PRECiSE 2 Results

Robust clinical response at Week 6 with significantly greater remission at 6 months (48% vs 29%, P≤.001) versus placebo

At Week 6 (following 3 induction doses of CIMZIA 400 mg), 64% of patients had a response. The remaining 36% of patients did not have a response and did not remain in the study.¹

CS=corticosteroids; IS=immunosuppressants.

The clinical response at Week 6 was consistent in a broad range of patients. In fact, baseline use of immunosuppressants or corticosteroids had no impact on the clinical response to CIMZIA.³

Nearly half of patients maintained remission at 6 months*⁴

*Refers to responders to 6-week, open-label induction therapy.
†Baseline Crohn's Disease Activity Index score of 220 to 450 defined as moderate to severe.
‡Open-label induction dose at Weeks 0, 2, and 4.

Among patients who had a response at Week 6, remission rates at 6 months were 48% in the CIMZIA group and 29% in the placebo group (clinical remission was defined as Harvey-Bradshaw Index levels ≤4).^1,4,5

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.

References:

1. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357:239-250.
2. Colombel JF, Hanauer S, Sandborn WJ, Panes J, Schreiber S. Subcutaneous certolizumab pegol is effective in patients with prior infliximab exposure, or concomitant immunosuppressant or glucocorticoid treatment: data from PRECiSE 2. Abstract presented at: Congress of the European Crohn's and Colitis Organization (ECCO); March 1-3, 2007; Innsbruck, Austria.
3. Sandborn WJ, Feagan BG, Stoinov S, et al; for the PRECiSE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;375:228-238.
4. CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2009.
5. Schreiber S, Panes J, Mason D, Lichtenstein G, Sandborn WJ. Sustained efficacy and tolerability of certolizumab pegol over 18 months: data from PRECiSE 2 and its extension studies (PRECiSE 3 and 4). Poster presented at: American College of Gastroenterology Annual Meeting; October 12-17, 2007; Philadelphia, PA.