The European Commission has approved a label update for Cosentyx (secukinumab) that will allow healthcare providers to prescribe doses of up to 300 mg — twice what was previously approved — for people with active ankylosing spondylitis (AS).
Cosentyx, developed and marketed by Novartis, is a biologic therapy initially approved for the treatment of AS in Europe in late 2015, with the U.S Food and Drug Administration following suit in January 2016. It is given via a subcutaneous (under-the-skin) injection to specifically bind to and block interleukin-17, a signaling molecule that drives inflammation. In this way, Consentyx is intended to suppress inflammation, easing AS symptoms.
The therapy was initially approved at doses of up to 150 mg based on two Phase 3 trials — MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375) — that showed a significant decrease in AS signs and symptoms at 16 weeks of treatment. This is still the recommended dose for AS patients in the U.S.
“This approval gives rheumatologists more flexibility to ensure their patients are able to achieve the best response to treatment,” Sam Khalil, global head of medical affairs immunology, hepatology and dermatology at Novartis, said in a press release. “It further encourages our ongoing efforts to reimagine care to ensure all patients are able to experience full relief from the signs and symptoms of AS.”
The decision to update the label in Europe is based on the results of an international Phase 3 trial called MEASURE 3 (NCT02008916). A total of 226 adults with AS were randomized to receive either 150 mg Cosentyx, 300 mg Cosentyx, or a placebo. The trial’s primary objective was the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate, which refers to a 20% improvement/worsening in four domains: patient global assessment of disease, pain, function, and inflammation.
Results showed significantly superior ASAS 20 response rates in both Cosentyx groups (60.5% with 300 mg and 58.1% with 150 mg) over placebo (36.8%). These improvements were particularly noticeable in patients who had never been treated with anti-TNF (tumor necrosis factor) therapies, which also work by lessening inflammation.
Besides AS, Cosentyx is also approved for the treatment of plaque psoriasis and psoriatic arthritis. More than 250,000 patients have been treated worldwide with Cosentyx since its launch, according to Novartis.
The company recently submitted a request to the European Medicines Agency to extend the therapy’s indications to non-radiographic axial spondyloarthritis. Similar to AS, this condition is a subtype of axial spondyloarthritis.