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.

Key words::

• Crohn’s disease
• Infliximab
• Long-term experience
• Maintenance therapy
• Pediatric
• Tumor necrosis factor-α

Transparency

Declaration of funding

Centocor Research & Development, Inc., Malvern, PA, USA and Schering-Plough Corp., Kenilworth, NJ, USA provided support for this study.

Declaration of financial/other relationships

J.H. has disclosed that he has received research funding in conjunction with the conduct of this study and other studies sponsored by Centocor Research & Development, Inc.; and that he has served as a Consultant to Centocor Research & Development, Inc. R.B, J.M, G.V-W. and H.S.W. received research funding in conjunction with this and other studies; served as a Consultant to Centocor Research & Development, Inc.; and received an honorarium from Centocor Research & Development, Inc. W.C. and S.K. have disclosed that they have received research funding in conjunction with the conduct of this study; served as consultants to Centocor Research & Development, Inc.; and received honoraria from Centocor Research & Development, Inc. S.C. has disclosed that he has received research funding in conjunction with the conduct of this study and received other research grants and chaired conferences sponsored by Centocor Research & Development, Inc. G.F. has disclosed that he has received research funding in conjunction with the conduct of this study and served as a consultant to Centocor Research & Development, Inc. A.G. has disclosed that he has received research funding in conjunction with the conduct of this study. T.D.W. has disclosed that he has served as a consultant to Centocor Research & Development, Inc. M.B., J.J. and Y.L. have disclosed that they are employees of Centocor Research & Development, Inc.

Acknowledgments

The authors thank James P. Barrett, an employee of Centocor Ortho Biotech, Inc. Medical Affairs Publication Group, for editorial and writing support.

Some of the results presented in this article were published as an abstract and presented as a poster (Poster of Distinction) at Digestive Disease Week 2009 annual meeting in Chicago, IL, USA (American Journal of Gastroenterology 2009;132[Suppl. 1];A-671:W1181); May 30 to June 4, 2009; and as a poster at the 2009 Pediatric Inflammatory Bowel Disease Congress in Paris, France; September 9–12, 2009.