Tildrakizumab is a humanized monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.



Trade name Ilumya



It is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis.



Targets IL23.



Pregnancy category AU: B1.



Routes of administration: Subcutaneous injection



It blocks interleukin-23 (IL-23), a cytokine that plays a key role in managing the immune system and autoimmune disease.



It is available as a single-dose prefilled syringe containing 100 mg of tildrakizumab in 1 ml of solution for subcutaneous administration.



It is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of the interleukin-23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. 



IL-23 plays a critical role in modulating inflammatory and immune responses.



The IL-23/Th17 pathway is crucial for the pathogenic mechanisms of psoriasis.



IL-23 acts at the top of the inflammatory pathway, activating the proliferation of pathogenic Th17 cells and subsequent production of proinflammatory cytokines, including IL-17.



IL-23 is a heterodimer with two subunits, p19 and p40. 



The p40 subunit is also shared with IL-12, a cytokine that is involved in the immune response. 



Treatments that  targets the p40 subunit block both IL-23 and IL-12 and have been associated with an increased risk of infections.



Tildrakizumab binds only to the p19 subunit of IL-23, and  this specific blockage, inhibits the release of proinflammatory cytokines and chemokines that mediate epidermal hyperplasia, keratinocyte immune activation, and tissue inflammation inherent in psoriasis.



It is available as a single-use, pre-filled syringe and is administered via subcutaneous injection.



The recommended dose is 100 mg at weeks 0, and 4 and every 12 weeks thereafter.



The drug has been studied in around 1,800 patients in two double-blind, randomized and controlled Phase-3 trials, titled reSURFACE 1 and reSURFACE 2,[13] followed by a 4-year extension period.



Tildrakizumab was proven to have superior efficacy to etanercept, an effective anti-TNFα treatment for psoriasis, with a significantly higher proportion of patients achieving responses at weeks 12 and 28.



After 3 years of continued treatment with tildrakizumab, response levels were well maintained in week 28 responders.



IL-23 targeting may only minimally impair the ability to generate a proper immune response.



Tildrakizumab most common (≥ 1%) side effects associated  with treatment are upper respiratory infections, headache, gastroenteritis, nausea, diarrhea, injection site pain, and back pain.



In the reSURFACE 1 and 2 clinical trials, the overall incidence of side effects was low and comparable to placebo.



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