CIMZIA® (certolizumab pegol) can make a difference with a rapid response

CIMZIA significantly improved the signs and symptoms of disease for moderate to severe RA patients1,2

RAPID 1 STUDY
ACR20 response rates1,2,5*

  • Primary efficacy measure was ACR20 response at week 24 for RAPID 11,2
  • Some CIMZIA RA patients experienced a rapid response within 1 to 2 weeks1,2,5
In the RAPID 1 Study, ACR20 response at week 24 (primary endpoint) was 59% in the CIMZIA 200 mg q2w +MTX qw group (n=393) compared with 14% for placebo q2w + MTX qw (n=199) (P<0.001). Some CIMZIA RA patients experienced a rapid ACR20 response within 1 to 2 weeks. References: (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.
  • The same patients may not have responded at each time point.
  • ITT-NRI: intent-to-treat nonresponder imputation
  • Distinct patient populations comparison between indications is NOT intended

Important Safety Information

  • 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 not indicated for use in pediatric patients.
  • Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteroids or methotrexate) may be at a greater risk of infection.

CIMZIA improved the signs and symptoms of disease for PsA and AS patients1,10,11

  • Primary efficacy measure was ACR20 response at week 121,10
  • Some CIMZIA PsA patients experienced a rapid response within 1 to 2 weeks1,10
In the RAPID-PsA Study, ACR20 response at week 12 (primary endpoint) was 58% in the CIMZIA 200 mg q2w group (n=138) compared with 24% for placebo q2w (n=136) (P<0.001). Some CIMZIA PsA patients experienced a rapid ACR20 response within 1 to 2 weeks. References: (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.
  • The same patients may not have responded at each time point.
  • ITT-NRI: intent-to-treat nonresponder imputation
  • Distinct patient populations comparison between indications is NOT intended
  • See RAPID-PsA study design
  • Primary efficacy variable was ASAS20 response at week 121,11
  • Some CIMZIA AS patients experienced a rapid response within 1 to 2 weeks1,11
In the AS-1 Study (AS subpopulation), ASAS20 response at week 12 (primary efficacy variable) was 57% in the CIMZIA 200 mg q2w group (n=65) compared with 37% for placebo q2w (n=57) (nominal P value). Some CIMZIA AS patients experienced a rapid ASAS20 response within 1 to 2 weeks. References: (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.
  • The same patients may not have responded at each time point.
  • ITT-NRI: intent-to-treat nonresponder imputation
  • Distinct patient populations comparison between indications is NOT intended
  • See AS-1 study design

ACR50/70 responses were achieved and consistent through 52 weeks for some moderate to severe RA patients5

Choose an option below for a closer look at response rates for either ACR50 or ACR70.

RAPID 1 STUDY

Time course of ACR50 response rates*

Graph of time course of ACR50 response rates: In the RAPID 1 Study, ACR50 response at week 24 was 37% in the CIMZIA 200 mg q2w + MTX qw group (n=393) compared with 8% for placebo q2w + MTX qw (n=199) (P<0.001). Reference: (5) Data on file. UCB, Inc.; Smyrna, GA.

MTX: methotrexate

RAPID 1 STUDY

Time course of ACR70 response rates*

Graph of time course of ACR70 response rates: In the RAPID 1 Study, ACR70 response at week 24 was 21% in the CIMZIA 200 mg q2w + MTX qw group (n=393) compared with 3% for placebo q2w + MTX qw (n=199) (P<0.001). Reference: (5) Data on file. UCB, Inc.; Smyrna, GA.
  • ITT-NRI: intent-to-treat nonresponder imputation.
  • The same patients may not have responded at each time point.
  • P<0.001 vs placebo for both outcome measures (ACR50 and ACR70).
  • ACR50 and 70 were prespecified secondary endpoints at weeks 24 and 522
  • RAPID 1: Co-primary trial end point of ACR20 response at week 24 was 59% with CIMZIA + MTX vs 14% for placebo + MTX (P<0.001)1,2
  • See RAPID 1 study design

Important Safety Information

  • Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including children, adolescents, and young adults. Acute and chronic cases of leukemia have also been reported. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.