10 research outputs found
S1065 Predictors of Endoscopic Response and Remission in Patients with Active Crohn's Disease Treated with Certolizumab Pegol: A Logistic Regression Analysis of the Music Data
S1058 Certolizumab Pegol Improves Health-Related Quality of Life in Crohn's Disease Patients for Whom Infliximab Treatment Was Not Successful: Results from the WELCOME Study
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Regain of Response and Remission by Dose Adjustment in Patients with Crohnʼs Disease Who Responded to Certolizumab Pegol: Results from the WELCOME Study 1214
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Efficacy of Certolizumab Pegol is Not Affected by Baseline Anti-infliximab Antibody Status in Patients with Crohnʼs Disease with Secondary Infliximab Failure 1217
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Efficacy of Certolizumab Pegol in Crohnʼs Disease Patients with Secondary Failure to Infliximab Is Not Affected by Concomitant Medications 1216
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143 Welcome: A Randomized, Double-Blind, Controlled Trial Comparing Certolizumab Pegol 400 Mg Every 2 Weeks with Every 4 Weeks for Maintenance of Response and Remission in Patients with Moderate to Severe Crohn's Disease with Secondary Failure to Infliximab
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Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease and Secondary Failure to Infliximab
Patients with moderate to severe Crohn's disease who receive infliximab may experience secondary failure (loss of response and/or hypersensitivity). Data on the utility of switching to certolizumab pegol in these patients are limited.
A total of 539 patients with active Crohn's disease and secondary failure to infliximab were enrolled in a 26-week trial. Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0, 2, and 4. Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24. The primary end point was response at week 6. Secondary end points included remission at week 6 and response and remission at week 26.
At week 6, 334 of 539 patients (62.0%) achieved response and 212 of 539 (39.3%) achieved remission. A total of 329 patients were randomized and received maintenance therapy. At week 26, 39.9% (67 of 168) and 36.6% (59 of 161) of patients in the every-4-weeks and every-2-weeks groups were in clinical response, respectively (
P = .55). Corresponding remission rates at week 26 were 29.2% and 30.4%, respectively (
P = .81). Serious infections occurred in 9 of 539 (1.7%) and 12 of 373 (3.2%) of patients during induction and maintenance, respectively. A single malignancy (skin carcinoma) occurred in a patient receiving every-4-weeks maintenance therapy.
Response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients with moderate to severely active Crohn's disease and secondary failure to infliximab. Among these patients, certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission
Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab
Patients with moderate to severe Crohn's disease who receive infliximab may experience secondary failure (loss of response and/or hypersensitivity). Data on the utility of switching to certolizumab pegol in these patients are limited. A total of 539 patients with active Crohn's disease and secondary failure to infliximab were enrolled in a 26-week trial. Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0, 2, and 4. Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24. The primary end point was response at week 6. Secondary end points included remission at week 6 and response and remission at week 26. At week 6, 334 of 539 patients (62.0%) achieved response and 212 of 539 (39.3%) achieved remission. A total of 329 patients were randomized and received maintenance therapy. At week 26, 39.9% (67 of 168) and 36.6% (59 of 161) of patients in the every-4-weeks and every-2-weeks groups were in clinical response, respectively (P = .55). Corresponding remission rates at week 26 were 29.2% and 30.4%, respectively (P = .81). Serious infections occurred in 9 of 539 (1.7%) and 12 of 373 (3.2%) of patients during induction and maintenance, respectively. A single malignancy (skin carcinoma) occurred in a patient receiving every-4-weeks maintenance therapy. Response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients with moderate to severely active Crohn's disease and secondary failure to infliximab. Among these patients, certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remissio