Regulatory Decision Summary for Cosentyx

Authorization was based on a three-part, randomized withdrawal study (Study F2304) in 86 patients 2 to < 18 years of age with active enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPsA). Of the 86 patients enrolled, 52 (60%) were diagnosed with ERA and 34 (40%) were diagnosed with JPsA. The primary endpoint was time to disease flare. Treatment with Cosentyx resulted in a statistically significant and clinically meaningful reduction in the risk of flare.

The most commonly reported (≥15%) adverse events were nasopharyngitis (31%), nausea (22%), upper respiratory tract infection (22%), diarrhea (20%), and cough (15%). The majority of treatment-emergent adverse events (AEs) were mild or moderate intensity, non-serious, and did not require treatment discontinuation.

Uncertainty remains for the youngest group of patients (2 to < 6 years) because there is potential risk of increased exposure due to their lower body weight. This concern could not be alleviated since the available clinical data in this age group is too sparse.

The recommended dose of the drug is based on body weight. For patients weighing < 50 kg the dose is 75 mg. For patients weighing ≥ 50 kg the dose is 150 mg. Cosentyx is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing (every 4 weeks).

Juvenile idiopathic arthritis (JIA) represents a heterogeneous group of chronic idiopathic arthritis of at least 6 weeks’ duration that presents in children and adolescents less than 16 years of age. ERA and JPsA are two of seven categories of JIA. ERA and JPsA are characterized by persistent disease activity, functional limitations and disability, which may debilitate patients and lead to long-lasting, irreversible damage if left untreated.

Data from this submission indicated a meaningful treatment benefit of secukinumab for the treatment of active ERA or JPsA. The safety profile was consistent with the established profile in adults and paediatric patients with other autoimmune diseases, and risks were deemed to be adequately addressed with labelling. As such, the benefit-risk profile for the use of secukinumab for the treatment of active ERA or active JPsA in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy is considered favourable

An updated Risk Management Plan (RMP) for Cosentyx was reviewed by Health Canada and considered acceptable.

For further details about Cosentyx, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.