Secukinumab (2) – Cosentyx®
Psoriatic arthritis (PA), Radiographic axial spondyloarthritis (AS)Psoriatic arthritis (PA), Bekhterev's disease
Characteristics
| Start date | 15.12.2015 |
|---|---|
| Resolution | 02.06.2016 |
| INN | Secukinumab |
| Brand name | Cosentyx® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-202 |
| ATC code | L04AC10 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | M45.00, M45.01, M45.02, M45.03, M45.04, M45.05, M45.06, M45.07, M45.08, M45.09 |
| Alpha-ID codes (AIS) | I28627Ankylosing spondylitis, I80914Spondylitis in chronic polyarthritis |
| DDD | 10 mg P |
| Therapeutic area | Musculoskeletal system diseases Axial spondyloarthritis / Ankylosing spondylitis (Bechterews disease), Psoriatic Arthritis (PA) |
| Reason for procedure |
New therapeutic indication
Reassessed in: Secukinumab (4) (18.02.2021) |
| Therapeutic indication of the resolution |
|---|
|
Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of adult patients with active psoriatic arthritis when the response to previous therapy with disease-modifying antirheumatic drugs (DMARDs) has been inadequate. | TNF-alpha inhibitors (etanercept or adalimumab or infliximab or golimumab) in combination with methotrexate, if necessary. |
| b) | Adults with active ankylosing spondylitis (AS, ankylosing spondylitis) who have had an inadequate response to conventional therapy | TNF-alpha inhibitor (etanercept or adalimumab or infliximab or golimumab) |
Studies and Results
|
No. of studies
(best subpopulation) |
3 (FIXTURE, F2306, F2312) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Gene/mutation specifics |
- Clinical trials
- The studies supporting the marketing authorisation for secukinumab in the indication of psoriatic arthritis consist of two placebo-controlled studies (F2306 and F2312).
- The studies supporting the marketing authorisation for secukinumab in the indication ‘ankylosing spondylitis’ consist of two placebo-controlled studies (F2305 and F2310).
a) Psoriatic arthritis (PsA)
- The pharmaceutical manufacturer has been unable to identify any studies suitable for demonstrating the additional benefit of compare secukinumab in adult patients with active psoriatic arthritis with the appropriate comparator therapy (TNF-alpha inhibitors [etanercept or adalimumab or infliximab or golimumab], where appropriate in combination with MTX).
- Furthermore, no indirect comparison was carried out.
b) Ankylosing spondylitis (AS; Bechterew’s disease)
- The pharmaceutical manufacturer has been unable to identify any studies suitable for demonstrating the additional benefit of compare secukinumab in adult patients with ankylosing spondylitis with the appropriate comparator therapy (TNF-alpha inhibitors [etanercept, adalimumab, infliximab or golimumab]).
- Furthermore, no indirect comparison was carried out.
Courtesy translation only, please refer to the German original.
Associated procedures
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