Effective maintenance therapy in Crohn's disease regardless of prior infliximab use.¹

PRECiSE 2 Trial

PRECiSE 2 was a randomized, double-blind, placebo-controlled trial in which 668 adults patients with a ≥3-month history of active Crohn's disease (a Crohn's Disease Activity Index [CDAI] score of 220-450) received 400 mg at weeks 0, 2, and 4 in open-label induction phase.² Patients who responded at week 6 were randomized to receive CIMZIA subcutaneously every 4 weeks (n=216) or placebo (n=212). Primary end point was response at week 26. The majority of patients in the intention-to-treat population had not previously been treated with an anti-TNF therapy (n=322).²

Results—Bio-Experienced Patients

• There was a significant difference in response at week 26 between the CIMZIA and placebo groups among patients who had previously received the biologic drug infliximab (44% vs 25%; P=0.02) and those who had not previously received infliximab (69% vs 40%; P< 0.001)²
• There was no significant difference in response and remission rates between the two groups for patients who were and those who were not receiving concomitant glucocorticoids, immunosuppressive agents, or both²

WELCOME Study

The WELCOME study was a 26-week prospective study that included patients with moderate to severe Crohn's disease who had initially responded to but eventually failed or had hypersensitivity to infliximab therapy (N=539). Primary end point was clinical response, measured as at least a 100 point reduction in CDAI score at week 6. The trial consisted of a 6-week, open-label induction phase (CIMZIA 400 mg at weeks 0, 2, and 4) and a double-blind maintenance phase (CIMZIA 400 mg every 2 or 4 weeks).³

Results—Bio-Experienced Patients

• At week 6, 62% of patients had a clinical response and clinical remission was reported in 39% of patients³
• At week 26, 40% of patients randomized to CIMZIA 400 mg every 4 weeks had a clinical response compared with a response rate of 37% of patients randomized to 400 mg every 2 weeks³

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.

Serious and sometimes fatal side effects have been reported with CIMZIA. These include tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.

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

*The CIMZIA Co-Pay Savings Card Program is valid for out-of-pocket expenses for CIMZIA for up to 17 uses. The CIMZIA Co-Pay Savings Card Program is 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), private insurance in the Commonwealth of Massachusetts, 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. The parties reserve the right to amend or end this program at any time without notice.