Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Date of authorisation: 10/11/2017, Revision: 16, Status: Authorised

Tremfya RSS Authorised This medicine is authorised for use in the European Union guselkumab Medicine Human Authorised 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) in adults and children from 6 years of age for whom treatment with medicines given by mouth or by injection is appropriate; psoriatic arthritis (scaly skin patches with joint inflammation) in adults, alone or with another medicine called methotrexate. It is used when medicines to treat the underlying inflammation (diseasemodifying medicines) have not worked well enough or have caused unacceptable side effects; ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) in adults. It is used to treat moderately- to severely-active disease when other treatments have not worked well enough, have stopped working, or have caused unacceptable side effects; Crohn’s disease (an inflammatory disease affecting the gut) in adults. It is used to treat moderately to severely active disease when other treatments have not worked well enough, have stopped working or have caused unacceptable side effects. Tremfya contains the active substance guselkumab. Expand section Collapse section How is Tremfya used? 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. For patients with plaque psoriasis and psoriatic arthritis, Tremfya is available as an injection in prefilled syringes or pens. It is injected under the skin in an area that is clear of psoriasis. After the first injection, treatment is repeated after 4 weeks and every 8 weeks thereafter (maintenance treatment). For patients with psoriatic arthritis who have a high risk of joint damage, the doctor may decide that Tremfya can be injected every 4 weeks instead of every 8 weeks during the maintenance phase. For patients with ulcerative colitis and Crohn’s disease, Tremfya is available as a solution for infusion (drip) into a vein and as an injection under the skin using pre-filled syringes or pens. Treatment starts with an infusion into a vein given every 4 weeks for 3 times (induction treatment). The induction treatment may also be given as an injection under the skin with the same schedule as for treatment given by infusion. The patient then begins maintenance treatment, which is given as an injection under the skin every 8 weeks or every 4 weeks thereafter, depending on how well treatment worked during the induction phase. The doctor may stop treatment if the patient’s condition does not improve after 16 weeks for adults with plaque psoriasis, or 24 weeks for children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis and Crohn’s disease. After training, adult patients or carers 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. How does Tremfya work? The active substance in Tremfya, guselkumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin-23 (IL-23) and block its activity. IL-23 is a protein 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, psoriatic arthritis, ulcerative colitis and Crohn’s disease. By blocking the action of IL-23, guselkumab reduces inflammation and other symptoms of these diseases. What benefits of Tremfya have been shown in studies? 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) of those 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. An additional study involving 92 adolescents and children from 6 years of age showed that Tremfya is also effective for treating moderate to severe plaque psoriasis in this age group. After 16 weeks, around 76% (31 out of 41) of patients receiving Tremfya had a reduction of at least 75% in PASI scores, compared with 20% (5 out of 25) of those receiving placebo. In addition, 66% (27 out of 41) of children given Tremfya had skin that was clear or almost clear of psoriasis, compared with 16% (4 out of 25) of children given placebo. 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. Ulcerative colitis Two main studies found that Tremfya was effective at treating adults with moderately to severely active ulcerative colitis, for whom other treatments did not work well enough or caused unacceptable side effects. In the first study, 23% (95 out of 421) of those who received Tremfya infusions over 8 weeks of induction treatment had clinical remission (a decrease in or disappearance of signs and symptoms of the disease) after 12 weeks, compared with 8% (22 out of 280) of patients who received placebo (a dummy treatment). Clinical remission was evaluated by the modified Mayo score, which measures changes in stool frequency, rectal bleeding (bleeding from the last several inches of the large intestine closest to the anus) and endoscopic subscore (measure of inflammation in the intestines based on a procedure that uses a tube with a camera to look inside the body). A second study involved patients from the first main study and another supporting study who had responded to induction treatment with Tremfya. The study looked at the effectiveness of maintenance treatment given by injection under the skin every 4 weeks at a higher dose or every 8 weeks at a lower dose. After 44 weeks, 45% (85 out of 188) of patients receiving the lower dose of Tremfya and 50% (95 out of 190) of patients receiving the higher dose of Tremfya were in clinical remission, compared with 19% (36 out of 190) of those who received placebo. Crohn’s disease Three main studies involving around 1,400 patients found that Tremfya was effective at treating adults with moderately to severely active Crohn’s disease, for whom other treatments did not work well enough or caused unacceptable side effects. In the first 2 studies patients received induction treatment with Tremfya by infusion, while in the third study the induction treatment was given as an injection under the skin. In all 3 studies, maintenance treatment was given by injection under the skin. The main measures of effectiveness were clinical remission (a decrease in or disappearance of signs and symptoms of the disease) and endoscopic response (improvement in inflammation in the intestines based on a procedure that uses a tube with a camera to look inside the body). Clinical remission was evaluated using the CDAI (Crohn’s disease activity index) score which measures different parameters including stool frequency, abdominal (belly) pain, and general well-being. Endoscopic response was based on at least a 50% improvement in a score called SES-CD (simple endoscopic score for Crohn’s disease) or on an SES-CD score of 2 or below. In the first study, clinical remission was achieved after 12 weeks of treatment in 47% (136 out of 289) of the patients receiving Tremfya compared with 22% (17 out of 76) of those who received placebo. Endoscopic response was achieved after 12 weeks of treatment in 38% (109 out of 289) of the patients receiving Tremfya compared with 11% (8 out of 76) of those receiving placebo. In the second study clinical remission was achieved after 12 weeks of treatment with Tremfya in 47% (138 out of 293) of patients compared with 15% (11 out of 72) of those receiving placebo. Endoscopic response was achieved after 12 weeks of treatment in 36% (106 out of 293) of the patients receiving Tremfya compared with 14% (10 out of 72) of those who received placebo. In the third study clinical remission was achieved after 12 weeks of treatment with Tremfya in 56% (129 out of 230) of patients compared with 21% (25 out of 117) of those receiving placebo. Endoscopic response was achieved after 12 weeks of treatment in 41% (95 out of 230) of the patients receiving Tremfya compared with 21% (25 out of 117) of those who received placebo. What are the risks associated with Tremfya? For the full list of side effects and restrictions with Tremfya, see the package leaflet. The most common side effects with Tremfya (which may affect more than 1 in 10 people with psoriasis, psoriatic arthritis and Crohn’s disease, and up to 1 in 10 people with ulcerative colitis) include infections in the nose and throat. Tremfya must not be used in patients who have an active infection that the doctor considers important. Why is Tremfya authorised in the EU? The European Medicines Agency decided that Tremfya’s benefits are greater than its risks in the treatment of moderate and severe plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease 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. Tremfya improved physical function and quality of life in patients with psoriatic arthritis. Long-term safety data have shown that it has few side effects. For patients with moderately to severely active ulcerative colitis and Crohn’s disease, the Agency considered treatment with Tremfya to be effective with a safety profile that is consistent with that already known for the medicine. After the induction phase, patients are likely to continue treatment with Tremfya because it can be injected every 4 to 8 weeks and adult patients or carers can inject it themselves, making it convenient to use. What measures are being taken to ensure the safe and effective use of Tremfya? 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. Other information about Tremfya Tremfya received a marketing authorisation valid throughout the EU on 10 November 2017. Tremfya : EPAR - Medicine overview English (EN) (153.21 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View Other languages (22) български (BG) (179.17 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View español (ES) (158.53 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View čeština (CS) (187.29 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View dansk (DA) (159.59 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View Deutsch (DE) (166.92 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View eesti keel (ET) (153.73 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View ελληνικά (EL) (189.75 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View français (FR) (161.09 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View hrvatski (HR) (184.83 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View italiano (IT) (157.86 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View latviešu valoda (LV) (190.75 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View lietuvių kalba (LT) (186.47 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View magyar (HU) (186.53 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View Malti (MT) (191.22 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View Nederlands (NL) (163.15 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View polski (PL) (188.06 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View português (PT) (159.73 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View română (RO) (181.2 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View slovenčina (SK) (185.7 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View slovenščina (SL) (185.14 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View Suomi (FI) (155.05 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View svenska (SV) (156.75 KB - PDF) First published: 30/11/2017 Last updated: 12/01/2026 View Tremfya : EPAR - Risk management plan English (EN) (1.23 MB - PDF) First published: 22/01/2021 Last updated: 19/12/2025 View Product information Tremfya : EPAR - Product Information English (EN) (11.66 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View Other languages (24) български (BG) (10.91 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View español (ES) (11.34 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View čeština (CS) (12.42 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View dansk (DA) (10.75 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View Deutsch (DE) (10.68 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View eesti keel (ET) (11.02 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View ελληνικά (EL) (10.96 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View français (FR) (12.27 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View hrvatski (HR) (10.99 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View íslenska (IS) (11.34 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View italiano (IT) (11.59 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View latviešu valoda (LV) (13.6 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View lietuvių kalba (LT) (11.59 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View magyar (HU) (10.25 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View Malti (MT) (12.56 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View Nederlands (NL) (10.91 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View norsk (NO) (12.05 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View polski (PL) (10.68 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View português (PT) (11.52 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View română (RO) (11.59 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View slovenčina (SK) (10.51 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View slovenščina (SL) (12.7 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View Suomi (FI) (11.39 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View svenska (SV) (10.53 MB - PDF) First published: 30/11/2017 Last updated: 23/03/2026 View Latest procedure affecting product information: VR/0000321306 23/03/2026 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). Tremfya : EPAR - All Authorised presentations English (EN) (37.38 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View Other languages (24) български (BG) (31.8 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View español (ES) (44.37 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View čeština (CS) (30.91 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View dansk (DA) (56.38 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View Deutsch (DE) (32.24 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View eesti keel (ET) (27.35 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View ελληνικά (EL) (40.55 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View français (FR) (37.32 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View hrvatski (HR) (35.3 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View íslenska (IS) (29.52 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View italiano (IT) (27.69 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View latviešu valoda (LV) (29.99 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View lietuvių kalba (LT) (30.42 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View magyar (HU) (29.81 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View Malti (MT) (40.55 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View Nederlands (NL) (28.79 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View norsk (NO) (39.59 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View polski (PL) (30.78 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View português (PT) (29.23 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View română (RO) (37.26 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View slovenčina (SK) (30.38 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View slovenščina (SL) (27.95 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View Suomi (FI) (28.64 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View svenska (SV) (49.72 KB - PDF) First published: 30/11/2017 Last updated: 19/12/2025 View Product details Name of medicine Tremfya International non-proprietary name (INN) or common name guselkumab Therapeutic area (MeSH) Psoriasis Crohn Disease Colitis, Ulcerative Anatomical therapeutic chemical (ATC) code L04AC Pharmacotherapeutic group Immunosuppressants Therapeutic indication Adult plaque psoriasis Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years 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. Ulcerative colitis Tremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment. Crohn’s disease Tremfya is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Authorisation details EMA product number EMEA/H/C/004271 Marketing authorisation holder Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Opinion adopted 14/09/2017 Marketing authorisation issued 10/11/2017 Revision 16 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Tremfya : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (183.63 KB - PDF) First published: 08/09/2025 Last updated: 23/03/2026 View Tremfya : EPAR - Procedural steps taken and scientific information after the authorisation (archive) English (EN) (218.49 KB - PDF) First published: 23/10/2018 Last updated: 08/09/2025 View Tremfya : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan Reference Number: EMADOC-1700519818-2494684 English (EN) (147.12 KB - PDF) First published: 19/12/2025 View Tremfya-X-0000248626 : EPAR - Assessment report - Variation Adopted Reference Number: EMADOC-1700519818-2583818 English (EN) (3.7 MB - PDF) First published: 19/12/2025 View CHMP post-authorisation summary of positive opinion for Tremfya (EMAX0000248626) Adopted Reference Number: EMADOC-1700519818-2494685 English (EN) (137.45 KB - PDF) First published: 16/10/2025 View Tremfya-H-C-004271-II-0044 : EPAR - Assessment report - Variation Reference Number: EMA/CHMP/444643/2024 English (EN) (11.15 MB - PDF) First published: 08/05/2025 View Tremfya-H-C-004271-X-0043-G : EPAR - Assessment report - Variation Adopted Reference Number: EMA/95032/2025 English (EN) (7.43 MB - PDF) First published: 08/05/2025 Last updated: 14/07/2025 View CHMP post-authorisation summary of positive opinion for Tremfya (X-43-G) Adopted Reference Number: EMA/CHMP/54843/2025 English (EN) (132.85 KB - PDF) First published: 28/02/2025 View Tremfya-H-C-4271-II-17 : EPAR - Assessment report - Variation Adopted Reference Number: EMA/600660/2020 English (EN) (7.15 MB - PDF) First published: 22/01/2021 View CHMP post-authorisation summary of positive opinion for Tremfya (II-17) Adopted Reference Number: EMA/CHMP/535466/2020 English (EN) (122.88 KB - PDF) First published: 16/10/2020 View Initial marketing authorisation documents Tremfya : EPAR - Public assessment report Adopted Reference Number: EMA/622081/2017 English (EN) (3.01 MB - PDF) First published: 30/11/2017 Last updated: 30/11/2017 View CHMP summary of positive opinion for Tremfya Adopted Reference Number: EMA/CHMP/556833/2017 English (EN) (78.82 KB - PDF) First published: 15/09/2017 Last updated: 15/09/2017 View News on Tremfya Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025 17/10/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025 28/03/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020 16/10/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017 15/09/2017 More information on Tremfya EMEA-001523-PIP02-14-M03 - paediatric investigation plan EMEA-001523-PIP03-18-M03 - paediatric investigation plan EMEA-001523-PIP05-19-M01 - paediatric investigation plan EMEA-001523-PIP04-19-M02 - paediatric investigation plan A Retrospective Cohort Study Using Health Administrative Claims Databases to Assess Adverse Pregnancy and Infant Outcomes in Women with Psoriasis Who Were Exposed to Guselkumab Versus Other Biologic Therapies During Pregnancy. PASS-EMA - post-authorisation study Shortening the time to confirm or to rebut Adverse events of interest related to innovative Therapies for immune-mediated inflammATory dIseases: cross-talking between different data sOURces. SATURATIOn study. - post-authorisation study Topics Medicines This page was last updated on 23/03/2026 Share this page