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Main Category: Eczema / Psoriasis
Also Included In: Dermatology
Article Date: 27 Sep 2012 – 10:00 PST Current ratings for:
Novartis Psoriasis Drug Shows Promising Results
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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, http://www.eczemablog.net/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 placeboNovartis 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 communique 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 disabilityThe affected areas feel as if they are burningSkin sorenessJoint problemsA secondary infectionsBetween 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
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Nordqvist, Christian. “Novartis Psoriasis Drug Shows Promising Results.” Medical News Today. MediLexicon, Intl., 27 Sep. 2012. Web.
7 Apr. 2013. APA

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posted by Rachel Bailey on 9 Nov 2012 at 1:33 pm

I would like to know if this drug would be considered for treatment of guttate psoriasis. I have this, also nails are affected. I was pleased to read the article, there may be some hope. I’ve had psoriasis since age of 12, am now 46 and totally fed up with it.

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AppId is over the quota AppId is over the quota Article adapted by Medical News Today from original press release. Click ‘references’ tab above for source.
Visit our eczema / psoriasis section for the latest news on this subject. 1. Paul C, Mroweitz U, Nakayama J et al. Secukinumab, a fully human, anti-interleukin (IL)-17A monoclonal antibody improves signs and symptoms of hand and foot psoriasis: results from a phase II regimen-finding trial. Presented at: 21st Congress of the European Academy of Dermatology and Venereology; 27-30 September, 2012; Prague, Czech Republic. Poster PRA12-0816.

2. Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.

3. Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.

4. Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010;9(9):703-18.

5. Radtke MA, Langenbruch AK, Schafer I et al. Nail psoriasis as a severity indicator: results from the PsoReal study. Patient Relat Outcome Meas. http://www.eczemablog.net/ 2011;2:1-6

6. Pettey AA, Balkrishnan R, Rapp et al. Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49(2) :271-275.

7. Gottlieb AB, Reich K, Philipp S et al. Secukinumab improves signs and symptoms of nail psoriasis: results from a phase II regimen-finding trial. Presented at: 21st Congress of the European Academy of Dermatology and Venereology; 27-30 September, 2012; Prague, Czech Republic. Poster PRA12-0668.

8. Wilsmann-Theis D, Terui T, Draelos Z et al. Improvement with secukinumab on patient reported skin related quality of life (QoL) and health status among moderate-to-severe plaque psoriasis patients: results from a phase II regimen-finding trial. Presented at: 21st Congress of the European Academy of Dermatology and Venereology; 27-30 September, 2012; Prague, Czech Republic. Poster: PRA12-0822.

9. Rapp SR, Feldman SR, Exum, ML et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3):401-407.Leipe J, Grunke M, Dechant C et al. Role of Th17 cells in human autoimmune arthritis. Arthritis Rheum. 2010;62:2876-2885.

10. Rich P.A. et al. Secukinumab, a new fully human monoclonal anti-Interleukin-17A antibody, in the treatment of moderate-to-severe plaque psoriasis: Interim efficacy and safety data from a phase II regimen-finding trial. Presented at: 20th Congress of the European Academy of Dermatology and Venereology; 20-24 October, 2011; Lisbon, Portugal. Oral presentation FC01.6.

11. Genovese M, Kellner H, Durez P, et al. Secukinumab treatment improves ACR50, HAQ-DI and EULAR remission rates in patients with rheumatoid arthritis. At: EULAR 2012, The Annual European Congress of Rheumatology; 6-9 June 2012, Berlin, Germany. Abstract 2925.

12. Baeten D, Sieper J, Emery P, et al. The anti-il17a monoclonal antibody secukinumab (AIN457) showed good safety and efficacy in the treatment of active ankylosing spondylitis. At: EULAR 2011, The Annual European Congress of Rheumatology, 25-28 May 2011, London, UK. Abstract 0174.

13. McInnes I, Sieper J, Braun J, et al. Anti-Interleukin 17A monoclonal antibody secukinumab reduces signs and symptoms of psoriatic arthritis in a 24-week multicenter, double-blind, randomized, placebo- controlled trial. Presented at: Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals; 4-9 November 2011; Chicago, IL. Abstract 19541.

14. Raychaudhuri SP, Farber EM. The prevalence of psoriasis in the world. J Eur Acad Dermatol Venereol. 2001;15:16–17.

15. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009;361:496-509.

16. Herrier R. Advances in the treatment of moderate-to-severe plaque psoriasis. Am J Health-Syst Pharm 2011;68:795-806.

17. Farley E, Masrour S, McKey J et al. Palmoplantar psoriasis: a phenotypical and clinical review with introduction of a new quality-of-life assessment tool. J Am Acad Dermatol. 2009;60(6):1024-1031.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “promising,” “on track,” “expected,” “encouraging,” “may,” “look forward to,” “to follow,” or similar expressions, or by express or implied discussions regarding potential marketing submissions or approvals for AIN457, or the timing of any such submissions or approvals, or regarding potential future revenues from AIN457. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with AIN457 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that AIN457 will be submitted or approved for approval in any market, or at any particular time. Nor can there be any guarantee that AIN457 will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding AIN457 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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UK, Burson-Marsteller. “Novartis Data Show AIN457 Significantly Reduced Signs And Symptoms In Patients With Hard-To-Treat Moderate-To-Severe Plaque Psoriasis.” Medical News Today. MediLexicon, Intl., 1 Oct. 2012. Web.
7 Apr. 2013. APA

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