* In adult patients with moderate to severely active rheumatoid arthritis,
Cimzia® provided rapid and sustained improvements in ACR responses, DAS 28
scores, HAQ-DI scores and in pain VAS over three years[1]
* Sustained inhibition of progression of structural joint damage was observed
in patients treated with Cimzia® up to 2.5 years[1]
ROME June 16th, 2010, 08.30 CET - UCB today announced data showing that rapid
improvements in ACR20, physical function, pain and fatigue of rheumatoid
arthritis (RA) as early as Week 1, following treatment with Cimzia®
(certolizumab pegol), together with methotrexate (MTX), was sustained up to 148
weeks.[1] Inhibition of progression of structural joint damage (seen at Week
24) was sustained up to the last x-ray evaluation at 2.5 years.[1] Cimzia® was
well tolerated with no new safety signals across three years.[1]
"These data have shown certolizumab pegol as an effective and well tolerated
therapy in patients treated for a sustained period of time," said lead
investigator Josef Smolen, M.D., and Chairman of the Department of Rheumatology,
Internal Medicine III, Medical University of Vienna, "As a chronic condition, it
is critical patients and physicians are confident that treatments deliver a
rapid response and are effective in the longer term to help maintain overall
quality of life."
The data presented were from an open label extension (OLE) to the phase III,
Rheumatoid Arthritis Prevention of Structural Damage (RAPID 2) study.[1] The OLE
was designed to investigate the long-term efficacy and safety of Cimzia® and
methotrexate (MTX) over three years (148 weeks).[1] Patients receiving Cimzia®
200mg or 400mg + MTX who completed RAPID 2 initially received Cimzia® 400mg +
MTX every other week (EOW) in the OLE; this Cimzia® dose was decreased from
400mg to 200mg EOW per protocol (after ≥6 months in the OLE).[1]*
Efficacy was measured by ACR 20/50/70 responder rates, DAS28[ESR].
Patient-reported outcomes included physical function (assessed using the Health
Assessment Questionnaire-Disability Index [HAQ-DI]) and pain (assessed on a
0-100-mm visual analogue scale [VAS]).
At 148 weeks, ACR responses in Cimzia® 200mg completers were sustained.[1]
Sixty-three percent of Cimzia® 200mg completers who entered the OLE had an ACR50
response.[1] ACR20/50/70 response rates were similar in CZP 400mg completers.[1]
Low disease activity (DAS28[ESR]<3.2) was reported in 39% of patients with 36%
of patients originally treated with 200mg Cimzia® and 42% originally treated
with 400mg Cimzia®. Twenty percent of patients had remission at week 148[1] (19%
of patients originally treated with 200mg Cimzia® and 20% originally treated
with 400 mg Cimzia®).[1]
Improvements in HAQ-DI scores were sustained over 3 years in Cimzia® 200mg
completers,[1] as were improvements in pain VAS.[1] Results were similar in
Cimzia® 400mg completers.[1]
Inhibition of radiographic progression observed during the double-blind phase
(weeks 0-24) was sustained up to the last x-ray evaluation at 2.5 years.[1] The
mean change from baseline in modified total Sharp score (mTSS) for the combined
Cimzia® dose groups at Week 128 was 0.75.[1]
There was no increase in incidence of AEs in the OLE, nor were any new safety
signals observed.[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.
These and other Cimzia® data are available on display during the 2010 Annual
Meeting of the European League Against Rheumatism in Rome, Italy, June 16 - 19.
* 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. Methotrexate
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 RAPID 2
This Phase III double-blind placebo-controlled trial, involving 619 patients
with active adult-onset RA was designed to evaluate the efficacy and
tolerability of subcutaneous (SC) liquid certolizumab pegol (200 and 400 mg)
together with MTX every 2 weeks compared to placebo together with MTX in
patients with active RA despite ≥ 6 months treatment with MTX.* Patients were
randomly allocated to receive one of three treatment regimens: 246 patients
received certolizumab pegol (liquid formulation) 400 mg and at Weeks 0, 2 and
4, then 200 mg every two weeks; 246 patients received certolizumab pegol (liquid
formulation) 400 mg every 2 weeks;* 127 patients received placebo every 2 weeks.
RAPID 2 met its primary endpoint ACR20 response rate at Week 24, and secondary
endpoints: change from baseline in mTSS, ACR 50 and ACR 70 responses at Week
24. Significantly more patients in the certolizumab pegol 200 and 400 mg groups
achieved an ACR20 response versus placebo (p≤ 0.001); rates were 57.3%, 57.6%,
and 8.7%, respectively. Certolizumab pegol 200 and 400 mg also significantly
inhibited radiographic progression; mean changes from baseline in mTSS at Week
24 were 0.2 and -0.4, respectively, versus 1.2 for placebo (rank analysis p≤
0.01). Certolizumab pegol treated patients reported rapid and significant
improvements in physical function versus placebo (p≤ 0.001).
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.
References
[1] Smolen JS et al. Efficacy and Safety of Certolizumab Pegol Plus Methotrexate
in patients With Rheumatoid Arthritis: 3-Year Data From the RAPID 2 Study. 2010
Meeting of the European League Against Rheumatism (EULAR). Rome, Italy, June 16
- 19. SAT0127.
[HUG#1424217]
Press release (PDF):
http://hugin.info/133973/R/1424217/372882.pdf