What it's for (Indications)
- Secukinumab, marketed under the brand name Cosentyx, is a fully human monoclonal antibody approved for the treatment of several chronic inflammatory conditions.
- Its primary indications include moderate to severe plaque psoriasis (PsO) in adult patients who are candidates for systemic therapy or phototherapy.
- It is also indicated for the treatment of active psoriatic arthritis (PsA) in adults, active ankylosing spondylitis (AS) in adults, and active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation.
- Furthermore, secukinumab is approved for pediatric patients aged 4 years and older with active enthesitis-related arthritis (ERA) and for pediatric patients aged 2 years and older with active juvenile psoriatic arthritis (JPsA).
- The efficacy and safety profile of secukinumab have been established through extensive clinical trials demonstrating significant improvements in disease activity and quality of life across these diverse patient populations by targeting a key inflammatory cytokine.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | The dosage regimen for secukinumab varies depending on the specific indication and patient characteristics, always administered via subcutaneous injection. For adult patients with plaque psoriasis, the recommended initial dose is 300 mg at Weeks 0, 1, 2, 3, and 4, followed by a maintenance dose of 300 mg every 4 weeks. Some patients may respond well to a 150 mg dose. For active psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, the typical initial dose is 150 mg at Weeks 0, 1, 2, 3, and 4, followed by 150 mg every 4 weeks. For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis or an inadequate response to TNFα inhibitors, a 300 mg dose may be considered. Pediatric dosing for enthesitis-related arthritis and juvenile psoriatic arthritis is weight-based, typically 75 mg or 150 mg, administered at similar initial and maintenance frequencies. Patients should be trained on proper subcutaneous injection techniques, and the medication should be stored correctly. |
Safety & Warnings
Common Side Effects
- Secukinumab, while generally well-tolerated, is associated with a range of side effects, some of which can be serious.
- Common adverse reactions reported in clinical trials include nasopharyngitis (common cold), diarrhea, upper respiratory tract infections, headache, and nausea.
- Less frequently observed, but still reported, side effects include oral herpes, urticaria, and superficial candidiasis.
- More serious potential side effects include an increased risk of infections, such as serious bacterial, fungal, or viral infections, given its immunosuppressive mechanism.
- Cases of inflammatory bowel disease (Crohn's disease and ulcerative colitis), including new onset or exacerbation, have been reported.
- Hypersensitivity reactions, including rare instances of anaphylaxis, can occur.
- Patients should be closely monitored for any signs or symptoms of infection or severe allergic reaction throughout the treatment period.
Serious Warnings
- Black Box Warning: Secukinumab (Cosentyx) does not carry a formal Black Box Warning from the U.S. Food and Drug Administration (FDA). However, it is crucial for healthcare providers and patients to be aware of several 'Serious Warnings' that warrant careful consideration and monitoring during treatment. These serious warnings include: 1. **Risk of Infections:** Secukinumab, an immunomodulator, may increase the risk of serious infections. Patients should be evaluated for tuberculosis (TB) infection prior to initiation of treatment. Secukinumab should not be administered to patients with active TB. Patients should be monitored for signs and symptoms of infection during and after treatment. 2. **Inflammatory Bowel Disease (IBD):** New onset or exacerbation of Crohn's disease and ulcerative colitis has been reported in patients treated with secukinumab. Caution should be exercised when prescribing secukinumab to patients with IBD. 3. **Hypersensitivity Reactions:** Anaphylaxis and other serious allergic reactions have occurred. If a severe hypersensitivity reaction occurs, discontinue secukinumab immediately and initiate appropriate therapy. These warnings highlight the importance of diligent patient screening, ongoing monitoring, and prompt management of potential adverse events to ensure patient safety.
- Several critical warnings are associated with secukinumab therapy.
- Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment; secukinumab should not be administered to patients with active TB.
- For patients with latent TB, anti-TB therapy should be considered before starting secukinumab.
- Due to its immunomodulatory effects, secukinumab may increase the risk of serious infections.
- Patients must be monitored closely for the development of signs and symptoms of infection during and after treatment.
- New onset or exacerbation of inflammatory bowel disease (Crohn's disease and ulcerative colitis) has been reported; therefore, secukinumab should be used with caution in patients with a history of IBD.
- Hypersensitivity reactions, including anaphylaxis, have been reported, necessitating immediate discontinuation if a severe reaction occurs.
- Live vaccines should not be administered concurrently with secukinumab, and the immune response to inactivated vaccines may be diminished.
How it Works (Mechanism of Action)
Secukinumab functions as a selective, high-affinity, fully human monoclonal immunoglobulin G1 kappa (IgG1κ) antibody that directly targets and neutralizes interleukin-17A (IL-17A). IL-17A is a naturally occurring cytokine that plays a pivotal role in inflammatory and immune responses, and it is a key pathogenic cytokine implicated in various chronic inflammatory conditions such as plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and axial spondyloarthritis. By binding to IL-17A, secukinumab effectively prevents its interaction with the IL-17 receptor, located on various cell types, thereby interrupting the pro-inflammatory signaling cascade. This action inhibits the release of pro-inflammatory cytokines, chemokines, and mediators that contribute to inflammation, tissue damage, and cellular proliferation, particularly in the skin and joints, ultimately leading to a reduction in disease symptoms and progression.
Commercial Brands (Alternatives)
No other brands found for this formula.