Cosentyx® (secukinumab) PsO dosing
Cosentyx® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.1,2
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.1,2
Information on the Cosentyx safety profile may be found on the Safety profile page of this website and the Cosentyx Summary of product Characteristics.1,2
Cosentyx flexible dosing schedule for adult PsO
The recommended dose of Cosentyx in adults with PsO is 300 mg delivered at Weeks 0, 1, 2, 3 and 4, followed by a monthly maintenance dose.1,2
Based on clinical response, patients with PsO weighing ≥90 kg may benefit from a maintenance dose of 300 mg every 2 weeks.1,2
For patients who weigh <90 kg, the recommended Cosentyx dose is 300 mg with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.1,2
For patients who weigh ≥90 kg, the recommended Cosentyx dose is 300 mg at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Maintenance dosing may be up-titrated for patients weighing ≥90 kg to 300 mg every 2 weeks depending on clinical response.1
Tailor the dosing of Cosentyx based on clinical response
You can tailor the dosing of Cosentyx based on your PsO patients’ clinical response. In the A2324 Q2W clinical trial, FASTER and LONG-LASTING skin clearance was seen in patients (≥90 kg) treated with Cosentyx 300 mg Q2W vs 300 mg Q4W.3
PASI 90 response to Year 1 (exploratory endpoint)3
Adapted from Augustin M, et al. 2022.3
A2324 Q2W was a multicentre, double-blind, parallel-group trial on patients with moderate to severe PsO weighing ≥90 kg (N=331) treated with Cosentyx 300 mg Q2W or Q4W.
Primary endpoint of PASI90 response at Week 16 for Cosentyx 300 mg Q2W vs Q4W was met, p<0.05.3
FAST
of patients ≥90 kg achieved PASI 90 with Cosentyx 300 mg Q2W at Week 16, which was significantly higher than those patients treated with Cosentyx 300 mg Q4W (72.8% vs 50.0%, respectively; p<0.05).3
LONG-LASTING
of patients ≥90 kg achieved PASI 90 (exploratory endpoint) with Cosentyx 300 mg Q2W at Year 1 (76.4% vs 52.4%, respectively; p<0.05).3
The recommended dose is 300 mg of Cosentyx with initial dosing at Weeks 0, 1, 2, 3 and 4 followed by monthly maintenance dosing. Based on clinical response, a maintenance dose of 300 mg Q2W may provide additional benefit for patients with a body weight of 90 kg or higher.1,2
Download our Q2W leave piece to learn more about flexible dosing for your eligible PsO patients weighing ≥90 kg
Cosentyx pre-filled injections for plaque PsO
75 mg pre-filled syringe
Cosentyx (secukinumab) offers a range of pre-filled injections. The pre-filled syringes are available in three dosages: 75 mg, 150 mg, and 300 mg; the pre-filled pens are available in two dosages: 150 mg and 300 mg. This includes the UnoReady® 300 mg pen, which provides your patients with a latex-free, and convenient option for effective treatment. The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen are not indicated for administration to paediatric patients with a weight <50 kg.1,2
In the MATURE study at 28 weeks, 100% of patients were ‘satisfied’ or ‘very satisfied’ with using the UnoReady® 300 mg pen (n=37: 32.4% and 67.6%, respectively).*4
*MATURE was a 52-week, randomised, double-blind, placebo controlled study that evaluated efficacy, safety, tolerability and PK of Cosentyx in patients with moderate to severe PsO via one 300 mg/2 ml UnoReady pen injection (n=41) or two 150 mg/1 ml pre-filled syringe injections (n=41) vs placebo. Patients self-administered treatment at Weeks 0, 1, 2, 3, 4 and 8 followed by Q4W dosing starting at Week 12 up to Week 48. The co-primary endpoints of PASI 75 and IGA mod 2011 0/1 response rates at Week 12 were met (p<0.0001 for both).4
What your eligible patients should know when switching to the Cosentyx UnoReady® 300 mg pen
The Cosentyx UnoReady® pen delivers the potential benefits of Cosentyx 300 mg in one injection. In the MATURE study at 28 weeks 100% of patients (n=41) were ‘satisfied’ or ‘very satisfied’ with using the UnoReady® pen.1,2,4,5
There are some differences between using the Cosentyx SensoReady® and UnoReady® pen that eligible patients should be aware of:†5,6
†After proper training in subcutaneous injection technique, patients may self-inject Cosentyx or may be injected by a caregiver if a physician determines that this is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients or caregivers should be instructed to inject the full amount of Cosentyx according to the instructions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.1,2
Cosentyx dosing schedule for paediatric PsO
In paediatric PsO treatment, the recommended Cosentyx dose varies depending on the child’s body weight.1,2
The dosing schedule of Cosentyx begins with the initial dose at Weeks 0, 1, 2, 3 and 4, followed by a monthly maintenance dose. Each dose of Cosentyx, whether 75 mg, 150 mg, or 300 mg, is administered as a single subcutaneous injection. The 300 mg dose may be given as one 300 mg injection or two 150 mg injections.1,2
If your patient weighs under 50 kg, the dosing regimen for Cosentyx involves a weekly 75 mg subcutaneous injection during the initial 4-week phase, followed by a monthly maintenance dose of 75 mg. The Cosentyx injection doses are administered as a single 75 mg subcutaneous injection.1,2
The 150 mg and 300 mg solution for injection, available in pre-filled syringe and pen formats, is not indicated for paediatric patients with a weight below 50 kg. Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.1,2
If your patient weighs over 50 kg, the recommended Cosentyx dosing schedule begins with a weekly subcutaneous injection of 150 mg during the initial dosing phase, followed by a monthly maintenance dose of 150 mg. This dose can be increased to 300 mg if deemed beneficial for certain patients. The Cosentyx 300 mg dose can be administered as a single subcutaneous injection or as two separate injections of 150 mg each.1
Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs.1
Cosentyx dosing precautions and considerations
The efficacy of Cosentyx across its various indications has been established through clinical studies. Based on the available evidence, a clinical response is normally achieved within the first 16 weeks of treatment, however, if your patients don’t demonstrate a response to the prescribed Cosentyx dose within this timeframe, consideration should be given to discontinuing the treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.1,2
Cosentyx dosing and special populations
No dose adjustments are required for elderly individuals aged 65 and over. The safety and efficacy of Cosentyx in children below the age of 6 years have not yet been established. Cosentyx has not been studied in patients with renal or hepatic impairment and therefore no dose recommendations can be made in these populations.1
There are no adequate data from the use of Cosentyx in pregnant women. As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy. Because of the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.1,2
Cosentyx missed dose
Encourage your patient to promptly consult with you in the event that they miss a scheduled dose, so that you may determine when they should take the subsequent Cosentyx injection dose.5
Cosentyx overdose
In clinical studies, doses of Cosentyx up to 30 mg per kg (approximately 2,000 to 3,000 mg) have been administered intravenously without encountering dose-limiting toxicity. In the rare event of a Cosentyx overdose, patients should be monitored for any adverse reactions and their symptoms treated appropriately.1,2
This is not an exhaustive list of warnings and precautions. Please refer to the Cosentyx SmPC for full information.
The most frequently reported adverse reactions are upper respiratory tract infections (17.1%) (most frequently nasopharyngitis, rhinitis).1,2
Explore more safety information here for additional details regarding the safety profile of Cosentyx
Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated. Please refer to the Cosentyx SmPC for full product information and administration, including dosing in special populations, before prescribing.1,2
Therapeutic indications1,2
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1,2
AS, ankylosing spondylitis; ERA, enthesitis-related arthritis; HS, hidradenitis suppurativa; IGA mod 2011/01, Investigator's Global Assessment modified 2011 Investigator's Global Assessment modified 2011; JPsA, juvenile psoriatic arthritis; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; PASI, psoriasis area and severity index; PK, pharmacokinetics; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; SmPC, Summary of Product Characteristics.
References
Cosentyx® (secukinumab) GB Summary of Product Characteristics.
Cosentyx® (secukinumab) NI Summary of Product Characteristics.
Augustin M, et al. Br J Dermatol 2022;186:942-954.
Sigurgeirsson B, et al. Dermatol Ther 2022;35(3):e15285.
Cosentyx 300 mg solution for injection pre-filled pen. Patient Information Leaflet.
Cosentyx 150 mg solution for injection pre-filled pen. Patient Information Leaflet.
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.