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news.Novartis has announced that new analyses of AIN457 (secukinumab) Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity (p
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This data was presented at the European Association of Dermatology and Venereology (EADV) Congress, in Amsterdam, Netherlands. Secukinumab’s new mode of action stops interleukin-17A (IL-17A), which plays a central role in the development of psoriasis.
In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI (Psoriasis Area and Severity Index) (p<0.0001).
Skin clearance was sustained through one year of treatment (p<0.0001). This is important as historically, psoriasis patients’ disease severity at the start of treatment has been shown to negatively impact their response to other therapies.
Disease severity subgroups were PASI <=20 and PASI >20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel* (etanercept), a standard of care anti-TNF medication.
"We are excited to continue seeing new positive results for secukinumab in psoriasis, this time showing consistent high rates of skin clearance regardless of disease severity as well as the positive relationship clearing skin has on patients’ quality of life," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals.
"With global regulatory approvals anticipated shortly, we hope to bring secukinumab to patients living with this debilitating disease, which impacts much more than their skin."
In addition to the disease severity data, another secukinumab analysis showed that significantly more patients on active treatment experienced clear or almost clear skin with no quality of life impairment, as measured by PASI 100/PASI 90 and the Dermatology Quality of Life Index (DLQI) 0/1, compared to those with PASI scores less than 90 (p<0.001). In the analyzed studies, more than 70% of secukinumab 300 mg patients experienced clear or almost clear skin during the first 16 weeks of treatment.
Psoriasis’ effect on patients’ quality of life is similar to cancer, heart disease, arthritis, type 2 diabetes and depression. The painful symptoms limit psoriasis patients’ ability to undertake daily activities and impact their social relationships.