Tremfya
Authorised
This medicine is authorised for use in the European Union
guselkumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Tremfya is a medicine used to treat moderate to severe plaque psoriasis (a disease causing red, scaly skin patches) when treatments applied to the skin are not suitable.
It is also used to treat psoriatic arthritis (scaly skin patches with joint inflammation) alone or with another medicine called methotrexate. For psoriatic arthritis, Tremfya is used when medicines to treat the underlying inflammation (disease-modifying medicines) have not worked well enough or when the patient cannot take these medicines.
Tremfya contains the active substance guselkumab.
Tremfya can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating the conditions for which Tremfya is used.
Tremfya is available as an injection in pre-filled syringes or pens. It is injected under the skin in an area that is clear of psoriasis. The recommended dose is 100 mg, followed by a further dose after 4 weeks and then 100 mg every 8 weeks. For patients with psoriatic arthritis who have a high risk of joint damage, the doctor may decide that it can be injected every 4 weeks. The doctor may stop treatment if the condition does not improve after 16 or 24 weeks.
After training, patients may inject Tremfya themselves if the doctor considers it appropriate.
For more information about using Tremfya, see the package leaflet or contact your doctor or pharmacist.
The active substance in Tremfya, guselkumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity. Interleukin 23 is a messenger substance that controls the growth and maturation of some types of T cells. These T cells, which are part of the body's immune system (the body's natural defences), are involved in causing inflammation that is linked to plaque psoriasis and psoriatic arthritis. By blocking the action of interleukin 23, guselkumab reduces inflammation and other symptoms of the disease.
Plaque psoriasis
Three main studies involving 2,700 adults found Tremfya effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough. A main measure of effectiveness was a reduction of at least 90% in PASI scores. PASI is a measure of disease severity and area of skin affected.
The first two studies compared Tremfya with adalimumab (another medicine used for treating psoriasis) and placebo (a dummy treatment). After 16 weeks, about 71% of patients (588 out of 825) receiving Tremfya had a reduction of at least 90% in PASI scores, compared with 48% (282 out of 582) of those receiving adalimumab and under 3% (11 out of 422) receiving placebo. Improvement in psoriasis symptoms was maintained beyond 48 weeks with Tremfya treatment.
The third study involved 871 patients who were treated with ustekinumab (another medicine used for treating psoriasis). Patients whose psoriasis did not improve sufficiently after 16 weeks either received Tremfya or continued treatment with ustekinumab for at least 24 weeks. During this period, symptoms of psoriasis improved to a greater extent in patients receiving Tremfya than in those remaining on ustekinumab.
Psoriatic arthritis
A study looked at the effect of Tremfya in 381 patients with psoriatic arthritis for whom standard treatments did not work. Around 52% of those treated with Tremfya every 8 weeks and 59% of those treated with Tremfya every 4 weeks had a 20% improvement in a symptom score (called ACR20) after 24 weeks. This compared with 22% of those receiving placebo.
In another study, involving 739 patients, 64% of patients receiving Tremfya every 8 or 4 weeks had a 20% improvement in symptom score after 24 weeks, compared with 33% of those receiving placebo.
The most common side effects with Tremfya (which may affect more than 1 in 10 people) are infections in the nose and throat.
Tremfya must not be used in patients who have an infection that the doctor considers important.
For the full list of side effects and restrictions, see the package leaflet.
The European Medicines Agency decided that Tremfya’s benefits are greater than its risks in the treatment of moderate and severe plaque psoriasis and psoriatic arthritis and that it can be authorised for use in the EU.
The Agency considered that Tremfya is effective and longer-term studies for plaque psoriasis have shown that it remains effective with continued use. It improved physical function and quality of life in patients with psoriatic arthritis. Long-term safety data have shown that it has few side effects. Patients are likely to continue treatment with Tremfya because it can be injected every 8 weeks (after the first 4 weeks) and patients can inject it themselves, making it convenient to use.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tremfya have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tremfya are continuously monitored. Side effects reported with Tremfya are carefully evaluated and any necessary action taken to protect patients.
Tremfya received a marketing authorisation valid throughout the EU on 10 November 2017.
Product information
Latest procedure affecting product information:
N/0042
21/06/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Tremfya
- Active substance
- Guselkumab
- International non-proprietary name (INN) or common name
- guselkumab
- Therapeutic area (MeSH)
- Psoriasis
- Anatomical therapeutic chemical (ATC) code
- L04AC
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Plaque psoriasis
Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic arthritis
Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).
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