RAPID-axSpA study showed certolizumab pegol reduced signs and symptoms of axial spondyloarthritis
-- First randomized, controlled, Phase 3 study of an anti-TNF to
enroll patients with active axial spondyloarthritis (axSpA),
including patients with ankylosing spondylitis (AS) and axSpA
without radiographic evidence of AS (nr-axSpA)(1)
-- Certolizumab pegol improved signs and symptoms in the overall
study population, with improvements in the AS and nr-axSpA
sub-populations(1)
-- In the axSpA study population certolizumab pegol improved
patient-reported outcomes such as back pain, fatigue and physical
functioning and also improved productivity in the workplace and in
the household(2,3)
-- Certolizumab pegol is not approved for the treatment of axSpA.
UCB intends to file global regulatory submissions for certolizumab
pegol in axSpA by the end of 2012
BRUSSELS, Nov. 13, 2012 /PRNewswire/ -- UCB announced extensive
results from the Phase 3 study - RAPID™-axSpA - at the
American College of Rheumatology's (ACR) 2012 Annual Scientific
Meeting in Washington D.C., U.S.
RAPID™-axSpA enrolled patients with active axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and axSpA without radiographic evidence of AS (non-radiographic axSpA [nr-axSpA]). The study showed that compared to placebo, both dosing regimens of certolizumab pegol reduced the signs and symptoms of axSpA in the overall study population with improvements observed in both the AS and nr-axSpA sub-populations. Results also indicated that certolizumab pegol improved productivity in the workplace and in the household, increased participation in daily activities, reduced inflammation in the sacroiliac joint and spine, and improved patient-reported outcomes such as back pain, fatigue and physical functioning.1,2,3,4
Certolizumab pegol is not approved for the treatment of axSpA. UCB intends to file global regulatory submissions for certolizumab pegol in axSpA by the end of 2012.
"AxSpA is a debilitating condition that primarily presents in a young, active population and comprises of a spectrum of clinical symptoms, with the main one being chronic inflammatory back pain," said Professor Deodhar, Medical Director, Rheumatology Clinics Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, U.S. "People living with AS have X-ray evidence of structural damage in the sacroiliitic joints and are the most well-defined sub-population, while patients with axSpA without radiographic evidence of AS are less well acknowledged today."
"The RAPID™-axSpA study is the first randomized, controlled, Phase 3 trial of an anti-TNF to include the broad axSpA population including patients with both AS and nr-axSpA," said Professor Robert Landewe, University of Amsterdam and Atrium Medical Center Heerlen, the Netherlands. "The study showed that the disease burden was similar at baseline for the AS and nr-axSpA sub-populations. Certolizumab pegol reduced the clinical burden of axSpA, with similar reductions compared to placebo observed across both certolizumab pegol dosing regimens in both AS and nr-axSpA sub-populations."
RAPID™-axSpA: primary efficacy variable and select secondary variables as presented at ACR 2012
Abstract title: Effect of certolizumab pegol on signs and symptoms
of axial spondyloarthritis and non-radiographic axial
spondyloarthritis: 24 week results of a double blind randomized
placebo-controlled phase 3 axial spondyloarthritis study1
The primary efficacy variable of the RAPID™-axSpA study was the ASAS20 response rate at week 12. The study met its primary endpoint and clinical improvements in the ASAS20 responses were statistically significant in both dosing arms vs. placebo (57.7%, 63.6% vs. 38.3% for 200 mg every 2 weeks and 400 mg every 4 weeks certolizumab pegol vs. placebo, n=111, 107 and 107, p<0.05). Improvements were observed as early as week one (40.5%, 34.6% vs. 14.2% for 200 mg every two weeks and 400 mg every four weeks certolizumab pegol vs. placebo).
The improvement in ASAS20 response at week 12 was observed at week 24. Sub-population analyses also indicated improvements at weeks 12 and 24 in both AS and nr-axSpA sub-populations. At weeks 12 and 24 both dosing regimens of certolizumab pegol indicated improvements vs. placebo in measurements of disease activity, spinal mobility and physical function in the entire axSpA population with improvements also observed vs. placebo in both the AS and nr-axSpA sub-populations.
Adverse events occurred in 70.4% vs. 62.6% of certolizumab pegol (combined dose) treated patients vs. placebo, serious AEs in 4.7% vs. 4.7% and serious infections in 1.1% vs. 0.1 The most common adverse events (occurred in >5% of patients taking certolizumab pegol or placebo) were nasopharyngitis, upper respiratory tract infection, increased creatine phosphokinase and headache.5
RAPID™-axSpA: select secondary and other variables as presented at ACR 2012
Abstract title: Improvements in productivity at paid work and
within household, and increased participation in daily activities
after 24 weeks of certolizumab pegol treatment of axial
spondyloarthritis patients, including patients with ankylosing
spondylitis: results of a phase 3 double-blind randomized
placebo-controlled study 2
Both dosing regimens of certolizumab pegol compared to placebo showed improved household productivity in patients with axSpA. Household work days missed per month due to axSpA for patients taking both dosing regimens of certolizumab pegol decreased from baseline to week 24. For patients taking certolizumab pegol 200 mg every 2 weeks the number of days decreased from 5.8 at baseline to 3.0 at week 4 and 2.3 at week 24 (n=111) vs. 6.9, 5.4 and 5.6 for placebo (n=107). Compared to placebo patients taking both doses of certolizumab pegol also reported a decrease in the number of days per month where household work productivity was reduced by half or more from baseline through to week 24.
Both dosing regimens of certolizumab pegol compared to placebo also
showed improved workplace productivity in patients with
axSpA. Employed patients taking both dosing regimens of
certolizumab pegol reported reduced absenteeism from work with a
decrease in days missed per month due to axSpA from week 4 through
to week 24. For patients taking certolizumab pegol 200 mg every 2
weeks, the number of days missing from work per month decreased
from 2.3 at baseline to 1.4 at week 4 and 1.1 at week 24 (n=77, 78
and 80) vs. 2.4, 1.9 and 2.0 for placebo (n=67, 68 and 66).
Employed patients taking both doses of certolizumab pegol also
reported a decrease in work presenteeism, i.e. a reduction in the
number of days per month where work productivity was reduced by
half or more due to axSpA.
Abstract title: Effect of certolizumab pegol on inflammation of
spine and sacroiliac joints in patients with axial
spondyloarthritis: 12 week magnetic resonance imaging results of a
phase 3 double blind randomized placebo-controlled study4
In a magnetic resonance imaging sub-study (n=153) reduction in
inflammation of the sacroiliac joints (SIJ) and spine was observed
in the overall axSpA study population and in the AS and nr-axSpA
sub-populations, with both dosing regimens of certolizumab pegol
(200 mg every 2 weeks and 400 mg every 4 weeks) vs. placebo.
Abstract title: Rapid improvements in patient reported outcomes with certolizumab pegol in patients with axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study 3
Both dosing regimens of certolizumab pegol compared to placebo improved patient reported outcomes, including back pain, fatigue, physical function and health-related quality of life in the entire study population.
Bath AS Functional Index (physical function): Week 12 mean
change from baseline: -1.92, -2.01 vs. -0.56 for 200 mg every 2
weeks and 400 mg every 4 weeks certolizumab pegol vs. placebo
Total spinal pain Numeric Rating Scale: Week 12 mean change from
baseline: -3.03, -2.91 vs. -1.40 for 200 mg every 2 weeks and 400
mg every 4 weeks certolizumab pegol vs. placebo
Fatigue Numeric Rating Scale: Week 12 mean change from baseline:
-2.25, -2.21 vs. -0.85 for 200 mg every 2 weeks and 400 mg every 4
weeks certolizumab pegol vs. placebo
SF-36 physical component summary: Week 12 mean change from
baseline: +9.07, +8.13 vs. +2.36 for 200 mg every 2 weeks and 400
mg every 4 weeks certolizumab pegol vs. placebo
SF-36 mental component summary: Week 12 mean change from baseline:
+3.32, +4.08 vs. +1.22 for 200 mg every 2 weeks and 400 mg every 4
weeks certolizumab pegol vs. placebo
AS Quality of Life: Week 12 mean change from baseline: -4.59, -4.17
vs. -1.31 for 200 mg every 2 weeks and 400 mg every 4 weeks
certolizumab pegol vs. placebo
In the U.S., certolizumab pegol is indicated for the treatment of
adult patients with moderately-to-severely active rheumatoid
arthritis (RA), and for reducing the signs and symptoms of Crohn's
disease (CD) and maintaining clinical response in adult patients
with moderately-to-severely active disease who have had an
inadequate response to conventional therapy.6 Certolizumab pegol is
marketed under the trade name Cimzia®.
In the European Union, Cimzia® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.7
Note to editors 1,8,9,10
About RAPID™-axSpA
The ongoing 158 week RAPID™-axSpA study is double-blind and
placebo-controlled up to week 24, dose-blind up to week 48 and then
open-label to week 158. Patients (n=325) with active axSpA
were randomized 1:1:1 to receive certolizumab pegol 200 mg every
two weeks, 400 mg every four weeks or placebo (n=111, 107 and 107).
This dosing schedule followed a loading dose of certolizumab pegol
(400 mg) at weeks 0, 2 and 4. Patients enrolled in the study must
have failed at least one non-steroidal anti-inflammatory drug
(NSAID). Up to 40% of patients could have received one previous
anti-TNF, provided they were not primary non-responders, as
determined by the investigator. Within the placebo arm, patients
who failed to achieve an ASAS20 response at weeks 14 and 16 were
re-randomized at week 16 to receive certolizumab pegol 200 mg every
2 weeks or 400 mg every 4 weeks, following the loading dose.
About SpA and axSpA
SpA is the overall name of a family of inflammatory rheumatic
diseases that can affect the spine and joints, ligaments and
tendons. There are two main types of clinical presentation of SpA
– axSpA (symptoms predominantly related to the spine) and
peripheral SpA (symptoms predominantly related to the peripheral
joints).
About AS
AS is a chronic inflammatory rheumatic disease of the spine and is
the most defined subset of axSpA. The symptoms of AS can vary, but
most people experience back pain and stiffness due to inflammation
which can proceed to fusion of the vertebrae. The condition can be
severe, with around 1 in 10 people at risk of long-term disability.
The condition usually occurs between 15 and 35 years of age, and
rarely starts in old age, with prevalence estimated to be between
0.1% - 1.1% of the population. AS is more common in men than in
women.
About axSpA without radiographic evidence of AS
Patients with no definitive sacroiliitis on conventional
radiographs but similar clinical features and showing either
sacroiliitis on MRI or who are HLA-B27 positive have axSpA without
radiographic evidence of AS (non-radiographic axSpA
[nr-axSpA]).
About ASAS20
The Assessment of SpondyloArthritis international Society (ASAS20)
improvement criteria is defined as an improvement of at least 20%
and absolute improvement of at least one unit on a 0-10 scale in at
least three of the four following domains: patient global
assessment, pain assessment, patient function, and inflammation and
the absence of deterioration in the remaining domain.
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.
Cimzia® (certolizumab pegol) in the U.S. important safety information
Risk of Serious Infections and Malignancy
Patients treated with CIMZIA are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:
Active tuberculosis, including reactivation of latent
tuberculosis. Patients with tuberculosis have frequently
presented with disseminated or extrapulmonary disease.
Patients should be tested for latent tuberculosis before CIMZIA use
and during therapy. Treatment for latent infection should be
initiated prior to CIMZIA use.
Invasive fungal infections, including histoplasmosis ,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other
invasive fungal infections may present with disseminated, rather
than localized disease. Antigen and antibody testing for
histoplasmosis may be negative in some patients with active
infection. Empiric anti-fungal therapy should be considered
in patients at risk for invasive fungal infections who develop
severe systemic illness .
Bacterial, viral and other infections due to opportunistic
pathogens, including Legionella and Listeria.
The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in
children and adolescent patients treated with TNF blockers, of
which CIMZIA is a member. CIMZIA is not indicated for use in
pediatric patients.
Patients treated with CIMZIA are at an increased risk for
developing serious infections involving various organ systems and
sites that may lead to hospitalization or death.
Opportunistic infections due to bacterial, mycobacterial, invasive
fungal, viral, parasitic, or other opportunistic pathogens
including aspergillosis, blastomycosis, candidiasis,
coccidioidomycosis, histoplasmosis, legionellosis, listeriosis,
pneumocystosis and tuberculosis have been reported with TNF
blockers. Patients have frequently presented with
disseminated rather than localized disease.
Treatment with CIMZIA should not be initiated in patients with an active infection, including clinically important localized infections. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with CIMZIA should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.
Malignancies
During controlled and open-labeled portions of CIMZIA studies of
Crohn's disease and other diseases , malignancies (excluding
non-melanoma skin cancer) were observed at a rate of 0.5 per 100
patient-years among 4,650 CIMZIA-treated patients versus a rate of
0.6 per 100 patient-years among 1,319 placebo-treated patients. In
studies of CIMZIA for Crohn's disease and other investigational
uses, there was one case of lymphoma among 2,657 CIMZIA-treated
patients and one case of Hodgkin lymphoma among 1,319
placebo-treated patients. In CIMZIA RA clinical trials
(placebo-controlled and open label) a total of three cases of
lymphoma were observed among 2,367 patients. This is
approximately 2-fold higher than expected in the general
population. Patients with RA, particularly those with highly
active disease, are at a higher risk for the development of
lymphoma. The potential role of TNF blocker therapy in the
development of malignancies is not known.
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy less than or equal to 18 years of age), of which CIMZIA is a member. Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma, while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.
Heart Failure
Cases of worsening congestive heart failure (CHF) and new onset CHF
have been reported with TNF blockers. CIMZIA has not been formally
studied in patients with CHF. Exercise caution when using CIMZIA in
patients who have heart failure and monitor them carefully.
Hypersensitivity
Symptoms compatible with hypersensitivity reactions, including
angioedema, dyspnea, hypotension, rash, serum sickness, and
urticaria, have been reported rarely following CIMZIA
administration. If such reactions occur, discontinue further
administration of CIMZIA and institute appropriate therapy.
Hepatitis B Reactivation
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. Some cases have been fatal. Evaluate
patients at risk for HBV infection for prior evidence of HBV
infection before initiating CIMZIA therapy. Exercise caution in
prescribing CIMZIA for patients identified as carriers of HBV, with
careful evaluation and monitoring prior to and during treatment. In
patients who develop HBV reactivation, discontinue CIMZIA and
initiate effective anti-viral therapy with appropriate supportive
treatment.
Neurologic Reactions
Use of TNF blockers, including CIMZIA, has been associated with
rare cases of new onset or exacerbation of clinical symptoms and/or
radiographic evidence of central nervous system demyelinating
disease, including multiple sclerosis, and with peripheral
demyelinating disease, including Guillain-Barre syndrome. Rare
cases of neurological disorders, including seizure disorder, optic
neuritis, and peripheral neuropathy have been reported in patients
treated with CIMZIA. Exercise caution in considering the use of
CIMZIA in patients with these disorders.
Hematologic Reactions
Rare reports of pancytopenia, including aplastic anemia, have been
reported with TNF blockers. Medically significant cytopenia (e.g.,
leukopenia, pancytopenia, thrombocytopenia) has 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 hematologic
abnormalities.
Drug Interactions
An increased risk of serious infections has been seen in clinical
trials of other TNF blocking agents used in combination with
anakinra or abatacept. Formal drug interaction studies have
not been performed with rituximab or natalizumab; however because
of the nature of the adverse events seen with these combinations
with TNF blocker therapy, similar toxicities may also result from
the use of CIMZIA in these combinations. Therefore, the
combination of CIMZIA with anakinra, abatacept, rituximab, or
natalizumab is not recommended. Interference with certain
coagulation assays has been detected in patients treated with
CIMZIA. There is no evidence that CIMZIA therapy has an effect on
in vivo coagulation. CIMZIA may cause erroneously elevated aPTT
assay results in patients without coagulation abnormalities.
Autoimmunity
Treatment with CIMZIA may result in the formation of autoantibodies
and, rarely, in the development of a lupus-like syndrome.
Discontinue treatment if symptoms of lupus-like syndrome
develop.
Immunizations
Do not administer live vaccines or live-attenuated vaccines
concurrently with CIMZIA.
Adverse Reactions
In controlled Crohn's clinical trials, the most common adverse
events that occurred in greater than or equal to 5% of CIMZIA
patients (n=620) and more frequently than with placebo (n=614) were
upper respiratory infection (20% CIMZIA, 13% placebo), urinary
tract infection (7% CIMZIA, 6% placebo), and arthralgia (6% CIMZIA,
4% placebo). The proportion of patients who discontinued treatment
due to adverse reactions in the controlled clinical studies was 8%
for CIMZIA and 7% for placebo.
In controlled RA clinical trials, the most common adverse events that occurred in greater than or equal to 3% of patients taking CIMZIA 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo), hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo), back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo), pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute bronchitis (3% CIMZIA,1% placebo), fatigue (3% CIMZIA, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving CIMZIA 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA and 2.5% for placebo.
Please see www.ucb.com for full prescribing information: http://www.ucb.com/_up/ucb_com_products/documents/Cimzia%20COL%2004-2012_Immunizations%20and%20TB_Updated.pdf
Cimzia® (certolizumab pegol) in EU/ EEA important safety
information
Cimzia® 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® 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 and nausea. 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® due to adverse events vs. 2.5% for
placebo.
Cimzia® 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 or moderate to severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia®. Treatment with Cimzia must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia® if infection becomes serious. Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia®.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. Carriers of HBV who require treatment with Cimzia® should be closely monitored and in the case of HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
TNF antagonists including Cimzia® may increase the risk 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® should be discontinued and appropriate therapy instituted.
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®.
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 hematological abnormalities.
The use of Cimzia® in combination with anakinra or abatacept 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. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia® 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 June 2012.
References
Abstract Number 777: Landewe R., Rudwaleit M., van der Heijde D.
et al. Effect of certolizumab pegol on signs and symptoms of
ankylosing spondylitis and non-radiographic axial
spondyloarthritis: 24 week results of a double blind randomized
placebo-controlled phase 3 axial spondyloarthritis study. Presented
at the Annual Scientific Meeting of the American College of
Rheumatology (ACR) 2012.
Abstract Number 1372: Van der Heijde D., Braun J., Rudwaleit M. et
al. Improvements in productivity at paid work and within household
and increased Participation in Daily Activities After 24 Weeks of
Certolizumab Pegol Treatment of Axial Spondyloarthritis Patients,
Including Patients with Ankylosing Spondylitis: Results of a Phase
3 Double-Blind Randomized Placebo-Controlled Study. Presented at
the Annual Scientific Meeting of the American College of
Rheumatology (ACR) 2012.
Abstract Number 558: Sieper J., Kivitz A., van Tubergen A. et al.
Rapid improvements in patient reported outcomes with certolizumab
pegol in patients with axial spondyloarthritis, including
ankylosing spondylitis and non-radiographic axial
spondyloarthritis: 24 week results of a phase 3 double blind
randomized placebo-controlled study. Presented at the Annual
Scientific Meeting of the American College of Rheumatology (ACR)
2012.
Abstract Number 1705: Van der Heijde D., Maksymowych W., Landewe R.
et al. Effect of certolizumab pegol on inflammation of spine and
sacroiliac joints in patients with axial spondyloarthritis: 12 week
magnetic resonance imaging results of a phase 3 double blind
randomized placebo-controlled study. Presented at the Annual
Scientific Meeting of the American College of Rheumatology (ACR)
2012.
UCB Data on file
Cimzia® US Prescribing Information. Accessed October 10 th 2012
from
http://www.ucb.com/_up/ucb_com_products/documents/Cimzia%20COL%2004-2012_Immunizations%20and%20TB_Updated.pdf
Cimzia® EU Summary of Product Characteristics. Accessed October
10 th 2012 from
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf
Guideline on Clinical Investigation of Medicinal Products for the
Treatment of Ankylosing Spondylitis, European Medicines Agency.
Accessed August 24 th 2012 from
www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003424
Ankylosing Spondylitis, NHS Choices. Accessed August 24 th 2012
from
http://www.nhs.uk/conditions/Ankylosing-spondylitis/Pages/Introduction.aspx
The Assessment of SpondyloArthritis international Society (ASAS)
handbook: a guide to assess spondyloarthritis, Assessment of
Spondyloarthritis International Society. Accessed August 24 th 2012
from http://www.asas-group.org/education.php?id=01
For further information
Eimear O Brien, Director, Brand Communications
T +32.2.559.9271, eimear.obrien@ucb.com
Andrea Levin, Senior PR Manager, US Communications and Public
Relations
T +1 770 970 8352, andrea.Levin@ucb.com
Antje Witte, Investor Relations UCB
T +32.2.559.9414, antje.witte@ucb.com
France Nivelle, Global Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical
company focused on the discovery and development of innovative
medicines and solutions to transform the lives of people living
with severe diseases of the immune system or of the central nervous
system. With more than 8,500 people in about 40 countries, the
company generated revenue of EUR 3.2 billion in 2011. 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. All statements,
other than statements of historical fact, are statements that could
be deemed forward-looking statements, including estimates of
revenues, operating margins, capital expenditures, cash, other
financial information, expected legal, political, regulatory or
clinical results and other such estimates and results. By their
nature, such forward-looking statements are not guarantees of
future performance and are subject to risks, uncertainties and
assumptions which could cause actual results to differ materially
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, the inability to obtain
necessary regulatory approvals or to obtain them on acceptable
terms, costs associated with research and development, changes in
the prospects for products in the pipeline or under development by
UCB, effects of future judicial decisions or governmental
investigations, product liability claims, challenges to patent
protection for products or product candidates, changes in laws or
regulations, exchange rate fluctuations, changes or uncertainties
in tax laws or the administration of such laws and hiring and
retention of its employees. UCB is providing this information as of
the date of this press release and expressly disclaims any duty to
update any information contained in this press release, either to
confirm the actual results or to report a change in its
expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
SOURCE UCB
Web Site: http://www.ucb.com
Posted: November 2012
