Guselkumab (5) – Tremfya®
Moderate to severe plaque psoriasis; 6 to < 18 years
Characteristics
| Start date | 01.01.2026 – Marketing authorisation: 18.12.2025 |
|---|---|
| Resolution | 18.06.2026 |
| INN | Guselkumab |
| Brand name | Tremfya® |
| Pharm. company | Johnson & Johnson |
| G-BA Procedure ID | D-1290 |
| ATC code | L04AC16 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L40.0Nummular psoriasis |
| Alpha-ID codes (AIS) | I109655Plaque psoriasis |
| Therapeutic area | Skin diseases |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adolescents and children aged 6 years and over who are eligible for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Kinder und Jugendliche im Alter von 6 bis < 18 Jahre mit mittelschwerer bis schwerer Plaque-Psoriasis, die für eine systemische Therapie in Frage kommen |
Studies and Results
- Clinical trials
- For the benefit assessment of guselkumab for the treatment of children and adolescents aged 6 to < 18 years with moderate to severe plaque psoriasis who are eligible for systemic therapy, the pharmaceutical manufacturer presents results from the pivotal, multicentre, randomised Phase III PROTOSTAR trial, in which guselkumab was compared with etanercept and placebo.
Children and adolescents aged 6 to < 18 years with moderate to severe plaque psoriasis who are eligible for systemic therapy
- For children and adolescents aged 6 to < 18 years with moderate to severe plaque psoriasis who are eligible for systemic therapy, the additional benefit over the appropriate comparator therapy is not proven.
- On balance, the G-BA therefore concludes that for children and adolescents aged 6 to < 18 years with moderate to severe plaque psoriasis who are eligible for systemic therapy, the additional benefit of guselkumab compared with the appropriate comparator therapy is not proven.
- Overall assessment
- Taking into account all of the aforementioned limitations, the data presented from the PROTOSTAR study are not suitable for assessing any additional benefit.
- In its overall assessment, the G-BA therefore concludes that for children and adolescents aged 6 to < 18 years with moderate to severe plaque psoriasis who are eligible for systemic therapy, The additional benefit of guselkumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Guselkumab (5) | Tremfya® | Johnson & Johnson | Moderate to severe plaque psoriasis; 6 to < 18 years | 360–440 | 100% additional benefit not proven | |
| Guselkumab (4) | Tremfya® | Johnson & Johnson | Crohn’s disease, previously treated | 12,600–78,300 | 46% Indication of minor additional benefit | |
| Guselkumab (3) | Tremfya® | Johnson & Johnson | Ulcerative colitis, previously treated | 29,100 | 100% additional benefit not proven | |
| Guselkumab (2) | Tremfya® | Janssen-Cilag GmbH | Psoriatic arthritis (PA) | 29,100 | 100% additional benefit not proven | |
| Guselkumab (1) | Tremfya® | Janssen-Cilag GmbH | Plaque psoriasis (PP) | 52,200–234,400 | 45% Proof of considerable additional benefit |
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