Rhapsido (remibrutinib)
Rhapsido has been approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Rhapsido contains the active ingredient remibrutinib.
Rhapsido is approved to treat chronic spontaneous urticaria (CSU). CSU affects the skin and is thought to be an autoimmune disease (when the immune system mistakenly attacks the body’s own cells, tissues and organs). In CSU, immune cells called mast cells and basophils are activated and release inflammatory chemicals, such as histamine. These chemicals widen blood vessels which causes them to leak fluid, irritating nerve endings. This causes redness, itching, and swelling. CSU causes repeated episodes of itchy welts (hives), swelling under the skin (angioedema), or both. The hives are very itchy, usually clear within 24 hours, and often return daily. CSU can last for years and, in some people, for decades.
Rhapsido, an oral medication, blocks an enzyme called BTK (Bruton’s tyrosine kinase). BTK is an important enzyme in the activation process that causes mast cells and basophils to release stored inflammatory chemicals. By blocking BTK, Rhapsido dampens this process. In CSU, the reduction in the levels of histamine and other inflammatory chemicals released by mast cells and basophils leads to reduced itching, hives, and swelling.
The effectiveness and safety of Rhapsido were assessed in two clinical trials. A total of 925 adult patients were enrolled. Patients were diagnosed with CSU that was inadequately controlled despite treatment with second generation H1 antihistamines.
In these randomised, double-blind, placebo-controlled trials, patients were randomly assigned into groups to compare Rhapsido treatment against a placebo (tablets with no active substance) for 24 weeks. Until this point, both participants and the researchers did not know who received the Rhapsido treatment. This made the study as fair and reliable as possible by minimising human bias. This was followed by a 28-week study period where all participants received Rhapsido.
The main goal of the trials was to measure a change in the UAS7 score (Urticaria Activity Score over 7 days) from the beginning of the trial to week 12. The UAS7 score measures how severe CSU symptoms are based on scores recorded daily by patients.
Key findings from clinical studies
After 12 weeks, compared to placebo:
- patients taking Rhapsido had bigger reductions in itch and hives, shown by lower UAS7 scores.
- patients taking Rhapsido had larger reductions in ISS7 scores (an itch intensity score) and HSS7 scores (the total number of hives on the skin).
- more patients achieved good symptom control (UAS7 score of less than or equal to 6).
- more patients had no symptoms at all (UAS7 score of 0).
- more patients reported that their skin condition did not affect their quality of life.
- Rhapsido led to longer periods without angioedema.
Some patients achieved improved symptom control after 2 weeks of treatment.
The studies also showed that Rhapsido was effective out to 52 weeks of treatment, a significant result given Rhapsido is intended for long-term treatment.
The majority of the side effects associated with Rhapsido were minor. Bleeding in the skin and mucous membranes, upper respiratory tract infections, a decrease in neutrophils and nausea were more common with Rhapsido treatment, but these were only minor or low-grade.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Rhapsido and the medicine can be registered in Australia.
More detailed information on why the TGA approved Rhapsido will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Rhapsido can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Rhapsido can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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