Rapid and durable efficacy

CIMZIA delivered sustained joint improvement over 4 years

  • Placebo (n=136) rates at Week 24: 
ACR20: 24%; ACR50: 13%; ACR70: 4%1,2
  • ACR response criteria assess changes in swollen and tender joints, pain, functional ability, patient and physician global assessment, and acute-phase reactant
  • Limitations of OLE data: Potential bias due to open-label treatment and no long-term placebo comparator for ACR responder rates beyond Week 24
  • Line graph to Week 216 represents patients who were randomized initially to CIMZIA 200 mg Q2W

ACR20/50/70 response rates in CIMZIA 200 mg Q2W patients (n=138)1-3*†

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Some patients experienced ACR20 response as early as 1 to 2 weeks after starting CIMZIA1,3

*The same patients may not have responded at each time point.1-3
†RS-NRI: randomized set nonresponder imputation.
‡P<0.001 vs. placebo.1-3

Study design

RAPID-PsA2

RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARD (non-biologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135), or placebo (n=136). Patients were stratified by prior TNFi exposure; primary nonresponders were excluded.

CIMZIA inhibited progression of structural damage

  • Patients treated with CIMZIA 400 mg Q4W did not demonstrate greater inhibition of radiographic progression compared with placebo-treated patients at Week 24
  • Limitations of OLE data include potential bias due to open-label treatment, lack of long-term placebo control beyond Week 24, and potential enrichment of population with responders

Mean change in mTSS at Week 241,2§||

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Of those receiving CIMZIA 200 mg Q2W (n=98), 8 of 10 X-rayed patients experienced no radiographic progression over 4 years3¶

X-rayed patients receiving CIMZIA 200 mg Q2W were analyzed using observed case analysis. Radiographic data do not have long-term placebo comparison beyond 24 weeks.

§Randomized set; for placebo patients who escaped early to CIMZIA, the Week 24 values were linearly extrapolated; ANCOVA model.3  
||For placebo patients who escaped early to CIMZIA, the Week 24 values were linearly extrapolated. The P value of CIMZIA vs. placebo is based on ANCOVA. For patients with 2 radiographs, but a missing Week 24 or baseline film, linear
extrapolation was performed in all approaches.  
¶“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.4 

ACR, American College of Rheumatology; ACR20, American College of Rheumatology criteria for 20% response; ACR50, American College of Rheumatology criteria for 50% response; ACR70, American College of Rheumatology criteria for 70% response; ANCOVA, analysis of covariance; DMARD, disease-modifying antirheumatic drug; mTSS, modified Total Sharp Score; OLE, open-label extension; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNFi, tumor necrosis factor inhibitor.

Long-term skin clearance

CIMZIA delivered skin improvements over 4 years

  • Placebo rates at Week 24: PASI 90: 6%; PASI 100: 2%2
  • Baseline psoriatic skin involvement ≥3% of body surface area (62% overall) and median PASI at baseline was 7.1 for placebo and 7.0 for CIMZIA2
  • Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24

PASI 75/90/100 response rates in a subpopulation of CIMZIA 200 mg Q2W patients with PsA (n=90)1,2*†

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*RS-NRI: randomized set nonresponder imputation.
†PASI 75 response rate at Week 24 in patients with baseline psoriatic skin involvement ≥3% body surface area was a prespecified secondary end point for the combined-dose CIMZIA group.
‡Nominal P value.

Study design

RAPID-PsA2

RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARD (non-biologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135), or placebo (n=136). Patients were stratified by prior TNFi exposure; primary nonresponders were excluded.

DMARD, disease-modifying antirheumatic drug; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNFi, tumor necrosis factor inhibitor.

Resolution of enthesitis, dactylitis, and nail psoriasis

Post hoc analysis: Total resolution of enthesitis defined as reduction to LEI=0 from baseline LEI >0.

  • 63% of CIMZIA patients and 67% of placebo patients had enthesitis at baseline2
  • Prespecified secondary end point was change from baseline in LEI at Weeks 12 and 24 (other time points were exploratory)
  • Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
  • This subgroup analysis is a post hoc analysis. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant

Total resolution of enthesitis over 4 years (post hoc analysis of combined doses from 4-year OLE of RAPID-PsA)3,4

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~7 of every 10 patients with baseline involvement achieved total resolution of enthesitis over 4 years3,4

Post hoc analysis, RS, LOCF (n=35 patients with LDI >0 at baseline): Total resolution defined as LDI=0 in patients who at baseline had at least 1 digit affected and with a difference in circumference ≥10% compared with the opposite digit LDI >0.

  • 34% of CIMZIA patients and 33% of placebo patients had dactylitis at baseline4
  • Prespecified secondary end point was change from baseline in LDI at Weeks 12 and 24 (other time points were exploratory)
  • Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
  • This subgroup analysis is a post hoc 
analysis of the CIMZIA 200 mg study arm of RAPID-PsA. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant
     

Total resolution of dactylitis over 4 years (RS, LOCF) (post hoc analysis
from 4‑year OLE of RAPID-PsA)3,4

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>8 of every 10 patients with baseline involvement achieved total resolution of dactylitis3,4

Post hoc analysis: Total resolution rates for nail psoriasis in the most severe nail of the hand are presented for patients affected by this condition at baseline. This condition was defined at baseline as mNAPSI >0 for nail psoriasis.3,4

  • Change from baseline in mNAPSI score in the subgroup of subjects with psoriatic nail disease at baseline was a prespecified other efficacy variable
  • Limitations of OLE data include potential for enrichment of long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue. This subgroup analysis is a post hoc analysis. The 
RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant

Total resolution of nail psoriasis in the most severe nail of the hand over 4 years (LOCF) (post hoc analysis from 4-year OLE of RAPID-PsA)3,4

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~6 of every 10 patients with baseline involvement achieved total resolution of nail psoriasis over 4 years3,4

*92 patients of the 138 patients in the CIMZIA 200 mg Q2W arm had baseline nail disease and were evaluated through Week 216.

Study design

RAPID-PsA2

RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARD (non-biologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135), or placebo (n=136). Patients were stratified by prior TNFi exposure; primary nonresponders were excluded.

CZP, certolizumab pegol; DMARD, disease-modifying antirheumatic drug; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LOCF, last observation carried forward; mNAPSI, modified Nail Psoriasis Severity Index; OLE, open-label extension; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; RS, randomized set; TNFi, tumor necrosis factor inhibitor.

Efficacy in TNFi-experienced patients

Improvement in signs and symptoms regardless of prior TNFi experience3,4

  • Primary efficacy variable of ACR20 response at Week 12 (P<0.001). ACR20 responses for CIMZIA 200 mg Q2W and placebo were 58% and 24%, respectively1,4
  • 20% of patients had prior TNFi exposure, primary nonresponders excluded1,4
  • Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24

ACR20/50/70 response rates at Year 43*

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*RS-NRI: randomized set nonresponder imputation.
†CIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W.

Study design

RAPID-PsA2

RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARD (non-biologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135), or placebo (n=136). Patients were stratified by prior TNFi exposure; primary nonresponders were excluded.

ACR, American College of Rheumatology; DMARD, disease-modifying antirheumatic drug; OLE, open-label extension; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNFi, tumor necrosis factor inhibitor.

Minimal disease activity

MDA: A holistic treatment goal for patients with PsA

MDA is a single holistic treatment goal that encompasses multiple measures commonly used by rheumatologists to assess PsA patients.

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CIMZIA helped ~6 of 10 patients achieve MDA at Year 43

  • Post hoc analysis: In RAPID-PsA, MDA (fulfilling ≥5 of 7 criteria) in patients randomized initially to either CIMZIA dose level (200 mg Q2W or 400 mg Q4W) was analyzed post hoc.

At Year 4:

  • 58% and 39% of patients treated with CIMZIA achieved MDA by OC and NRI, respectively

  • Limitation of OLE: Responder rates do not have long-term placebo comparator beyond Week 24

MDA over 216 weeks (post hoc analysis of combined doses from 4-year OLE of RAPID-PsA)3

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Study population included in bio-naïve and bio-experienced patients

*n at Week 216.

GRAPPA: Updated treatment recommendations for PsA 20216

In the most recent update to GRAPPA treatment recommendations, the goals of therapy for all patients with PsA are:

  • To achieve the lowest possible level of disease activity, including LDA or MDA in all domains of disease
  • To optimize functional status
  • To minimize complications

See guidelines for full recommendations. This information is not intended to be medical advice.

Study design

RAPID-PsA2

RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARD (non-biologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135), or placebo (n=136). Patients were stratified by prior TNFi exposure; primary nonresponders were excluded.

DMARD, disease-modifying antirheumatic drug; GRAPPA, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis; LDA, low disease activity; MDA, minimal disease activity; NRI, nonresponder imputation; OC, observed case; OLE, open-label extension; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNFi, tumor necrosis factor inhibitor; VAS, visual analog scale.

Meaningful relief patients can feel

CIMZIA helped patients achieve lasting pain reduction

  • Baseline pain score was 60 (VAS: 0=no pain and 100=most severe pain) for both the placebo arm and the CIMZIA 200 mg Q2W arm3,4†
  • Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24

Change from baseline in patient global assessment of arthritis pain through Year 43,4*†

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50% reduction in pain score at Year 4 with CIMZIA 
200 mg Q2W3,4

*Pain assessment is a part of the ACR score. Pain assessment is done by the patient, hence individual assessment/score may vary from patient to patient. Patient assessment of arthritis pain, VAS: 0=no pain and 100=most severe pain. 
†Randomized set. LOCF is used for missing data, early withdrawals, or placebo escape.
 

Study design

RAPID-PsA2

RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARD (non-biologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135), or placebo (n=136). Patients were stratified by prior TNFi exposure; primary nonresponders were excluded.

Help improve 8 key functions in patients’
daily lives

  • Change from baseline in HAQ-DI scores represents improvements in patients’ ability to perform certain activities of daily living in the RAPID-PsA study. Physical function was a prespecified end point
  • MCID was defined as a reduction in HAQ-DI from baseline of ≥0.3

Mean improvement from baseline in physical function—PsA HAQ-DI improvement through Week 241,2,4‡

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‡ITT-LOCF: intent-to-treat last observation carried forward. 

ACR, American College of Rheumatology; ACR20, American College of Rheumatology criteria for 20% response; ACR50, American College of Rheumatology criteria for 50% response; ACR70, American College of Rheumatology criteria for 70% response; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire Disability Index; LOCF, last observation carried forward; MCID, minimal clinically important difference; OLE, open-label extension; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNFi, tumor necrosis factor inhibitor; VAS, visual analog scale.

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IMPORTANT SAFETY INFORMATION & INDICATIONS

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.

INDICATIONS

CIMZIA is indicated for:

  • Reducing 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
  • Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
  • Treatment of adult patients with active psoriatic arthritis (PsA)
  • Treatment of adults with active ankylosing spondylitis (AS)
  • Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
  • Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

IMPORTANT SAFETY INFORMATION (CONT)

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 refer to full Prescribing Information.