Novartis 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<0.0001). 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 per cent 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 analysed studies, more than 70 per cent 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.

The analyses pooled data from four pivotal phase III studies of secukinumab in moderate-to-severe plaque psoriasis: ERASURE, FIXTURE, FEATURE and JUNCTURE.

ERASURE (Efficacy of Response And Safety of two fixed secukinumab Regimens in psoriasis), FIXTURE (the Full year Investigative examination of secukinumab vs. etanercept Using 2 dosing regimens to determine efficacy in psoriasis), FEATURE (First study of secukinumab in pre-filled syringes in subjects with chronic plaque-type psoriasis Response) and JUNCTURE (Judging the efficacy of secukinumab in patients with psoriasis using autoinjector: a Clinical Trial evaluating treatment Results) are part of the secukinumab phase III programme in moderate-to-severe plaque psoriasis, which involved more than 3,300 patients in over 35 countries.

All studies assessed the efficacy, safety and tolerability of the induction period (at Week 12) and maintenance therapy (at Week 52) with secukinumab 300 mg or 150 mg in patients with moderate-to-severe plaque psoriasis. The studies were multicentre, randomised, double-blind, placebo-controlled (FIXTURE: also active controlled), parallel-group trials.

Secukinumab had an acceptable safety profile consistent with phase II studies; incidence of adverse events was similar between both secukinumab treatment arms (300 mg and 150 mg).

The analysis focussed on patients on active treatment in the FIXTURE and ERASURE studies.

Secukinumab (AIN457) is a fully human monoclonal antibody being investigated for diseases that affect the immune system. Secukinumab stops a protein called interleukin-17A (IL-17A) from its involvement in the development of psoriasis. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies.

Secukinumab is the first therapy selectively targeting IL-17A to publish Phase III results in psoriasis and to report results in psoriatic arthritis (PsA). Regulatory submissions for secukinumab in the EU and US were completed in 2013.

Phase III results for secukinumab in moderate-to-severe plaque psoriasis were first presented in October 2013 and March 2014. phase IIIb studies are also ongoing, including the head-to-head CLEAR study of secukinumab versus Stelara in moderate-to-severe plaque psoriasis and studies in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis. Secukinumab is also in clinical trials for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA).