Novartis announced late-breaking two-year results for Cosentyx (secukinumab) showing up to 80 per cent of patients with ankylosing spondylitis (AS) had no radiographic progression in the spine on x-ray assessment. This is the first time that data on structural spinal progression in AS have been presented for an interleukin-17A (IL-17A) inhibitor.
In addition, Cosentyx showed a sustained response in improvements of signs and symptoms, physical function and quality of life in AS patients over two years. These results from an extension phase of the MEASURE 1 pivotal study were revealed at the 2015 annual meeting of the American College of Rheumatology (ACR) in San Francisco, United States.
Cosentyx is the first IL-17A inhibitor and the first biologic treatment other than the current standard of care - anti-tumour necrosis factor medicines (anti-TNFs) - to demonstrate efficacy in phase III AS studies. AS is a life-long and painful inflammatory disease that can cause irreversible joint and/or spinal damage for patients if not treated effectively.
"Many patients with ankylosing spondylitis will go on to experience stiffening of the spine. Cosentyx has shown the potential to reduce structural damage of the spine in ankylosing spondylitis patients across two years," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals.
"Cosentyx is a real contender for becoming a new standard for treating ankylosing spondylitis patients."
These results are important because up to 70 per cent of patients with severe AS develop spinal fusion (where the bones grow together) over 10 to 15 years, which significantly reduces mobility. New treatment options are also urgently needed as many patients do not respond adequately to current medications such as non-steroidal anti-inflammatories and anti-TNF therapies with up to 40 per cent of patients not responding sufficiently to the latter.
Data from 125 patients presented for Cosentyx 150 mg showed that 74 per cent achieved an ASAS 20 response (Assessment of Spondyloarthritis International Society response criteria) at two years. The study enrolled patients who had either never taken, or who had previously been treated with, the current standard of care biologic, anti-TNF therapy. Quality of life and physical function scores were also maintained over two years. Cosentyx was well tolerated over the two year treatment period with a safety profile consistent with that observed in previous studies across multiple indications.
These results are from the MEASURE 1 study and represent the longest Cosentyx AS phase III study presented to date. MEASURE 1 is a two-year, multi-center, randomized, placebo-controlled phase III study assessing the efficacy and safety of Cosentyx in patients with active AS. The study has now entered a three-year extension period. 371 patients were enrolled and administered a Cosentyx intravenous loading dose of 10 mg/kg every two weeks for the first four weeks of treatment, followed by monthly subcutaneous maintenance dosing (75 mg and 150 mg). Primary endpoints assessed superiority of Cosentyx against placebo at week 16 in the proportion of patients achieving at least a 20 per cent improvement in the ASAS 20 response criteria. From week 16, patients in the placebo arm of the study were re-randomized to Cosentyx 75 mg or 150 mg based on ASAS 20 response, with non-responders switched at week 16, and responders at week 24. In total, 103/124 and 97/125 patients randomized to Cosentyx 75 mg and 150 mg respectively completed 104 weeks. Observed analyses included in the extension phase at 104 weeks included only data available at a given time point. Patients with missing data at that time point were not included.
AS is part of a family of life-long inflammatory diseases that also includes psoriatic arthritis (PsA). It generally results in serious impairment of movement in the spine and physical function, which has an impact on quality of life. People in their teens and twenties, particularly males, are affected most often. Family members of those with AS are at higher risk.
Cosentyx is a human monoclonal antibody that selectively neutralizes circulating IL-17A. Cosentyx is the first IL-17A inhibitor with positive phase III results for the treatment of AS and PsA. Research suggests that IL-17A may play an important role in driving the body's immune response in psoriasis, PsA and AS.
In October 2015, Cosentyx was recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP) for the treatment of AS and PsA patients.
For patients with AS and PsA, the recommended dose is Cosentyx 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2 and 3, followed by monthly maintenance dosing starting at week 4. For PsA patients with concomitant moderate-to-severe plaque psoriasis, or who are anti-TNF inadequate responders, the recommended dose is Cosentyx 300 mg. Cosentyx is an investigational treatment in the US for AS and PsA.
In total, 49 countries have approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis which includes the European Union and European Economic Area countries. In January 2015, Cosentyx (at a recommended dose of 300 mg in the US and EU) became the first IL-17A inhibitor approved in the EU and US for the treatment of moderate-to-severe plaque psoriasis. In Europe, Cosentyx is the only first-line biologic approved for the systemic treatment of moderate-to-severe plaque psoriasis in adult patients. In the US, Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). In addition, Cosentyx has been approved in Switzerland, Australia, Canada and a number of other countries for the treatment of moderate-to-severe plaque psoriasis. In Japan, Cosentyx is approved for the treatment of moderate-to-severe plaque psoriasis and also for the treatment of PsA. More than 9,600 patients have been treated with Cosentyx in clinical trials across multiple indications, and over 9,000 patients have been treated in the post-marketing setting.