Safety and efficacy of adalimumab in pediatric patients with crohn disease

Matthew J. Wyneski, Alex Green, Marsha Kay*, Robert Wyllie, Lori Mahajan

*Corresponding author for this work

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Objectives: Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumornecrosis factor-αinhibitor to infliximab.To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients withCD.Our aimwas to examine the safety and efficacy of adalimumab therapy in pediatric patients with CD. Patients and Methods: We performed a retrospective chart review of 15 pediatric patients with CD who received adalimumab at a single institution between January 2003 and March 2007. All of the patients had a history of an attenuated response or anaphylaxis to infliximab. Each patient's chart was reviewed for age at diagnosis, sex, extent of disease, age at start of adalimumab therapy, course of therapy, side effects noted during therapy, concurrent medications, and response to adalimumab. Clinical response to adalimumab was classified as complete, partial, or no response based on the patients' ability to be weaned from steroids, increased or decreased need for steroids, or need for surgery during the course of treatment. This study was approved by the Cleveland Clinic Institutional Review Board. Results: Fifteen pediatric patients withCDreceived adalimumab for a 33-month period. Of those, 14 patients had adequate followup, and 1 patient was lost to follow-up. The mean age at initiation of therapy was 16.6 years (median 17.9 years, range 10.3- 21.8 years, SD 3.1 years). The majority of patients received an 80-mg loading dose administered subcutaneously and 40-mg doses subsequently every 2 weeks. The median duration of therapy was 6.5 months (range 1-31 months). A total of 272 injections were given. Of the 14 patients with sufficient data for follow-up, 7 (50%) had a complete response, 2 (14%) had a partial response, and 5 (36%) had no response to adalimumab. Complete response was achieved after a median of 5 injections (range 3-11). Of the 14 patients with adequate follow-up, 5 had fistulizing disease; 3 of these maintained fistula closure, 1 had temporary closure, and 1 required surgery to assist with closure. Twenty-six adverse events occurred during therapy. Eight (57%) patients had at least 1 adverse effect. The most common events were abdominal pain and nausea. No serious adverse events were reported, no serious infections occurred, and no adverse events required discontinuation of adalimumab. Conclusions: Adalimumab was well tolerated in pediatric patients with CD. Complete or partial response was observed in 64% of patients. No serious adverse events occurred during therapy.Additional studies are needed to evaluate the efficacy and to determine optimal dosing of adalimumab in the pediatric population with CD.

Original languageEnglish (US)
Pages (from-to)19-25
Number of pages7
JournalJournal of Pediatric Gastroenterology and Nutrition
Volume47
Issue number1
DOIs
StatePublished - Jul 1 2008

Fingerprint

Crohn Disease
Pediatrics
Safety
Adalimumab
Therapeutics
Steroids
Injections
Research Ethics Committees
Lost to Follow-Up
Anaphylaxis
Nausea
Abdominal Pain
Fistula

Keywords

  • Adalimumab
  • Crohn disease
  • Inflammatory bowel disease
  • Infliximab
  • Infusion reaction
  • Tumor necrosis factor-α

ASJC Scopus subject areas

  • Gastroenterology
  • Pediatrics, Perinatology, and Child Health

Cite this

Wyneski, Matthew J. ; Green, Alex ; Kay, Marsha ; Wyllie, Robert ; Mahajan, Lori. / Safety and efficacy of adalimumab in pediatric patients with crohn disease. In: Journal of Pediatric Gastroenterology and Nutrition. 2008 ; Vol. 47, No. 1. pp. 19-25.
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abstract = "Objectives: Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumornecrosis factor-αinhibitor to infliximab.To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients withCD.Our aimwas to examine the safety and efficacy of adalimumab therapy in pediatric patients with CD. Patients and Methods: We performed a retrospective chart review of 15 pediatric patients with CD who received adalimumab at a single institution between January 2003 and March 2007. All of the patients had a history of an attenuated response or anaphylaxis to infliximab. Each patient's chart was reviewed for age at diagnosis, sex, extent of disease, age at start of adalimumab therapy, course of therapy, side effects noted during therapy, concurrent medications, and response to adalimumab. Clinical response to adalimumab was classified as complete, partial, or no response based on the patients' ability to be weaned from steroids, increased or decreased need for steroids, or need for surgery during the course of treatment. This study was approved by the Cleveland Clinic Institutional Review Board. Results: Fifteen pediatric patients withCDreceived adalimumab for a 33-month period. Of those, 14 patients had adequate followup, and 1 patient was lost to follow-up. The mean age at initiation of therapy was 16.6 years (median 17.9 years, range 10.3- 21.8 years, SD 3.1 years). The majority of patients received an 80-mg loading dose administered subcutaneously and 40-mg doses subsequently every 2 weeks. The median duration of therapy was 6.5 months (range 1-31 months). A total of 272 injections were given. Of the 14 patients with sufficient data for follow-up, 7 (50{\%}) had a complete response, 2 (14{\%}) had a partial response, and 5 (36{\%}) had no response to adalimumab. Complete response was achieved after a median of 5 injections (range 3-11). Of the 14 patients with adequate follow-up, 5 had fistulizing disease; 3 of these maintained fistula closure, 1 had temporary closure, and 1 required surgery to assist with closure. Twenty-six adverse events occurred during therapy. Eight (57{\%}) patients had at least 1 adverse effect. The most common events were abdominal pain and nausea. No serious adverse events were reported, no serious infections occurred, and no adverse events required discontinuation of adalimumab. Conclusions: Adalimumab was well tolerated in pediatric patients with CD. Complete or partial response was observed in 64{\%} of patients. No serious adverse events occurred during therapy.Additional studies are needed to evaluate the efficacy and to determine optimal dosing of adalimumab in the pediatric population with CD.",
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Safety and efficacy of adalimumab in pediatric patients with crohn disease. / Wyneski, Matthew J.; Green, Alex; Kay, Marsha; Wyllie, Robert; Mahajan, Lori.

In: Journal of Pediatric Gastroenterology and Nutrition, Vol. 47, No. 1, 01.07.2008, p. 19-25.

Research output: Contribution to journalArticle

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T1 - Safety and efficacy of adalimumab in pediatric patients with crohn disease

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AU - Green, Alex

AU - Kay, Marsha

AU - Wyllie, Robert

AU - Mahajan, Lori

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N2 - Objectives: Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumornecrosis factor-αinhibitor to infliximab.To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients withCD.Our aimwas to examine the safety and efficacy of adalimumab therapy in pediatric patients with CD. Patients and Methods: We performed a retrospective chart review of 15 pediatric patients with CD who received adalimumab at a single institution between January 2003 and March 2007. All of the patients had a history of an attenuated response or anaphylaxis to infliximab. Each patient's chart was reviewed for age at diagnosis, sex, extent of disease, age at start of adalimumab therapy, course of therapy, side effects noted during therapy, concurrent medications, and response to adalimumab. Clinical response to adalimumab was classified as complete, partial, or no response based on the patients' ability to be weaned from steroids, increased or decreased need for steroids, or need for surgery during the course of treatment. This study was approved by the Cleveland Clinic Institutional Review Board. Results: Fifteen pediatric patients withCDreceived adalimumab for a 33-month period. Of those, 14 patients had adequate followup, and 1 patient was lost to follow-up. The mean age at initiation of therapy was 16.6 years (median 17.9 years, range 10.3- 21.8 years, SD 3.1 years). The majority of patients received an 80-mg loading dose administered subcutaneously and 40-mg doses subsequently every 2 weeks. The median duration of therapy was 6.5 months (range 1-31 months). A total of 272 injections were given. Of the 14 patients with sufficient data for follow-up, 7 (50%) had a complete response, 2 (14%) had a partial response, and 5 (36%) had no response to adalimumab. Complete response was achieved after a median of 5 injections (range 3-11). Of the 14 patients with adequate follow-up, 5 had fistulizing disease; 3 of these maintained fistula closure, 1 had temporary closure, and 1 required surgery to assist with closure. Twenty-six adverse events occurred during therapy. Eight (57%) patients had at least 1 adverse effect. The most common events were abdominal pain and nausea. No serious adverse events were reported, no serious infections occurred, and no adverse events required discontinuation of adalimumab. Conclusions: Adalimumab was well tolerated in pediatric patients with CD. Complete or partial response was observed in 64% of patients. No serious adverse events occurred during therapy.Additional studies are needed to evaluate the efficacy and to determine optimal dosing of adalimumab in the pediatric population with CD.

AB - Objectives: Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumornecrosis factor-αinhibitor to infliximab.To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients withCD.Our aimwas to examine the safety and efficacy of adalimumab therapy in pediatric patients with CD. Patients and Methods: We performed a retrospective chart review of 15 pediatric patients with CD who received adalimumab at a single institution between January 2003 and March 2007. All of the patients had a history of an attenuated response or anaphylaxis to infliximab. Each patient's chart was reviewed for age at diagnosis, sex, extent of disease, age at start of adalimumab therapy, course of therapy, side effects noted during therapy, concurrent medications, and response to adalimumab. Clinical response to adalimumab was classified as complete, partial, or no response based on the patients' ability to be weaned from steroids, increased or decreased need for steroids, or need for surgery during the course of treatment. This study was approved by the Cleveland Clinic Institutional Review Board. Results: Fifteen pediatric patients withCDreceived adalimumab for a 33-month period. Of those, 14 patients had adequate followup, and 1 patient was lost to follow-up. The mean age at initiation of therapy was 16.6 years (median 17.9 years, range 10.3- 21.8 years, SD 3.1 years). The majority of patients received an 80-mg loading dose administered subcutaneously and 40-mg doses subsequently every 2 weeks. The median duration of therapy was 6.5 months (range 1-31 months). A total of 272 injections were given. Of the 14 patients with sufficient data for follow-up, 7 (50%) had a complete response, 2 (14%) had a partial response, and 5 (36%) had no response to adalimumab. Complete response was achieved after a median of 5 injections (range 3-11). Of the 14 patients with adequate follow-up, 5 had fistulizing disease; 3 of these maintained fistula closure, 1 had temporary closure, and 1 required surgery to assist with closure. Twenty-six adverse events occurred during therapy. Eight (57%) patients had at least 1 adverse effect. The most common events were abdominal pain and nausea. No serious adverse events were reported, no serious infections occurred, and no adverse events required discontinuation of adalimumab. Conclusions: Adalimumab was well tolerated in pediatric patients with CD. Complete or partial response was observed in 64% of patients. No serious adverse events occurred during therapy.Additional studies are needed to evaluate the efficacy and to determine optimal dosing of adalimumab in the pediatric population with CD.

KW - Adalimumab

KW - Crohn disease

KW - Inflammatory bowel disease

KW - Infliximab

KW - Infusion reaction

KW - Tumor necrosis factor-α

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