Risk Management Plan Summary

Transcription

1 Risk Management Plan Summary TREMFYA (guselkumab) 100 mg/ml pre-filled syringe Document Version: 1.0 ( ) Based on EU RMP version 1.2 Marketing authorization holder: Janssen-Cilag AG, Gubelstr. 34, 6300 Zug Disclaimer: The Risk Management Plan (RMP) is a comprehensive document submitted as part of the application dossier for market approval of a medicine. The RMP summary contains information on the medicine's safety profile and explains the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimize them. The RMP summary of TREMFYA is a concise document and does not claim to be exhaustive. As the RMP is an international document, the summary might differ from the product information «Arzneimittelinformation / Information sur le medicament» approved and published in Switzerland, e.g. by mentioning risks occurring in populations or indications not included in the Swiss authorization. Please note that the reference document which is valid and relevant for the effective and safe use of TREMFYA in Switzerland is the «Arzneimittelinformation / Information sur le medicament» (see approved and authorized by Swissmedic. Janssen-Cilag AG is fully responsible for the accuracy and correctness of the content of the published summary RMP of TREMFYA. VERSION 1.0,

2 VI.2. Elements for a Public Summary Plaque is a long-lasting condition causing inflammation and plaques of thickened skin called plaques. It is caused by a problem with the immune system where a protein causes inflammation (redness) and makes skin cells divide at a much faster rate than normal. The skin cells then build up and cause the typical thickened, scaly plaques. VI.2.1. Overview of Disease Epidemiology Psoriasis is a common, chronic (long-lasting), inflammatory skin disease that commonly runs in families. The severity (amount of redness, thickness or scaling) and duration of varies from patient to patient. Up to 4.8% of the general population is affected by depending on factors such as geographic area and race. Men and women are equally affected. Most patients have an onset of between 20 and 30 years of age, or between 50 and 60 years of age. Psoriasis is associated with many other conditions, such as heart disease, cancer, psychiatric disease, diabetes, and high blood pressure. Studies have found that patients with severe have a higher death rate compared to people without. Heart disease is the most common cause of death among patients, followed by infection and cancer. VI.2.2. Summary of Treatment Benefits Guselkumab is used to treat adult. Guselkumab was compared to placebo (a dummy treatment) and adalimumab (another treatment for plaque ) in 2 main trials of 1,829 adults with plaque. In each of these 2 trials, after 16 weeks of treatment, approximately 85% of the patients receiving guselkumab had clear or almost clear skin, compared with about 8% of the patients receiving placebo and 67% of the patients receiving adalimumab. In an additional trial, among 268 adults with plaque who first received ustekinumab (another treatment for plaque ) and had an inadequate response after 16 weeks of treatment, 48% of the patients who switched to receiving guselkumab and 23% of the patients who continued receiving ustekinumab had clear or almost clear skin after a total of 28 weeks of treatment. VI.2.3. Unknowns Relating to Treatment Benefits Guselkumab has been shown to improve the symptoms of in patients 18 years of age or older with moderate. It is not known if guselkumab works for milder forms of, or in other non-plaque forms of, or in children younger than 18 years with. The guselkumab trials did not include patients with chronic kidney or liver disease, or kidney or liver failure, so it is not known if the drug works in these patients and if it is safe to use in these patients. VERSION 1.0,

3 VI.2.4. Summary of Safety Concerns Important Identified Risks Risk What is known Preventability None None None Important Potential Risks Risk infection ( infection) Cancer () Allergic reactions ( reactions [including anaphylaxis and serum sickness]) cardiovascular events Suicidal ideation and behavior Missing Information Risk Use in children (Use in paediatric patients) Use during What is known (Including reason why it is considered a potential risk) Tremfya is a type of drug that can affect the immune system and may make you less able to fight infection. Some infections could become serious. Medicines such as Tremfya decrease the activity of the immune system. This may increase the risk of cancer. It is not known whether cancer could occur from treatment with Tremfya, so it is considered a potential risk. Allergic reactions (anaphylaxis) may occur after taking Tremfya. Signs include: difficulty breathing or swallowing low blood pressure, which can cause dizziness or light-headedness swelling of the face, lips, mouth or throat. Since patients have increased risk for heart attacks, strokes, and death related to heart attacks and strokes, these events are considered a potential risk for guselkumab. In clinical trials that lasted for 1 year there was no increase in these events beyond what is already expected in patients. The available literature evidence suggests a higher incidence and prevalence of psychiatric disorders, including depression, among patients with compared to those without. Clinical trial data available with guselkumab do not suggest an increased risk of suicidal ideation and behavior events with guselkumab treatment in patients with plaque beyond what is already expected in patients. What is known Tremfya has not been studied in children. It is not known whether Tremfya works in people younger than 18 years of age or if it is safe to use in people younger than 18 years of age. Tremfya has not been studied in pregnant women, and it is not VERSION 1.0,

4 Risk ( ) Use in nursing mothers ( lactation) Use in patients older than 65 years of age (Use in patients 65 years of age) Use in patients with severe liver problems (Use in patients with severe hepatic impairment) Use in patients with severe kidney problems (Use in patients with severe renal impairment) ( beyond 1 year in to severe plaque ) What is known known whether it affects a developing foetus. Tremfya has not been studied in nursing mothers, and it is not known whether it affects infants. No dose adjustment is required. There is limited information in subjects aged 65 years treated with guselkumab. Tremfya has not been studied in patients with severe liver problems. Tremfya has not been studied in patients with severe kidney problems. Tremfya has not been studied for more than 1 year in adult patients with plaque. Information will be collected in patients who are treated with Tremfya for more than 1 year. VI.2.5 Summary of Risk Minimisation Measures by Safety Concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the Package Leaflet (PL). The measures in these documents are known as routine risk minimisation measures. The SmPC and PL for guselkumab can be found on the EMA s website. The company considers that the risks with this medicine can be managed with the information in the SmPC and PL; therefore, no special conditions or restrictions for its safe and effective use (additional risk minimisation measures) have been proposed. VERSION 1.0,

5 VI.2.6 Planned Postauthorisation Development Plan List of Studies in Postauthorisation Development Plan Study/activity (including study number) Objectives Safety concerns/ efficacy issue addressed CNTO1959PSO3001 infection CNTO1959PSO3002 infection Status (planned, ongoing) Ongoing Ongoing Date for submission of (interim and) final results December 2016 Final Report: May 2021 December 2016 Final Report: June 2021 VERSION 1.0,

6 Study/activity (including study number) Objectives Safety concerns/ efficacy issue addressed Status (planned, ongoing) Date for submission of (interim and) final results Company-sponsored Observational Cohort Study infection Planned 4Q 2025 Final Report: 4Q 2030 Use in patients 65 years of age Electronic Administrative Health Claims Databases Review Monitor outcomes in women exposed to guselkumab during and linked infant outcomes during the first 6 months following prenatal exposure to guselkumab lactation Planned 4Q 2025 Final report: 4Q 2030 VERSION 1.0,

7 Study/activity (including study number) Objectives Safety concerns/ efficacy issue addressed PsOBEST Registry infection Use in patients 65 years of age Status (planned, ongoing) Planned Date for submission of (interim and) final results After enrolment of the first 500 patients treated with guselkumab (of which 250 have been treated for at least 1 year) Final Report: 4Q 2030 Studies Which are a Condition of the Marketing Authorisation Not applicable VERSION 1.0,