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Results from JUNCTURE also showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at Week 12 compared with placebo: 86.7% (300mg) and 71.7% (150mg), versus 3.3% for placebo (P<.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at Week 12 compared with placebo: 73.3% (300mg) and 53.3% (150mg), versus 0% placebo (P<.0001).

Additionally, more secukinumab patients in both studies experienced an improvement in PASI of greater than or equal to 90% (PASI 90) from baseline as compared to placebo, which is a higher standard of skin clearance compared to PASI 75. In FEATURE 60.3% (300mg) and 45.8% (150mg) of secukinumab patients achieved a PASI 90 response at Week 12 compared to 0% of placebo patients (P<.0001). In JUNCTURE, 55% (300mg) and 40% (150mg) of secukinumab patients achieved a PASI 90 response at Week 12 compared to 0% of placebo patients (P<.0001).

In FEATURE (n=177), the most common adverse events (AEs) in any treatment group including placebo were diarrhea, nasopharyngitis and headache. There were a total of four serious adverse events in the study – three (5.1%) in the 300mg secukinumab arm and one (1.7%) in the placebo arm. Two patients (one in secukinumab 300mg arm, one in placebo arm) discontinued due to AEs. In JUNCTURE (n=182), the most common AEs in any treatment group including placebo were nasopharyngitis, headache, pruritus and hypertension. There were a total of five serious adverse events in the study – one (1.7%) in the 300mg secukinumab arm, three (4.9%) in the 150mg secukinumab arm and one (1.6%) in the placebo arm. One patient in the placebo arm discontinued due to adverse event.

A secondary endpoint of both FEATURE and JUNCTURE measured patient satisfaction and usability with self-injection of secukinumab via PFS and AI, respectively. Satisfaction was assessed in both studies using a self-administered Self-Injection Assessment Questionnaire (SIAQ) which measures overall subject experience with subcutaneous self-injection before the first self-injection and after dosing on the domains of feelings about injections, self-confidence, satisfaction with self-injection, injection-site reactions, ease of use, and self-image. Overall, patient- reported acceptability of both the PFS and AI were high at baseline across both studies and remained high during the study. These studies were presented in separate posters at AAD.

Studies presented at AAD are part of a clinical program reporting results in moderate-to-severe plaque psoriasis with more than 3,000 patients in over 35 countries.

FEATURE is a randomized double-blind, placebo-controlled, multicenter, Phase III study involving 177 subjects with moderate- to-severe plaque psoriasis. In this study, prefilled syringes (PFS) were introduced into the secukinumab clinical program. The co-primary endpoints were assessed at Week 12 and compared secukinumab efficacy versus placebo according to PASI 75 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response. Secondary endpoints included PASI 90 response up to Week 12 and patient satisfaction with self-injection of secukinumab via PFS determined by a self administered Self-Injection Assessment Questionnaire (SIAQ). The trial is ongoing.

JUNCTURE is a double-blind, placebo-controlled, multicenter, Phase III study involving 182 subjects with moderate-to-severe plaque psoriasis. In this study, the autoinjector/pen (AI) was introduced into the secukinumab clinical program. The co-primary endpoints were PASI 75 and Investigator's Global Assessment modified 2011 (IGA mod 2011) 0/1 response for secukinumab vs placebo at Week 12. Secondary endpoints included PASI 90 response up to Week 12 and patient satisfaction with self-injection of secukinumab via the AI device determined by a self-administered Self-Injection Assessment Questionnaire (SIAQ). The trial is ongoing.

Genentech has announced that the FDA approved Xolair ® (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy5. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response.

CIU is diagnosed when hives occur without an identifiable cause, spontaneously present, and reoccur for more than six weeks. CIU can have burdensome symptoms including swelling, severe itch, pain, and discomfort that may last for many months and even years. Approximately 1.5 million people in the U.S. develop CIU at some stage in their life. Women are twice as likely as men to experience CIU and most develop symptoms between the ages of 20 and 40.

Xolair is the first biologic medicine and first medicine approved by the FDA for CIU since non-sedating H1-antihistamines. Xolair is approved for people 12 years and older with CIU who remain symptomatic despite treatment with H1-antihistamine therapy. Xolair is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. It is jointly developed by Genentech and Novartis Pharma AG and is co-promoted in the U.S. with Novartis Pharmaceuticals Corporation.

The efficacy and safety profile of Xolair for the treatment of CIU was evaluated in two clinical studies called ASTERIA I and ASTERIA II. In these studies, patients 12 to 75 years old received doses of Xolair at 150 mg, 300 mg or placebo. Xolair or placebo