Continuous Therapy With Certolizumab Pegol Maintains Remission of Patients With Crohn's Disease for up to 18 Months  Gary R. Lichtenstein, Ole Ø. Thomsen, Stefan Schreiber, Ian C. Lawrance, Stephen B. Hanauer, Ralph Bloomfield, William J. Sandborn  Clinical Gastroenterology and Hepatology  Volume 8, Issue 7, Pages 600-609 (July 2010) DOI: 10.1016/j.cgh.2010.01.014 Copyright © 2010 AGA Institute Terms and Conditions

Figure 1 Study design for the PRECiSE 2 and 3 studies. Clinical Gastroenterology and Hepatology 2010 8, 600-609DOI: (10.1016/j.cgh.2010.01.014) Copyright © 2010 AGA Institute Terms and Conditions

Figure 2 (A) Response rates (reduction from baseline in HBI score, ≥3) and (B) remission rates (HBI score, ≤4) in PRECiSE 2 and PRECiSE 3 at weeks 26, 52, and 80 (intention-to-treat population). (C) Sustained response and (D) remission rates in PRECiSE 3 in patients who were already in response/remission at week 26 of PRECiSE 2. aHBI scores were not measured at week 6 so response and remission rates for the CDAI are presented in these graphs. bRecalculated CDAI scores. Criterion for entry into maintenance phase of PRECiSE 2 was a CDAI response; therefore, CDAI response rate at week 6 should be 100%. However, as a result of investigator error, such as miscalculated CDAI scores and other protocol deviations, the actual CDAI response rate in the intention-to-treat population is slightly lower. Clinical Gastroenterology and Hepatology 2010 8, 600-609DOI: (10.1016/j.cgh.2010.01.014) Copyright © 2010 AGA Institute Terms and Conditions

Figure 3 Activity of Crohn's disease as measured by the HBI at baseline and throughout PRECiSE 3, and geometric mean plasma concentrations of certolizumab pegol throughout PRECiSE 3. czp, certolizumab pegol. These data are based on the entire study population, ie, although a patient may have provided an HBI score at a particular visit, they may not have provided a blood sample. Clinical Gastroenterology and Hepatology 2010 8, 600-609DOI: (10.1016/j.cgh.2010.01.014) Copyright © 2010 AGA Institute Terms and Conditions

Figure 4 Effect of anti–certolizumab pegol antibodies on the geometric mean plasma certolizumab pegol concentrations in PRECiSE 3 for patients from the (A) continuous treatment arm and (B) drug-interruption treatment arm (safety population). czp, certolizumab pegol. Clinical Gastroenterology and Hepatology 2010 8, 600-609DOI: (10.1016/j.cgh.2010.01.014) Copyright © 2010 AGA Institute Terms and Conditions