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Discover more about the only biologic with 3-year data exclusive to patients with nr-axSpA.1

In the C-axSpAnd study, 47% of patients treated with CIMZIA 200 mg Q2W + NBBM (n=159) vs. 7% of patients taking placebo + NBBM (n=158) achieved ASDAS-MI at Week 52.2,3

ASDAS-MI: Ankylosing Spondylitis Disease Activity Score-Major Improvement; NBBM: non-biologic background medication; nr-axSpA: non-radiographic axial spondyloarthritis; Q2W: every 2 weeks.

Many patients with nr-axSpA are not diagnosed

Up to 1.7 million individuals in the US live
with nr-axSpA, and yet it is estimated that

65% OF THOSE LIVING WITH
nr-axSpA ARE UNDIAGNOSED4-7*

Men and women may have different signs and symptoms of nr-axSpA

  • Men typically suffer from chronic back pain and stiffness8,9
  • Women may also experience fatigue and widespread pain similar to fibromyalgia10,11

Identify nr-axSpA patients using the following ASAS classification criteria

  • In patients with back pain for ≥3 months and age of onset <45 years9

Imaging criteria9

Sacroiliitis on imaging and ≥1 SpA feature

Active inflammation on MRI highly suggestive of sacroiliitis associated with SpA

OR

Clinical criteria9

HLA-B27+ and ≥2 other SpA features

SpA features9

  • IBP
  • Arthritis
  • Enthesitis (heel)
  • Uveitis
  • Dactylitis
  • Psoriasis
  • CD/UC
  • Good response
    to NSAIDs
  • Family history of SpA
  • HLA-B27+
  • Elevated CRP
  • IBP
  • Arthritis
  • Enthesitis (heel)
  • CD/UC
  • Good response
    to NSAIDs
  • Uveitis
  • Dactylitis
  • Psoriasis
  • Family history of SpA
  • HLA-B27+
  • Elevated CRP

It is important to note that diagnostic criteria for nr-axSpA have not been established. The classification criteria are standardized definitions, primarily intended to create well-defined, relatively homogeneous cohorts for clinical research. They are not intended to capture the entire universe of possible patients in the community.

*Based on DRG: Disease Landscape and Market Forecast Analysis for 2021.

Derived from full ASAS axSpA classification criteria, which differentiates criteria for nr-axSpA and AS.

ASAS: Assessment of SpondyloArthritis international Society; AS: ankylosing spondylitis; CD: Crohn’s disease; CRP: C-reactive protein; DRG: Decision Resources Group; HLA-B27: human leukocyte antigen-B27; IBP: inflammatory back pain; MRI: magnetic resonance imaging; nr-axSpA: non-radiographic axial spondyloarthritis; NSAID: nonsteroidal anti-inflammatory drug; SpA: spondyloarthritis; UC: ulcerative colitis.

C-axSpAnd study design1-3:

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 to 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 non-biological background medication (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.

Rapid results—clinical response in some patients within 2 weeks2,3,7

ASDAS-MI responders (FAS, NRI)2,7

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ASDAS is a validated, highly discriminatory instrument for assessing patient disease activity
that measures both tangible patient-reported outcomes and objective inflammation.12

Utilization and dosage adjustment of NBBM (including NSAIDs, DMARDs, corticosteroids, opioids, and non-opioid analgesics) were permitted at any time.2

Patient-reported outcomes were back pain, duration of morning stiffness, Patient’s Global Assessment of Disease Activity, and peripheral pain/swelling.9,13

*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.3

ASAS40 responders (FAS, NRI)2,7§

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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 three domains on a scale of 10.

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

§Secondary effective variable.

ASAS: Assessment in SpondyloArthritis international Society; ASDAS-MI: Ankylosing Spondylitis Disease Activity Score-Major Improvement; DMARD: disease-modifying anti-rheumatic drug; FAS: full analysis set; NBBM: non-biologic background medication; NRI: non-responder imputation; NSAID: nonsteroidal anti-inflammatory drug; Q2W: every 2 weeks.

C-axSpAnd study design1-3:

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 to 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 non-biological background medication (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.

Durable improvements were felt at 1 year and at 3 years1-3

ASDAS-Major Improvement responders

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nrazSpA

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.

ASAS40 responders

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nraxSpA

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 three domains on a scale of 10.13

*Data are from C-axSpAnd, full analysis set, non-responder imputation; P<0.0001 CIMZIA vs. placebo.

Data are from C-axSpAnd SFE, patients initially randomized to CIMZIA in C-axSpAnd, non-responder imputation.

ASAS: Assessment in SpondyloArthritis international Society; ASDAS: Ankylosing Spondylitis Disease Activity Score; ASDAS-MI: Ankylosing Spondylitis Disease Activity Score-Major Improvement; DMARD: disease-modifying anti-rheumatic drug; NSAID: nonsteroidal anti-inflammatory drug; NBBM: non-biologic background medication; OC: observed case; Q2W: every 2 weeks; SFE: safety follow-up extension.

C-axSpAnd study design1-3:

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 to 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 non-biological background medication (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.

Meaningful improvements in disease activity1,3,7,14,15

ASDAS disease activity category distribution of CIMZIA + NBBM patients

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

Symptom reduction through Week 12

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*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.

ASDAS: Ankylosing Spondylitis Disease Activity Score; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; FAS: full analysis set; LOCF: last observation carried forward; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; NBBM: non-biologic background medication.

Safety profile in C-axSpAnd2,3,7

TEAEs at Year 1 and Year 31*

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TEAEs through Week 523*

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Adverse events in ≥5% of patients7

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The adverse events observed in CIMZIA patients with nr-axSpA are consistent with clinical experience. 

* For Weeks 0–52, data are reported for the double-blind safety set (N=317), and for Weeks 52–156 for the SFE safety set (N=243).

The majority of hepatic events were transient in nature and occurred in patients with either a medical history of prior hepatic-related events and/or who were using concomitant medications that are associated with the potential development of hepatic events. The most frequently reported hepatic adverse events in both treatment groups was an increase in ALT (CIMZIA group: 3.1% [5/159], IR=3.5/100 patient-years; placebo group: 1.9% [3/159], IR=3.2/100 patient-years).

At 52 weeks.

ALT: alanine aminotransferase; CPK: creatine phosphokinase; IR: incidence rate; nr-axSpA: non-radiographic axial spondyloarthritis; SFE: safety follow-up extension; TEAE: treatment-emergent adverse event.

 

The CIMplicity® Covered™ Program

For eligible,* commercially insured patients who self-administer CIMZIA, this patient support program can help secure coverage when their prescription is initially denied or delayed by insurance. Once a prior authorization has been submitted, patients may receive prefilled syringes for up to 2 years or until coverage is approved, whichever comes first.

In addition to the CIMplicity Covered Program, CIMplicity®† includes:

  • CIMplicity Savings Program
    May help provide eligible commercial patients with a $0 copay
  • Nurse Navigator—a nurse partner for a patient’s CIMZIA journey
    A patient’s Nurse Navigator is their dedicated, compassionate point of contact for discussing their CIMZIA experiences.§ Their Nurse Navigator is ready to help find answers to questions about treatment support, payment assistance, and more so they can manage their condition with confidence

Effective October 1, 2021, nr-axSpA ICD-10 codes13||

Sub-category (M45.A) for nr-axSpA

  • Created specifically for nr-axSpA to provide clarity in electronic medical records and with payors
  • Designed to help people living with nr-axSpA receive early and accurate diagnosis and appropriate treatment

See the ICD-10 codes for each nr-axSpA category.

* Eligibility: Eligible patients with a valid prescription for CIMZIA can receive treatment with the CIMZIA Prefilled Syringe at no cost for up to two years or until the patient’s coverage is approved, whichever comes first. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program or where otherwise prohibited by law. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. For initial enrollment into the program, the patient must be experiencing a delay in, or have been denied, coverage for CIMZIA by their commercial insurance plan. To maintain eligibility in the program, the following are required: (1) a prior authorization request has been submitted and/or coverage remains unavailable for the patient; and (2) if the prior authorization is denied by the payer, the prescriber must submit an appeal within the first sixty (60) days of the prior authorization denial and a prior authorization must be submitted every six (6) months thereafter or documentation as may otherwise be required by the payer. UCB reserves the right to rescind, revoke, or amend this Program without notice.

The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA. The CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions apply.

Savings Program Eligibility: Available to individuals with commercial prescription insurance coverage for CIMZIA. Not valid for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, similar federal- or state-funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (ie, Medicare, Medicaid, Medigap, TRICARE, VA, and DoD) for reimbursement. The parties reserve the right to amend or end this program at any time without notice.

§ Nurse Navigators do not provide medical advice and will refer a patient to their healthcare professional for any treatment-related questions.

|| UCB cannot recommend ICD-10 coding for the nr-axSpA patient. It is at the sole discretion of healthcare professionals to determine the coding that best characterizes patients’ clinical presentation.

Common therapies may not address the underlying cause of disease or inflammation16-18

For patients with active disease despite treatment with NSAIDs, the ACR/SAA/SPARTAN Treatment Guidelines strongly recommend a TNFi as the first-line biologic therapy*

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List of therapies
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A list of therapies

*Recommendations are from the ACR/SAA/SPARTAN 2019 guidelines. See guidelines for full recommendations. Recommendations for nr-axSpA extrapolated from evidence in AS due to limited literature available for nr-axSpA.16

This information is not intended to be medical advice. Healthcare providers should exercise their professional judgment when treating their own patients.

ACR: American College of Rheumatology; AS: ankylosing spondylitis; nr-axSpA: non-radiographic axial spondyloarthritis; NSAID: nonsteroidal anti-inflammatory drug; SAA: Spondylitis Association of America; SpA: spondyloarthritis; SPARTAN: Spondyloarthritis Research and Treatment Network; TNFi: tumor necrosis factor inhibitor.

Resources: Comprehensive resources for your CIMZIA patients

Help your patients get started with CIMZIA

We offer a wide selection of services and resources to help your CIMZIA patients throughout therapy. Explore the options below to learn more.

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nr-axSpA Therapy brochure

Patient brochure

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Classification flashcard

Classification flashcard

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ICD-10 coding update flashcard

ICD-10 coding update flashcard

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CIMplicity enrollment form

CIMplicity enrollment form

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Business Associate Agreement Form

Business Associate Agreement Form

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Patient CIMplicity Start Card

Patient CIMplicity Start Card

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CIMplicity logo

CIMplicity can help provide ongoing support for your patients throughout their journey.

PATIENT SUPPORT

The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA. The CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions may apply.

IMPORTANT SAFETY INFORMATION & 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.