Novartis has revealed thee results of its pivotal Phase III FUTURE 2 study of secukinumab in psoriatic arthritis (PsA) with majority of patients showing sustained improvements over the course of one year of treatment.
Secukinumab is the first interleukin-17A (IL-17A) inhibitor to demonstrate efficacy in a Phase III study in adult patients with active PsA. PsA is a long-term, debilitating, inflammatory disease associated with joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage.
Novartis has published the findings in The Lancet. The findings revealed that sustained improvements have been observed with subcutaneous secukinumab 300 mg and 150 mg over one year of treatment in the majority of patients (64 per cent for both doses), as measured by the American College of Rheumatology response criteria (ACR 20).
When looked at ACR 50 response rates, they were also sustained to one year in secukinumab 300 mg and 150 mg (44 per cent and 39 per cent respectively). Secukinumab met the primary endpoint of the study, which was ACR 20 at Week 24 with response rates significantly higher in the secukinumab 300 mg (54 per cent; p<0.0001) and 150 mg (51 per cent; p<0.0001) groups versus placebo (15 per cent), with clinical improvements observed as early as Week 3. ACR 20 and 50 are standard tools used to assess improvement of PsA signs and symptoms, and represent a 20 per cent and 50 per cent improvement from baseline, respectively. "Secukinumab is the first IL-17A inhibitor to show consistent efficacy through one year in Psoriatic Arthritis, Psoriasis, and Ankylosing spondylitis" said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "Novartis has recently filed global regulatory submissions for secukinumab in both psoriatic arthritis and ankylosing spondylitis and will continue to work to bring this important advance to patients with these debilitating diseases." Secukinumab 300 mg and 150 mg also significantly improved a key secondary endpoint which was improvement in psoriasis symptoms, as measured by 90 per cent improvements in Psoriasis Area and Severity Index score (PASI 90). Achieving PASI 90 means that patients can attain clear to almost clear skin. This is important as the majority of people living with PsA have a history of, or concomitant, psoriasis, another long-term condition which is characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain. Although the secukinumab benefits seen in FUTURE 2 were generally higher in patients without previous treatment with standard of care anti-TNF therapy, clinical benefits were observed in both anti-TNF-naïve patients and those with an inadequate response to anti-TNFs. This is important as many patients do not respond to, or tolerate these therapies and approximately 40 per cent of people are dissatisfied with current treatments. There is therefore, a high unmet need for patients with PsA. Secukinumab was well tolerated in FUTURE 2, with a safety profile consistent with that observed in the psoriasis clinical trial program involving nearly 5,000 patients. The most common adverse events (AEs) were upper respiratory tract infections and the common cold.
