Published Press Releases
BRUSSELS, BELGIUM, October 23, 2006 - 2:00 pm CET —
UCB today announced a new post hoc analysis of the PRECiSE 2 clinical trial
program for the anti-TNF CIMZIA™ (certolizumab pegol). This demonstrated that
remission and response was maintained in moderate to severe Crohn's disease,
irrespective of disease duration. The higher response and remission rates with
CIMZIA™ (certolizumab pegol) were observed in patients who had been diagnosed
with Crohn's disease for less than one year.
These data will be presented this week at both the 14th United European Gastroenterology
Week (UEGW) in Berlin, Germany, and the 2006 American College of Gastroenterology
(ACG) Annual Scientific Meeting in Las Vegas, Nevada, USA. The UEGW data presentation
will be by PRECiSE 2 principal investigator Professor Stefan Schreiber, Professor
of Medicine and Gastroenterology at the Christian-Albrechts University, Kiel,
Germany, and the ACG data presentation by lead study author William J. Sandborn,
M.D., Professor of Medicine at the Mayo Clinic College of Medicine, USA.
These results build on those of PRECiSE 2 previously presented, which showed
that subcutaneous administration of CIMZIA™ (certolizumab pegol), given every
four weeks with an additional induction dose at week 2, gave statistically significant
rates of response and remission at Week 26 compared to placebo in patients responding
at Week 6.1 CIMZIA™ (certolizumab pegol) may offer an alternative to currently
“The PRECiSE program provides valuable information on the effect of a
once-monthly, subcutaneous CIMZIA injection following an induction phase with
an additional dose at week 2. These new data in early Crohn's disease
may change the way we use anti-TNF therapy in the future, and support studies
investigating early intervention. I am confident that these studies will establish
that Crohn's patients should begin CIMZIA therapy as early as possible
after being diagnosed, in order to achieve the greatest possible treatment benefits,”
commented Professor Schreiber.
New Analyses and Early Intervention in Crohn's Disease Treatment
The new data showed that in patients with disease duration of less than one
year, 89.5% of CIMZIA™ (certolizumab pegol) patients maintained their clinical
response at Week 26 vs. 37.1% on placebo (p<0.01). Clinical response was
defined as a ≥100 point decrease in Crohn's Disease Activity Index (CDAI).2
In patients with disease duration of less than three years, clinical response
was maintained at Week 26 in 75.9% of patients, and in patients with disease
duration of five years or more, the response rate was 57.3% (both statistically
significantly greater than with placebo). A similar pattern was observed for
remission rate at Week 26, defined as CDAI ≤ 150 points2;
68.4% of CIMZIA™ (certolizumab pegol) patients with less than one year's
disease duration were in remission, compared to 58.6% with less than three years
disease duration, and 44.3% with five years or more disease duration (all greater
than corresponding placebo rates).
PRECiSE Clinical Trials Program
The PRECiSE Program, composed of four studies (PRECiSE 1, 2, 3, and 4), represents
an innovative, large, comprehensive development program for CIMZIA™ (certolizumab
pegol) in Crohn's disease, including over 1,300 patients, with a planned
follow-up phase of up to five years.
PRECiSE 1 is a unique trial in patients with active Crohn's
disease — the first reported Phase III double-blind, placebo-controlled
study of an anti-TNF extending to 26 weeks, in which eligible patients were
randomized at study baseline without pre-selection of responders. Both co-primary
endpoints were met with statistical significance.3
In the previously reported PRECiSE 2 study, patients responding
at Week 6 to open-label induction therapy with CIMZIA™ (certolizumab pegol)
were randomized to either placebo (n=210) or CIMZIA™ (certolizumab pegol) (n=215)
and followed for a total of 26 weeks. In this trial, 62.8% of CIMZIA™ (certolizumab
pegol) patients, compared to 36.2% of placebo patients, maintained clinical
response at Week 26 (p<0.001). Clinical response was defined as a ≥100 point
decrease in CDAI.
Similarly, 47.9% of CIMZIA™ (certolizumab pegol) patients were in clinical
remission at week 26 compared to 28.6% on placebo (p<0.001).1 Remission was
defined as CDAI ≤ 150 points.
Serious adverse events occurred in 5.6% of CIMZIA™ (certolizumab pegol) patients
during the double blind phase. One case of tuberculosis, which responded well
to anti-tuberculosis therapy, was observed in the CIMZIA™ (certolizumab pegol)
arm of the PRECiSE 2 trial. Local injection reactions were low in PRECiSE 2
(2.8%), and less frequent than seen with placebo. The percentage of patients
who tested positive for auto-antibody formation at Week 26 (and were negative
at baseline) was only 8.3% for anti-nuclear antibodies and 1.0% for anti-double-stranded
DNA antibodies in PRECiSE 2. No cases of lupus were reported.1
PRECiSE 3 and 4 are both long-term (up to five years) open-label
trials assessing the longer-term efficacy, safety and tolerability of CIMZIA™
(certolizumab pegol) in patients from PRECiSE 1 and PRECiSE 2, and are currently
New Studies Initiated
UCB continues to study the clinical profile of CIMZIA™ (certolizumab pegol)
in Crohn's disease. Enrollment has commenced in a new clinical trial involving
600 patients called WELCOME. The study will further examine the effects of CIMZIA™
(certolizumab pegol) in patients failing or intolerant to infliximab. In addition,
the MUSIC study will investigate the impact of CIMZIA™ (certolizumab pegol)
on endoscopic and mucosal healing, and the CONCISE trial will examine the corticosteroid-sparing
effect of CIMZIA™ (certolizumab pegol) in Crohn's disease.
About CIMZIA™ (certolizumab pegol)
UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIA™ (certolizumab
pegol) in the treatment of Crohn's disease on February 28th, 2006 and
on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMEA) for the same indication. CIMZIA™ (certolizumab
pegol) is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha
antibody (TNF-alpha; Tumour Necrosis Factor), evaluated as once-monthly dosing
administered subcutaneously. The engineered Fab' fragment retains the biologic
potency of the original antibody without the cytotoxicity mediated by the Fc
portion present in the original monoclonal antibodies. CIMZIA™ (certolizumab
pegol) has a high affinity for human TNF-alpha, selectively neutralizing 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 of diseases.
About Crohn's Disease
Crohn's disease is a chronic, progressive and debilitating inflammatory
disease of the gastrointestinal tract, most commonly affecting the end of the
small intestine (the ileum) and beginning of the large intestine (the colon).
Together with ulcerative colitis, Crohn's disease belongs to the group
of illnesses known as inflammatory bowel disease. Crohn's disease affects
nearly one million people worldwide, including an estimated 500,000 people in
the United States and a further 500,000 people in Europe4. People with Crohn's
disease may suffer an ongoing cycle of “flare-up” and remission.
Symptoms of the disease include persistent diarrhoea, abdominal pain, and loss
of appetite/weight, fever or rectal bleeding. Severe symptoms may result in
the need for surgical intervention. In an effort to provide Crohn's disease
patients with disease management information and resources designed expressly
with their needs in mind, UCB has launched patient Web sites in the U.S (CrohnsandMe.com)
and Europe (CrohnsandMe.eu). Both are dynamic, cutting-edge Web sites focused
on helping patients thoroughly understand Crohn's disease and live with
it every day.
UCB (http://www.ucb-group.com) is a leading
global biopharmaceutical company dedicated to the research, development and
commercialisation 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 over 8,300 people in over 40
countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on
the Euronext Brussels Exchange and its worldwide headquarters are located in
Enquiries, please contact:
|Jean-Christophe Donck, UCB
|Garry Daniels, UCB
Phone : +44.1753.777.116
Phone: +44 7831 569940
1 Schreiber S et al. Certolizumab pegol, a humanised anti-TNF PEGylated Fab'
fragment is safe and effective in the maintenance of response and remission
following induction in active Crohn's disease: a Phase III study (PRECiSE).
Gut 2005; 54 (Suppl VII) A82.
2 The CDAI score, or Crohn's Disease Activity Index, measures the severity
of Crohn's disease 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.
3 Sandborn WJ, Feagan BG, Stoinov S et al. Certolizumab pegol administered
subcutaneously is effective and well tolerated in patients with active Crohn's
disease: results from a 26-week, placebo-controlled Phase III study (PRECiSE
1). Presented at Digestive Disease Week, Los Angeles, California, USA, 23rd
4 Source: Crohn's and Colitis Foundation of America. Disease Information
http://www.ccfa.org/info/about/crohns Accessed October 3, 2006.