AIN457 (secukinumab) can considerably improve the symptoms of moderate-to-severe plaque psoriasis on the feet, hands and nails when taken once weekly during the first four weeks of treatment, compared to placebo therapy, Swiss pharmaceutical giant Novartis announced today.

Novartis added that the patients on secukinumab enjoyed improved quality of life by the twelfth week of therapy.

Prof. Kristian Reich, one of the study investigators said:

“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. 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 AIN457 (secukinumab) trial results were presented today at the European Academy of Dermatology and Venereology (EADV) 21st Congress, in Prague, Czech Republic.

According to new data on the Phase II trial, AIN457 is almost three times as effective than placebo in alleviating moderate-to-severe plague psoriasis on the hands, feet and nails during the first month of treatment (54.3% versus 19.2% on placebo). Novartis added that “patients also benefited if they received AIN457 once every four weeks, with 39.0% experiencing either “clear” or “minimal” psoriasis after 12 weeks of treatment. Another analysis found that these AIN457 treatment schedules also notably reduced the signs and symptoms of finger nail psoriasis compared to placebo.”

The most common adverse events reports were infections.

Other data include:

  • Twenty-five times more patients on AIN457 experienced improvements in skin-related quality of life after 12 weeks of treatment compared to those on placebo (40.8% vs 1.6%)

  • 36.2% of patients on AIN457 had considerable improvements in pain and discomfort compared to just 1.5% of those on placebo

  • 16.3% of those on AIN457 experienced improvement in anxiety and depressive symptoms compared to 6.2% of those on placebo

Novartis explained that the effects of psoriasis on health-related quality of life are similar to those reported in such diseases as type 2 diabetes, arthritis, heart attack, cancer, and depression.

John Hohneker, Head of Development for Integrated Hospital Care for the Pharmaceuticals Division of Novartis, said:

“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. We look forward to receiving the results of the larger-scale and longer-term Phase III studies, which are expected in 2013.”

The AIN457 pivotal human studies for the treatment of moderate-to-severe plaque psoriasis are “on track”, the company says. The trials, involving over 3,000 participants, are attracting interest among both patients and health care professionals. Novartis says it will be releasing data on the Phase III trials in 2013. Soon after, if the data is favorable, submissions to regulatory authorities will be presented.

In an online communiqué today, Novartis wrote:

“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 diseases.

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.”

Psoriasis is a scaly, dry skin disorder. Experts say it is probably caused by genetic mutations in the patient; the immune system attacks good tissue, mistaking it for a harmful pathogen. The consequence is an overproduction of skin cells.

Skin cells are usually replaced every 21 to 28 days. In psoriasis patients, they are replaced much more quickly; from two to six days. The sufferer develops thick and extensive plaques (skin lesions), causing scaling, itching and pain. Over one third of all plaque psoriasis patients have moderate-to-severe symptoms.

About 2% to 3% of people worldwide are affected to some degree by plaque psoriasis – at least 125 million patients. The condition generally develops in patients aged from 11 to 45 years. Even though psoriasis is not contagious, patients are commonly discriminated against and socially excluded.

Those with symptoms on their nails, feet and hands experience considerably greater physical disabilities compared to those whose psoriasis occurs on other parts of the body. Signs and symptoms over the long-term may include:

  • Functional disability
  • The affected areas feel as if they are burning
  • Skin soreness
  • Joint problems
  • A secondary infections

Between 10% and 55% of all psoriasis patients have symptoms on their feet, hands and nails. It is notoriously difficult to treat and requires systemic treatment.

Written by Christian Nordqvist