Novartis’s secukinumab meets Phase 3 goals
pharmafile | October 1, 2015 | News story | Research and Development | Novartis, Secukinumab, arthritis
Novartis has announced that its secukinumab medication for treatment of psoriatic arthritis (PsA), met its primary endpoint in the pivotal phase 3 study, FUTURE 1, and that secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a phase 3 study in patients with active PsA.
Results published online in the New England Journal of Medicine (NEJM), show secukinumab achieved a 20% reduction in the American College of Rheumatology response criteria (ACR 20) at Week 24, showing rapid and significant clinical improvements versus placebo.
ACR is a standard tool used to assess improvement of PsA signs and symptoms, taking into account such factors as tender and swollen joints, pain and disability.
In addition, secukinumab, a human monoclonal antibody, met all secondary endpoints in the trial, including improvements in skin and joint diseases and joint structural damage progression.
PsA is a painful, debilitating condition causing inflammation of joints and skin, and is part of a family of long-term diseases impacting joints, known as spondylorarthritis. Symptoms can lead to significant disability, poor quality of life and reduced life expectancy.
Importantly, in FUTURE 1, clinical benefits with secukinumab were observed regardless of prior exposure to anti-tumour-necrosis-factor (anti-TNF) medicines, the current standard of care.
Many patients do not respond to, or tolerate these therapies and approximately 45% of people are dissatisfied with current treatments. Therefore, says Novartis, there is a high unmet need for patients with PsA.
Study results showed that half of patients (50.0% and 50.5%) in both secukinumab-treated dose groups (150 mg and 75 mg; p<0.001) achieved ACR 20 response compared with only 17.3% of placebo patients. Clinically significant improvements with secukinumab were observed as early as week 1 and sustained throughout 52 weeks of treatment.
Secukinumab was well tolerated in the study, with a safety profile consistent with that observed in the large psoriasis clinical trial program involving nearly 4,000 patients. The most common adverse events (AEs) were common cold, headache and upper respiratory tract infections.
Vasant Narasimhan, global head of development, Novartis Pharmaceuticals, says: “Secukinumab is the first IL-17A inhibitor with detailed positive results for the treatment of PsA, further validating the importance of the role IL-17A plays in spondyloarthritis. Novartis looks forward to advancing this important therapy to address the unmet need for patients living with PsA.”
FUTURE 1 is the first multi-center, randomiSed, placebo-controlled Phase 3 study to evaluate the efficacy of secukinumab in IL-17A inhibition in PsA. The study enrolled 606 patients with active PsA, including patients who had been previously treated with DMARDs (disease-modifying anti-rheumatic drugs) and patients who had an inadequate response or did not tolerate anti-TNFs, and assessed secukinumab with intravenous loading (10 mg/kg) and subcutaneous (75 mg and 150 mg) maintenance dosing.
In the study, patients received an intravenous loading dose every two weeks for the first four weeks of treatment followed by monthly subcutaneous doses of 75 mg or 150 mg compared to placebo.
Joel Levy
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