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First and only FDA-approved treatment for non-radiographic axial spondyloarthritis (nr-axSpA)

FDA APPROVED

for non-radiographic
axial spondyloarthritis

CIMZIA® (certolizumab pegol) is indicated for the treatment of adults with active non‑radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

C-AXSPAND IS THE FIRST 52-WEEK, RANDOMIZED, PLACEBO-CONTROLLED* STUDY TO FOLLOW ADULT PATIENTS WITH nr-axSpA

The pivotal nr-axSpA trial for CIMZIA included 317 patients who were ≥18 years of age with adult-onset active axSpA for at least 12 months. Patients had objective signs of inflammation (positive CRP [>ULN] and/or positive MRI), but without radiographic evidence of damage on sacroiliac joints1

ASDAS-MI at week 52 (primary end point)1,37

P<0.0001

CIMZIA (n=159)

47%

Placebo (n=158)

7%
 

ASAS40 at week 12 (secondary end point)1,37

P<0.0001

CIMZIA (n=159)

48%

Placebo (n=158)

11%

Patients saw improvement of their signs and symptoms1

*C-AXSPAND STUDY DESIGN: The efficacy and safety of CIMZIA were assessed in a multicenter, randomized, double-blind, placebo-controlled study in 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 on sacroiliac joints. Patients were treated with a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4 or placebo followed by 200 mg of CIMZIA every 2 weeks or placebo. Utilization and dose adjustment of concomitant medications (including NSAIDs, DMARDs, corticosteroids, and opioids) were permitted at any time. The primary end point was the proportion of patients achieving an Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) response at week 52.

ASDAS is a validated, highly discriminatory composite index to assess patient disease activity in axSpA through objective evidence of systemic inflammation and patient-reported outcomes. Major improvement was defined as a change from baseline of ≥2.0 in the ASDAS and/or reaching the lowest possible ASDAS value.

ASAS criteria measure improvements in pain, function, morning stiffness, and patients’ overall assessment of disease activity. ASAS40 is an improvement of >40% and absolute improvement of >10 units on a 0–100 scale in ≥3 of the 4 domains.38

ASAS: Assessment in SpondyloArthritis international Society; ASDAS-MI: Ankylosing Spondylitis Disease Activity Score-Major Improvement; CRP: C-reactive protein; MRI: magnetic resonance imaging; ULN: upper limit of normal.