Please refer to the full Prescribing Information at CIMZIAhcp.com.
CIMZIA® (certolizumab pegol) is the first and only FDA-approved treatment for adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.1
The pivotal C-axSpAnd study investigated the safety and efficacy of CIMZIA 200 mg every 2 weeks (Q2W) in patients with nr-axSpA receiving non-biologic background medications (NBBM). These NBBMs included non-steroidal anti-inflammatory drugs (NSAIDs); slow-acting anti-rheumatic drugs (SAARDs) such as sulfasalazine, methotrexate, and hydroxychloroquine; oral or intravenous corticosteroids, and opioid or nonopioid analgesics. The placebo-controlled study was conducted over 52 weeks in 317 adult patients with nr-axSpA with objective signs of inflammation, defined as sacroiliitis on magnetic resonance imaging (MRI) and/or elevated C-reactive protein (CRP) (Figure 12).2
The primary end point of C-axSpAnd was major improvement in the Ankylosing Spondylitis Disease Activity Score (ASDAS-MI), defined as a change from baseline of greater than or equal to 2.0 in the ASDAS and/or reaching the lowest possible ASDAS of 0.6 at week 52. C-axSpAnd met the primary end point, with 47% of patients achieving ASDAS-MI in the CIMZIA + NBBM arm vs 7% receiving placebo and NBBM at Week 52 (P <0.0001) (Figure 13).2
Patients receiving CIMZIA also experienced significantly greater improvements in several end points (Figure 14).2
The safety profile for patients with nr-axSpA treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with CIMZIA (Figure 15).1,2 There was 1 malignancy reported in the Placebo + NBBM group and 2 in the CIMZIA+ NBBM group. There were no deaths, serious cardiovascular events or opportunistic infections during the study.1,2
The study highlights the high burden of disease and limitations of non-biologic treatments to provide adequate disease control in patients with active nr-axSpA and objective signs of inflammation who failed at least two NSAIDs.2
Figure 12. The C-axSpAnd Study Design1,2,3
ASDAS, Ankylosing Spondylitis Disease Activity Score; LD, loading dose; MI, major improvement; MTX, methotrexate; NBBM, non-biologic background medication; NSAID; non-steroidal anti-inflammatory drug; Q2W, every 2 weeks; SAARD, slow-acting anti-rheumatic drugs; SSZ, sulfasalazine.
Switch to open-label CIMZIA or other treatment permitted at any point from either arm. Both treatment arms were allowed to optimize background therapy including but not limited to: NSAIDs; SAARDs such as SSZ, MTX, and hydroxychloroquine, non-opioid and opioid analgesic therapy, and low-dose corticosteroids at the discretion of the treating rheumatologist
Figure 13. C-axSpAnd Primary Efficacy Variable: Major Improvements in ASDAS (ASDAS-MI) Over 52 Weeks1,2,5,*, †, ‡
ASDAS-MI, Ankylosing Spondylitis Disease Activity Score–Major Improvement; NBBM, non-biologic background medications;
PBO, placebo; Q2W, every 2 weeks.
*ASDAS-MI defined as change in ASDAS from baseline ≥2.0 and/or reaching the lowest possible ASDAS of 0.6. Nonresponder imputation. Full analysis set of patients completing the double blind period. The same patients may not have responded at each time point.2 † P <0.0001 CIMZIA + NBBM versus placebo + NBBM. ‡Efficacy variables not in hierarchy, not adjusted for multiplicity. Nominal P value
Figure 14. CIMZIA® (certolizumab pegol) Provided Additional Positive Outcomes for Patients With nr-axSpA1-4,*
ASAS40, Assessment in SpondyloArthritis international Society, improvement of ≥40% from baseline; ASDAS-MI, Ankylosing Spondylitis Disease Activity Score—Major Improvement; ASQoL, ankylosing spondylitis quality of life; AU, anterior uveitis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; NS, not significant; SIJ, sacroiliac joint; SPARCC, Spondyloarthritis Research Consortium of Canada.
*Uveitis (uveitis flares) at week 52 was a failed secondary end point included within hierarchical testing.
Figure 15. The Safety Profile Was Consistent With Previous CIMZIA® (certolizumab pegol) Trials1,2
TB, tuberculosis; TEAE, treatment-emergent adverse event.
Jeffrey Stark, MD
Jeffrey Stark, MD
Important Safety Information
CIMZIA® (certolizumab pegol) 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.
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.
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.
HEPATITIS B VIRUS REACTIVATION
1. CIMZIA® [prescribing information]. Smyrna, GA: UCB, Inc.; 2019.
2. Deodhar A, Gensler LS, Kay J, et al. A 52-week randomized placebo-controlled trial of certolizumab pegol in non-radiographic axial spondyloarthritis [published online March 8, 2019]. Arthritis Rheumatol. doi: 10.1002/art.40866.
3. Deodhar A, Gensler LS, Kay J, et al. A 52-week randomized placebo-controlled trial of certolizumab pegol in non-radiographic axial spondyloarthritis [supplementary appendix] [published online March 8, 2019]. Arthritis Rheumatol. doi: 10.1002/art.40866.
4. Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016;68(2):282-298.
5. UCB, Inc. Data on file.
©2019 UCB, Inc., Smyrna, GA 30080. All rights reserved.
CIMZIA® is a registered trademark of the UCB Group of Companies. All other trademarks are the property of their respective holders.
Version: August 2019
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