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Early Data On Cimzia® Shows Promise In Crohn's Patients Without Infliximab
Data
from the WELCOME trial presented at the third congress of the European
Crohn's and Colitis Organisation (ECCO) show that, at the six week
mark, Cimzia® (certolizumab pegol) is effective in Crohn's patients
showing intolerance or no response to infliximab.
Crohn's
Disease (CD) is a gastrointestinal disorder which is indicated by
chronic
inflammation of the wall of the digestive tract, usually in the ileum
or large intestines. It usually affects young people, between the ages
of 15 and 35, and approximately half a million people have the disease
in Europe alone. The disease involves constant cycles of flare-ups and
remission throughout the life of the patient, and without proper
treatment, must be addressed surgically. It is considered an
inflammatory bowel disease (IBD), similar to ulcerative colitis.
Cimzia® is the first
and only PEGylated anti-TNF-alpha (anti-tumor necrosis
factor-alpha). The drug itself shows affinity for the human tumor
necrosis factor-alpha (TNF-alpha), a cytokine that helps trigger many
physiological responses including the immune reaction. This attraction
allows the drug to neutralize TNF-alpha's potential pathophysiological
effects.
Excess TNF-alpha production has been associated with a wide variety of
diseases, and in recent research, TNF-alpha has become a central target
for basic research and clinical investigation regarding pathological
inflammation. In particular, Cimzia® has been studied for more than a
decade in several clinical settings, including treatments for
rheumatoid arthritis and Crohn's disease.
This
is the first presentation from WELCOME, a Phase IIIb multicenter study
of 539 Crohn's patients in which infliximab treatment was not
successful. (WELCOME stands for 26-Week open-label trial
Evaluating the clinical benefit and tolerability of certoLizumab pegol
induCtiOn and Maintenance in patients suffering from CD with prior loss
of response or intolErance to infliximab.) In the study, the effects of
Cimzia® were studied during a six-week
induction period in which all patients received 400mg of Cimzia®
subcutaneously at zero, two, and four weeks. At week six, subjects were
randomized to continued administration of Cimzia® every two or four
weeks.
Concomitant medications included:
immunosuppressants (46%); corticosteroids (38%) or both (18%).
Patients were analyzed
according to the Crohn's Disease Activity Index (CDAI) score. which
measures the severity of Crohn's by integrating factors
including intensity of symptoms, medication levels, and general
well-being. A higher score indicates a more active case of Crohn's
while a lower score indicates a milder presentation. By
week six,
61% of the patients had achieved the primary endpoint response, with a
decrease in score of 100 points or more from baseline. Additionally,
39% of patients showed disease remission, defined as a total CDAI score
less than 150 points.
Investigator Professor Severine
Vermeire of Katholieke Universiteit Leuven, Belgium commented on the
data. "These
induction results are very promising," she said.
"The WELCOME data show that certolizumab pegol could be a treatment
option for patients with Crohn's disease who are refractory to other
biological agents, showing consistent results across all patient
groups."
The drug Cimzia® has demonstrated a low
incidence of injection site pain in the WELCOME study, in less than 2%
of cases. Common adverse events (AEs) included: headache;
nasopharyngitis, or the common cold; nausea;
vomiting; pyrexia, or fever; and arthralgia, or joint pain. Serious
adverse events (SAEs) were present in 7% of cases, and were most
commonly gastrointestinal (5%) or infections and infestations (2%).
Cimzia®
was approved in Switzerland for the treatment of Crohn's Disease in
September 2007. In the European Union, the Committee for Medicinal
Products for Human Use (CHMP) has adopted a negative opinion on the
market authorization application (MAA) for Cimzia® in the treatment of
patients with Crohn's disease. UCB utilised the appeal process to
request a CHMP re-examination of the submission. A decision is expected
during the first half of 2008.
About UCB:
UCB, Brussels, Belgium (www.ucb-group.com)
is a global leader in the biopharmaceutical industry dedicated to the
research, development and commercialization of innovative
pharmaceutical and biotechnology products in the fields of central
nervous system disorders, allergy/respiratory diseases, immune and
inflammatory disorders and oncology. UCB focuses on securing a leading
position in severe disease categories. Employing around 12,000 people
in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007.
UCB S.A. is listed on the Euronext Brussels Exchange and, through its
affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZ
PHARMA AG (Monheim, Germany) is a member of the UCB Group.
Source: UCB /BXS: UCB /ISIN:
BE0003739530
Written by Anna Sophia McKenney
View drug information on Cimzia.
Copyright: Start Sanatate
Not to be reproduced without permission of Start Sanatate
Early de date de pe Cimzia ? promit aratã în Crohn cu infliximab la pacienþii fãrã - Early Data On Cimzia® Shows Promise In Crohn's Patients Without Infliximab - articole medicale engleza - startsanatate