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Deliver rapid and durable results that provide meaningful relief.

In the RAPID-axSpA study, 57% of patients treated with CIMZIA 200 mg Q2W (n=65) vs. 37% of patients taking placebo (n=57) achieved ASAS20 at Week 12.1

AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; Q2W: every 2 weeks.

RAPID-axSpA study design2,3:

The RAPID-axSpA trial (nr-axSpA and AS patients) was a 204-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 325 patients aged ≥18 years who had either nr-axSpA (n=147) or AS (n=178). Patients were randomized to CIMZIA 200 mg Q2W (n=111), CIMZIA 400 mg Q4W (n=107), or placebo (n=107). CIMZIA-treated patients were given a loading dose of 400 mg of CIMZIA at Weeks 0, 2, and 4. The 24-week, double-blind, placebo-controlled period was followed by a dose-blind phase. CIMZIA-treated patients continued to receive their original dose regimen after Week 24 (200 mg Q2W [n=105] or 400 mg Q4W [n=98]). Placebo-treated patients who did not achieve an ASAS20 response at Weeks 14 and 16 were re-randomized to CIMZIA 200 mg Q2W (n=27) or CIMZIA 400 mg Q4W (n=29), and those who completed therapy to Week 24 were re-randomized to CIMZIA 200 mg Q2W (n=20) or CIMZIA 400 mg Q4W (n=21). An open-label period followed at Week 48 and continued to Week 204. Note: At the conclusion of the RAPID-axSpA study, CIMZIA was not yet approved for treating patients with nr-axSpA.

Sustained improvement in signs and symptoms of AS over 4 years

ASAS20/40 response rates in an AS subpopulation through Year 41,2,4*†

RAPID-axSpA study chart
RAPID-axSpA study chart

Some experienced ASAS20 responses as early as 1 to 2 weeks after starting CIMZIA1,2

  • Placebo rates at Week 242
    • ASAS20: 33%
    • ASAS40: 16%
  • ASAS criteria measure improvements in pain, function, morning stiffness, and patients’ overall assessment of disease activity
  • Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24‖

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

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

‡ASAS20 at Week 12 in the AS subpopulation was a pre-specified analysis of the primary efficacy endpoint. Nominal P value.

§ASAS20 and ASAS40 at Week 204 were pre-specified secondary endpoints.

‖Line graph to Week 204 represents patients who were randomized initially to CIMZIA 200 mg Q2W.

AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; OLE: open-label extension; Q2W: every 2 weeks.

RAPID-axSpA study design2,3:

The RAPID-axSpA trial (nr-axSpA and AS patients) was a 204-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 325 patients aged ≥18 years who had either nr-axSpA (n=147) or AS (n=178). Patients were randomized to CIMZIA 200 mg Q2W (n=111), CIMZIA 400 mg Q4W (n=107), or placebo (n=107). CIMZIA-treated patients were given a loading dose of 400 mg of CIMZIA at Weeks 0, 2, and 4. The 24-week, double-blind, placebo-controlled period was followed by a dose-blind phase. CIMZIA-treated patients continued to receive their original dose regimen after Week 24 (200 mg Q2W [n=105] or 400 mg Q4W [n=98]). Placebo-treated patients who did not achieve an ASAS20 response at Weeks 14 and 16 were re-randomized to CIMZIA 200 mg Q2W (n=27) or CIMZIA 400 mg Q4W (n=29), and those who completed therapy to Week 24 were re-randomized to CIMZIA 200 mg Q2W (n=20) or CIMZIA 400 mg Q4W (n=21). An open-label period followed at Week 48 and continued to Week 204. Note: At the conclusion of the RAPID-axSpA study, CIMZIA was not yet approved for treating patients with nr-axSpA.

CIMZIA demonstrated consistent improvements in disease activity through 4 years1,2,4

BASDAI improvement from baseline through Year 4 in AS1,2,4*†

RAPID axSpA study image
RAPID axSpA study image

BASDAI components of disease activity

ASIconsASIcons

Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24 and potential enrichment of population with responders.

The BASDAI consists of a 0 to 10 numerical rating scale, which is used to answer questions pertaining to major symptoms of AS.5

Baseline BASDAI score was 6.52 for CIMZIA patients and 6.44 for patients treated with placebo.2,4

*RS-LOCF: randomized set last observation carried forward.

†Change from baseline in BASDAI scores in the AS subpopulation was a pre-specified endpoint. Nominal P value.

‡MCID was defined as a reduction of 1 unit on the NRS.4

CIMZIA provided AS patients with meaningful improvements in back pain

Total and nocturnal spine pain improvement from baseline through Week 244§||

RAPID axSpA study image
RAPID axSpA study image
  • Total spine pain is a component of ASAS response criteria measured by a 10-point NRS6
  • Results were similar for both total spine pain and nocturnal back pain through Week 244
  • MCID was defined as a reduction of 1 unit on the NRS4
  • Baseline total and nocturnal spine pain scores were 7.0 and 6.7 for CIMZIA patients and 7.3 and 7.3 for patients treated with placebo, respectively4

§FAS-LOCF: full analysis set last observation carried forward.

||Nocturnal back pain was evaluated by a 10-point numeric rating scale.

Change from baseline in total spine pain scores in the AS subpopulation was a prespecified endpoint. Nominal P value.

Significant clinical improvements in physical function in AS patients1,2,4

BASFI improvement through Week 241,2,4#

RAPID axSpA study image
RAPID axSpA study image

At 24 weeks, CIMZIA demonstrated a 2.7-fold greater percent improvement in functioning from baseline vs. placebo2

  • Change from baseline in BASFI scores in the AS sub-population represents improvements in patients’ ability to perform certain activities of daily living, which was a pre-specified secondary endpoint. Nominal P value
  • MCID was defined as a reduction from baseline of -1 unit on the BASFI NRS in RAPID-axSpA

#RS-LOCF: randomized set last observation carried forward.

AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; MCID: minimum clinically important difference; MTX: methotrexate; NRS: numeric rating scale; OLE: open-label extension; Q2W: every 2 weeks.

Safety profile through 24 weeks in the AS subpopulation of RAPID-axSpA1,4

Incidence of TEAEs through Week 241,4

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

*For the entire placebo group, CIMZIA data from placebo subjects are not utilized.

†Drug-related TEAEs are those with a relationship of “related,” “possibly related,” or those with missing responders.

Adverse events in ≥5% of patients (CIMZIA 200 mg) through Week 241,4

Adverse events through Week 24 chart
Adverse events through Week 24 chart

*For the entire placebo group, CIMZIA data from placebo subjects are not utilized.

AS: ankylosing spondylitis; 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.