Proven efficacy in joints that lasts – regardless of prior biologic experience2,5
Sustained improvement in joint pain and stiffness due to psoriatic arthritis
Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. 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.
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found
here.
CIMZIA®
(certolizumab pegol):
Joint-symptom relief that lasts
Limitation of OLE: ACR responder rates did not have a long-term placebo comparator beyond Week 24.
The ACR response criteria assess changes in swollen and tender joints, pain, functional ability, patient and physician assessment, and acute phase reactant.6
ACR20/50/70, American College of Rheumatology criteria for 20%-50%-70% response; NRI, nonresponder imputation; OLE, Open open-label extension; PsA, psoriatic arthritis; Q2W, every 2 weeks.
aRS-NRI: Randomized set nonresponder imputation.
bAll CIMZIA patients received a loading dose of 400 mg at Weeks 0, 2, 4.
Important Safety Information
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Prevent the progression of joint damage
Lasting inhibition of joint damage
of patients assessed radiographically experienced no progression of joint damage over 4 years (CIMZIA 200 mg Q2W; n=98).6a The remainder experienced minimal progression.
Patients treated with CIMZIA 400 mg Q4W did not demonstrate greater inhibition of radiographic progression compared with placebo-treated patients at Week 24. The radiographic primary end point was changed from baseline in mTSS at Week 24 [–0.02 with CIMZIA 200 mg Q2W (n=138) vs. 0.18 with placebo (n=136)].1,5
Open-label extension (OLE) limitation: Weeks 48 through 216 were an OLE phase of the study. As with any long-term, uncontrolled OLE, there were several limitations with this portion of the study.
IL, interleukin; mTSS, modified Total Sharp Score; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNF, tumor necrosis factor.
a“No progression” was defined as a change from baseline in mTSS of ≤0.5. When “no progression” was defined as a change from baseline in mTSS of ≤0, 63.3% of x-rayed patients experienced no progression.6
bInformation presented here is specific to the use of anti-TNFs; refer to complete ACR/NPF Guidelines for the Treatment of Psoriatic Arthritis for greater context. For patients with severe skin involvement, anti-IL-17 therapy may be considered.
Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. 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.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
The 2018 American College of Rheumatology/National Psoriasis Foundation (ACR/NPF) Guidelines for the Treatment of Psoriatic Arthritis Recommend Anti-TNF Therapy as7b:
FIRST-LINE OPTION
For treatment-naïve patients with active PsA
SECOND-LINE OPTION
For patients with active PsA despite therapy with another anti-TNF or oral medication
For patients with active PsA despite anti-IL-17 or anti-IL-12/23 therapy
IL, interleukin; mTSS, modified Total Sharp Score; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNF, tumor necrosis factor.
a“No progression” was defined as a change from baseline in mTSS of ≤0.5. When “no progression” was defined as a change from baseline in mTSS of ≤0, 63.3% of x-rayed patients experienced no progression.6
bInformation presented here is specific to the use of anti-TNFs; refer to complete ACR/NPF Guidelines for the Treatment of Psoriatic Arthritis for greater context. For patients with severe skin involvement, anti-IL-17 therapy may be considered.
Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. 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.
Anaphylaxis or serious allergic reactions may occur. Some of these reactions occurred after the first administration of CIMZIA. Hypersensitivity reactions have been reported rarely following CIMZIA administration. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Long-term relief of joint pain and stiffness regardless of prior biologic use
Limitation of OLE: ACR responder rates did not have a long-term placebo comparator beyond Week 24.
aRandomized set. Nonresponder imputation.
bCIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W.
ACR20/50/70, American College of Rheumatology criteria for 20%-50%-70% response; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNF, tumor necrosis factor.
aRandomized set. Nonresponder imputation.
bCIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W.
Important Safety Information
Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including children, adolescents, and young adults. Acute and chronic cases of leukemia have also been reported. Post marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Proven efficacy in joints that lasts– regardless of prior biologic experience1,5,6
CIMZIA provides powerful symptom relief even with previous biologic use
Anti-TNF-experienced
CIMZIA combined dose (n=54)c
In the placebo group (n=26), patients achieved ACR 20/50/70 rates of 12%, 4% and 4%, respectively.
Anti-TNF-naïve
CIMZIA combined dose (n=219)c
In the placebo group (n=110), patients achieved ACR 20/50/70 rates of 26%, 15% and 5%, respectively.
The primary efficacy end point for Study PsA001 was ACR20 response at Week 12.
aRandomized set. Nonresponder imputation.
bACR20 response rates were stratified by baseline prior TNF inhibitor exposure, which was a prespecified secondary end point.
Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. 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. 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.
Concurrent administration of CIMZIA with certain biological DMARDs, including anakinra, abatacept and rituximab, is not recommended due to an increased risk of serious infections. In pre-marketing controlled trials of all patient populations combined, the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
