Date: 2014-03-22
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 72nd Annual Meeting of the American Academy of Dermatology (AAD) in Denver, USA
Company: Novartis (Switzerland)
Product: secukinumab (AIN457)
Action
mechanism: monoclonal antibody. Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A (IL-17A). Research shows that IL-17A plays a key role in driving the body\'s autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country:
Trial
details: FEATURE and JUNCTURE are the first phase III studies to evaluate secukinumab in clearing patients\' skin with the PFS and AI administration. Both methods allow secukinumab self-administration anywhere (including the workplace or home) versus healthcare professional administration, if allowed by local regulations.
FEATURE (First study of sEcukinumAb in pre-filled syringes in subjecTs with chronic plaqUe-type psoriasis REsponse) was a randomized double-blind, placebo-controlled, multicenter, phase III study involving 177 subjects with moderate-to-severe plaque psoriasis. In this study, a PFS was introduced into the secukinumab program.
JUNCTURE (Judging the efficacy of secUkinumab in patients with psoriasis using autoiNjector: a Clinical Trial evalUating treatment REsults) was a double-blind, placebo-controlled, multicenter, phase III study involving 182 subjects with moderate-to-severe plaque psoriasis. In this study, the AI device was introduced into the secukinumab program[2].
In both studies, the co-primary endpoints, PASI 75 and IGA mod 2011 at Week 12, were used to demonstrate superiority of secukinumab vs. placebo. Secondary endpoints included PASI 90 at Week 12 and patient satisfaction of secukinumab administered via PFS and AI, determined by a self-administered SIAQ. The trials are continuing up to one year (52 weeks).
Latest
news: * On March 22, 2014, Novartis has announced results from the pivotal phase III FEATURE and JUNCTURE studies showing secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, demonstrated consistent high efficacy when administered with a convenient pre-filled syringe (PFS) or autoinjector/pen (AI).These results, along with patient-reported outcomes showing high patient satisfaction with PFS and AI, are being presented for the first time at the 72nd Annual Meeting of the American Academy of Dermatology (AAD) in Denver, USA.
The FEATURE and JUNCTURE studies met all primary and pre-specified secondary endpoints. Across the co-primary endpoints in both studies, secukinumab 300 mg demonstrated significant improvements in PASI 75 at Week 12 versus placebo (75.9% vs. 0% for FEATURE; 86.7% vs. 3.3% for JUNCTURE, p<0.0001), and was also superior to placebo according to the Investigator\'s Global Assessment (IGA mod 2011).
Patients also benefitted from rapid and significant skin clearance with secukinumab in both studies. Already by Week 3, patients taking secukinumab 300 mg experienced superior efficacy in clearing skin compared to placebo. In addition, the 300 mg dose showed numerically and clinically relevant improvements compared to 150 mg.
Importantly, in both studies more secukinumab 300 mg patients experienced almost clear skin, described as Psoriasis Area and Severity Index 90 (PASI 90), at Week 12 (60.3% for FEATURE and 55% for JUNCTURE, p<0.0001) compared to placebo. PASI 90 is considered the best evidence of efficacy, and a more robust measure of the extent of skin clearance compared to standard efficacy measures that have been used in most psoriasis clinical studies, such as PASI 75.Both studies measured usability and patient satisfaction with secukinumab delivered via PFS and AI. At Week 1, all patients successfully self-injected secukinumab by following instructions, with no administration issues observed. Patient satisfaction scores were consistently high, showing acceptability of the PFS and AI. Satisfaction was assessed using a self-administered Self-Injection Assessment Questionnaire (SIAQ), which measures overall experience, feelings about injections, self-confidence, satisfaction with self-injection, injection-site reactions, ease of use, and self-image before and after treatment.
Secukinumab demonstrated a positive safety profile consistent with findings from previous studies, with adverse events (AEs) similar between both secukinumab treatment arms (300 mg and 150 mg). In FEATURE, the most common AEs in any treatment group were diarrhea, nasopharyngitis and headache. In JUNCTURE, the most common AEs in any treatment group were nasopharyngitis, headache and pruritus. There were no deaths reported during either study, and no new or unexpected safety findings were observed.
The FEATURE and JUNCTURE results support the head-to-head phase III FIXTURE data first presented in October 2013, which showed secukinumab cleared skin faster and for longer than Enbrel(etanercept). Clinically relevant differences were observed as early as Week 2 in FIXTURE, and by Week 16 nearly three quarters (72%) of secukinumab 300 mg patients experienced almost clear skin (PASI 90). Secukinumab efficacy was also sustained over the full one year study, with significantly more secukinumab 300 mg patients experiencing PASI 90 at Week 52 compared to Enbrel (65% vs. 33%).
