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 UNDIAGNOSED3-6*
There's an average delay in diagnosis
RANGING FROM 5 TO 8 YEARS AND UP TO 107-10
Men and women may have different signs and symptoms of nr-axSpA
- Men typically suffer from chronic back pain and stiffness11,12
- More than 50% of patients with nr-axSpA are women. They may also experience fatigue and widespread pain similar to fibromyalgia5,13,14
Identify nr-axSpA patients using the following ASAS classification criteria†
- In patients with back pain for ≥3 months and age of onset <45 years12
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.
Rapid results—clinical response in some patients within 2 weeks1,2,6
ASDAS-MI responders (FAS, NRI)1,6
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 Global Assessment of Disease Activity, and peripheral pain/swelling.12,17
*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
C-axSpAnd1,2,18
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.
ASAS40 responders (FAS, NRI)1,6§
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.
§Secondary effective variable.
ASAS, Assessment in SpondyloArthritis international Society; ASDAS-MI, Ankylosing Spondylitis 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 improvements were felt at 1 year and at 3 years1,2,18
ASDAS-MI responders
46% of patients initially randomized to CIMZIA in C-axSpAnd achieved ASDAS-MI at Year 3 using observed case analysis (n=95)
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
68% of patients initially randomized to CIMZIA in C-axSpAnd achieved ASAS40 at Year 3 using observed case analysis (n=96)
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 10.17
*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.
C-axSpAnd1,2,18
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, Ankylosing Spondylitis 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 improvement in disease activity2,6,16,18,19
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 Weeks 0 to 52), and Week 156 (includes only patients who remained on CIMZIA from Weeks 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.
Meaningful improvement in nocturnal spine pain2,6
Differences at Week 52 vs. placebo#
Nocturnal spinal pain change from baseline* *
AT WEEK 12, PATIENTS ON CIMZIA EXPERIENCED A REDUCTION IN TOTAL SPINAL PAIN
The mean change from baseline was -3.1 vs. -0.9 for placebo.1
#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.
C-axSpAnd1,2,18
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). 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, 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; nr-axSpA, non-radiographic axial spondyloarthritis; Q2W, every 2 weeks; SPARCC, SpondyloArthritis Research Consortium of Canada.
Meaningful improvements in SIJ inflammation2,6
Significant differences in MRI observed at Week 12 vs. placebo*†
Change in MRI assessment of inflammatory activity in SIJ (SPARCC, observed case analysis)
*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 526
§Results were derived using the FAS data block.
||Weeks 12 and 52: Efficacy variables not in hierarchy, not adjusted for multiplicity.2
C-axSpAnd1,2,18
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). 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; SU, sacroiliac joint; SPARCC, SpondyloArthritis Research Consortium of Canada.
Consistent and long-term safety data1,2,6
SFE from Year 1 through Year 318*
TEAEs through Week 522*
Adverse events in ≥5% of patients through Week 526‡
The adverse events observed in CIMZIA patients with nr-axSpA are consistent with clinical experience.
*For Weeks 0 to 52, data are reported for the double-blind safety set (n=317), and for Weeks 52 to 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 event 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
Helps provide eligible, commercial patients with a $0 co-pay‡
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 so they can manage their condition with confidence§
Effective as of October 1, 2021, nr-axSpA ICD-10 codes17||
Subcategory (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
*Eligibility: Eligible patients with a valid prescription for CIMZIA can receive treatment with the CIMZIA Prefilled Syringe at no cost for up to 2 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 payer (i.e., 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 inflammation21-23
For patients with active disease despite treatment with NSAIDs, the ACR/SAA/SPARTANT Treatment Guidelines strongly recommend a TNFi as the first-line biologic therapy.*†
Recommendations for AS and
nr-axSpA are similar Recommendations for AS and nr-axSpA are similar
TNFis are recommended over secukinumab or ixekizumab as the first biologic to be used
Secukinumab or ixekizumab is recommended over the use of a second TNFi in patients with primary nonresponse to the first TNFi
TNFis, secukinumab, and ixekizumab are favored over tofacitinib
Co-administration of low-dose methotrexate with a TNFi is not recommended, nor is a strict treat-to-target strategy, or discontinuation or tapering of biologics in patients with stable disease
Sulfasalazine is recommended only for persistent peripheral arthritis when TNFis are contraindicated
*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.21
†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; SPARTAN, Spondyloarthritis Research and Treatment Network; TNFi, tumor necrosis factor inhibitor.
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SPOTLIGHT nr-axSpA: Perspectives on diagnosis and management
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.