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They've suffered for years without an nr-axSpA diagnosis. They deserve meaningful results.

Choose CIMZIA—the first and only FDA-approved TNF inhibitor for the treatment of nr-axSpA.

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 52.1,2

ASDAS-MI: Ankylosing Spondylitis Disease Activity Score-Major Improvement; NBBM: non-biologic background medication; nr-axSpA: non-radiographic axial spondyloarthritis; TNF: tumor necrosis factor; 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 UNDIAGNOSED3,4*

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

  • Men typically suffer from chronic back pain and stiffness5,6
  • Women may also experience fatigue and widespread pain similar to fibromyalgia7,8

Identify nr-axSpA patients using the following ASAS classification criteria

  • In patients with back pain for ≥3 months and age of onset <45 years6

Imaging criteria6

Sacroiliitis on imaging and ≥1 SpA feature

Active inflammation on MRI highly suggestive of sacroiliitis associated with SpA

OR

Clinical criteria6

HLA-B27+ and ≥2 other SpA features

SpA features6

  • 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 design1,2:

A 52-week, multicenter, randomized, double-blind, placebo-controlled study of 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for at least 12 months, but without definitive radiographic evidence of structural damage to sacroiliac joints. Patients were randomized to CIMZIA 200 mg every 2 weeks + NBBM or placebo + NBBM. Patients in the CIMZIA arm received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4. Utilization and dosage adjustment of concomitant medications, including NSAIDs, DMARDs, corticosteroids, and opioids, were permitted at any time. Escape to open-label CIMZIA was allowed at any time, but no patients did so before Week 12.

Almost half of all CIMZIA-treated patients achieved ASDAS-MI at 1 year1-3*

ASDAS-MI responders (FAS, NRI)1,3

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ASDAS-MI responders (FAS, NRI)1,3
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ASDAS-MI responders (FAS, NRI)1,3

ASDAS is a validated, highly discriminatory instrument for assessing patient disease activity
that measures both tangible patient-reported outcomes and objective inflammation.9

Utilization and dosage adjustment of NBBM (including NSAIDs, DMARDs, corticosteroids, opioids, and non-opioid analgesics) were permitted at any time.1

Patient-reported outcomes were back pain, duration of morning stiffness, Patient’s Global Assessment of Disease Activity, and peripheral pain/swelling.6,10

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

Almost half of CIMZIA + NBBM patients achieved ASAS40 at 12 weeks1-3*

ASAS40 responders (FAS, NRI)1,2*

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ASAS40 responders (FAS, NRI)1,2*
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ASAS40 responders (FAS, NRI)1,2*

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.

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 design1,2:

A 52-week, multicenter, randomized, double-blind, placebo-controlled study of 317 subjects ≥18 years of age with adult-onset active axial spondyloarthritis for at least 12 months, but without definitive radiographic evidence of structural damage to sacroiliac joints. Patients were randomized to CIMZIA 200 mg every 2 weeks + NBBM or placebo + NBBM. Patients in the CIMZIA arm received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4. Utilization and dosage adjustment of concomitant medications, including NSAIDs, DMARDs, corticosteroids, and opioids, were permitted at any time. Escape to open-label CIMZIA was allowed at any time, but no patients did so before Week 12.

~70% of patients achieved low or no disease activity at 1 year3,9*

ASDAS disease activity category distribution of CIMZIA + NBBM patients (FAS, OC)3,9

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ASDAS disease activity category distribution of CIMZIA + NBBM patients (FAS, OC)2,3,10
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ASDAS disease activity category distribution of CIMZIA + NBBM patients (FAS, OC)2,3,10

Comparison of the distribution of the CIMZIA-treated patients by ASDAS disease-activity category at baseline vs. 52 weeks for patients who remained in the double-blind study, using observed case analysis.

*Includes patients who continued on CIMZIA for the full year, in addition to optimized NBBM.

ASDAS: Ankylosing Spondylitis Disease Activity Score; DMARD: disease-modifying anti-rheumatic drug; FAS: full analysis set; NBBM: non-biologic background medication; NSAID: nonsteroidal anti-inflammatory drug; OC: observed case.

RAPID-axSpA study design11,12:

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.

Patients experienced relief in signs and symptoms over 4 years

The RAPID-axSpA trial included both nr-axSpA and AS patients. At 12 weeks, 58% of patients treated with CIMZIA 200 mg Q2W, 64% of patients treated with CIMZIA 400 mg Q4W, and 38% of patients taking placebo achieved ASAS20 (primary efficacy variable).12

ASAS40 response rates in CIMZIA (combined dose) nr-axSpA patients over 204 weeks (n=97) (NRI)3,11,12*†‡

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RAPID-axSpA trial chart
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RAPID-axSpA trial chart

At 4 years, 43% of nr-axSpA patients taking CIMZIA maintained an ASAS40 response3,11,12*†‡  

The most frequent serious adverse events in nr-axSpA patients (n=141) receiving CIMZIA included colitis (excluding infective) (1.4%), cholelithiasis (1.4%), and back pain (1.4%).11§

At Week 24, placebo patients were randomized to CIMZIA 200 mg Q2W or 400 mg Q4W.11,12
Limitation of open-label extension: ASAS responder rates do not have long-term placebo comparator beyond Week 24.
Note: At the conclusion of the RAPID-axSpA study, CIMZIA was not yet approved for treating patients with nr-axSpA.

*ASAS40 was evaluated as an other secondary end point. The same patients may not have responded at each time point. Randomized set, non-responder imputation.

CIMZIA doses combined: 200 mg Q2W + 400 mg Q4W.

Line graph to Week 204 represents patients who were initially randomized to CIMZIA 200 mg Q2W or 400 mg Q4W.

§Safety outcomes are reported for the safety set, which consisted of all patients treated with at least 1 dose of CIMZIA at any point in the study to Week 204.

ASAS: Assessment of SpondyloArthritis international Society; AS: ankylosing spondylitis; nr-axSpA: non-radiographic axial spondyloarthritis; NRI: non-responder imputation; Q2W: every 2 weeks; Q4W: every 4 weeks.

Safety profile through 52 weeks in C-axSpAnd1-3

TEAEs through Week 522

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C-EARLY study chart

Adverse events in ≥5% of patients3

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RAPID 1 study chart

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

*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).

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

Pave the way to a fast start once you’ve decided to prescribe CIMZIA

Insurance coverage for CIMZIA is excellent for nr-axSpA*

7 out of 9 TOP PAYERS
COVER FIRST-LINE USE

of CIMZIA for patients with nr-axSpA3

CIMplicity® Covered™ Program

  • Eligible, commercially insured patients can receive free treatment of CIMZIA Prefilled Syringe for up to 2 years while approval is being obtained
  • Commercially insured, eligible patients whose coverage is delayed or denied can receive up to two years of treatment with the CIMZIA Prefilled Syringe at no cost. Eligibility restrictions apply
  • Extra resources and tools are ready to set patients up for success
  • Our Nurse Navigators serve as your patient’s single point of contact for providing injection training (if applicable), discussing their CIMZIA experiences, and answering financial questions§
  • Personalized tools, like nutrition education, patient journals, and emotional assistance are available to help build up their treatment support

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 payers
  • 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.

*CIMZIA coverage for the treatment of ankylosing spondylitis differs from the coverage for treatment of nr-axSpA.

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.

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 Nurse Program does not provide medical advice and does not replace the care of the healthcare provider.

||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 inflammation14-16

For patients with active disease despite treatment with NSAIDs, the ACR/SAA/SPARTAN Treatment Guidelines strongly recommend a TNFi as the first-line biologic therapy14*

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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.14

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

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.