The Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of moderate to severe plaque psoriasis in patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
The approval was based on data from a randomized, double-blind, placebo- and active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT02471144) that evaluated the efficacy and safety of secukinumab in 162 patients 6 years of age and older with severe plaque psoriasis who were candidates for systemic therapy. Patients were randomly assigned to receive secukinumab 75mg (if weighing less than 50kg) or 150mg (if weighing 50kg or more), placebo, or etanercept.
The coprimary endpoints were the proportion of patients who achieved a reduction in Psoriasis Area and Severity Index (PASI) score of at least 75% (PASI 75) from baseline to week 12 and the proportion of patients who achieved an Investigator’s Global Assessment (IGA) modified 2011 score of ‘clear’ or ‘almost clear’ (0 or 1) with at least a 2-point improvement from baseline to week 12.
Results showed that at week 12, a greater proportion of patients treated with secukinumab 75mg and 150mg met the coprimary and key secondary endpoints compared with placebo:
- PASI 75 response: 55% for 75mg vs 10% for placebo; 86% for 150mg vs 19% for placebo; 70% for total secukinumab vs 15% for total placebo.
- IGA of clear or almost clear: 32% for 75mg vs 5% for placebo; 81% for 150mg vs 5% for placebo; 56% for total secukinumab vs 5% for total placebo.
- PASI 90 response: 41% for 75mg vs 5% for placebo; 81% for 150mg vs 0% for placebo; 60% for total secukinumab vs 2% for total placebo.
The approval was also supported by a 208-week, randomized, open-label, multicenter phase 3 trial (ClinicalTrials.gov Identifier: NCT03668613) that evaluated the safety of secukinumab in 84 patients 6 to under 18 years of age with moderate to severe plaque psoriasis. The safety profile of secukinumab was consistent with that seen in adult plaque psoriasis trials; no new safety signals were observed.
After initial counseling and injection technique training, Cosentyx can be administered by an adult caregiver using the prefilled syringes (75mg/0.5mL, 150mg/mL) or the Sensoready pen (150mL/mL).
- Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis. [press release]. Basel, Switzerland: Novartis; June 1, 2021.
- Cosentyx [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2021.