Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA). Secukinumab is a human monoclonal antibody (mAb) that selectively binds to and neutralizes IL-17A.
FUTURE 1 and FUTURE 2 are multi-center, randomized, placebo-controlled studies designed to evaluate the efficacy of IL-17A inhibition with secukinumab in PsA in more than 1,000 patients. The primary endpoints in both studies were met with statistically significant improvements in signs and symptoms of PsA achieved with secukinumab vs. placebo at Week 24, as measured by a 20% reduction in the American College of Rheumatology (ACR20) response criteria. Between 50–54% of secukinumab patients achieved ACR20 in both FUTURE 1 (P<0.0001) and FUTURE 2 (P<0.0001). This is in comparison to 17.3% and 15.3% of placebo patients who achieved ACR20, respectively.
Exploratory analyses in FUTURE 1 showed more secukinumab-treated patients in the 75mg (20.3%) and 150mg (20.8%) dose groups experienced ACR20 responses by Week 1 vs. placebo (5.4%) (P<0.0001). In FUTURE 2, more secukinumab-treated patients in the 150mg (42.0%) and 300mg (37.0%) dose groups experienced ACR20 responses by Week 3 (150mg P<0.0001; 300mg P<0.001) vs. placebo (15.3%).
An additional exploratory analysis in FUTURE 1 showed that a majority of secukinumab-treated patients who achieved ACR20 responses at Week 24 also maintained the response at Week 52 with continued treatment. Additional analyses evaluated clinical benefits in anti-TNF naïve patients and also in patients who had an inadequate or no response to anti-TNFs. Those who had prior exposure to anti-TNFs included 29.5% (FUTURE 1) and 35.0% (FUTURE 2) of study participants. In FUTURE 1, patients on secukinumab had significantly less progression of joint structural damage compared to placebo, as evaluated by erosion and joint narrowing scores. Improvements in joint damage were shown in both anti-TNF naïve patients and in the patients with inadequate or no response to anti-TNFs. Additionally, secukinumab demonstrated significant improvements in skin psoriasis in both FUTURE 1 and FUTURE 2 compared to placebo.
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