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Time to choose a different PsA biologic? Choose CIMZIA.

Deliver rapid and durable results that provide meaningful relief.

In the RAPID-PsA study, 58% of patients treated with CIMZIA 200 mg Q2W (n=138) vs. 24% of patients taking placebo (n=136) achieved ACR20 at Week 12.1,2

ACR: American College of Rheumatology; PsA: psoriatic arthritis; Q2W: every 2 weeks.

RAPID-PsA study design2:

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 DMARDs (nonbiologic 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 non-responders were excluded.

CIMZIA delivered sustained joint improvements over 4 years

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

CIMZIA delivered sustained joint improvements over 4 years
CIMZIA delivered sustained joint improvements over 4 years

Some CIMZIA patients achieved an ACR20 response as early as 1 to 2 weeks1,2

  • 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
  • Limitation 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

*The same patients may not have responded at each time point.1-3

†Randomized set. Non-responder imputation.

‡P<0.001 vs. placebo.1-3

CIMZIA inhibited progression of structural damage

Mean change in mTSS at Week 241,2§||

RAPID-PsA study chart
RAPID-PsA study chart

Of those receiving CIMZIA 200 mg Q2W (n=98),
8 out 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

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

§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 analysis of covariance. For patients with two 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; 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.

RAPID-PsA study design2:

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 DMARDs (nonbiologic 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 non-responders were excluded.

CIMZIA delivered improvements in patients’ skin over 4 years

PASI75/90/100 response rate in a subpopulation of CIMZIA 200 mg Q2W patients with PsA (n=90)1,2*†

PASI75/90/100 response rate in a subpopulation of CIMZIA 200 mg Q2W patients with PsA (n=90)1,2,4*†
PASI75/90/100 response rate in a subpopulation of CIMZIA 200 mg Q2W patients with PsA (n=90)1,2,4*†
  • Placebo rates at Week 24—PASI90: 6%; PASI100: 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

*RS-NRI: randomized set non-responder imputation.

†PASI75 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.

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.

RAPID-PsA study design2:

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 DMARDs (nonbiologic 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 non-responders were excluded.

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

Total resolution of enthesitis over 4 years (post hoc analysis of combined doses from 4-year OLE of RAPID-PsA)(2,7)
Total resolution of enthesitis over 4 years (post hoc analysis of combined doses from 4-year OLE of RAPID-PsA)(2,7)

~7 out of every 10 patients with baseline involvement went on to achieve total resolution of enthesitis over 4 years3,4

Post hoc analysis: Total resolution of enthesitis defined as the percent of patients with baseline involvement defined by LEI >0 achieving complete clearance (LEI=0).

  • 63% of CIMZIA patients and 67% of placebo patients had enthesitis at baseline2
  • Pre-specified secondary end point was “Change from baseline in the LEI at Weeks 12 and 24 (other timepoints 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 dactylitis over 4 years (RS, LOCF) (post hoc analysis from 4‑year OLE of RAPID-PsA)3,4

RAPID-PsA study chart
RAPID-PsA study chart

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

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
  • Pre-specified secondary end point was “Change from baseline in LDI at Weeks 12 and 24 (other timepoints 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 CZP 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 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

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)(2,7)
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)(2,7)

~6 out of every 10 patients with baseline involvement went on to achieve total resolution of nail psoriasis over 4 years3,4

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 modified (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 pre-specified other efficacy variable
  • Limitations of OLE 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

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

CZP: certolizumab pegol; DMARD: disease-modifying antirheumatic drug; LDI: Leeds Dactylitis Index; LEI: Leeds Enthesitis Index; LOCF: last observation carried forward; mNAPSI: 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.

RAPID-PsA study design2:

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 DMARDs (nonbiologic 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 non-responders were excluded.

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

ACR20/50/70 response at Year 43*

RAPID-PsA 4-year OLE study chart
RAPID-PsA 4-year OLE study chart
  • 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 non-responders excluded1,4
  • Limitations of open-label extension data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24

*Randomized set—NRI.

†CIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W.

ACR: American College of Rheumatology; DMARD: disease-modifying antirheumatic drug; NRI: non-responder imputation; PsA: psoriatic arthritis; Q2W: every 2 weeks; Q4W: every 4 weeks; TNFi: tumor necrosis factor inhibitor.

RAPID-PsA study design2:

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 DMARDs (nonbiologic 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 non-responders were excluded.

CIMZIA helped patients achieve a reduction in pain that lasts

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

Change from baseline in patients’ global assessment of arthritis pain through Year 42,7*†
Change from baseline in patients’ global assessment of arthritis pain through Year 42,7*†

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

  • 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

*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.

Help patients get back to daily life with CIMZIA

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

Mean improvement from baseline in physical function—PsA HAQ-DI improvement through Week 24(1,6,7‡)
Mean improvement from baseline in physical function—PsA HAQ-DI improvement through Week 24(1,6,7‡)

8 meaningful measures for patients: HAQ-DI

Misc. icon grouping
Misc. icon grouping
  • 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

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

ACR: American College of Rheumatology; DMARD: disease-modifying antirheumatic drug; HAQ-DI: Health Assessment Questionnaire Disability Index; LOCF: last observation carried forward; MCID: minimum 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.

Safety profile through 24 weeks in RAPID-PsA1,2

Incidence of TEAEs through Week 242

Incidence of TEAEs through Week 24 chart
Incidence of TEAEs through Week 24 chart

*Placebo escape at Week 16; data not adjusted for exposure.2

†Myocardial infarction. Considered unrelated to study medication by investigators.2

TEAEs with an incidence of >3% of patients (CIMZIA 200 mg) through Week 241,4

TEAEs with an incidence of >3% of patients (CIMZIA 200 mg) through Week 24(1)
TEAEs with an incidence of >3% of patients (CIMZIA 200 mg) through Week 24(1)
  • Most AEs were mild to moderate in severity

‡Not adjusted for exposure.

§Placebo escape at Week 16.2

AE: adverse event; CPK: creatine phosphokinase; PsA: psoriatic arthritis; TEAE: treatment-emergent adverse event.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS

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.

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.