Basel, 10 October 2014 - Novartis today 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).
星期五, 2014, 10月 10 - 07:15
New analyses of Phase III data show consistent efficacy in clearing psoriasis skin with AIN457 (secukinumab) regardless of how bad patients' disease is at start of treatment
Significant positive responses to secukinumab seen in patients with severe psoriasis at start of treatment
Significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life, as shown by additional secukinumab analyses
Regulatory reviews for secukinumab are underway; a US FDA advisory committee meeting is scheduled for 20 October and CHMP recommendation is anticipated in Q4 2014
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Basel, 10 October 2014 - Novartis today 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% 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,.
About the disease severity analyses 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 program 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 multicenter, randomized, 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) ,.
About the PASI 90 HRQoL analysis presented at EADV The analysis focused on patients on active treatment in the FIXTURE and ERASURE studies.
About secukinumab (AIN457) and interleukin-17A (IL-17A) 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).
About Novartis in specialty dermatology Novartis is committed to developing innovative, life-changing specialty dermatology therapies, redefining treatment paradigms and transforming patient care in severe skin diseases where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes Xolair® (omalizumab) and secukinumab (AIN457). There are also more than 10 compounds in early stage development for a wide range of severe skin diseases in the Novartis specialty dermatology portfolio. For more information about the Novartis commitment to severe skin disease care, please visit: www.skintolivein.com.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "underway," "scheduled," "recommendation," "anticipated," "excited," "hope," "being investigated," "investigational," "ongoing," "committed," "early stage development," "commitment," or by express or implied discussions regarding potential marketing approvals, new indications or labeling for AIN457, Xolair or any other dermatology products, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that AIN457 or any other dermatology products will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that Xolair will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that AIN457, Xolair or any other dermatology products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding these products 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; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; unexpected manufacturing issues; general economic and industry conditions, 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.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
*Enbrel® is marketed by Pfizer in Europe and by Amgen in the United States. **Stelara® is a registered trademark of Janssen Biotech, Inc.
References  LJ Spelman, A Blauvelt, J Loffler, C Papavassilis, T Fox. "Secukinumab Shows Efficacy Regardless of Baseline Disease Severity in Subjects With Moderate to Severe Plaque Psoriasis: A Pooled Analysis From Four Phase 3 Studies." European Association of Dermatology and Venereology Congress. Amsterdam, Netherlands.10 October 2014.  McLeod LD, Mallya UG, Fox T, Strober BE. "Psoriasis Patients With PASI 90 Response Achieve Greater Health-Related Quality-of-Life Improvements Than Those With PASI 75 Response." European Association of Dermatology and Venereology Congress. Amsterdam, Netherlands. 10 October 2014.  Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.  Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.  Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.  Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-21.  Krueger J, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130(1):145-154.  Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J Dermatol. 2009;160(2):319-24.  Rakkhit T, Panko JM, Christensen TE, et al. Plaque thickness and morphology in psoriasis vulgaris associated with therapeutic response. Br J Dermatol. 2009;160:1083-1089.  Na JI, Kim JH, Park KC, Youn SW. Low-dose etanercept therapy in moderate to severe psoriasis in KoreanJ Dermatol. 2008;35:484-490.  European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf Accessed May 2014.  Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.  Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009; 361(5):496-509.  Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.  Farley E, Menter A. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb; 146(1):9-15.  Novartis data on file. 2013: Clinical study reports for CAIN457A2302 [ERASURE] ; CAIN457A2303 [FIXTURE] ; CAIN457A2304 [SCULPTURE] ; CAIN457A2307 [JUNCTURE] ; CAIN457A2308 [FEATURE].
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