CIMZIA® (certolizumab pegol) can make a difference in physical function

CIMZIA delivered clinically significant improvements in physical function in PsA patients1,5,10,13

RAPID-PsA STUDY

Mean improvement from baseline in physical function (HAQ-DI)1,5,10,13

SEE RAPID-PsA STUDY DESIGN
  • RAPID-PsA: Clinical primary endpoint of ACR20 response at week 12 was 58% for CIMZIA vs 24% for placebo (P<0.001)1,10
RAPID-PsA Study: Graph representing mean improvement from baseline in physical function (HAQ-DI). Reference: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (5) Data on file. UCB, Inc.; Smyrna, GA. (10) Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48-55. (13) Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res. 2014;66(7):1085-1092. RAPID-PsA Study: Graph representing mean improvement from baseline in physical function (HAQ-DI). Reference: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (5) Data on file. UCB, Inc.; Smyrna, GA. (10) Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48-55. (13) Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res. 2014;66(7):1085-1092.
  • Change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) score was a prespecified secondary endpoint at week 24.
  • Changes from baseline in HAQ-DI scores represent improvements in patients' ability to perform certain activities of daily living
  • MCID was defined as a reduction in HAQ-DI from baseline of ≥0.35
  • FAS-LOCF: full analysis set last observation carried forward

Important Safety Information

  • Treatment with TNF blockers, including CIMZIA, may rarely result in new onset or exacerbation of clinical symptoms and/or radiographic evidence of central or peripheral nervous system demyelinating disease, as well as the development of a lupus-like syndrome.
  • Rare reports of blood dyscrasias have been reported with CIMZIA; patients should be advised to seek medical attention if they develop.
  • Patients on CIMZIA should not receive live or live-attenuated vaccines.
SEE RAPID-PsA STUDY DESIGN

CIMZIA delivered clinically significant improvements in physical function in RA and AS patients1,2,11

  • RAPID 1: Co-primary trial endpoint of ACR20 response at week 24 was 59% for CIMZIA + MTX vs 14% for placebo + MTX (P<0.001)1,2
RAPID 1 Study: Graph representing mean improvement from baseline in physical function (HAQ-DI). Reference: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (2) Keystone E, van der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty–two–week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58:3319-3329. (5) Data on file. UCB, Inc.; Smyrna, GA.
  • ITT-NRI: intent-to-treat nonresponder imputation.
  • Change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) score was a prespecified endpoint at weeks 24 and 52.
  • Changes from baseline in HAQ-DI scores represent improvements in patients' ability to perform certain activities of daily living
  • MCID was defined as a reduction in HAQ-DI from baseline of ≥0.22
  • ITT-LOCF: intent-to-treat last observation carried forward
  • See RAPID 1 study design
  • AS-1: Primary efficacy variable of ASAS20 response in the AS subpopulation at week 12 was 57% for CIMZIA vs 37% for placebo (nominal P value)1,11
AS-1 Study: Graph representing mean improvement from baseline in physical function (BASFI). Reference: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (5) Data on file. UCB, Inc.; Smyrna, GA. (11) Landewe R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled phase 3 study. Ann Rheum Dis. 2014;73(1):39-47.
  • Change from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) score was a prespecified secondary endpoint at weeks 12 and 24.
  • Changes from baseline in BASFI scores represent improvements in patients' ability to perform certain activities of daily living
  • MCID was defined as a reduction of 1 unit on the BASFI numerical rating scale (NRS)
  • FAS-LOCF: full analysis set last observation carried forward
  • Distinct patient populations comparison between indications is NOT intended
  • See AS-1 study design