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Recent Developments in Therapies and Strategies Against COVID-19
Published in Hanadi Talal Ahmedah, Muhammad Riaz, Sagheer Ahmed, Marius Alexandru Moga, The Covid-19 Pandemic, 2023
Misbah Hameed, M. Zia-Ul-Haq, Marius Moga
Baricitinib is considered a good agent to be used in combination with other drugs because of its pharmacokinetic properties that include low plasma protein binding and minimum interface with CYP enzymes (cytochromes P450). However, its usage is also associated with some serious side effects, especially the risk of infections from some opportunistic pathogens, particularly when used with immunosuppressing agents such as corticosteroids. In some patients using baricitinib, tuberculosis infection was observed. Thus, it is suggested that patients receiving Baricitinib should be verified for tuberculosis infection before and during therapy. In addition to this, pulmonary embolism and deep venous thrombosis has also been reported [41].
Emerging Oral Treatments: Oral JAK Inhibitors for Alopecia Areata
Published in Rubina Alves, Ramon Grimalt, Techniques in the Evaluation and Management of Hair Diseases, 2021
Jared Marc John, Rodney Sinclair
The JAK inhibitor tofacitinib targets JAK3/JAK1 over JAK2 and TYK2. It is FDA approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Ruxolitinib is a JAK1/JAK2 inhibitor that is FDA approved for myelofibrosis, polycythaemia vera and graft-versus-host disease. Baricitinib is a JAK1/JAK2 inhibitor that is FDA approved for rheumatoid arthritis [4, 8, 12]. Other experimental JAK inhibitors are in various trial stages for dermatological conditions (Table 11A.1).
Immune system modulators
Published in Gabriel Virella, Medical Immunology, 2019
Richard M. Silver, Stephen Elmore
Tyrosine kinases have recently been identified to be significant mediators of intracellular signaling and regulatory pathways. When certain ligands bind to an associated cell-surface receptor, these kinases are triggered to phosphorylate particular amino acids, thus activating proteins. These can then translocate to the nucleus to allow for transcription of particular genes. Although a number of tyrosine kinases exist, the JAK kinase family has emerged as a particularly effective target for treating rheumatoid arthritis and perhaps other autoimmune diseases as well. Tofacitinib is an orally administered small molecule JAK kinase inhibitor that works on JAK1 and JAK3. Blockade of these signals leads to a reduction in a number of cytokines and interferons involved in the inflammatory processes important to the pathogenesis of rheumatoid arthritis. Side effects of tofacitinib include increased infection risk, especially with herpes zoster, as well as cytopenias, elevated serum transaminases, and hyperlipidemia. Tofacitinib is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, and is administered as a once-daily extended-release pill or a twice-daily regular dose. Baricitinib is another small molecule JAK1 and JAK2 inhibitor that was recently approved for the treatment of patients with moderate-to-severe rheumatoid arthritis. Studies of tofacitinib, baricitinib, and other JAK inhibitors for the treatment of other autoimmune diseases, e.g., systemic lupus erythematosus, are currently underway.
Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 years and up to 3.9 years of treatment: an updated integrated analysis of eight clinical trials
Published in Journal of Dermatological Treatment, 2023
Thomas Bieber, Norito Katoh, Eric L. Simpson, Marjolein de Bruin-Weller, Diamant Thaçi, Antonio Torrelo, Angelina Sontag, Susanne Grond, Maher Issa, Xiaoyu Lu, Tracy Cardillo, Katrin Holzwarth, Jacob P. Thyssen
Baricitinib, an oral selective inhibitor of JAK1/JAK2, inhibits elements of the inflammatory pathway (1). These elements are key mechanisms for chronic, inflammatory diseases but, as with all drug treatments, baricitinib can be associated with undesirable effects. In a previous integrated analysis of safety across eight clinical trials in moderate to severe AD, the most common TEAEs that increased relative to placebo were headache, increased creatine phosphokinase, herpes simplex, and upper respiratory tract infections, while the frequencies of AEs of special interest were low (7). These AEs of special interest have been identified from clinical trials of JAK inhibitors in rheumatologic disease as events of concern or of potential relevance to this class of drug and include herpes virus reactivation, serious infections, malignancy, and cardiovascular events (9,10). In this report, we present an updated assessment of pooled safety data of baricitinib in patients with AD through 3.9 years of treatment for a total of 4628.4 years of patient exposure. Baricitinib maintained a safety profile similar to that previously reported in AD (7), with rates in All-bari of adverse events of special interest that were low and within the range of background rates observed in AD populations.
Emerging clinical investigational drugs for the treatment of amyotrophic lateral sclerosis
Published in Expert Opinion on Investigational Drugs, 2023
Loreto Martinez-Gonzalez, Ana Martinez
(NCT05189106) is a reversible Janus‐associated kinase (JAK) inhibitor. This pyrrolopyrimidine has been approved for the treatment of rheumatoid arthritis and severe COVID-19 in the U.S. and many other countries. Baricitinib reduces inflammation and suppresses the immune system by interfering with cytokine signaling induced via the JAK/STAT [23]. The ongoing clinical development includes a biomarker-driven trial in people with subjective cognitive disorder, mild cognitive impairment, Alzheimer’s disease (AD), ALS, or asymptomatic carriers of an ALS-related gene, such as a hexanucleotide expansion in the C9ORF72 gene, with evidence of abnormal inflammatory signaling in cerebrospinal fluid (CSF) at baseline. The main goal is to know if the orally administered doses of baricitinib reaches therapeutic levels in the CSF and suppresses inflammatory biomarkers associated with type I interferon signaling among the study participants.
Biologics and small molecules in the management of psoriatic arthritis: Reproduction related issues in female and male patients
Published in Expert Review of Clinical Pharmacology, 2021
Rebecca Fischer-Betz, Monika Østensen
During clinical trial participation (as of 01/01/2020), 36 women had become pregnant while receiving baricitinib (Lilly, data on file 2020). Twenty of these pregnancies involved known exposure to MTX or leflunomide (LEF) as study drug or background therapy. Pregnancy outcomes included 14 cases of spontaneous (n = 9) or induced (n = 5) abortions, 2 preterm deliveries, 10 term deliveries without abnormalities, seven pending outcomes and 1 case where the outcome was not available. In addition, there were 8 pregnancy cases in partners of male patients exposed to baricitinib, three pregnancies carried to term with no anomalies reported, also 2 cases of early miscarriage, in 3 the outcome was not available. A recent case report described the course of an unwanted pregnancy with baricitinib exposure throughout the first trimester up to the 17th week of pregnancy. The healthy newborn was born at term with normal weight and normal growth and psychomotor development at ninemonths [74].