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Also known as Secukinumab
Secukinumab/Adalimumab-Biosimilar · 1 trial · 1 indication
Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity. Percentage was calculated from a logistic regression model: logit(proportion) = treatment + baseline quick C-reactive protein (CRP) + baseline weight.
| Arm | Type | Description |
|---|---|---|
| TREAT-TO-TARGET (T2T) | EXPERIMENTAL | Patients received secukinumab 150 mg subcutaneous (s.c.) weekly until Week 4 (Baseline, Week 1, Week 2, Week 3, Week 4)) and then at Week 8. At Week 12, if ASDAS clinically important improvement was achieved and maintained, patients received treatment up to Week 32 if they maintained the response. If ASDAS clinically important improvement was not achieved, patients received an escalated dose of secukinumab 300 mg s.c. every 4 weeks until Week 20. At Week 24, patients who were receiving secukinumab 300 mg, and achieved ASDAS clinically important improvement, continued treatment up to Week 32. If patients did not achieve ASDAS clinically important improvement, they were switched to adalimumab biosimilar (Hyrimoz®) 40 mg s.c. every 2 weeks until Week 34. Each patient was treated for a maximum of 36 weeks (last dose of secukinumab at Week 32, last dose of adalimumab biosimilar (Hyrimoz®) at Week 34). |
| Standard-of-care (SOC) | ACTIVE_COMPARATOR | Patients received SOC treatment according to local practice standards by their treating rheumatologist following latest treatment recommendations with NSAIDs as the first-choice drug treatment and disease-modifying anti-rheumatic drugs (DMARDs) for patients with active disease despite the use (or intolerance/contraindication) of NSAIDs. |
| Name | Type | Description |
|---|---|---|
| Secukinumab/Adalimumab-Biosimilar | BIOLOGICAL | Secukinumab 150 mg, s.c. Secukinumab 300 mg, s.c. Adalimumab biosimilar 40 mg, s.c. |
| Standard-of-care | OTHER | Treatment according to local practice standards by the rheumatologist following latest treatment recommendations with NSAIDs as the first-choice drug treatment and DMARDs for patients with active disease despite the use (or intolerance/contraindication) of NSAIDs. |
Inclusion Criteria: * Diagnosis of Axial Spondyloarthritis, axSpA (either Non-Radiographic Axial Spondyloarthritis or Radiographic Axial Spondyloarthritis) fulfilling the Ankylosing Spondyloarthritis International Society classification criteria for axSpA * Active disease as defined by having an An...
Secukinumab is used for chronic plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, and moderate to severe chronic plaque-type psoriasis. It is being studied in clinical trials for these conditions, including active psoriatic arthritis with axial skeleton involvement.
Secukinumab is a monoclonal antibody, indicated by its -mab suffix. It is being developed for immunology indications, including psoriatic arthritis and giant cell arteritis, and is in Phase 3 clinical trials for several of these conditions.
Secukinumab is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials of Secukinumab across multiple countries, including the United States, Germany, and the United Kingdom.
Secukinumab is in Phase 3 clinical development for conditions such as axial psoriatic arthritis and giant cell arteritis. It has also completed Phase 1 and Phase 2 trials. Secukinumab is an investigational drug and is not approved for the indications being studied.
Secukinumab has been studied in clinical trials including NCT02721966 for active psoriatic arthritis with axial skeleton involvement, NCT03765788 for giant cell arteritis, NCT05380453 for new onset giant cell arteritis, and NCT06130540 for giant cell arteritis or polymyalgia rheumatica.
Secukinumab is the generic name for the drug also known as Cosentyx. It is a monoclonal antibody developed by Novartis AG for immunology indications such as psoriasis and psoriatic arthritis.