Many patients with nr-axSpA are not diagnosed
Up to 1.7 million individuals in the US live
with
65% OF THOSE LIVING WITH
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 criteria6
HLA-B27+ and ≥2 other SpA features
SpA features9
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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
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§
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
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
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
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
*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*
TEAEs through Week 523*
Adverse events in ≥5% of patients7‡
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*†
*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.
CIMplicity can help provide ongoing support for your patients throughout their journey.
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.