Maintenance Therapy with Certolizumab Pegol for Crohn’s Disease

Maintenance Therapy with Certolizumab Pegol for Crohn’s Disease

JULY 19, 2007 | Stefan Schreiber, M.D., Mani Khaliq-Kareemi, M.D., Ian C. Lawrance, M.D., Ole Østergaard Thomsen, M.D., Stephen B. Hanauer, M.D., Juliet McColm, M.D., Ralph Bloomfield, M.Sc., and William J. Sandborn, M.D., for the PRECISE 2 Study Investigators
The study evaluated the efficacy of certolizumab pegol maintenance therapy in adults with moderate-to-severe Crohn's disease. In a randomized, double-blind, placebo-controlled trial, patients who responded to induction therapy with 400 mg of certolizumab pegol at weeks 0, 2, and 4 were randomly assigned to receive either certolizumab pegol or placebo every 4 weeks through week 24. The primary endpoint was a clinical response at week 26 in patients with a baseline C-reactive protein (CRP) level of at least 10 mg per liter. Results showed that among patients with a response to induction therapy, 62% of those receiving certolizumab pegol maintained their response through week 26 compared to 34% of those receiving placebo (P<0.001). Additionally, 48% of patients in the certolizumab group achieved remission at week 26 compared to 29% in the placebo group (P<0.001). The safety profile was consistent with previous studies, with serious adverse events occurring in 6% of patients in the certolizumab group and 7% in the placebo group. Antibodies against certolizumab pegol developed in 9% of patients. The study concluded that continued administration of certolizumab pegol subcutaneously every 4 weeks is superior to placebo in maintaining response and remission in patients with moderate-to-severe Crohn's disease.The study evaluated the efficacy of certolizumab pegol maintenance therapy in adults with moderate-to-severe Crohn's disease. In a randomized, double-blind, placebo-controlled trial, patients who responded to induction therapy with 400 mg of certolizumab pegol at weeks 0, 2, and 4 were randomly assigned to receive either certolizumab pegol or placebo every 4 weeks through week 24. The primary endpoint was a clinical response at week 26 in patients with a baseline C-reactive protein (CRP) level of at least 10 mg per liter. Results showed that among patients with a response to induction therapy, 62% of those receiving certolizumab pegol maintained their response through week 26 compared to 34% of those receiving placebo (P<0.001). Additionally, 48% of patients in the certolizumab group achieved remission at week 26 compared to 29% in the placebo group (P<0.001). The safety profile was consistent with previous studies, with serious adverse events occurring in 6% of patients in the certolizumab group and 7% in the placebo group. Antibodies against certolizumab pegol developed in 9% of patients. The study concluded that continued administration of certolizumab pegol subcutaneously every 4 weeks is superior to placebo in maintaining response and remission in patients with moderate-to-severe Crohn's disease.
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Understanding Maintenance therapy with certolizumab pegol for Crohn's disease.