Anti-Human TNF alpha Recombinant Antibody Fab Fragment (Certolizumab Pegol) (CAT#: TAB-034-F(E))

Figure 1 Efficacy variables in the certolizumab pegol (CZP) intention-to-treat (ITT) (n = 492) and week-24 CZP completer populations (n = 342).

a Mean disease activity score in 28 joints (erythrocyte sedimentation rate) (DAS28(ESR)). b Mean health assessment questionnaire-disability index (HAQ-DI). c American College of Rheumatologists (ACR)20 response. d ACR50 and ACR70 responses. For patients who withdrew at week 16, observed data from the week-12 visit was also included in the week-24 data (start of open-label extension). MMRM mixed model repeated measures, NRI non-responder imputation.

Smolen, J. S., van Vollenhoven, R., Kavanaugh, A., Strand, V., Vencovsky, J., Schiff, M.,... & Carter, D. (2015). Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis research & therapy, 17(1), 245.

Figure 2 Efficacy variables in patients following dose reduction from certolizumab pegol (CZP) 400 mg every 2 weeks (Q2W) to CZP 200 mg Q2W (n = 369).

a Mean disease activity score in 8 joints (erythrocyte sedimentation rate) (DAS28(ESR)). bAmerican College of Rheumatology (ACR)20 response rates. c ACR50 and ACR70 response rates. This analysis is presented as weeks following dose-reduction visit (Week 0 is defined as the final efficacy assessment visit where a patient received the CZP 400 mg dose).

Smolen, J. S., van Vollenhoven, R., Kavanaugh, A., Strand, V., Vencovsky, J., Schiff, M.,... & Carter, D. (2015). Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis research & therapy, 17(1), 245.

Figure 3 Effect of CZP in patients with and without prior TNF inhibitor exposure at week 24 in terms of ACR response and the kinetics of ACR response.

CZP, Certolizumab pegol; Q2W, every 2 weeks; Q4W, every 4 weeks; PBO, placebo; TNF, tumour necrosis factor. (A) Percentages of patients with and without prior TNF inhibitor exposure achieving a response according to the American College of Rheumatology Criteria for 20% improvement (ACR20), 50% improvement (ACR50), and 70% improvement (ACR70) at week 24, by treatment group. (B) Percentages of patients with prior TNF inhibitor exposure achieving an ACR20, ACR50, and ACR70 response over time, by treatment group. (C) Percentages of patients without prior TNF inhibitor exposure achieving an ACR20, ACR50 and ACR70 response over time, by treatment group; *p<0.001; †p<0.05 versus placebo.

Mease, P. J., Fleischmann, R., Deodhar, A. A., Wollenhaupt, J., Khraishi, M., Kielar, D.,... & Van Der Heijde, D. (2014). 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). Annals of the rheumatic diseases, 73(1), 48-55.

Figure 4 Emotional Function and Systemic Symptoms were the domains that patients reported as being most improved by certolizumab pegol treatment.

Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores during 12 weeks subcutaneous treatment with either certolizumab pegol or placebo in patients with moderate-to-severe Crohn's disease (intent-to-treat population); least-squares means (adjusted for stratum, pooled country, and baseline score): a Bowel Symptoms domain, b Systemic Symptoms domain, c Emotional Function domain, and d Social Function domain.

Rutgeerts, P., Schreiber, S., Feagan, B., Keininger, D. L., O’Neil, L., & Fedorak, R. N. (2008). Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFα, improves health-related quality of life in patients with moderate to severe Crohn’s disease. International journal of colorectal disease, 23(3), 289-296.