What is the duration of the ixekizumab study?
Participants will take the mixture of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about 17 weeks, including follow-up. Screening must be completed prior to study start.
How is ixekizumab administered for the treatment of psoriasis?
Ixekizumab is administered as a subcutaneous injection, with a loading dose of 160 mg followed by 80 mg every 2 weeks for 12 weeks and then every 4 weeks. It is supplied in 80 mg prefilled syringes and autoinjectors. Shivani P. Reddy BS, ... Jashin J. Wu MD, in Therapy for Severe Psoriasis, 2016
What is the difference between brodalumab and ixekizumab?
In contrast to ixekizumab, brodalumab targets the IL-17 pathway through its receptor, rather than ligand. In a phase II study by Nakagawa and colleagues5 involving 151 Japanese patients, brodalumab was subcutaneously administered at weeks 1, 2, 4, 6, 8, and 10 at doses of either 70 mg, 140 mg, or 210 mg.
How does ixekizumab (Taltz) work?
Mechanism of action Ixekizumab (Taltz®) is a humanized IgG4 monoclonal antibody that binds and inhibits IL-17A, resulting in neutralization of IL-17A homodimers and IL-17A/F heterodimers (seeFig. 128. 9E).
What conditions does Taltz treat?
Taltz is approved to treat adults and children 6 years and older with moderate to severe plaque psoriasis (PsO) who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
What is ixekizumab used for?
Ixekizumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults and children 6 years of age and older whose psoriasis is too severe to be treated by topical medications alone.
What is the mechanism of action of ixekizumab?
Mechanism of Action Ixekizumab is a humanized monoclonal antibody (IgG) that selectively binds to interleukin 17A (IL-17A); this prevents interleukin 17A from binding to the IL-17 receptor. Thus, this attenuates an inflammatory response mediated by interleukin 17A.
What is the difference between ixekizumab and Secukinumab?
Compared with secukinumab, ixekizumab provides more quality-adjusted life-years (QALYs) to patients with psoriatic arthritis (PsA) and concomitant moderate to severe plaque psoriasis at a marginally lower cost, according to study results published in PharmacoEconomics – Open.
What is ixekizumab subcutaneous?
Descriptions. Ixekizumab injection is used to treat moderate-to-severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. This medicine is also used alone or together with other medicines (eg, methotrexate) to treat active psoriatic arthritis.
What type of drug is ixekizumab?
Taltz contains the active drug ixekizumab. It's a type of biologic drug (a drug made from living cells) called a humanized monoclonal antibody. Taltz comes in two forms: a prefilled syringe and a prefilled autoinjector pen. The drug is given by injection under your skin (subcutaneous injection).
How is ixekizumab made?
In particular, IL-17A has been found to be implicated in a variety of autoimmune diseases including Rheumatoid Arthritis and plaque psoriasis. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing.
Is ixekizumab an immunosuppressant?
Taltz is an immunosuppressant therapy, which means that it affects the functioning of your immune system. Other immunosuppressant drugs may interact with Taltz, and the combination may increase your risk of infection.
When was ixekizumab approved by the FDA?
Taltz was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
What is Q28.4 ixekizumab?
Q28.4 Ixekizumab is also indicated for active psoriatic arthritis. A dose of 160 mg at week 0 followed by 80 mg q4w is recommended for this indication. It may be given alone or can be used in combination with a conventional DMARD (MTX). 51.
What is the role of IL-17 in psoriasis?
IL-17, a proinflammatory cytokine involved in host defense against monilial infection, plays an important role in the pathogenesis of plaque psoriasis. The IL-17 group of molecules includes 6 ligands (A through F) and 5 receptors (RA through RE). Secukinumab, an IL-17A antagonist, was recently approved for the treatment of moderate-to-severe plaque psoriasis in adult patients eligible for systemic therapy. At present, 2 other biologic drugs that target the IL-17 signaling pathway have been investigated through phase III trials: ixekizumab and brodalumab. Most recently, ixekizumab was approved for psoriasis.
Is IL-17 high in patients with AS?
Serum concentrations of IL-23 and IL-17 have been found to be high in patients with AS. 37 Macrophages from patients with AS in response to lipopolysaccharide produce high levels of IL-23. 38 IL-17-positive cells in AS facet joints also have been demonstrated. 39 In addition to AS and PsA, high levels of IL-17 in the synovial fluid of patients with reactive arthritis and undifferentiated SpA have been reported. 40
Is IL-17A blockade monoclonal antibody?
IL-17A blockade with secukinumab, a human IgG1κ monoclonal antibody to IL-17A, has completed phase 1/2 trials on rheumatoid arthritis. In the phase 1 trial on rheumatoid arthritis, the endpoint for efficacy, an ACR20 response, was met. 29 In a phase 2 study on rheumatoid arthritis, the primary efficacy endpoint, an ACR20 response at 16 weeks, was not reached. Upper respiratory infections and pharyngitis occurred more frequently in the secukinumab-treated groups. 30 Efficacy, safety, and tolerability studies in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis are currently in progress. 31-33
What is the purpose of the IXekizumab study?
The purpose is to learn about how ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine, omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome P450. Each participant will complete two study periods.
How long does the study of Ixekizumab last?
The study will last about 17 weeks, including follow-up.
How long does plaque psoriasis last?
Inclusion Criteria: Males and females with chronic moderate or severe plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy. Men and women of childbearing potential must agree to use a reliable method of birth control and men may not donate sperm for the duration of the study.
How long does ixekizumab last?
Standard dose of subcutaneous ixekizumab for moderate to severe PsO will be given at 160 mg at week 0, followed by ixekizumab 80mg at weeks 2, 4, 6, 8, 10 and 12, then 4 weekly thereafter, for a total duration of 6 months. Ixekizumab will be withdrawn after 6 months. For some participants, there may be relapse of PsO.
Is stepwise therapy required for PSO?
The 2013 American Academy of Dermatology position statement have stated that the old paradigm of stepwise-therapy starting first with phototherapy and oral systemic therapies before biologic treatment is not required for patients with moderate to severe PsO.