Safety and efficacy of maintenance infliximab therapy for moderate-to-severe Crohn's disease in children: REACH open-label extension.

Abstract

OBJECTIVE:

Assess long-term effects of maintenance infliximab therapy in children with moderately-to-severely active Crohn's disease.

RESEARCH DESIGN AND METHODS:

One hundred twelve patients with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 received infliximab 5 mg/kg at weeks 0, 2, and 6 in the REACH study. Patients considered responders at week 10 were randomized to infliximab 5 mg/kg every 8 (q8w) or 12 (q12w) weeks. Patients who completed treatment through week 46, and who the investigator believed would benefit from continued treatment, could enter the open-label extension (OLE) and receive up to three additional years of infliximab. No hypothesis testing was performed.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov, identifier: NCT0020767.

RESULTS:

Sixty children entered the OLE: 33, 12, and 15 patients were receiving infliximab 5 mg/kg q8w, 5 mg/kg q12w, and 10 mg/kg q8w, respectively, at extension entry. Patients receiving infliximab for up to 3 years during the OLE maintained clinical benefit, with approximately 80% of patients consistently having no to mild disease activity per the physician's global assessment and very good to fair health in the past 2 weeks per the patient and parent/guardian global assessments. Patients with ≥1-year delay in bone age at baseline trended toward improvement in height during the OLE. Respiratory system disorders, most commonly upper respiratory infections, were the most prevalent adverse events reported; six (10%) patients had serious infections.

CONCLUSIONS:

Among children with moderately-to-severely active Crohn's disease who received infliximab for 46 weeks in REACH and then for up to 3 additional years in the REACH OLE, infliximab was effective in maintaining clinical benefit and was generally well-tolerated.

• Authors: Jeffrey Hyams, Thomas D Walters, Wallace Crandall, Subra Kugathasan, Anne Griffiths, Marion Blank, Jewel Johanns, Yinghua Lang, James Markowitz, Stanley Cohen, Harland S Winter, Gigi Veereman-Wauters, George Ferry, Robert Baldassano
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 27 Issue 3 Pg. 651-62 (Mar 2011) ISSN: 1473-4877 [Electronic] England
• PMID: 21241207 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal
• Infliximab

Topics

• Adolescent
• Algorithms
• Anti-Inflammatory Agents (adverse effects, therapeutic use)
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Child
• Crohn Disease (drug therapy)
• Female
• Follow-Up Studies
• Humans
• Infliximab
• Male
• Patient Selection
• Remission Induction
• Severity of Illness Index
• Time Factors
• Treatment Outcome