Rapid skin improvement
that can last
CIMZIA 400 mg Q2W demonstrated numerically higher efficacy results for PSO patients than CIMZIA 200 mg Q2W
Individual trial co-primary end points of PASI 75 and PGA 0/1 were statistically significant versus placebo at Week 16 at both doses.3
PASI 100 was a prespecified other end point at Week 16 not adjusted for multiplicity, and a post hoc analysis for Week 16 to Week 144.
*The results of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocols.
dEstimates presented are the results from MCMC models where missing data were imputed using data up to and including Week 48, the end of the double-blind maintenance period.
eThe co-primary efficacy end points at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1.
fThe primary end point in CIMPACT was PASI 75 at Week 12.
gPGA score of 0 (clear) or 1 (almost clear) based on a 5-point scale (0-4).
MCMC, Markov Chain Monte Carlo; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PSO, plaque psoriasis; Q2W, every 2 weeks; TNF, tumor necrosis factor.
aPooled from CIMPASI-1 and CIMPASI-2. Randomized set (Week 0–16); maintenance set (Week 16–48). Missing data were imputed using multiple imputation based on the MCMC method using data up to and including Week 48, the end of the double-blind maintenance period. PASI 100 was a prespecified other end point at Week 16 not adjusted for multiplicity, and a post hoc analysis for Week 16 to Week 144. PASI 50 nonresponders at Week 16, 32, or 40 were imputed as nonresponders at all subsequent time points.
bPlacebo responder rate at Week 16 was 7.5% for PASI 75. Placebo responder rate was 1.6% at Week 16 for PASI 90.
cPatients taking CIMZIA 200 mg Q2W received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
dEstimates presented are the results from MCMC models where missing data were imputed using data up to and including Week 48, the end of the double-blind maintenance period.
eThe co-primary efficacy end points at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1.
fThe primary end point in CIMPACT was PASI 75 at Week 12.
gPGA score of 0 (clear) or 1 (almost clear) based on a 5-point scale (0-4).
Important Safety Information 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.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
CIMZIA®
(certolizumab pegol),
an anti-TNF for your biologic-experienced patients1,2,8-10
Efficacy in Skin That Lasts – Regardless of Prior Biologic Experience2,5
Give your patients the possibility of long‑term efficacy with
CIMZIA®
(certolizumab pegol)
Per protocol, Week 16 placebo nonresponders were initiated on CIMZIA 400 mg Q2W through Week 144.
No protocol-mandated dose reduction in escape population. Of 116 patients, 33 were dosed down to CIMZIA 200 mg Q2W at the investigator’s discretion during the Week 16 through Week 144 treatment period.
The results of the post hoc analyses should be interpreted with caution as these analyses were not prespecified in the original protocols.
Patients in the 200 mg Q2W arm continued on 200 mg Q2W out to Week 144
Per protocol, at Week 48 all CIMZIA 400 mg Q2W responders who achieved ≥PASI 50 were dosed down to CIMZIA 200 mg Q2W from CIMPASI-1 and CIMPASI-2. The recommended dose of CIMZIA for adult patients with PSO is 400 mg Q2Wa,c-e
The response in these patients at Week 144 was consistent with the response in patients who continued at 200 mg Q2W to Week 144 in pooled data from the open-label extension period of CIMPASI-1 and CIMPASI-2c-e
Weeks 48 through 144 were an OLE phase of the study. As with any long-term, uncontrolled OLE, there were several limitations with this portion of the study. For example, PASI responder rates did not have a long-term placebo comparator beyond Week 16 (initiation of CIMZIA)
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.
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.
Post hoc analysis
Pooled PASI responder rates for CIMZIA 400 mg Q2W (n=116) at Week 1442a
No protocol-mandated dose reduction in escape population. Of 116 patients, 33 were dosed down to CIMZIA 200 mg Q2W at the investigator’s discretion during the Week 16 through Week 144 treatment period.
The results of the post hoc analyses should be interpreted with caution as these analyses were not prespecified in the original protocols.
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.
Real patients – real results
Before and after treatment with CIMZIA
Actual clinical trial patients from CIMPACT who reflect CIMZIA use. Individual results may vary.
Before - Baseline
Dosing: CIMZIA 400 mg Q2W
PASI score=12
After - Week 16
Dosing: CIMZIA 400 mg Q2W
PASI score=3 | PASI 75 Achieved
Before - Baseline
Dosing: CIMZIA 200 mg Q2W
PASI score=15
After - Week 12
Dosing: CIMZIA 200 mg Q2W
PASI score=1.8 | PASI 75 Achieved
Before - Baseline
Dosing: CIMZIA 400 mg Q2W
PASI score=12.6
After - Week 48
Dosing: CIMZIA 400 mg Q2W
PASI score=0 | PASI 100 Achieved
BIW, twice weekly; PASI, Psoriasis Area and Severity Index; PSO, plaque psoriasis; Q2W, every 2 weeks. For patients who were originally assigned to CIMZIA 400 mg Q2W and maintained this dosing through Week 48 (N=49), the PASI 100 responder rate was 45% (NRI).
Important Safety Information
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%).
Rare reports of blood dyscrasias have been reported with CIMZIA; patients should be advised to seek medical attention if they develop. Patients on CIMZIA should not receive live or live-attenuated vaccines. Concurrent administration of CIMZIA with certain biological DMARDs, including anakinra, abatacept and rituximab, is not recommended due to an increased risk of serious infections.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Proven efficacy regardless of prior biologic treatment
Comparable skin clearance in biologic-experienced vs biologic-naïve patients
*The results of the biologic-experienced PASI 90 data were part of the post hoc analysis and should be interpreted with caution as the analysis was not prespecified in the original protocols.
Subjects must not have been exposed to more than 2 biological response modifiers (including anti-TNF) for PsA or PSO prior to Baseline Visit.
aPrimary biologic nonresponse was an exclusion criterion in all 3 trials. Missing data were imputed using multiple imputation based on the MCMC method. The PASI 75 analysis is a prespecified pooled efficacy analysis of the CIMPASI-1, CIMPASI-2, and CIMPACT trials. The results of the biologic-experienced PASI 90 data were prespecified in the integrated summary of efficacy analysis but not adjusted for multiplicity.
bPatients taking CIMZIA 200 mg Q2W received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
IL, interleukin; MCMC, Markov Chain Monte Carlo; PASI, Psoriasis Area and Severity Index; PSO, plaque psoriasis; Q2W, every 2 weeks; TNF, tumor necrosis factor.
aPrimary biologic nonresponse was an exclusion criterion in all 3 trials. Missing data were imputed using multiple imputation based on the MCMC method. The PASI 75 analysis is a prespecified pooled efficacy analysis of the CIMPASI-1, CIMPASI-2, and CIMPACT trials. The results of the biologic-experienced PASI 90 data were prespecified in the integrated summary of efficacy analysis but not adjusted for multiplicity.
bPatients taking CIMZIA 200 mg Q2W received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
Important Safety Information
Use of TNF blockers, including CIMZIA, has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Treatment with TNF blockers, including CIMZIA, may rarely result in new onset or exacerbation of clinical symptoms and/or radiographic evidence of central or peripheral nervous system demyelinating disease, as well as the development of a lupus-like syndrome.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Proven efficacy regardless
of prior biologic treatment
Of the 850 patients randomized to receive placebo or CIMZIA in these studies, 30% had received prior biologic therapy* for the treatment of psoriasis (14% with ≥1 anti-TNF agent and 16% with an anti-IL agent)1
*Reason for discontinuation of prior biologic treatment unknown.
The CIMplicity® Navigator™ provides patient services designed for ease of patient initiation.
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
The CIMplicity® Navigator™ provides patient services designed for ease of patient initiation.
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
