Novartis announced new results for Cosentyx® (secukinumab) showing no further progression in joint damage in 84% of patients with psoriatic arthritis (PsA). In addition, Cosentyx maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment. These results from the extension phase of the FUTURE 1 study were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, United States.
Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to demonstrate efficacy in Phase III studies in PsA - a life-long inflammatory disease that affects the skin and joints. If not treated effectively, it can lead to irreversible joint damage and disability caused by years of inflammation.
PsA is part of a family of life-long inflammatory diseases that also includes ankylosing spondylitis (AS). Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons, and irreversible joint damage.
"Psoriatic arthritis patients need therapies that can prevent the progression of this debilitating disease. In this two-year study, Cosentyx showed no further progression in joint damage in over 80% of PsA patients while maintaining improvements in joint and skin disease, physical function, and quality of life," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "These results show the potential for Cosentyx to create an important new option for the treatment of psoriatic arthritis".
New medicines with an alternative way of working are needed as many patients do not achieve an adequate response from current treatments, such as disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatories or anti-tumor necrosis factor (anti-TNF) therapies. Many patients do not respond to or tolerate these therapies, with approximately 45% of PsA patients dissatisfied with their treatments.
These results from the FUTURE 1 study represent the longest Cosentyx Phase III study in PsA to date. Responses in joint and skin disease, physical function, and quality of life at Week 24, were maintained over two years. After two years of treatment, 67%* of patients (n=202) treated with Cosentyx 150 mg achieved the standard treatment goal of an ACR 20 response (American College of Rheumatology response criteria). In addition, 84% of patients showed no further progression in joint damage as shown by x-ray assessment**. Cosentyx was well tolerated with a safety profile consistent with that observed in previous studies.
FUTURE 1 is a two year, multi-center, randomized, placebo-controlled Phase III pivotal study to evaluate the efficacy of Cosentyx in patients with active PsA. FUTURE 1 enrolled 606 patients with active PsA and assessed Cosentyx with intravenous loading (10 mg/kg) and subcutaneous (75 mg and 150 mg) maintenance dosing. The primary endpoint assessed superiority of Cosentyx against placebo in the proportion of patients achieving the ACR 20 response at Week 24. From Week 16, patients in the placebo arm of the study were re-randomized to receive Cosentyx 150 mg or 75 mg at either Week 16 or Week 24, based on clinical response.
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.
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