CIMZIA Key Facts

Fast Response—after initial dosing¹

CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

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• In a large, randomized, placebo-controlled trial of patients with moderate-to-severe Crohn's disease (PRECiSE 2), the primary end point was a decrease in Crohn's Disease Activity Index (CDAI) score of ≥100 points (CR100). Remission was defined as a CDAI score of ≤150 points. In this post-hoc analysis, response rates over the six-week initial dosing period were evaluated.
• At ~1 week, statistically significant improvement in patient-reported symptom—CDAI diary: general well-being, abdominal pain, and loose/liquid stools²
• ~2⁄3 of all patients achieved CR100 response by week 6 in a clinical trial¹

Sustainable Results—long-term remission

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• At 4 years, 79% of observed patients were in remission with no dose escalation^3,4‡
• Reasons for discontinuation in the PRECiSE 2 and PRECiSE 3 clinical trials included: adverse events, patient decision, loss to follow-up, protocol noncompliance, and other^6,7§
• Recommended maintenance dosing: 400 mg every 4 weeks⁸

‡ Represents week 6 responder analysis from PRECiSE 2 open-label extension study. Observed remitter analysis at 48 months, n=34/43. Months on therapy includes PRECiSE 2 and PRECiSE 3.
§More than 1 reason for withdrawal could be recorded for a patient.

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 also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.

Stable Dosing—1 predictable subcutaneous Q4-week dose⁸

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• CIMZIA provided stable serum levels in clinical trials, yielding 1 predictable subcutaneous Q4-week dose^8*

* Initial dose at weeks 0, 2, and 4, then every 4 weeks as maintenance therapy.

Important Safety Information
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.

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.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.

NEXT: Clinical Trials »

Indication
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

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.

medication guide & prescribing information

important safety information regarding fungal infections

For more information 1-866-4-CIMZIA (1-866-424-6942)

*Not valid for prescriptions that are reimbursed, in whole or part, under Medicare (including Medicare Part D), Medicaid, similar federal or state funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico) or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (i.e., Medicare, Medicaid, Medigap, Tricare, VA and DoD) for reimbursement. Patients and pharmacists are responsible for notifying insurance carriers or other third party who pays for or reimburses any part of the prescription filled using this card as may be required by the insurance carrier's terms and conditions and applicable law. The parties reserve the right to amend or end this program at any time without notice.

Study Designs

PRECiSE 2^2,5
Pivotal trial 668 patients (adults with Crohn's disease ≥3 months) received CIMZIA 400 mg at weeks 0, 2, and 4 in open-label induction phase. Responders at week 6 received CIMZIA every 4 weeks (n=216) or placebo (n=212). Primary end point: response at week 26 in patients with baseline C-reactive protein (CRP) ≥10 mg/L. Clinical response was defined as a ge;100-point reduction in CDAI score and clinical remission as a CDAI score ≤150 points.

Open-label extension trial Patients completing the 26-week study could enter an ongoing open-label extension study (PRECiSE 3, n=141). Primary end point: to assess the effectiveness and safety of continuous CIMZIA therapy. Results 64% of patients showed response to open-label induction therapy. Among responders randomized to active treatment, response was maintained at week 26 in 62% of patients with a baseline CRP level of ≥10 mg/L vs 34% of patients in the placebo arm with similar CRP measures.

PRECiSE 3^1,3,5
Ongoing, open-label extension study of PRECiSE 1 and 2 to evaluate the long-term safety and effectiveness of CIMZIA in Crohn's disease over a period of years. All patients who successfully completed 6 months of CIMZIA therapy in PRECiSE 2 were eligible to participate in PRECiSE 3. Patients received CIMZIA 400 mg every 4 weeks starting at week 2 of the extension trial (n=141). Efficacy was assessed using the Harvey-Bradshaw Index (HBI), with remission defined as an HBI score ≤4. Nonresponders were defined as patients who withdrew or were given rescue medication. At 4 years' follow-up, 79% of observed patients were in remission. ITT results Overall remission rates per historical ITT analysis: 63% at 12 months, 50% at 24 months, 25% at 48 months.

WELCOME⁴
A 26-week prospective study that included patients with moderate to severe Crohn's disease who previously responded to but eventually failed or had hypersensitivity to infliximab therapy (N=539). The primary end point was clinical response (≥100-point reduction in CDAI) at week 6. The trial consisted of 2 phases: (1) a 6-week, open-label induction phase (CIMZIA 400 mg at weeks 0, 2, and 4); and (2) a double-blind maintenance phase (CIMZIA 400 mg every 2 or 4 weeks). At the end of open-label induction (week 6), 39.3% of patients had achieved remission and 62% had achieved response.

References:

1. Thomsen O, Schreiber S, Khaliq-Kareemi M, Hanauer SB, Bloomfield R, Sandborn WJ. Rapid onset of response and remission to subcutaneous certolizumab pegol and lack of influence of concomitant baseline medications in active Crohn's disease: results from the open-label induction phase of the PRECiSE 2 study. Poster presented at: Digestive Disease Week; May 19-24, 2007; Washington, DC.
2. Schreiber S, Khaliq-Kareemi M, Lawrence IC, Thomsen O, Bloomfield R, Sandborn WJ. Rapid improvement of patient-reported CDAI diary components by day 8 in active Crohn's disease patients treated with certolizumab pegol. Poster presented at: American College of Gastroenterology Annual Meeting; October 23-28, 2009; San Diego, CA.
3. Data on file. UCB, Inc; Smyrna, GA, 2010.
4. Lichtenstein GR, Thomsen OØ, Schreiber S, et al. Long-term remission with certolizumab pegol in Crohn's disease: efficacy over 4 years in patients with no prior TNF-a inhibitor exposure (PRECiSE 3 study). Abstract presented at: Digestive Disease Week; May 1-5, 2010; New Orleans, LA.
5. Schreiber S, Khaliq-Kareemi M, Lawrence IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357:239-250.
6. Sandborn W, Lichtenstein G, Schreiber S, Feagan B. The long-term, 30 months, efficacy and tolerability of certolizumab pegol therapy for Crohn's disease. Poster presented at: American College of Gastroenterology Annual Meeting; October 3-8, 2008; Orlando, FL.
7. Lichtenstein GR, Thomsen OØ, Schreiber S, et al. Long-term remission with certolizumab pegol in Crohn's disease over 3.5 years: results from the PRECiSE 3 study. Poster presented at: American College of Gastroenterology Annual Meeting; October 23-28, 2009; San Diego, CA.
8. CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2011.

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