

EXXELERATE: Primary end point
EXXELERATE was a head-to-head superiority study3
69% of patients taking CIMZIA achieved ACR20 at Week 12 and 35% achieved DAS28(ER) ≤3.2 at Week 104 vs. 71% and 33% of patients taking adalimumab, respectively.*†‡§||¶
The primary end points of superiority were not met. They included:
*CIMZIA 200 mg Q2W + MTX, adalimumab 40 mg Q2W + MTX.
†FAS-NRI, full analysis set nonresponder imputation.
‡P=0.467. Not significant.
§OR: 0.90 (95% CI: 0.67, 1.20).
||P=0.532. Not significant.
¶OR: 1.09 (95% CI: 0.82, 1.45).
DAS28, disease activity score, 28 joints; ESR, erythrocyte sedimentation rate; LDA, low disease activity.
EXXELERATE post hoc analysis: Remission/LDA
CIMZIA-treated patients achieved remission or LDA regardless of RF levels. Within the adalimumab subgroups, results were numerically lower in patients with high RF levels at Week 1044
Remission or LDA rates across all subgroups:
The primary end points of superiority were not met in the EXXELERATE trial. Because this is a post hoc analysis, the results were not powered to show statistical significance and clinical significance has not been established. For this reason, UCB cannot state this evidence as conclusive. Interpret with caution.
Remission/LDA4
*n at Week 2.
LDA: DAS28(CRP) >2.6 to ≤3.2; remission: DAS28(CRP) <2.6.
RF, rheumatoid factor.
EXXELERATE post hoc analysis: Drug concentration
CIMZIA drug concentration was consistent in all patients for up to 2 years4
The primary end points of superiority were not met in the EXXELERATE trial. Because this is a post hoc analysis, the results were not powered to show statistical significance and clinical significance has not been established. For this reason, UCB cannot state this evidence as conclusive. Interpret with caution.
Drug concentration4
Baseline characteristics
Baseline characteristics across subgroups by RF level4*†
Patients were stratified into 4 quartiles based on baseline RF levels.
Baseline characteristics4
*Age and BMI were consistent across treatment groups and quartiles, with mean age 53.1 years and mean BMI 28.2 kg/m2. There were tendencies for disease duration and proportion of patients on steroids to increase with increasing RF.
†This is a post hoc analysis. In the initial trial, the primary end points of superiority were not met. In addition, this post hoc analysis was not powered to show statistical significance. Clinical significance has not been established.
ACPA, anti-citrullinated protein antibodies; IQR, interquartile range; SD, standard deviation.
EXXELERATE study design
A Phase 4,104-week, randomized, single-blind, parallel-group, head-to-head superiority study3
The primary end points of superiority were not met.
EXXELERATE study design3
*Methotrexate dose (mg per week) was 17.5 mg for CIMZIA + MTX group and 18 mg for ADA + MTX group.
Peer perspectives on CIMZIA’s data in patients with high RF levels
Drs. Erin L. Arnold and Soha Dolatabadi present CIMZIA’s outcomes in moderate-to-severe RA
CIMZIA: Delivering Consistent Outcomes in Moderate-to-Severe Rheumatoid Arthritis Regardless of Baseline Rheumatoid Factor Levels
Considering Patient Characteristics: CIMZIA Outcomes Based on Rheumatoid Factor Levels and Treatment History
CIMplicity can help provide ongoing support for your patients throughout their journey.
Interested in CIMZIA
In-Office Injection?
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 a tumor necrosis factor (TNF) blocker indicated for:
CONTRAINDICATIONS
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue CIMZIA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.
HEART FAILURE
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
DRUG INTERACTIONS
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please refer to full Prescribing Information.
US-CZ-2400612
References: 1. CIMZIA® [prescribing information]. Smyrna, GA: UCB, Inc. 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(11):3319-3329. 3. Smolen JS, Burmester GR, Combe B, et al. Head-to-head comparison of certolizumab pegol versus adalimumbab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016;388(10061):2763-2774. 4. Data on file. UCB, Inc., Smyrna, GA.