Certolizumab pegol (Cimzia)
Approved in 2008 by the FDA for moderate-to-severe Crohns disease patients who have not responded to standard drug therapies.
The effectiveness of Certolizumab has been studied in the the PRECiSE clinical trials , which were both double-blind, randomized, placebo-controlled studies that enrolled a total of more than 1000 adults with active moderate to severe Crohn's disease. In PRECiSE-1 study, significant improvements in clinical response vs placebo was found at week 6 (35% vs 27%, P=0.02) and week 26 (37% vs 27%, P≤.05, as compared with placebo, but with no significant improvement in remission rates (Sandborn WJ et al, 2007). In PRECiSE-2 study, 62.8 % of patients receiving certolizumab 400 mg every 4 weeks maintained clinical response at week 26 vs 36.2% receiving placebo (P < 0.001). The primary endpoint was met with statistical significance, irrespective of CRP. Certolizumab pegol effectively maintained remission of Crohn's disease for up to 18 months. Continuous therapy was more effective than interrupted therapy (Lichtenstein GR et al, 2010)Lichtenstein GR, Yan S, et al. Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease. Gastroenterology. 2005 Apr;128(4):862-9 .
A recent study has shown that administration of 1 additional dose of certolizumab pegol to patients who relapsed on continuous maintenance therapy, and certolizumab pegol reinduction to those who relapsed after drug interruption, may be effective strategies for treating patients who have relapsed after successful induction therapy with certolizumab pegol (Sandborn WJ et al, 2010)Sandborn WJ, Schreiber S, et al. Reinduction With Certolizumab Pegol in Patients With Relapsed Crohn's Disease: Results From the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010 Apr 1.
Certolizumab is given by injection. Patients receive an injection every 2 weeks for the first 3 weeks. Once patients show signs of improvement, they receive an injection once a month.