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Tildrakizumab, sold under the brand name Ilumya among others, is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. It is approved for the treatment of adults with moderate-to-severe plaque psoriasis in the United States and in the European Union.
Read the full article on WikipediaSevere chronic plaque psoriasis Clinical criteria: Treatment Phase: Continuing treatment, Whole body Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, AND Patient must have demonstrated an adequate response to treatment with this drug, AND The treatment must be as systemic monotherapy (other than methotrexate), AND Patient must not receive more than 24 weeks of treatment under this restriction. Population criteria: Patient must be aged 18 years or older. Treatment criteria: Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 4 weeks old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
“Tildrakizumab 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.”
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