Cimzia(R) (certolizumab pegol) Data Showed Rapid Improvement in Signs and Symptoms Predicted Better Long-Term Outcomes in Rheumatoid Arthritis Patients

By Ucb, PRNE
Monday, May 9, 2011

Patients who achieved a clinical response at week 12 had a much greater probability of achieving a low disease activity state and had less radiographic progression at one year compared to non responders at week 12(1)

BRUSSELS, May 10, 2011 - UCB announced today results from a post hoc analysis of the RAPID 1 study
published in the Journal of Rheumatology. The results suggest moderate to
severe rheumatoid arthritis (RA) patients treated with Cimzia(R)
(certolizumab pegol), the only approved PEGylated anti-TNF, together with
methotrexate (MTX), achieved a rapid response associated with improved
long-term outcomes one year after treatment began.(1)

"These results are consistent with a growing body of clinical evidence
that suggest a potential for healthcare professionals to predict clinical
success as early as week 12 when treating rheumatoid arthritis patients with
certolizumab pegol," said lead investigator Edward Keystone, M.D., The
Rebecca MacDonald Center for Arthritis, Mount Sinai Hospital, The University
of Toronto
. "The data supports the importance of monitoring for a rapid
response, in line with recently published EULAR recommendations, and the need
to consider treatment adjustments in those patients who have not achieved a
clinical response at 12 weeks regardless of their treatment."

Rapid response rates following treatment with certolizumab
pegol were achieved across various clinical response measures, including
good/moderate EULAR response rates at weeks 6 and 12 (67.4% and 77.6%
respectively versus 27.0% and 29.1% for placebo) based on this post hoc
analysis. Similarly, ACR20 rates were 51.3% and 63.8% in patients treated
with certolizumab pegol versus 18.2% and 18.3% for placebo at week 6 and 12

Using the disease activity score, DAS28[ESR] greater than or equal to 1.2
responder definition, a higher proportion of patients treated with
certolizumab pegol (75.8%) responded at week 12 compared to placebo (27.5%).
Results suggest that a higher proportion of patients treated with
certolizumab pegol who responded at week 12, achieved DAS28 low disease
activity (LDA) at 52 weeks compared with patients who did not (37.2% versus
6.1%). Patients who responded at week 12 also experienced less radiographic
progression than those who did not. The majority of patients (approximately
75%) who responded at week 12 had a clinical response at week 6. These
patients reported further improved outcomes such as pain, physical function
and fatigue, a significantly greater response in terms of ACR20, 50 and 70
measures as well as higher rates of DAS28 LDA and remission, relative to
those who showed response at week 12.(1)

The data published were from the RAPID 1 study(1) - a Phase III
double-blind placebo-controlled trial. The trial was designed to establish
the efficacy and tolerability of certolizumab pegol together with MTX, in the
treatment of moderate to severely active RA in patients who did not
adequately respond to conventional treatment. The co-primary end points were
ACR20 score at week 24 and change in mTSS (modified Total Sharp Score) at
week 52. The post hoc analysis focused on patients who received MTX and
either 200mg subcutaneously or placebo every 2 weeks for 52 weeks accounting
for 393 patients in the ITT population (30 patients were excluded due to
nonimputable data).(1)

Patients participating in the trial all met the ACR classification for
RA, and had active disease at screening and an inadequate response to MTX
treatment (greater than or equal to 6 months with a stable dose of greater
than or equal to 10 mg weekly for greater than or equal to 2 months prior to

For the purpose of this post hoc analysis, patients were classified as
responders or non-responders based on DAS 28 > 1.2 and ACR20 response at week
6 and 12 respectively. Low disease activity was defined as DAS28 less than or
equal to 3.2. Remission was defined as DAS28 less than or equal to 2.6.
Improvement in disease activity, as measured by DAS28, was classified
according to the EULAR response criteria.(1)

Cimzia(R) (certolizumab pegol) in European Union/ EEA important safety
information Cimzia(R) was studied in 2367 patients with RA in controlled and
open label trials for up to 57 months. The commonly reported adverse
reactions (1-10%) in clinical trials with Cimzia(R) and post-marketing were
viral infections (includes herpes, papillomavirus, influenza), bacterial
infections (including abscess), rash, headache (including migraine),
asthenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic
disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension,
pruritis (any sites), hepatitis (including hepatic enzyme increase),
injection site reactions. Serious adverse reactions include sepsis,
opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia,
solid organ tumours, angioneurotic edema, cardiomyopathies (includes heart
failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation
(including thrombophlebitis, pulmonary embolism), cerebrovascular accident,
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal
impairment/nephropathy (includes nephritis). In RA controlled clinical
trials, 5% of patients discontinued taking Cimzia(R) due to adverse events
vs. 2.5% for placebo.

Cimzia(R) is contraindicated in patients with hypersensitivity to the
active substance or any of the excipients, active tuberculosis or other
severe infections such as sepsis or opportunistic infections, moderate to
severe heart failure.

Before initiation of Cimzia(R), 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(R). If an infection develops, monitor carefully, and stop
Cimzia(R) if infection becomes serious.

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

With the current knowledge, a possible risk for the development of
lymphomas, leukaemia or other malignancies in patients treated with a TNF
antagonist cannot be excluded. Rare cases of neurological disorders,
including seizure disorder, neuritis and peripheral neuropathy, have been
reported in patients treated with Cimzia(R).

Adverse reactions of the hematologic system, including medically
significant cytopenia, have been infrequently reported with Cimzia(R). 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(R). Consider discontinuation of
Cimzia(R) therapy in patients with confirmed significant haematological

The use of Cimzia(R) in combination with anakinra or abatacept is not
recommended due to a potential increased risk of serious infections. As no
data are available, Cimzia(R) should not be administered concurrently with
live vaccines or attenuated vaccines. The 14-day half-life of Cimzia(R)
should be taken into consideration if a surgical procedure is planned. A
patient who requires surgery while on Cimzia(R) should be closely monitored
for infections.

Please consult the full prescribing information in relation to other side
effects, full safety and prescribing information. European SmPC date of
revision February 2011.

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Cimzia(R) is the only PEGylated anti-TNF (Tumor Necrosis Factor).
Cimzia(R) 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(R)
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(R)
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(R) can
be given as monotherapy in case of intolerance to MTX or when continued
treatment with MTX is inappropriate. UCB is also developing Cimzia(R) in
other autoimmune disease indications. Cimzia(R) is a registered trademark of

About UCB

UCB, Brussels, Belgium ( 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 3.22 billion in 2010. 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.


(1) Keystone, EC. et al. Rapid Improvement in the Signs and Symptoms of
Rheumatoid Arthritis Following Certolizumab Pegol Treatment Predicts Better
Longterm Outcomes: Post-hoc Analysis of a Randomized Controlled Trial; The
Journal of Rheumatology; DOI: 10.3899/jrheum.100935;

For further Information: Scott Fleming, Global Communications Manager - Immunology, T +44-770-277-7378, scott.fleming at; Andrea Levin, Senior PR Manager, US Communications and Public Relations, T +1-770-970-8352, andrea.Levin at

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