Regulatory Decision Summary for Cosentyx

The safety and efficacy of Cosentyx were assessed in 555 patients in one double-blind, placebo-controlled phase III in patients with active nr-axSpA. Patients enrolled had active disease despite current or previous NSAID therapy, and increased CRP and/or evidence of sacroiliitis on MRI. Approximately 9.7% were anti-TNF-alpha-IR (inadequate responder) patients.

Patients were treated with Cosentyx 150 mg subcutaneous treatment with load (Weeks 0, 1, 2, 3, and 4) or without load (Weeks 0 and 4) followed by the same dose every 4 weeks or placebo, for 52 weeks. Starting Week 16, dose adjustment or addition of concomitant NSAIDs and disease-modifying antirheumatic drugs (DMARDs) was permitted. Starting at Week 20, patients were allowed to switch to open-label Cosentyx 150 mg monthly or other biologic at the discretion of the investigator and patient. There were 2 primary endpoints that assessed at least 40% improvement in Assessment of Spondyloarthritis International Society (ASAS40) at Week 16 and Week 52 in the anti-TNF-naïve population.

Treatment with Cosentyx resulted in clinically meaningful and statistically significant improvements in the measure of disease activity compared to placebo at Week 16 and Week 52. At Week 16, these measures included ASAS 40, ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI 50, high-sensitivity CRP (hsCRP), ASAS 20 response, ASAS partial remission compared to placebo. Efficacy was maintained up to Week 52. ASAS 40 responses were also improved at Week 16 in anti-TNF-alpha-IR patients for Cosentyx compared with placebo. Additional benefits such as physical function and health-related quality of life, spinal mobility, and reduction of inflammation in magnetic resonance imaging (MRI) were also demonstrated.

The most commonly reported adverse drug reactions up to Week 20 in secukinumab patients were nasopharyngitis, diarrhea, headache, and upper respiratory tract infection. The proportion of patients with infections in the Cosentyx groups was similar to the proportion in the placebo group in the 20-week placebo-controlled period. Over the entire treatment period, infections were reported in 59.5% of patients treated with Cosentyx, with 2.2% cases of serious infections. The safety profile observed in patients with nr-axSpA treated with Cosentyx is consistent with the safety profile in AS and is considered acceptable.

Overall, the benefits outweigh the risks of Cosentyx in adult patients with active nr-axSpA who are refractory to NSAIDs. The benefit/risk profile of Cosentyx is considered favourable in the target patient population.