New drug for mid-axis spina blinhroarthritis (axSpA)! Excellent time than Cimzia (Himinja) European label extension: continuous remission period can reduce the dose!

!--ewebeditor:page title"--August 09, 2020 // -- UCB recently announced that the European Medicines Agency (EMA) has approved the extension of the anti-inflammatory drug Cimzia (Chinese Commodity Name: Himinja?, generic name: certolizumab pegol, Pesseli bead anti-injection fluid) In adult patients with axSpA, the maintenance dose can be reduced to 200 mg once every 4 weeks (200 mg, Q4W) or 400 mg once every 4 weeks (400 mg, Q4W) in adult patients with axSpA.
approval makes Cimzia the only biologic in Europe to offer dose reduction solutions in a wide range of patients in the axSpA population.
Clinical Remission is recommended by the International Association for the Evaluation of Spine Arthritis (ASAS)/European Union against Rheumatology (EULAR) as the primary treatment target for axSpA and as a target for spinal arthritis (SpA).
, strategies to maintain remission are necessary to prevent the disease from worsening.
reduction in maintenance doses helps to manage axSpA patients in the long term while the disease is in constant remission.
this approach provides an additional option that preserves the clinical benefits of patients' continued treatment while responding to their specific needs and optimizing their treatment costs.
Cimzia's label expansion in Europe addresses under-recognized unsusced needs by providing the first documented dose reduction strategy for patients within the broad range of axSpA for continuous mitigation.
EMA label extension for the study of mid-axis spine arthritis (Photo: everydayhealth.com) is based on data from the IIIb Phase C-OPTIMISE trial in adult patients with early-activity axSpA.
In week 48 of the induction period, 43.9% (323/736) of patients achieved continued remission (strong orthosis activity score (ASDAS) at weeks 32 or 36 and 48 weeks.
In these patients, 313 patients were randomly divided into full maintenance doses (Cimzia 200mg Q2W), reduced maintenance doses (Cimzia 200 mg Q4W), placebos, and at week 96, 84%, 79%, and 20% of patients in the three groups maintained flares-free (flare, exacerbation).
in the reduced maintenance dose group, 60 percent of patients with flares recovered after 12 weeks of treatment with a fully maintained dose of Cimzia (200mg Q2W).
there was no difference in the response of patients with radiology axPA (r-axSpA) and non-radiology axSpA (nr-axSpA) during induction and maintenance.
, no new safety signals for Cimzia were observed during the study, compared to previous studies.
is an option in patients with ongoing remission, 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 of the
-Optimize study, said: "AxSpA patients typically 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.
, the choice to reduce maintenance doses may reduce costs and benefit the broader healthcare system.
"C-OPTIMISE is the first and only randomized controlled trial to compare maintenance dose sustainability and dose reduction with placebo in a wide range of axSpA populations," said Emmanuel Caeymaex, Executive Vice President and US Head of UCB Immuno solutions at UCB.
In combination with the clinical evidence that the early use of Cimzia to treat axSpA can improve clinical outcomes, axSpA patients have a treatment plan that can help them address the symptoms of all stages of the disease: from the beginning of biological therapy to remission 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 once patients receive continuous remission, they have the flexibility to reduce the dose.
" Cimzia is the only anti-tumor necrosis factor alpha (TNF-alpha) drug with no Fc domain, polyethyl glycol modification, which has a very high affinity for human TNF-alpha and can selectively neutralize the pathophysiological effects of TNF-alpha.
Because of its unique Fc-free domain molecular structure, Cimzia is the only anti-tumor necrosis agent (an-TNF) biologic agent that has strong scientific evidence that drugs do not metastasies 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 worldwide for the treatment of a variety of inflammatory diseases, with differences from country to country, including rheumatoid arthritis, psoriasis arthritis, plaque psoriasis, spinal arthritis, Crohn's disease, axSpA (including nr-axSpA and r-axSpA, also known as : strong straight spina bifids).
china, Cimzia was approved by the National Drug Administration (NMPA) in July 2019 for the treatment of patients with moderate to severe rheumatoid arthritis (RA).
is particularly noteworthy that Cimzia is the only treatment for rheumatoid arthritis biologics approved in China that states in the specification that it 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 Uber portfolio, and will also provide an important treatment option for Chinese women who need to manage RA without affecting pregnancy and breastfeeding programs.
()!--/ewebeditor:page--!--ewebeditor:page title"--source: CIMZIA !--?