Deucravacitinib (1) – Sotyktu®
Moderate to severe plaque psoriasis
Characteristics
| Start date | 15.04.2023 – Marketing authorisation: 24.03.2023 |
|---|---|
| Resolution | 05.10.2023 |
| INN | Deucravacitinib |
| Brand name | Sotyktu® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-934 |
| ATC code | L04AF07 IMMUNOSUPPRESSANTS (L04A) |
| ICD-10 codes (AIS) | L40.0Nummular psoriasis |
| Alpha-ID codes (AIS) | I109655Plaque psoriasis |
| Therapeutic area | Skin diseases Plaque psoriasis (PP) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Sotyktu is used to treat adult patients with moderate to severe plaque psoriasis who are eligible for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with moderate to severe plaque psoriasis who are not eligible for conventional therapy in the context of initial systemic therapy. | Adalimumab or bimekizumab or guselkumab or ixekizumab or secukinumab |
| b) | Adults with moderate to severe plaque psoriasis who have had an inadequate response to or have not tolerated systemic therapy. | Adalimumab or bimekizumab or brodalumab or guselkumab or infliximab or ixekizumab or risankizumab or secukinumab or ustekinumab |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- Clinical trials
- The pharmaceutical manufacturer has submitted studies IM011046 and IM011047 for the benefit assessment dossier.
- These are double-blind, randomised, multicentre studies, each of which included adult patients with plaque psoriasis who were eligible for phototherapy or systemic therapy.
a) Adults with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their first-line systemic treatment
- For the treatment of adults with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their first-line systemic therapy, the additional benefit is not proven.
- No suitable data are available for the assessment of the additional benefit of deucravacitinib compared with the appropriate comparator therapy in adult patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their first-line systemic treatment (patient group a), no suitable data are available.
b) Adults with moderate to severe plaque psoriasis who have responded inadequately to, or are unable to tolerate, systemic therapy
- For the treatment of adults with moderate to severe plaque psoriasis who have responded inadequately to, or are unable to tolerate, systemic therapy, the additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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