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Wednesday 16 June, 2010

UCB

Two-year Cimzia® (certolizumab pegol) data fro...






  * Treatment with Cimzia®  monotherapy* was associated with increased
    productivity inside the home and increased participation in family, social
    and leisure activities[1]

  * Improvements in productivity and increased participation in social
    activities were reported rapidly, as early as week 4, and sustained through
    2 years of monotherapy treatment[1]

ROME June 16th, 2010, 08.30 CET - UCB today announced new data presented at the
European League Against Rheumatism (EULAR) annual congress in Rome showing that
Cimzia®, the only approved PEGylated anti-TNF, provided rapid and sustained
improvements in household productivity and increased participation in social
activities for adult patients living with active rheumatoid arthritis (RA).[1]

"The target of RA treatment is to provide rapid and sustained relief from
disease pain and symptoms thus enabling patients to perform household, social,
leisure and family activities, the things that are really important," said Dr
Vibeke Strand, Adjunct Clinical Professor in the Division of Immunology and
Rheumatology, at Stanford University, California, and lead author.
"Observations, such as those made in this study with certolizumab pegol, suggest
that efficacious treatments can significantly improve productivity and improve
the quality of life for patients."

Patients in FAST4WARD(TM) were randomised to Cimzia® 400 mg every 4 weeks or
placebo for 24 weeks.* Those who completed or withdrew on/after Week 12 were
eligible to enter an open-label extension (OLE) study of Cimzia® 400 mg every 4
weeks as per protocol.* This analysis focuses on Cimzia® completers who entered
the OLE study and had 2 years (100 weeks) of Cimzia® exposure from baseline.

The Work Productivity Survey (WPS-RA) used in the study, is a validated
questionnaire that evaluated a variety of measures including household
productivity - assessed as missed days of household work, days with reduced
household productivity and rate of RA impact on household work productivity - as
well as the number of missed days of family, social and leisure activities.[1]

The WPS-RA was assessed every four weeks starting at baseline for the first 6
months and every 3 months thereafter, with analyses conducted on observed data
from the FAST4WARD(TM) phase III trial open label extension study (FAST4WARD(TM)
OLE).[1] Eligibility criteria for the open label extension included
participation in the FAST4WARD(TM) study for at least 12 weeks of blinded
treatment, without being withdrawn for a possible drug related adverse event or
non-compliance.[1]

Following Cimzia® monotherapy treatment, patients reported a rapid improvement
in productivity within the home.[1] By Week 4, patients reported a lower rate of
RA interference with household productivity than at baseline (3.7 rate compared
with 5.8 rate, on a 0-10 scale where 0=no interference and 10=complete
interference).[1] These improvements were sustained and by week 100, only 1
household work day (on average) was missed and only 1.1 household work day with
reduced productivity was reported, per month.[1]

These improvements in productivity within the home were seen in the majority of
patients.[1] In fact, by week 100, about 60% of patients did not miss any day of
household work and about 90% of patients reported ≤4 missed days of household
work per month.[1]

Patients treated with Cimzia® monotherapy also reported rapid and sustained
improvements in participation in family, social, and leisure activities.[1] By
Week 4, Cimzia®-treated patients missed on average fewer days per month of
family, social, or leisure activities than at baseline (1.5 days compared with
5.0 days).[1] By Week 100, on average 0.3 days of family, social, or leisure
activities were missed, per month.[1] At Week 100, over 80% of patients did not
miss any days of family, social, or leisure activities, per month, and all
patients reported ≤ 4 days of family, social, or leisure activities, missed per
month.[1]

The monthly improvements in household productivity reported by Cimzia® patients
resulted into annualized cumulative gains, with average incremental gains over
baseline of:

  * 108 full days of household work by 1 year and 199 by 2 years[1]

  * 136 more productive days of household work by 1 year and 245 by 2 years[1]

  * 58 days of social, family, or leisure activities by 1 year and 107 by 2
    years[1]

In Cimzia®'s pivotal clinical trials reported serious adverse reactions included
infections (including tuberculosis) and malignancies (including lymphoma). The
most common adverse reactions belonged to the system organ classes Infections
and Infestations, reported in 15.5% of patients on Cimzia® and 7.6% of patients
on placebo, and General disorders and administration site conditions, reported
in 10.0% of patients on Cimzia® and 9.7% of patients on placebo. A pooled
analysis of the safety data showed there was a low incidence of injection site
pain (1.5%) and a low level of discontinuations due to adverse events (5%).
Cimzia® demonstrated a favorable risk-benefit profile in patients with at least
up to two years of drug exposure.

* Cimzia®, in combination with methotrexate (MTX), is indicated for the
treatment of moderate to severe, active rheumatoid arthritis (RA) in adult
patients when the response to disease-modifying antirheumatic drugs (DMARDs)
including methotrexate, has been inadequate. Cimzia® can be given as monotherapy
in case of intolerance to methotrexate or when continued treatment with
methotrexate is inappropriate. The recommended starting dose of Cimzia® for
adult patients with rheumatoid arthritis is 400 mg (as 2 injections of 200 mg
each on one day) at weeks 0, 2 and 4, followed by a maintenance dose of 200 mg
every 2 weeks. MTX should be continued during treatment with Cimzia® where
appropriate.

For further information
Scott Fleming, Global Communications Manager - Immunology
T +44 770.277.7378,scott.fleming@ucb.com <mailto:scott.fleming@ucb.com>

Important safety information
The most common adverse reactions belonged to the system organ classes
Infections and infestations, reported in 15.5% of patients on Cimzia and 7.6% of
patients on placebo, and General disorders and administration site conditions,
reported in 10.0% of patients on Cimzia and 9.7% of patients on placebo. The
most serious adverse reactions were serious infections (including tuberculosis
and histoplasmosis), malignancies (including lymphoma) and heart failure. A
pooled analysis of the safety data show there was a low incidence of injection
site pain (1.5 percent) and low level of discontinuations due to adverse events.

Cimzia® is contraindicated in patients with active tuberculosis or other severe
infections such as sepsis, abscesses and opportunistic infections and in
patients with moderate to severe heart failure. Before initiation of Cimzia®,
evaluate patients for both active or inactive (latent) tuberculosis infection.
Monitor patients for the development of signs and symptoms of infection during
and after treatment with Cimzia®. If an infection develops, monitor carefully,
and stop Cimzia® if infection becomes serious.

Use of TNF blockers, including Cimzia®, may increase the risk of reactivation of
hepatitis B virus (HBV) in patients who are chronic carriers of this virus, of
new onset or exacerbation of clinical symptoms and/or radiographic evidence of
demyelinating disease, in the formation of autoantibodies and uncommonly in the
development of a lupus-like syndrome or of severe hypersensitivity reactions
following Cimzia administration. If a patient develops any of these adverse
reactions, Cimzia® should be discontinued and appropriate therapy instituted.

Adverse reactions of the hematologic system, including medically significant
cytopenia, have been infrequently reported with Cimzia®. Advise all patients to
seek immediate medical attention if they develop signs and symptoms suggestive
of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding,
pallor) while on Cimzia®. Consider discontinuation of Cimzia® therapy in
patients with confirmed significant haematological abnormalities.

The use of Cimzia® in combination with biological DMARDS such as anakinra,
abatacept and rituximab is not recommended due to a potential increased risk of
serious infections. As no data are available, Cimzia® should not be administered
concurrently with live vaccines or attenuated vaccines.

Please see full prescribing information before prescribing. This can be accessed
at:
www.ema.europa.eu/humandocs/PDFs/EPAR/cimzia/emea-combined-h1037en.pdf
<

http://www.ema.europa.eu/humandocs/PDFs/EPAR/cimzia/emea-combined-h1037en.pdf>

About CIMZIA®
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® 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.
The U.S. Food and Drug Administration (FDA) has approved Cimzia® for reducing
signs and symptoms of Crohn's disease and maintaining clinical response in adult
patients with moderately to severely active disease who have had an inadequate
response to conventional therapy and for the treatment of adults with moderately
to severely active rheumatoid arthritis. Cimzia® in combination with MTX, is
approved in the EU** for the treatment of moderate to severe active RA in adult
patients inadequately responsive to disease-modifying antirheumatic drugs
(DMARDs) including MTX. Cimzia® can be given as monotherapy in case of
intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is
also developing Cimzia® in other autoimmune disease indications. Cimzia® is a
registered trademark of UCB PHARMA S.A.

About UCB
UCB, Brussels, Belgium (www.ucb.com <

http://www.ucb.com>) is a biopharmaceutical
company dedicated to the research, development and commercialization of
innovative medicines with a focus on the fields of central nervous system and
immunology disorders. Employing more than 9000 people in over 40 countries, UCB
produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels
(symbol: UCB).

Forward-looking statements
This press release contains forward-looking statements based on current plans,
estimates and beliefs of management. Such statements are subject to risks and
uncertainties that may cause actual results to be materially different from
those that may be implied by such forward-looking statements contained in this
press release. Important factors that could result in such differences include:
changes in general economic, business and competitive conditions, effects of
future judicial decisions, changes in regulation, exchange rate fluctuations and
hiring and retention of its employees.

Reference
1.  Strand V, Purcaru O, van Vollenhoven R, Choy E, Fleischmann R. Certolizumab
pegol monotherapy provides sustained improvements in household productivity and
daily activities in patients with active rheumatoid arthritis over two years.
Poster presented at the EULAR Annual European Congress of Rheumatology;
2010, 16-19 June; Rome, Italy.



[HUG#1424209]





    Press release (PDF): 

http://hugin.info/133973/R/1424209/372881.pdf


  




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