Prescribing information

 

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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) (alone or in combination with methotrexate) in adults who have responded inadequately to disease-modifying anti-rheumatic drug therapy.

Importance of Cosentyx Q2W dosing for rheumatologists

 

  • Allows for a flexible dosing approach for PsA patients with concomitant PsO who are ≥90 kg and need additional benefit
  • May allow scope for better disease control without having to switch drug class
 

In adults with PsO or PsA and concomitant PsO, the recommended dose is 300 mg S/C 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 every 2 weeks (Q2W) may provide additional benefit for patients with a body weight of 90 kg or higher.1,2

Individual patient dosing may vary – please consult the Prescribing information for full details.

 

Why is this important?

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The benefits of some biologics may be attenuated among patients ≥90 kg.3,4 Additionally, a weight of ≥90 kg has been shown to be a predictor of increased psoriatic arthritis (PsA) risk.5

 

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In the MATURE study, Cosentyx demonstrated sustained skin clearance, with 73.2% of patients achieving PASI 90 at Week 16 and efficacy was sustained through 52 weeks.*6 However, for PsO patients and PsA patients with concomitant PsO, weighing ≥90 kg, who need additional benefit, up-titration to Q2W dosing is now an option.†1,2

 

 

Cosentyx 300 mg Q2W dosing is supported by the A2324 study results

The A2324 study aimed to investigate the short-term (16 weeks) and long-term (52 weeks) efficacy and safety of an increased dosing frequency of Cosentyx 300 mg Q2W compared to Cosentyx 300 mg Q4W in patients with chronic PsO, weighing ≥90 kg.7

Study design graphic. Multicentre, randomised, double-blind, parallel-group, Phase III study involving patients with moderate to severe PsO, with a bodyweight of ≥90 kg.

Study recruitment graphic. 331 patients, 67 sites worldwide from June 2018 to July 2020.

 

A dosing schedule of Q4W with Cosentyx is unlicensed for adult patients with PsO.1,2

 

Cosentyx efficacy in the A2324 trial

 

Cosentyx safety in the A2324 trial

Although Cosentyx is indicated for children, adolescents and adults, this document is intended to communicate the benefits for adults only.
*MATURE was a 52-week, multicentre, randomised, double-blind, placebo-controlled Phase III study (N=122). Co-primary endpoints: PASI 75 and IGA mod 2011 0/1 response rates at Week 12 vs placebo. Secondary endpoints: PASI 90 response at Week 12 (key secondary endpoint) and PASI 75/90/100 and IGA mod 2011 0/1 responses, DLQI score of 0/1, usability of the 2 mL AI (rated using a SIAQ), PK assessments, and safety, over 52 weeks. Results obtained with the group of patients randomised to Cosentyx 300 mg (2mL AI) from the start to the end of the study.6
Cosentyx can be up-titrated in patients weighing 90 kg or more, based on clinical response.1,2
AE, adverse event; CI, confidence interval; DLQI, Dermatology Quality of Life Index; HLT, high-level term; IBD, inflammatory bowel disease; IGA, Investigator’s Global Assessment; MACE, major adverse cardiovascular event; NMQ, Novartis MedRA; NR, non-responder; OR, odds ratio; PASI, Psoriasis Area and Severity Index; PsO, moderate-to-severe plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; SMQ, Standardised Med RA Query; SOC, system organ class; UP, up-titrated.

 

References

  1. Cosentyx® UK Summary of Product Characteristics.
  2. Cosentyx® NI Summary of Product Characteristics.
  3. Warren RB et al. J Invest Dermatol 2015;135:2632-2640.
  4. Warren RB et al. Br J Dermatol 2019 May;180(5):1069-1076.
  5. Merola J, et al. J Am Acad Dermatol 2022;86(4):748–757.
  6. Sigurgeirsson B, et al. Dermatol Ther 2021;35(3):e15285. Doi: 10.1111/dth.15285.
  7. Augustin M, et al. Br J Dermatol 2022;186(6):942–954.
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UK | September 2022 | 231837

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 via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]