Autor: |
S, Lichtiger, D G, Binion, D C, Wolf, D H, Present, A G, Bensimon, E, Wu, A P, Yu, A T, Cardoso, J, Chao, P M, Mulani, K G, Lomax, J D, Kent |
Rok vydání: |
2010 |
Předmět: |
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Zdroj: |
Alimentary pharmacologytherapeutics. 32(10) |
ISSN: |
1365-2036 |
Popis: |
Adalimumab induces and maintains remission in adults with Crohn's disease.To evaluate safety, fistula healing, quality of life and work productivity in adalimumab-treated patients who failed infliximab, including primary nonresponders.After a ≥8-week infliximab washout, patients with moderate-to-severe Crohn's disease received open-label adalimumab as induction (160/80 mg at weeks 0/2) and maintenance (40 mg every other week) therapies. At/after 8 weeks, patients with flare/nonresponse could receive weekly therapy. Minimum study duration was 8 weeks, continuing until the commercial availability of adalimumab for Crohn's disease.Of 673 patients enrolled, 17% were infliximab primary nonresponders and 83% were initial responders. Three percent of patients had serious infections (mainly abscesses). Complete fistula healing was achieved by 34/88 (39%) patients with baseline fistulas. Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients, as well as the subgroup of primary nonresponders.Blinded clinical trials have shown adalimumab to be both an effective first-line therapy for anti-TNF-naïve patients and an important treatment option for infliximab-refractory or -intolerant patients. This trial presents open-label experience to support further the safety and effectiveness of adalimumab in patients who failed infliximab therapy, including primary nonresponders (NCT00338650). |
Databáze: |
OpenAIRE |
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