Safety and efficacy of maintenance infliximab therapy for moderate-to-severe Crohn's disease in children: REACH open-label extension.
OBJECTIVE
Assess long-term effects of maintenance infliximab therapy in children with moderately-to-severely active Crohn's disease.


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.


BACKGROUND
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.
Division of Digestive Diseases and Nutrition, Connecticut Children's Medical Center, Hartford, CT 06106, USA. jhyams@ccmckids.org
Jeffrey
J
Hyams
Thomas D
TD
Walters
Wallace
W
Crandall
Subra
S
Kugathasan
Anne
A
Griffiths
Marion
M
Blank
Jewel
J
Johanns
Yinghua
Y
Lang
James
J
Markowitz
Stanley
S
Cohen
Harland S
HS
Winter
Gigi
G
Veereman-Wauters
George
G
Ferry
Robert
R
Baldassano
D000293:Adolescent; D000465:Algorithms; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D008297:Male; D018579:Patient Selection; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab