Ilumya Flashcards
(30 cards)
What is IL23?
IL23 (interleukin 23) is a cytokine produced by dendtric cells and other immune cells the differentiation of Th17 cells.
(IL-23) is a member of the IL-12 family of cytokines with pro-inflammatory properties. Its ability to potently enhance the expansion of T helper type 17 (Th17) cells indicates the responsibility for many of the inflammatory autoimmune responses. Emerging data demonstrate that IL-23 is a key participant in central regulation of the cellular mechanisms involved in inflammation. Both IL-23 and IL-17 form a new axis through Th17 cells, which has evolved in response to human diseases associated with immunoactivation and immunopathogeny, including bacterial or viral infections and chronic inflammation. Targeting of IL-23 or the IL-23 receptor or IL-23 axis is a potential therapeutic approach for autoimmune diseases
Describe IL23 role in the inflammation cascade during psorasis?
IL23 causes dendritic cells and macrophages to produce TNF and other cytokines. IL23 consists of subunit p40 which is the same subunit found on IL12 and P19, which is unique to IL23.
Describe the administration and dosage of Ilumya
100mg Week 0, then week 4, then every 12 weeks to follow.
Inject into clear skin, do not inject within 2 inches around naval, where skin is tender or bruised, scars, stretch marks, blood vessels, or where affected by psorasis.
How to prep drug prior to injection
remove from fridge and allow to sit for 30min in room temp, only remove from carton when ready to inject, color should be slightly colorless to slightly yellow.
what is the generic name for Ilumya?
Tidrakizumab-asmn
when was it approved by fda?
March 21 2018
How many patients have the moderate to severe form?
20%
Age range?
adults only
what are the contraindications and warnings?
patients gets angiodema and/or uticaria, can increase risk of infection, evaluate patient for tuberculosis, be sure they are up to date of all age appropriate immunizations
what are potential adverse reactions?
1) infections- 23% of patients experienced a mild infection and 22% in placebo group
2) hypersensitivity such as uticeria
3) potential for immunogenicity which exists with all therapeutic proteins, 6.5% of patients at week 64 have developed antibodies to Ilumya
Should you avoid the use of live vaccines with patients using Ilumya?
Yes
What is Ilumya mechanism of action?
Ilumya is a monoclonal antibody (mAb) that specifically binds to the p19 subunit of IL23 and inhibits its interaction with the IL23 receptor. IL23 is a naturally occurring cytokine that is involved in inflammatory and immune response.
What is the difference between human and humanized
Ilumya is humanized is taken from anitbodies from humans and a small percentage from mice. Human is 100% human antibodies. Most doc don’t ask about this
safe during nursing, pregnancy, and geriatric patients?
Geriatric is safe. Pregnancy is safe but we can’t proactively say it because its off label. Pregnant woman were excluded from the trial, however some did develop pregnancy during the trial and i can get you a medical letter on that to see the outcome.
how does body weight effect the drug concentration?
concentrations were lower in patients with higher body weight
Storage and handling of Ilumya
Syringes much be refridgerated are are stable for up to 30 days
How to counsel/advise the patient on Ilumya
read the label, explain benefits and risks, seek medical attention is any adverse or hypersensitivity reactions occur, make sure the patients understands its important to communicate any history of infection
What is tildrakizumab?
Its an humanized IgG1 antibody that specifically binds to the p19 subunit of the IL23
What were baseline characteristics of randomized patients in Ilumya trials 1 and 2 discussed in the PI?
younger than 18 years old, PGA less than 3, candidates for phytotherapy or systematic therapy
What is PASI 75?
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis.
What were baseline characteristics of randomized patients in Ilumya trials 1 and 2 discussed in the PI?
younger than 18 years old, PGA (physician global assessment) less than 3, candidates for phytotherapy or systematic therapy
What is PGA?
Physician Global Assessment. Another way to measure the severity of psorasis similar to PASI.
What percent of patients achieved achieved PGA 0/1 at week 12 in trials 2 and 3?
55-59%
In trial 3 what were the percentages of patients achiveing PASI at week 12
Ilumya 100mg 61%, Ilumya 200mg 66%
