Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis
| Autor: | Jeffrey, Hyams, Lakshmi, Damaraju, Marion, Blank, Jewel, Johanns, Cynthia, Guzzo, Harland S, Winter, Subra, Kugathasan, Stanley, Cohen, James, Markowitz, Johanna C, Escher, Gigi, Veereman-Wauters, Wallace, Crandall, Robert, Baldassano, Anne, Griffiths, H S, Winter |
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| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Anti-Inflammatory Agents Azathioprine Severity of Illness Index Maintenance Chemotherapy Maintenance therapy Gastrointestinal Agents Internal medicine Severity of illness medicine Humans Adverse effect Child Hepatology business.industry Gastroenterology Antibodies Monoclonal Induction Chemotherapy medicine.disease Ulcerative colitis Infliximab Confidence interval Surgery Treatment Outcome Delayed hypersensitivity Colitis Ulcerative Female business medicine.drug |
| Zdroj: | Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 10(4) |
| ISSN: | 1542-7714 |
| Popis: | Background & Aims We evaluated the efficacy and safety of infliximab for inducing and maintaining benefit in children with moderately to severely active ulcerative colitis (UC). Methods Patients (6–17 years old) who had active UC (Mayo scores of 6–12; endoscopic subscores ≥2) and had not responded to or tolerated conventional treatment were given 5 mg/kg infliximab at weeks 0, 2, and 6. The primary end point was response at week 8 (decreases in Mayo scores ≥30% and ≥3 points and decreases in rectal bleeding subscores of ≥1 or an absolute subscore of ≤1). At week 8, only responders were randomly assigned to groups given infliximab every 8 or 12 weeks (q8w or q12w) and followed through week 54. Maintenance end points included pediatric UC activity index scores Results At week 8, infliximab induced a response in 73.3% of patients (44 of 60) (95% confidence interval, 62.1%–84.5%; a positive result was defined by 95% confidence interval lower limit >40%). Among responders, twice as many were in remission at week 54 after q8w (8 of 21, 38.1%) than q12w (4 of 22, 18.2%; P = .146) therapy. Assuming the q8w remission rate for responders, the overall remission rate at week 54 would be 28.6%. Serious adverse events and infusion reactions occurred in similar proportions in the q8w and q12w groups. No deaths, malignancies, opportunistic infections, tuberculosis, or delayed hypersensitivity reactions were reported. Conclusions Infliximab was safe and effective, inducing a response at week 8 in 73.3% of pediatric patients with moderate to severely active UC who did not respond to conventional therapy. The overall remission rate at week 54 for all enrolled patients was 28.6%, assuming the more effective q8w remission rate. |
| Databáze: | OpenAIRE |
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