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

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

AS-1 STUDY
ASAS20 response rates,
AS subpopulation1,5,11*

  • Primary efficacy variable was ASAS20 response at week 12 for AS-11,11
  • Some CIMZIA AS patients experienced a rapid response within 1 to 2 weeks1,11
In the AS-1 Study, ASAS20 response (AS subpopulation) 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

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 significantly improved the signs and symptoms of disease for RA and PsA patients1,2,10

  • 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
  • See RAPID 1 study design
  • Primary efficacy measure was ACR20 response at week 12 for RAPID-PsA1,10
  • 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

Improvements in ASAS40 response rates

AS-1 STUDY

Time course of ASAS40 response rates, AS subpopulation1,5,11*†‡

Graph of time course of ASAS40 response rates, AS subpopulation: In the AS-1 Study, ASAS40 response at week 12 was 40% in the CIMZIA 200 mg q2w group (n=65) compared with 19% for placebo q2w (n=57) (nominal P value). 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.
  • Full analysis set. Nonresponder imputation used for patients with missing data or those who escaped therapy.
  • The same patients may not have responded at each time point.
  • ASAS40 is an additional secondary efficacy variable.
  • 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
  • See AS-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.