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     272  0 Kommentare Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx as a potential treatment in a JIA population at EULAR 2021 - Seite 3

    The primary endpoint of the study was time to flare in the treatment period 2 (Week 12 to Week 104). Secondary endpoints in treatment period 1 (up to Week 12) included evaluation of JIA ACR 30/50/70/90/100 responses and each JIA ACR core component, change from baseline of the Juvenile Arthritis Disease Activity Score (JADAS), and total enthesitis and dactylitis count. Additional secondary endpoints during treatment period 2 from Week 12 to Week 104 included: effect of withdrawing secukinumab treatment with respect to JIA ACR 30/50/70/90/100 response and inactive disease; secukinumab serum concentration; safety/tolerability and immunogenicity of secukinumab.

    An extension study of secukinumab to evaluate the long-term efficacy, safety and tolerability up to four years in patients with JPsA and ERA is currently ongoing.

    About Cosentyx (secukinumab)
    Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)8,11,12. Cosentyx is the only biologic with proven efficacy in all six key manifestations of PsA8,13,14.

    Cosentyx is backed by more than 14 years of clinical experience and long-term five-year clinical data across three indications of psoriasis, PsA and AS, as well as real-world evidence6-8. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axial spondyloarthritis, PsA and psoriatic disease, with more than 400,000 patients treated worldwide with Cosentyx since launch9.

    Disclaimer
    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. 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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    Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx as a potential treatment in a JIA population at EULAR 2021 - Seite 3 Phase III JUNIPERA study met its primary endpoint, with Cosentyx (secukinumab) showing significantly longer time to flare (longer time to worsening of symptoms1) vs. placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic …