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• W2979198532 abstract "Purpose: The WELCOME study prospectively evaluated certolizumab pegol (CZP) in moderate to severe Crohn's disease patients who had previously responded to infliximab but were no longer responding or had developed hypersensitivity. Here we report on the efficacy of CZP 400 mg q2w for regaining response in patients who initially responded to CZP induction but then relapsed following treatment with either CZP 400 mg q2w or q4w. Methods: WELCOME, a 26-week, Phase IIIb, multicenter trial, consisted of a 6-week open-label induction with CZP 400 mg at Weeks 0, 2, and 4 followed by a double-blind randomized maintenance phase. Patients in clinical response at Week 6 received CZP 400 mg q2w or q4w through Week 24. Patients who relapsed after randomization were allowed to receive open-label CZP 400 mg q2w and were treated up to Week 24. Clinical response was defined as a decrease of ≥100 points in the Crohn's Disease Activity Index (CDAI) from baseline and remission as a CDAI score of ≤150 points. Results: At Week 6, 62% (334/539) of patients who received CZP induction were in clinical response. Of these, 161 were randomized to CZP q2w and 168 to CZP q4w. Response and remission rates at Week 26 were 36.6% and 30.4% for CZP q2w and 39.9% and 29.2% for CZP q4w, with no significant differences observed between the dosing regimens. Over the study period 125 of the 329 randomized patients switched to open-label CZP q2w. Overall, response was observed in almost half of the patients and remission in over a quarter within the initial 3 visits following the switch (Table). The dosing regimen they were randomized to did not have any influence on response or remission rates in the switch phase. 93 patients (53 from the q4w and 40 from the q2w group) were not in response at the time they switched to open-label therapy. Over the course of the study 71% of these regained response with CZP q2w, with 80% of them doing so within the 3 dose re-induction period (Table). No new safety concerns were observed with the CZP 400 mg q2w regime.TableConclusion: CZP is effective for induction and maintenance therapy in patients with moderate to severe Crohn's disease who have previously lost response and/ or developed hypersensitivity to infliximab. Among patients who responded to induction therapy with CZP 400 mg, continuing therapy q4w is as effective as q2w as the initial strategy for maintenance of response and remission through Week 26. For those patients who respond to induction treatment with CZP and relapse during maintenance treatment, dosage adjustment to CZP 400 mg q2w proved a successful management strategy with over two thirds regaining response and 80% doing so within the re-induction period. Disclosure: Dr Sandborn is a consultant for UCB; Dr D'Haens is a consultant for UCB; Dr Vermeire is a consultant for UCB; Dr Colombel is a consultant for UCB; Dr Fedorak is a consultant for UCB; Dr Spehlmann is a consultant for UCB; Dr Wolf is a consultant for UCB; Dr Mitchev is an employee of UCB; Dr Jamoul is an employee of UCB; Dr Abreu is a consultant for UCB; Dr Rutgeerts is a consultant for UCB. This research was supported by an industry grant from UCB." @default.
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• W2979198532 date "2009-10-01" @default.
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• W2979198532 title "Regain of Response and Remission by Dose Adjustment in Patients with Crohnʼs Disease Who Responded to Certolizumab Pegol: Results from the WELCOME Study" @default.
• W2979198532 doi "https://doi.org/10.14309/00000434-200910003-01214" @default.
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