Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children.
OBJECTIVE
The REACH study evaluated the safety and efficacy of infliximab in children with moderately to severely active Crohn's disease.


METHODS
Patients (n = 112) with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 received infliximab 5 mg/kg at weeks 0, 2, and 6. Patients responding to treatment at week 10 were randomized to infliximab 5 mg/kg every 8 or 12 weeks through week 46. A concurrent immunomodulator was required. Clinical response (decrease from baseline in the PCDAI score > or =15 points; total score < or =30) and clinical remission (PCDAI score < or =10 points) were evaluated at weeks 10, 30, and 54.


RESULTS
At week 10, 99 of 112 (88.4%) patients responded to infliximab (95% confidence interval: [82.5%, 94.3%]) and 66 of 112 (58.9%) patients achieved clinical remission (95% confidence interval: [49.8%, 68.0%]). At week 54, 33 of 52 (63.5%) and 29 of 52 (55.8%) patients receiving infliximab every 8 weeks did not require dose adjustment and were in clinical response and clinical remission, respectively, compared with 17 of 51 (33.3%) and 12 of 51 (23.5%) patients receiving treatment every 12 weeks (P = .002 and P < .001, respectively).


CONCLUSIONS
Pediatric patients responding to an induction regimen of infliximab were more likely to be in clinical response and remission at week 54 without dose adjustment when their maintenance therapy was given every 8 weeks rather than every 12 weeks. Allowing for dose intensification in the case of relapse, remission rates, but not response rates, at week 54 were superior with every 8-week dosing compared with every 12-week dosing.
Hyams
Jeffrey
J
Connecticut Children's Medical Center, Hartford, Conneticut 06106, USA. jhyams@ccmckids.org
Crandall
Wallace
W
Kugathasan
Subra
S
Griffiths
Anne
A
Olson
Allan
A
Johanns
Jewel
J
Liu
Grace
G
Travers
Suzanne
S
Heuschkel
Robert
R
Markowitz
James
J
Cohen
Stanley
S
Winter
Harland
H
Veereman-Wauters
Gigi
G
Ferry
George
G
Baldassano
Robert
R
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000906:Antibodies / Q000097:blood; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D001827:Body Height / Q000187:drug effects; D002648:Child; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000069285:Infliximab; D008297:Male; D009656:North America; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000906:Antibodies; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007155:Immunologic Factors; D000069285:Infliximab