Rapid results

Why focus on ASDAS: It is a validated, highly discriminatory instrument for assessing a patient’s disease activity3,4

Iconography of a person's torso and arms with pain indicating shapes in the chest area. Iconography of a test tube with a drop of liquid inside. Graphic showcasing effectiveness of ASDAS study, highlighting a patient’s disease activity from INACTIVE to VERY HIGH.
Iconography of a person's torso and arms with pain indicating shapes in the chest area. Iconography of a test tube with a drop of liquid inside. Graphic showcasing effectiveness of ASDAS study, highlighting a patient’s disease activity from INACTIVE to VERY HIGH.

Rapid results—clinical response in some patients within 2 weeks1,2,5

  • Utilization and dosage adjustment of NBBM (including NSAIDs, DMARDs, corticosteroids, opioids, and non-opioid analgesics) were permitted at any time1
  • Patient-reported outcomes were back pain, duration of morning stiffness, Patient Global Assessment of Disease Activity, and peripheral pain/swelling6,7

ASDAS-MI responders (FAS,NRI)1,5

Graphic that showcases ASAS40 responders.
Graphic that showcases ASAS40 responders.

*ASDAS-MI was defined as a change from baseline of ≥2.0 in the ASDAS and/or reaching the lowest possible ASDAS value (0.6). The same patients may not have responded at each time point.2
† Nominal P value. 
‡P <0.0001.
 

Study design

C-axSpAnd1,2,8

C-axSpAnd was a Phase 3, multicenter study investigating the efficacy and safety of CIMZIA in patients with nr-axSpA and objective signs of inflammation. C-axSpAnd consisted of a 1-year, randomized, double-blind, placebo-controlled period (Weeks 0-52) and a 2-year, open-label, safety follow-up extension (SFE; Weeks 52-156).

 

In the double-blind period of C-axSpAnd, 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for ≥12 months, but without definitive radiographic evidence of structural damage on sacroiliac joints, were randomized 1:1 to CIMZIA (400 mg loading dose at Weeks 0, 2, and 4, followed by 200 mg Q2W; n=159) or placebo (n=158), which they received in addition to their current NBBM. Patients could make allowed changes to their NBBM or switch to open-label CIMZIA at any time during the study, although changes before Week 12 were discouraged.

 

At Week 52 of the study, patients from both initial treatment groups (including those who had switched to open-label CIMZIA), who completed the double-blind period and consented to entering the SFE (n=243), received open-label CIMZIA 200 mg Q2W (in addition to NBBM) for an additional 104 weeks. Safety and clinical outcome data were analyzed descriptively by initial randomization groups.

ASAS criteria measure improvements in pain, function, morning stiffness, and patients’ overall assessment of disease activity. ASAS40 is an improvement of ≥40% and ≥2 units in 3 domains on a scale of 10.


 

The same patients may not have responded at all time points.

ASAS40 responders (FAS,NRI)1,5§

Chart
Chart

§Secondary efficacy variable.  
||P<0.0001.  
Nominal P value.  
 

ASAS, Assessment of SpondyloArthritis international Society; ASDAS-MI, Axial Spondyloarthritis Disease Activity Score-Major Improvement; DMARD, disease-modifying antirheumatic drug; FAS, full analysis set; NBBM, non-biologic background medication; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, nonresponder imputation; NSAID, nonsteroidal anti-inflammatory drug; Q2W, every 2 weeks.

Durable efficacy

Durable improvements were felt at 1 year and at 3 years1,2,8

  • ASDAS-MI was defined as a reduction from baseline of ≥2.0 in the ASDAS and/or reaching the lowest possible ASDAS value (0.6)
  • Utilization and dosage adjustment of NBBM (including NSAIDs, DMARDs, corticosteroids, opioids, and non-opioid analgesics) were permitted at any time, subject to restrictions published previously

ASDAS-MI responders

Graphic that showcases ASDAS-MI responders at year 1 and at 3 years.
Graphic that showcases ASDAS-MI responders at year 1 and at 3 years.

46% of patients initially randomized to CIMZIA in C-axSpAnd achieved ASDAS-MI at Year 3 using observed case analysis (n=95)

C-axSpAnd included the 1-year pivotal trial followed by a 2-year safety extension.

  • ASAS criteria measure improvements in pain, function, morning stiffness, and patients’ overall assessment of disease activity. ASAS40 is an improvement of ≥40% and ≥2 units in 3 domains on a scale of 107

ASAS40 responders
 

Graphic that showcases ASAS40 responders at year 1 and year 3.
Graphic that showcases ASAS40 responders at year 1 and year 3.

68% of patients initially randomized to CIMZIA in C-axSpAnd achieved ASAS40 at Year 3 using observed case analysis (n=96)

*Data are from C-axSpAnd, FAS, NRI; P<0.0001 CIMZIA vs. placebo. 
†Data are from C-axSpAnd SFE, patients initially randomized to CIMZIA in C-axSpAnd, NRI. There was no placebo comparator.

Study design

C-axSpAnd1,2,8

C-axSpAnd was a Phase 3, multicenter study investigating the efficacy and safety of CIMZIA in patients with nr-axSpA and objective signs of inflammation. C-axSpAnd consisted of a 1-year, randomized, double-blind, placebo-controlled period (Weeks 0-52) and a 2-year, open-label, safety follow-up extension (SFE; Weeks 52-156).

 

In the double-blind period of C-axSpAnd, 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for ≥12 months, but without definitive radiographic evidence of structural damage on sacroiliac joints, were randomized 1:1 to CIMZIA (400 mg loading dose at Weeks 0, 2, and 4, followed by 200 mg Q2W; n=159) or placebo (n=158), which they received in addition to their current NBBM. Patients could make allowed changes to their NBBM or switch to open-label CIMZIA at any time during the study, although changes before Week 12 were discouraged.
 

At Week 52 of the study, patients from both initial treatment groups (including those who had switched to open-label CIMZIA), who completed the double-blind period and consented to entering the SFE (n=243), received open-label CIMZIA 200 mg Q2W (in addition to NBBM) for an additional 104 weeks. Safety and clinical outcome data were analyzed descriptively by initial randomization groups.

ASAS, Assessment of SpondyloArthritis international Society; ASDAS-MI, Axial Spondyloarthritis Disease Activity Score-Major Improvement; DMARD, disease-modifying antirheumatic drug; FAS, full analysis set; NBBM, non-biologic background medication; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, nonresponder imputation; NSAID, nonsteroidal anti-inflammatory drug; Q2W, every 2 weeks; SFE, safety follow-up extension.

Meaningful improvements

Meaningful improvement in disease activity2,4,5,8,9

  • Comparison of the distribution of patients treated with CIMZIA by ASDAS disease activity category at baseline, Week 52 (includes only patients who remained on CIMZIA treatment from Weeks 0 to 52), and Week 156 (includes only patients who remained on CIMZIA from Weeks 0 to 156). Observed case analysis

ASDAS disease activity category distribution of CIMZIA + NBBM patients

Multiple graphics that showcase ASDAS disease activity category distribution.
Multiple graphics that showcase ASDAS disease activity category distribution.

Symptom reduction through Week 12

Graphic of symptom reduction through week 12.
Graphic of symptom reduction through week 12.

*BASDAI is composed of patient-reported outcomes.
†In patients with a baseline MASES score >0. Nominal P value; efficacy variable not in hierarchy, not adjusted for multiplicity.
‡Percentage change from baseline.
§P<0.001 vs. placebo.
||Nominal P value.
Baseline value.

Meaningful improvement in nocturnal spinal pain2,5

Differences at Week 52 vs. placebo#

  • The mean change from baseline was -3.1 vs. -0.9 for placebo1

Nocturnal spinal pain change from baseline**

Graphic of spinal pain changes from baseline.
Graphic of spinal pain changes from baseline.

At Week 12, patients on CIMZIA experienced a reduction in total spinal pain

#Results were derived using the FAS data block LOCF. Both groups in addition to optimized NBBM.
**See Table 13 in CIMZIA Prescribing Information for total spinal pain data.
††Week 12: Efficacy variable not in hierarchy, not adjusted for multiplicity. Week 52: Secondary efficacy variable in hierarchy.
‡‡CIMZIA vs placebo. All time points other than Week 52 have nominal P values.

Study design

C-axSpAnd1,2,8

C-axSpAnd was a Phase 3, multicenter study investigating the efficacy and safety of CIMZIA in patients with nr-axSpA and objective signs of inflammation. C-axSpAnd consisted of a 1-year, randomized, double-blind, placebo-controlled period (Weeks 0-52) and a 2-year, open-label, safety follow-up extension (SFE; Weeks 52-156).
 

In the double-blind period of C-axSpAnd, 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for ≥12 months, but without definitive radiographic evidence of structural damage on sacroiliac joints, were randomized 1:1 to CIMZIA (400 mg loading dose at Weeks 0, 2, and 4, followed by 200 mg Q2W; n=159) or placebo (n=158), which they received in addition to their current NBBM. Patients could make allowed changes to their NBBM or switch to open-label CIMZIA at any time during the study, although changes before Week 12 were discouraged.
 

At Week 52 of the study, patients from both initial treatment groups (including those who had switched to open-label CIMZIA), who completed the double-blind period and consented to entering the SFE (n=243), received open-label CIMZIA 200 mg Q2W (in addition to NBBM) for an additional 104 weeks. Safety and clinical outcome data were analyzed descriptively by initial randomization groups.

ASDAS, Axial Spondyloarthritis Disease Activity Score; BASDAI, Bath Axial Spondyloarthritis Disease Activity Index; BASFI, Bath Axial Spondyloarthritis Functional Index; FAS, full analysis set; LOCF, last observation carried forward; MASES, Maastricht Axial Spondyloarthritis Enthesitis Score; NBBM, non-biologic background medication; nr-axSpA, non-radiographic axial spondyloarthritis; Q2W, every 2 weeks; SPARCC, SpondyloArthritis Research Consortium of Canada.

Impact on patients

Meaningful improvements in SIJ inflammation2,5

  • Significant differences in MRI observed at Week 12 vs. placebo*†

Change in MRI assessment of inflammatory activity 
in SIJ (SPARCC, observed case analysis)

Graphic of change in MRI assessment of inflammatory activity in SIJ (SPARCC, observed case analysis) between baseline, week 12, and week 52.
Graphic of change in MRI assessment of inflammatory activity in SIJ (SPARCC, observed case analysis) between baseline, week 12, and week 52.

*The relationship between this improvement

and clinical outcomes is unknown.

†Both groups in addition to optimized NBBM.  
‡Week 12: Secondary efficacy variable in hierarchy. Week 52: 

Efficacy variable not in hierarchy, not adjusted for multiplicity. 
 

Patients reported improved work productivity by Week 12 and Week 525

Graphic showcasing patients reported improved work productivity by week 12 and week 52.
Graphic showcasing patients reported improved work productivity by week 12 and week 52.

§Results were derived using the FAS data block.
||Weeks 12 and 52: Efficacy variables not in hierarchy, not adjusted for multiplicity.2

Study design

C-axSpAnd1,2,8

C-axSpAnd was a Phase 3, multicenter study investigating the efficacy and safety of CIMZIA in patients with nr-axSpA and objective signs of inflammation. C-axSpAnd consisted of a 1-year, randomized, double-blind, placebo-controlled period (Weeks 0-52) and a 2-year, open-label, safety follow-up extension (SFE; Weeks 52-156).
 

In the double-blind period of C-axSpAnd, 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for ≥12 months, but without definitive radiographic evidence of structural damage on sacroiliac joints, were randomized 1:1 to CIMZIA (400 mg loading dose at Weeks 0, 2, and 4, followed by 200 mg Q2W; n=159) or placebo (n=158), which they received in addition to their current NBBM. Patients could make allowed changes to their NBBM or switch to open-label CIMZIA at any time during the study, although changes before Week 12 were discouraged.
 

At Week 52 of the study, patients from both initial treatment groups (including those who had switched to open-label CIMZIA), who completed the double-blind period and consented to entering the SFE (n=243), received open-label CIMZIA 200 mg Q2W (in addition to NBBM) for an additional 104 weeks. Safety and clinical outcome data were analyzed descriptively by initial randomization groups.

FAS, full analysis set; MRI, magnetic resonance imaging; NBBM, non-biologic background medication; nr-axSpA, non-radiographic axial spondyloarthritis; Q2W, every 2 weeks; SIJ, sacroiliac joint; SPARCC, SpondyloArthritis Research Consortium of Canada.

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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.

US-CZ-2400178