different between biologic treatments, and the magnitude of risk did not differ between IMID type.

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September 2023

May 2023

Immunogenicity and Safety of Adjuvanted Recombinant Zoster Vaccine in Rheumatoid Arthritis Patients on Anti-Cellular Biologic Agents or JAK Inhibitors: A Prospective Observational Study

Int JMol Sci 2023;24(8):6967 doi 10.3390/ijms24086967

A prospective observational study showed that recombinant zoster vaccine (RZV) immunogenicity is not impaired in RA patients on JAK inhibitors or anti-cellular bDMARDs.

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April 2023

Incidence of Interstitial Lung Disease in Patients with Rheumatoid Arthritis Treated With Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs

JAMA Netw Open. 2023;6(3):e233640 doi: 10.1001/jamanetworkopen.2023.3640

Retrospective cohort study results suggest that treatment with tofacitinib, and perhaps other JAK inhibitors, may provide a benefit in reducing the risk of developing RA-Interstitial Lung Disease (ILD).

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January 2023

Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

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