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Secukinumab Shows Symptom Improvement in Pivotal Arthritis Studies
Positive results have been reported from the pivotal FUTURE 1 and FUTURE 2 studies, in which secukinumab (IN457, Novartis) demonstrated rapid and significant clinical improvements in the signs and symptoms of psoriatic arthritis (PsA) compared with placebo. PsA is part of a family of long-term joint diseases known as spondyloarthritis, which also includes ankylosing spondylitis.
Many patients do not respond to or tolerate anti-tumor necrosis factor (anti-TNF) medications, the current standard of care for PsA, and approximately 45% of patients are dissatisfied with current treatments.
Secukinumab stops the action of interleukin-17A (IL-17A), which is central to the development of inflammatory diseases.
The new results were presented November 17 at the American College of Rheumatology (ACR) Congress in Boston, Massachusetts.
FUTURE 1 and FUTURE 2 were the first phase III, multicenter, randomized, placebo-controlled studies to evaluate the efficacy of IL-17A inhibition with secukinumab in patients with PsA. In the FUTURE 1 trial, patients received an intravenous loading dose every 2 weeks for the first 4 weeks of treatment followed by monthly subcutaneous doses of 75 mg or 150 mg compared with placebo, and FUTURE 2 compared a subcutaneous loading dose of secukinumab (75 mg, 150 mg, or 300 mg) with placebo. A total of more than 1,000 patients were enrolled in both studies.
Clinically and statistically significant improvements in the signs and symptoms of PsA were achieved with secukinumab compared with placebo, as measured by a 20% reduction in the ACR response criteria (ACR 20), a standard tool used to assess improvement at week 24. Fifty percent and 54% of secukinumab-treated patients achieved at least ACR 20 in the FUTURE 1 (150 mg; P < 0.0001) and FUTURE 2 (150 and 300 mg; P < 0.0001) trials, respectively. This was in comparison with 17% and 15% of placebo-treated patients who achieved ACR 20 in FUTURE 1 and FUTURE 2.
Secukinumab-treated patients in all dose groups experienced rapid onset of effect as early as week 1 in FUTURE 1 (P < 0.0001) and week 3 in FUTURE 2 (150 mg, P < 0.0001 and 300 mg, P < 0.001). Long-term data from the FUTURE 1 trial also confirmed that these improvements were sustained through 52 weeks of treatment.
Importantly, clinical benefits with secukinumab were observed in patients who had not been treated with anti-TNF therapies (anti-TNF naïve), and in patients who had shown an inadequate or no response to anti-TNFs. Those who had prior exposure to anti-TNFs accounted for 30% and 35% of study participants in the FUTURE 1 and FUTURE 2 trials, respectively.
In FUTURE 1, more than 80% of patients experienced no progression of joint structural damage, which occurs in approximately two-thirds of patients with PsA and is associated with loss of function and disability. Improvements in joint damage were shown both in anti-TNF–naïve patients and in patients with an inadequate response or no response to anti-TNF medications.
Source: Novartis; November 17, 2014.