First Presentation of Six-Week Data from the WELCOME Study at ECCO
Brussels, Belgium - 4 March 2008 - 7:00 am CET - Six-week data from
the WELCOME trial presented at the 3rd congress of the European
Crohn's and Colitis Organisation (ECCO) show Cimzia� (certolizumab
pegol), the first and only PEGylated anti-TNF-alpha, to be effective
in Crohn's patients who are intolerant, or are no longer responding
This is the first presentation of the initial six-week induction
results from WELCOME, a 539-patient, Phase IIIb multicentre study of
the effects of Cimzia� on Crohn's patients for whom infliximab
treatment was not successful. During this six-week induction stage,
all patients received 400mg of Cimzia� sub-cutaneous at Weeks 0, 2
and 4. At Week 6, 61 percent of the patients had achieved the
primary endpoint of response, defined as a decrease in Crohn's
Disease Activity Index (CDAI)* score >=100 points from baseline. In
addition, 39 percent of the patients were in remission, defined as a
CDAI score <=150 points.
"These induction results are very promising," commented study
investigator Professor Severine Vermeire of Katholieke Universiteit
Leuven, Belgium. "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."
In the WELCOME study, Cimzia� has demonstrated a low incidence of
injection site pain* (less than 2 percent). The most commonly
occurring AEs were headache, nasopharyngitis, nausea, vomiting,
pyrexia and arthralgia. The incidence of serious adverse events
(SAEs) was 7 percent and the most frequent SAEs involved
gastrointestinal disorders (5 percent) and infections and
infestations (2 percent).
In September 2007, Cimzia� was approved in Switzerland for the
treatment of Crohn's disease and it was launched in January 2008.
* MedDRA Preferred term
About Cimzia� (certolizumab pegol)
Cimzia� was approved for the treatment of Crohn's Disease in
Switzerland in September 2007. In the European Union, the Committee
for Medicinal Products for Human Use (CHMP) has adopted a negative
opinion on the market authorisation 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.
Cimzia� has been studied in clinical settings for more than 10 years,
beginning with rheumatoid arthritis trials in 1998, and a rigorous
clinical trial program in Crohn's disease. Cimzia� has been studied
in more than 2000 Crohn's patients totalling over 2200 patient-years
Cimzia� is the first and only PEGylated anti-TNF-alpha (Tumor
Necrosis Factor alpha). Cimzia� has a high affinity for human
TNF-alpha, selectively neutralising the pathophysiological effects of
TNF-alpha. Over the past decade, TNF-alpha has emerged as a major
target of basic research and clinical investigation. This cytokine
plays a key role in mediating pathological inflammation, and excess
TNF-alpha production has been directly implicated in a wide variety
The WELCOME (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) study consisted of an initial open-label induction
period of six weeks when patients received 400mg of Cimzia� at Weeks
0, 2 and 4. After the induction period, 61 percent of patients had
reached the primary endpoint of response (defined as decrease in CDAI
score >=100 points from baseline). Responders at Week 6 were then
randomised to either Cimzia� 400mg maintenance every two or every
Participants receiving a concomitant medication were:
immunosuppressant (46 percent); corticosteroids (38 percent) or
immunosuppressant and corticosteroids (18 percent). Cimzia� was
consistently effective across all patient groups. The most common AEs
were headache, nasopharyngitis, nausea, vomiting, pyrexia and
arthralgia. The incidence of serious adverse events (SAEs) was 7
percent and the most frequent SAEs involved gastrointestinal
disorders (5 percent) and infections and infestations (2 percent).
About Crohn's Disease
Crohn's disease is a chronic, progressive, destructive disorder that
causes inflammation of the gastrointestinal (GI) tract, most commonly
at the end of the small intestine (the ileum) and beginning of the
large intestine (the colon). If not effectively treated, it results
in the need for surgery. Crohn's disease usually affects young people
between the ages of 15 and 35, with approximately half a million
people affected in Europe alone. People with Crohn's can
experience an ongoing cycle of flare-up and remission throughout
their lives. Together with ulcerative colitis, Crohn's disease is an
inflammatory bowel disease (IBD).,
* The CDAI, or Crohn's Disease Activity Index, score measures the
severity of CD by taking into account a number of factors such as
intensity of symptoms, medication, and general well-being. Patients
with high scores have highly active Crohn's disease, while low scores
indicate the disease is less active.
1. Vermeire S et al. Assessment of Certolizumab Pegol in the
Treatment of Crohn's Disease in Patients for Whom Infliximab
Treatment was not Successful: Open-label Induction Results from the
WELCOME Study. Oral presentation at the Congress of European Crohn's
and Colitis Organisation, Lyon, France, February 2008.
2. Data on file
3. Crohn's and Colitis Foundation of America. Disease Information
page (www.ccfa.org/info/about/crohns accessed on 3 May 2007).
4. European Federation of Crohn's & Ulcerative Colitis Associations
Newsletter number 24 May 2006, page 19.
5. Best WR et al. Development of a Crohn's disease activity index.
National Cooperative Crohn's Disease Study. Gastroenterology; 1976,
70 (3): 439-444.
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