Ixekizumab (5) – Taltz®
Juvenile psoriatic arthritis, aged ≥ 6 years
Characteristics
| Start date | 01.10.2025 – Marketing authorisation: 22.08.2025 |
|---|---|
| Resolution | 19.03.2026 |
| INN | Ixekizumab |
| Brand name | Taltz® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-1239 |
| ATC code | L04AC13 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L40.5Arthropathic psoriasis |
| Therapeutic area | Skin diseases |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Juvenile psoriatic arthritis (JPsA) Taltz, either on its own or in combination with methotrexate, is indicated for the treatment of active JPsA in patients aged 6 years and over and weighing at least 25 kg who have previously had an inadequate response to, or have been unable to tolerate, conventional therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Kinder und Jugendliche ab 6 Jahren mit aktiver juveniler Psoriasis-Arthritis und einem Körpergewicht von mindestens 25 kg, die unzureichend auf eine konventionelle Therapie angesprochen haben oder diese nicht vertragen |
Studies and Results
- Clinical trials
- The COSPIRIT-JIA trial, on which the marketing authorisation is based, was an open-label, randomised trial comparing ixekizumab with adalimumab.
Children and adolescents aged 6 years and over with active juvenile psoriatic arthritis and a body weight of at least 25 kg, who have responded inadequately to, or are intolerant of, conventional therapy
- The additional benefit is not proven.
- The pharmaceutical manufacturer has not provided any data to assess the additional benefit of ixekizumab compared with the appropriate comparator therapy.
- In line with the pharmaceutical manufacturer’s approach in the dossier, no studies could be identified that allow a comparison of ixekizumab with the appropriate comparator therapy.
- An additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Ixekizumab (6) | Taltz® | Lilly Deutschland GmbH | Enthesitis-associated arthritis, ≥ 6 years | 240–290 | 100% additional benefit not proven | |
| Ixekizumab (5) | Taltz® | Lilly Deutschland GmbH | Juvenile psoriatic arthritis, aged ≥ 6 years | 120–180 | 100% additional benefit not proven | |
| Ixekizumab (4) | Taltz® | Lilly Deutschland GmbH | Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg | 270–2,035 | 100% additional benefit not proven | |
| Ixekizumab (3) | Taltz® | Lilly Deutschland GmbH | Axial spondyloarthritis | 36,300 | 100% additional benefit not proven | |
| Ixekizumab (2) | Taltz® | Lilly Deutschland GmbH | Psoriatic arthritis (PA) | 29,100 | 35% Hint for minor additional benefit | |
| Ixekizumab (1) | Taltz® | Lilly Deutschland GmbH | Plaque psoriasis (PP) | 52,200–234,400 | 55% Indication of considerable additional benefit |
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