

Rapid results
Why focus on ASDAS: It is a validated, highly discriminatory instrument for assessing a patient’s disease activity3,4
Rapid results—clinical response in some patients within 2 weeks1,2,5
ASDAS-MI responders (FAS,NRI)1,5
*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.
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§
§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 responders
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.
ASAS40 responders
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.
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
ASDAS disease activity category distribution of CIMZIA + NBBM patients
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#
Nocturnal spinal pain change 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.
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
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 525
§Results were derived using the FAS data block.
||Weeks 12 and 52: Efficacy variables not in hierarchy, not adjusted for multiplicity.2
C-axSpAnd1,2,8
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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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 a tumor necrosis factor (TNF) blocker indicated for:
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:
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.
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.
HEART FAILURE
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
DRUG INTERACTIONS
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please refer to full Prescribing Information.
US-CZ-2400612
References: 1. CIMZIA® [prescribing information]. Smyrna, GA: UCB, Inc. 2. Deodhar A, Gensler LS, Kay J, et al. A fifty-two-week, randomized, placebo-controlled trial of certolizumab pegol in nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(7):1101-1111. 3. van der Heijde D, Lie E, Kvien TK, et al. ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 2009;68(12):1811-1818. 4. Machado P, Landewé R, Lie E, et al. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 2011;70(1):47-53. 5. Data on file. UCB, Inc.; Smyrna, GA. 6. Rudwaleit M, van der Heijde D, Landewé R, et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68(6):777-783. 7. Sieper J, Rudwaleit M, Baraliakos X, et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009;68(suppl 2):ii1-ii44. 8. van der Heijde D, Gensler LS, Maksymowych WP, et al. Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study. RMD Open. 2022;8(1):e002138. 9. Machado P, Landewé R, van der Heijde D; Assessment of SpondyloArthritis international Society (ASAS). Ankylosing Spondylitis Disease Activity Score (ASDAS): 2018 update of the nomenclature for disease activity states. Ann Rheum Dis. 2018;77(10):1539-1540. 10. Maksymowych WP, Wichuk S, Dougados M, et al. MRI evidence of structural changes in the sacroiliac joints of patients with non-radiographic axial spondyloarthritis even in the absence of MRI inflammation. Arthritis Res Ther. 2017;19(1):126.