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    Home > Medical News > Latest Medical News > Elyse extends to Cimzia's European label: continuous remission reduces dosage.

    Elyse extends to Cimzia's European label: continuous remission reduces dosage.

    • Last Update: 2020-10-05
    • Source: Internet
    • Author: User
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    Clinical Remission is recommended by the International Association for the Evaluation of Spinal Arthritis (ASAS)/European Alliance against Rheumatology (EULAR) as the primary treatment target for axSpA and as the target for spinal arthritis (SpA).
    , strategies to maintain remission are necessary to prevent the disease from worsening.
    maintenance dose helps to manage axSpA patients over the long term while the disease is in constant remission.
    this approach provides an additional option that preserves the clinical benefits of patients continuing treatment while responding to the specific needs of patients and optimizing their treatment costs.
    Cimzia's label expansion in Europe addresses under-recognized unsealed needs by providing the first verified dose reduction strategy for patients within the broad axSpA range for continuous remission.
    EMA label extension is based on data from phase IIIb C-OPTIMISE trials conducted in adult patients with early active axSpA.
    In the 48th week of the induction period, 43.9% (323/736) of patients achieved continuous remission (Strong Spinal Inflammation Activity Score (ASDAS) at week 32 or week 36 and week 48 .lt;1.3).
    in these patients, 313 patients were randomly assigned to a fully maintained dose (Cimzia 200mg Q2W), a reduced maintenance dose (Cimzia 200 mg Q4W), a placebo, and 84%, 79%, and 20% of patients in three groups maintained flare-free (flare, aggravated).
    in the reduced maintenance dose group, 60 percent of patients with flares recovered after 12 weeks of treatment with fully maintained dose Cimzia (200mg Q2W).
    there was no difference in response in patients with radiological axSpA (r-axSpA) and non-radiological axSpA (nr-axSpA) during induction and maintenance.
    , no new safety signals for Cimzia were observed compared to previous studies.
    in patients who receive continuous remission, reducing the dose is an option, but treatment should not be discontinued because of the high risk of flares.
    Robert Landewe, M.D., of the Amsterdam Rheumatology and Clinical Immunology Center and lead investigator on the C-Optimize study, said: "Patients with AxSpA usually develop symptoms in their 20s and may therefore be concerned about continuing treatment for life.
    Cimzia label extension now provides healthcare providers with a proven dose reduction strategy to meet patient needs.
    addition, the option of reducing maintenance doses may reduce costs and benefit the broader health care system.
    "C-OPTIMISE is the first and only randomized controlled trial in a wide range of axSpA populations to maintain dose continuity and dose reduction with placebos," said Emmanuel Caeymaex, Executive Vice President and HEAD of UCB Immunology Solutions.
    clinical evidence that early use of Cimzia to treat axSpA improves clinical outcomes, axSpA patients have a treatment plan that can help them address symptoms at all stages of the disease: from the beginning of biotherapy to mitigation and maintenance.
    our clinical studies of axSpA show that r-axSpA and nr-axSpA are part of the same disease entity.
    if treated early, remission is a realistic goal, and patients have the flexibility to reduce their dose once they have sustained remission.
    " Cimzia is the only anti-tumor necrosis factor alpha (TNF-alpha) drug with no Fc domain, polyethyl glycolization modification, which has a very high affinity for human TNF-alpha and is able to selectively neutralize the pathophysiological effects of TNF-alpha.
    Because of its unique Fc-free domain molecular structure, Cimzia is the only anti-tumor necrotizer (an-TNF) biologic agent that has strong scientific evidence that drugs do not metastasy to fetuses and infants when treated in female patients of childbearing age, from pregnancy to late pregnancy and lactation.
    To date, Cimzia has been approved by many countries and regions around the world for the treatment of a variety of inflammatory diseases, including: rheumatoid arthritis, psoriasis arthritis, plaque psoriasis, spinal arthritis, Crohn's disease, axSpA (including nr-axSpA and r-axSpA, the latter also known as: strong spina bifistitis (AS) and so on.
    , Cimzia was approved by the State Drug Administration (NMPA) in July 2019 for the treatment of patients with moderate to severe rheumatoid arthritis (RA).
    particular note that Cimzia is the only biological agent approved in China that states in the instruction manual that can be used throughout pregnancy if clinically necessary.
    in December 2019, Cimzia was officially launched in China, the first biotherapy approved in China by the Yospybi portfolio, and will also provide an important treatment option for Chinese female patients who need to manage RA without affecting pregnancy and breastfeeding programs.
    original source: CIMZIA s first and Only Biologic Approved in Europe with the Option for a Reduced Maintenance Dose for Patients Across Full Axial Spondyloarthritis Spectrum.
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