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References
1.

CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.

2.

Data on file. UCB, Inc., Smyrna, GA.

3.

Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from two phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314. e6.

4.

Gordon KB, Warren RB, Gottlieb AB, et al. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: three-year results from two randomised phase 3 trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2011. doi:10.1111/BJD.19393.

5.

Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73(1):48-55.

6.

van der Heijde D, Deodhar A, FitzGerald O, et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4(1):e000582.

7.

Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.

8.

Porter C, Armstrong-Fisher S, Kopotsha T, et al. Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): consequences for FcRn mediated in vitro transcytosis and ex vivo human placental transfer. J Reprod Immunol. 2016;116:7-12.

9.

Pasut G. PEGylation of biological molecules and potential benefits: pharmacological properties of certolizumab pegol. BioDrugs. 2014;28 (suppl 1):Section 15-Section 23.

10.

Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11):1323-1332.

11.

Enbrel [prescribing information]. Thousand Oaks, CA: Amgen Inc.

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Humira [prescribing information]. North Chicago, IL: Abbvie Inc.

13.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.

14.

Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.

15.

Ilumya [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.

16.

Siliq [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.

17.

Stelara [prescribing information]. Horsham, PA: Janssen Biotech, Inc.

18.

Taltz [prescribing information]. Indianapolis, IN: Eli Lilly and Company.

19.

Tremfya [prescribing information]. Horsham, PA: Janssen Biotech, Inc.

20.

Weir N, Athwal D, Brown D, et al. A new generation of high-affinity humanized PEGylated Fab’ fragment anti-tumor necrosis factor-alpha monoclonal antibodies. Therapy. 2006;3:535-545.

21.

Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev. 2002;54:531-545.

22.

Harris JM, Chess RB. Effect of PEGylation on pharmaceuticals. Nat Rev Drug Discov. 2003;2:214-221.

23.

Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79(2):266-276.e5.


Important Safety Information

Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.

References

Important Safety Information

Indications

CIMZIA (certolizumab pegol) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

CIMZIA is indicated for the treatment of adults with active psoriatic arthritis.


CONTRAINDICATIONS

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.


SERIOUS INFECTIONS

Patients treated with CIMZIA are at 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.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB 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. Consider empiric anti-fungal therapy 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.


Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start CIMZIA during an active infection, including localized infections.

Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.

If an infection develops, monitor carefully and initiate appropriate therapy.


MALIGNANCY

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.

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.

In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.

In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.

Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.

Cases of acute and chronic leukemia were reported with TNF blocker use.


HEART FAILURE

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.


HYPERSENSITIVITY

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. 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.


HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Test patients for HBV infection before initiating treatment with CIMZIA.

Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.

Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.


NEUROLOGIC REACTIONS

TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.


HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.

Consider stopping CIMZIA if significant hematologic abnormalities occur.


DRUG INTERACTIONS

Do not use CIMZIA in combination with other biological DMARDs.


AUTOIMMUNITY

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.


IMMUNIZATIONS

Patients on CIMZIA should not receive live or live-attenuated vaccines.


ADVERSE REACTIONS

The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).


Please see full Prescribing Information by visiting
cimziahcp.com.

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.

MCMC, Markov Chain Monte Carlo; PASI, Psoriasis Area and Severity Index; PSO, plaque psoriasis; Q2W, every 2 weeks; OLE, open-label extension.
aPASI 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.  
bEstimates of responder rate reflect the simple average response across multiple imputed data sets. Estimates presented are the results from MCMC models where missing data were imputed using the pooled analyses from Week 16 through Week 144 from CIMPASI-1, CIMPASI-2, and CIMPACT where the last 2 years were open label. All other missing data were imputed using multiple imputation based on MCMC methodology.
cEstimates of responder rate reflect the simple average response across the multiple imputed data sets. Estimates presented are the results from MCMC models where missing data were imputed using data across the entire 3-year period of pooled analyses from CIMPASI-1 and CIMPASI-2, where the last 2 years were open label.
dFor some patients (with body weight ≤90 kg), CIMZIA 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week, can be considered.
eAll patients received CIMZIA 200 mg Q2W at Week 48; dose adjustments were permitted during the open-label phase based on PASI response and were either mandatory or at the discretion of the investigator.

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).

IL, interleukin; MCMC, Markov Chain Monte Carlo; PASI, Psoriasis Area and Severity Index; PSO, plaque psoriasis; Q2W, every 2 weeks; TNF, tumor necrosis factor. 

MCMC, Markov Chain Monte Carlo; PASI, Psoriasis Area and Severity Index; PSO, plaque psoriasis; Q2W, every 2 weeks.
aEstimates of responder rate reflect the simple average response across multiple imputed data sets. Estimates presented are the results from MCMC models where missing data were imputed using the pooled analyses from Week 16 through Week 144 from CIMPASI-1, CIMPASI-2, and CIMPACT where the last 2 years were open label. All other missing data are imputed using multiple imputation based on MCMC methodology.

Primary/Key Secondary and Other End Points at Week 16 Across All 3 Trials1,2c-g*

CIMPASI-1e

PGA 0/1: Placebo (n=51) 4%; CIMZIA 200 mg Q2W (n=95) 45%; CIMZIA 400 mg Q2W (n=88) 55%

PASI 75: Placebo (n=51) 7%; CIMZIA 200 mg Q2W (n=95) 65%; CIMZIA 400 mg Q2W (n=88) 75%

PASI 90: Placebo (n=51) 0%; CIMZIA 200 mg Q2W (n=95) 36%; CIMZIA 400 mg Q2W (n=88) 44%

PASI 100: Placebo (n=51) 0%; CIMZIA 200 mg Q2W (n=95) 14%; CIMZIA 400 mg Q2W (n=88) 13%

CIMPASI-2e

PGA 0/1: Placebo (n=49) 3%; CIMZIA 200 mg Q2W (n=91) 61%; CIMZIA 400 mg Q2W (n=87) 65%

PASI 75: Placebo (n=49) 13%; CIMZIA 200 mg Q2W (n=91) 81%; CIMZIA 400 mg Q2W (n=87) 82%

PASI 90: Placebo (n=49) 5%; CIMZIA 200 mg Q2W (n=91) 50%; CIMZIA 400 mg Q2W (n=87) 52%

PASI 100: Placebo (n=49) 3%; CIMZIA 200 mg Q2W (n=91) 19%; CIMZIA 400 mg Q2W (n=87) 23%

CIMPACTf

PGA 0/1: Placebo (n=57) 4%; CIMZIA 200 mg Q2W (n=165) 52%; CIMZIA 400 mg Q2W (n=167) 62%

PASI 75: Placebo (n=57) 4%; CIMZIA 200 mg Q2W (n=165) 69%; CIMZIA 400 mg Q2W (n=167) 75%

PASI 90: Placebo (n=57) 0%; CIMZIA 200 mg Q2W (n=165) 40%; CIMZIA 400 mg Q2W (n=167) 49%

PASI 100: Placebo (n=57) 0%; CIMZIA 200 mg Q2W (n=165) 12%; CIMZIA 400 mg Q2W (n=167) 16%

Pooled PASI 75, PASI 90, and PASI 100 Responder Rates to Week 48 From CIMPASI-1 and CIMPASI-22a
Primary/Key Secondary and Other End Points at Week 16 Across All 3 Trials1,2c-g*
i

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.

Give your patients the possibility of longterm efficacy with

CIMZIA®

(certolizumab pegol)

Post Hoc Analysis: 3-year Pooled Responder Rates in Placebo Nonresponders who Escaped to CIMZIA 400 mg Q2W at Week 16 from CIMPASI-1, CIMPASI-2, and CIMPACT (Open Label)2a,b

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.

Pooled PASI Responder Rates at Week 16 in Biologic-Experienced Patients by Prior Biologic Class in CIMPASI-1, CIMPASI-2, and CIMPACT2a

*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.
a
Primary 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.

My skin symptoms are bothering me.
I need a solution that can work quickly.
I’m just so tired of feeling like I have to cover up my skin – especially in the summer!
Is there something that I can try that may continue to work over time?
I’d love to get back to the beach next summer with clearer skin, so I can enjoy the sunshine with my kids.
It’s definitely reassuring to hear that it’s been on the market for many years.
Thanks, I’m interested in seeing them.
Can this solution really work for me if I’ve previously used an anti‑TNF?
That’s helpful to know. Thank you!
Will I be able to afford my medication?
Will I be able to afford my medication?
I understand, and I want you to feel comfortable in your own skin. Let’s consider CIMZIA – it may help you find lasting relief from your skin symptoms.
There have been many patients who have maintained symptom relief out to 3 years!
I understand your wanting that for yourself…let me share some other things with you…
CIMZIA is an anti-TNF with a heritage that we have come to trust. We understand the risks and the benefits over many years and many indications. Let's discuss how CIMZIA may be able to help you and important safety information that we should consider.
I’d like to show you how CIMZIA may help relieve your skin symptoms. Here are some before and after photos of clinical trial patients with moderate to severe plaque psoriasis treated with CIMZIA.
Remember that individual results vary.
Yes, CIMZIA has shown comparable efficacy in patients who have previously been on an anti-TNF, who have previously been on an anti-IL-17, and for those in whom CIMZIA is their first biologic ever.
CIMZIA has also helped to relieve skin symptoms for some patients with a history of more than one anti-TNF.

Rapid skin improvement
that can last

CIMZIA 400 mg Q2W demonstrated numerically higher efficacy results for PSO patients than CIMZIA 200 mg Q2W

My skin symptoms are bothering me. I need a solution that can work quickly.
Yes, I understand wanting clearer skin.
Pooled PASI 75, PASI 90, and PASI 100 Responder Rates to Week 48 From CIMPASI-1 and CIMPASI-22a
Primary/Key Secondary and Other End Points at Week 16 Across All 3 Trials1,2c-g*
i

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.

I’m just so tired of feeling like I have to cover up my skin – especially in the summer!
Is there something that I can try that may continue to work over time?

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

I understand, and I want you to feel comfortable in your own skin. Let’s consider CIMZIA – it may help you find lasting relief from your skin symptoms.

Give your patients the possibility of longterm efficacy with

CIMZIA®

(certolizumab pegol)

Post Hoc Analysis: 3-year Pooled Responder Rates in Placebo Nonresponders who Escaped to CIMZIA 400 mg Q2W at Week 16 from CIMPASI-1, CIMPASI-2, and CIMPACT (Open Label)2a,b

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.

There have been many patients who have maintained symptom relief out to 3 years!
Open-label Extension: Week 48 to Week 144 Pre-specified Pooled Responder Rates in CIMPASI-1 and CIMPASI-24

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.

I’d love to get back to the beach next summer with clearer skin, so that I can enjoy the sunshine with my kids.

Post hoc analysis

Pooled PASI responder rates for CIMZIA 400 mg Q2W (n=116) at Week 1442a

PASI 75
PASI 90
PASI 100

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.

I understand your wanting that for yourself…let me share some other things with you…
CIMZIA is an anti-TNF with a heritage that we have come to trust. We understand the risks and the benefits over many years and many indications. Let's discuss how CIMZIA may be able to help you and important safety information that we should consider.
It’s definitely reassuring to hear that it’s been on the market for many years.
I’d like to show you how CIMZIA may help relieve your skin symptoms. Here are some before and after photos of clinical trial patients with moderate to severe plaque psoriasis treated with CIMZIA. Remember that individual results vary.
Thanks, I’m interested in seeing them.

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.

Can this solution really work for me if I’ve previously used an anti-TNF?

Proven efficacy regardless of prior biologic treatment

Comparable skin clearance in biologic-experienced vs biologic-naïve patients

Yes, CIMZIA has shown comparable efficacy in patients who have previously been on an anti-TNF, who have previously been on ananti-IL-17, and for those in whom CIMZIA is their first biologic ever.
Pooled PASI Responder Rates at Week 16 in Biologic-Experienced Patients by Prior Biologic Class in CIMPASI-1, CIMPASI-2, and CIMPACT2a

*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.
a
Primary 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.

CIMZIA has also helped to relieve skin symptoms for some patients with a history of more than one anti-TNF.
That’s helpful to know. Thank you!
Will I be able to afford my medication?

Important Safety Information You Should Know About CIMZIA® (certolizumab pegol) 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.

Important Safety Information & Indications
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Christopher's story
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Christopher's story

Important Safety Information You Should Know About CIMZIA® (certolizumab pegol) 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.

Important Safety Information

Indications

CIMZIA (certolizumab pegol) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

CIMZIA is indicated for the treatment of adults with active psoriatic arthritis.


CONTRAINDICATIONS

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.


SERIOUS INFECTIONS

Patients treated with CIMZIA are at 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.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB 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. Consider empiric anti-fungal therapy 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.


Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start CIMZIA during an active infection, including localized infections.

Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.

If an infection develops, monitor carefully and initiate appropriate therapy.


MALIGNANCY

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.

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.

In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.

In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.

Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.

Cases of acute and chronic leukemia were reported with TNF blocker use.


HEART FAILURE

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.


HYPERSENSITIVITY

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. 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.


HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Test patients for HBV infection before initiating treatment with CIMZIA.

Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.

Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.


NEUROLOGIC REACTIONS

TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.


HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.

Consider stopping CIMZIA if significant hematologic abnormalities occur.


DRUG INTERACTIONS

Do not use CIMZIA in combination with other biological DMARDs.


AUTOIMMUNITY

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.


IMMUNIZATIONS

Patients on CIMZIA should not receive live or live-attenuated vaccines.


ADVERSE REACTIONS

The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).


Please see full Prescribing Information by visiting
cimziahcp.com.

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