Certolizumab Pegol for Active Crohn's Disease: A Placebo-Controlled, Randomized Trial

BACKGROUND & AIMS: Certolizumab pegol (CZP) is a pegylated-conjugated Fab' against tumor necrosis factor (TNF). Additional data are needed regarding the efficacy of induction therapy with CZP in active Crohn's disease (CD). METHODS: A placebo-controlled trial evaluated the efficacy of CZP therapy in 439 adults with moderate to severe CD naive to anti-TNF therapy. Patients were randomized to receive CZP (400 mg subcutaneously) or placebo at weeks 0, 2, and 4. The primary end point was clinical remission at week 6. RESULTS: Clinical remission rates at week 6 in the CZP and placebo groups were 32 and 25 (P = .174), respectively. Remission rates at weeks 2 and 4 in the CZP and placebo groups were 23 and 16 (P = .033) and 27 and 19 (P = .063), respectively. Clinical response rates at weeks 2, 4, and 6 in the CZP and placebo groups were 33 and 20 (P = .001), 35 and 26 (P = .024), and 41 and 34 (P = .179), respectively. There were significantly greater rates of clinical remission at week 6 for CZP in patients with increased concentrations of C-reactive protein (>= 5 mg/L) at entry. Serious adverse events developed in 5 and 4 of patients in the CZP and placebo groups, respectively. CONCLUSIONS: The primary end point did not reach statistical significance. Significant differences between CZP and placebo were observed in patients who had increased concentrations of C-reactive protein when the study began. Future clinical trials should emphasize the treatment of patients who have objective evidence of inflammation in addition to symptoms of active disease.