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FAST4WARD(TM) study for at least 12 weeks of blinded treatment, without being withdrawn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 EULARAnnual European Congress of Rheumatology; 2010, 16-19 June; Rome, Italy.
HUG#1424209
Press release (PDF) http://hugin.info/133973/R/1424209/372881.pdf