FIXTURE and ERASURE studies of secukinumab for Plaque Psoriasis reported in NEJM- Novartis

Novartis announced that detailed results from two pivotal phase III studies evaluating the interleukin-17A (IL-17A) inhibitor secukinumab (AIN457) were published online in the New England Journal of Medicine (NEJM). Secukinumab met all primary and key secondary endpoints at Week 12 in the ERASURE and FIXTURE studies showing superiority to Enbrel (etanercept) in improving moderate-to-severe Plaque Psoriasis symptoms in the FIXTURE study, and superiority over placebo in both studies. Over half of secukinumab 300 mg patients experienced clear (PASI 100) or almost clear (PASI 90) skin, described as Psoriasis Area and Severity Index 90 or 100 (PASI 90/PASI 100) by Week 12 (59.2% for ERASURE and 54.2% for FIXTURE, p<0.001). in comparison, only 20.7% of enbrel-treated patients experienced pasi 90 or 100 in fixture. secukinumab 300 mg patients' response continued to improve from week 12, with more than 70% experiencing clear or almost clear skin by week 16 (72.4% and 36.8% for pasi 90 and 100, respectively) in the fixture study, which was maintained in the majority of patients up to week 52 (with continued treatment). pasi measures the redness, scaling and thickness of psoriatic plaques and the extent of involvement in each region of the body. treatment efficacy is assessed by the reduction of the score from baseline (i.e. a 75% reduction is known as pasi 75, a 90% reduction is known as pasi 90, and pasi 100 is completely clear skin). pasi 90 and 100 are more robust measures of the extent of skin clearance compared to standard measures, such as pasi 75, that have been used in most psoriasis clinical studies.>

Data published in NEJM also show that secukinumab-treated patients had their symptoms resolved faster than those treated with Enbrel in the FIXTURE study. In addition to high rates of clear to almost clear skin, secukinumab patients also reported superior improvements in itching, pain and scaling, compared to placebo at Week 12, in ERASURE. Similarly, health-related quality of life (HRQoL) was significantly improved among secukinumab-treated patients at Week 12 compared to placebo in both studies, as assessed by the Dermatology Quality of Life Index (DLQI).

See- Langley RG, Elewski BE, Lebwohl M, et al. "Secukinumab in plaque psoriasis: results of two phase three trials". New Engl J Med. 2014 [published online ahead of print 9 July 2014]