Novartis Data Show AIN457 Significantly Reduced Signs And Symptoms In Patients With Hard-To-Treat Moderate-To-Severe Plaque Psoriasis

Date: Oct-01-2012Novartis has announced new Phase II data showing AIN457 (secukinumab) may significantly improve moderate-to-severe plaque psoriasis on the hands, feet and nails when used every week for the first month of treatment, compared to placebo1,7. Additional analysis on patients with moderate-to-severe plaque psoriasis also showed that AIN457 may successfully improve quality of life by Week 12 in the study8.

"These new AIN457 data are particularly welcome since they demonstrate significant
improvement in the signs and symptoms of patients, even when difficult-to-treat areas
are involved," said Prof. Kristian Reich, one of the study investigators and Professor of
Dermatology, Venereology, and Allergology in Hamburg, Germany. "Many patients with
hand, foot or nail psoriasis are restricted in their daily life and work because they may not
be able to walk or use their hands, negatively impacting their quality of life."

The results were presented at the European Academy of Dermatology and
Venereology (EADV) 21st Congress, in Prague, Czech Republic. They provide additional
insight into the safety and efficacy of AIN457, following the presentation of the study's
primary endpoint at EADV in 2011.

The new data from the sub-analyses undertaken on the Phase II study show AIN457 was
nearly three times more effective than placebo at reducing moderate-to-severe plaque
psoriasis on the hands and/or feet when given every week during the first month of
treatment (54.3% of patients vs. 19.2% respectively, p=0.005), as measured by the
Investigator's Global Assessment (IGA)1. Patients also benefited if they received AIN457
once every four weeks, with 39.0% experiencing either "clear" or "minimal" psoriasis after
12 weeks of treatment1. Another analysis found that these AIN457 treatment schedules
also notably reduced the signs and symptoms of finger nail psoriasis compared to
placebo7.

The study safety analysis of these data showed a comparable safety profile between
treatment and placebo, with the most common adverse events (AEs) observed being
infections1,7.

Other new data presented at EADV in the total moderate-to-severe plaque psoriasis
study population show that AIN457 improved skin-related quality of life in 25 times more
patients after 12 weeks of treatment when given every week for the first month,
compared to placebo (40.8% vs. 1.6%, panxiety and depression versus placebo (16.3% vs. 6.2%), as
measured by EuroQol (EQ-5D)8. The effect of psoriasis on patients' health-related quality
of life has been shown to be similar to diseases such as cancer, heart attack, arthritis,
type 2 diabetes and depression9.

"These encouraging results show that through its novel mode of action, AIN457 may
significantly increase treatment success and improve the quality of life of patients
suffering from moderate-to-severe plaque psoriasis," said John Hohneker, Head of
Development for Integrated Hospital Care for the Pharmaceuticals Division of Novartis.
"We look forward to receiving the results of the larger-scale and longer-term Phase III
studies, which are expected in 2013."

All core pivotal trials for AIN457 in moderate-to-severe plaque psoriasis are on track,
involving more than 3,000 patients worldwide, and indicating a high interest from both
medical and patient communities. Phase III data in moderate-to-severe plaque psoriasis
is expected in 2013, with regulatory submissions to follow shortly thereafter.

About the study

Data are based on a double-blind, parallel group, placebo-controlled Phase II study
involving 404 patients, which met its primary endpoint of PASI 75 (Psoriasis Area and
Severity Index) responses at Week 1210. It was designed to evaluate the safety and
efficacy of AIN457 in different regimens (weekly for the first month; once every four
weeks; or single dose) of 150 mg given subcutaneously10.

The undertaken sub-analyses included assessment of AIN457 treatment efficacy in 131
patients with hand and/or foot psoriasis, often described as palmoplantar psoriasis1. All
404 patients were involved in assessing health-related quality of life, and data from 304
patients were used to assess AIN457 treatment efficacy in nail psoriasis7,8.

About AIN457

AIN457 is a fully human monoclonal antibody inhibiting interleukin-17A (IL-17A), a key
pro-inflammatory cytokine. Proof-of-concept and Phase II studies in moderate-to-severe
plaque psoriasis and arthritic conditions (psoriatic arthritis, ankylosing spondylitis and
rheumatoid arthritis) have suggested that AIN457 may provide a new mechanism of
action for the treatment of immune-mediated diseases10-13. The Phase III programs for
these potential indications are ongoing, and first interpretable results are expected in
2013 for moderate-to-severe plaque psoriasis and in 2014 for arthritic conditions. Phase
II studies are also ongoing in other areas, including multiple sclerosis.

About psoriasis

Approximately 2% of the world's population, or around 125 million patients, are affected
by plaque psoriasis, a chronic disease characterized by thick and extensive skin lesions,
called plaques, known to cause itching, scaling and pain14,15. More than one third of
patients with plaque psoriasis suffer from its moderate-to-severe form16.

Patients with hand, foot and nail psoriasis endure significantly greater physical disabilities
than those whose psoriasis is limited to other parts of the body5,6. This includes functional
disability, burning sensations, skin soreness, prolonged duration of psoriasis and the risk
of joint involvement and secondary infections5,6. Estimated to affect between 10% and
55% of all psoriasis patients, nail, hand and foot psoriasis is notoriously difficult to treat
and often requires systemic treatment such as biologics to maintain an adequate clinical
response5,6,17.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.