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: Chapter in Book/Report/Conference proceedingChapter

Abstract

Objectives: Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumor necrosis factor-a inhibitor to infliximab. To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients with CD. Our aim was 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 with CD received adalimumab for a 33-month period. Of those, 14 patients had adequate follow-up, 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)
Title of host publicationBiologic Treatment of Pediatric Inflammatory Bowel Disease
Subtitle of host publicationA Decade of JPGN Contributions
PublisherWolters Kluwer Health Adis (ESP)
ISBN (Electronic)9781469887142
ISBN (Print)9781469887166
StatePublished - Apr 24 2014

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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

  • Medicine(all)

Cite this

Wyneski, M. J., Green, A., Kay, M., Wyllie, R., & Mahajan, L. (2014). Safety and efficacy of adalimumab in pediatric patients with crohn disease. In Biologic Treatment of Pediatric Inflammatory Bowel Disease: A Decade of JPGN Contributions Wolters Kluwer Health Adis (ESP).
Wyneski, Matthew J. ; Green, Alex ; Kay, Marsha ; Wyllie, Robert ; Mahajan, Lori. / Safety and efficacy of adalimumab in pediatric patients with crohn disease. Biologic Treatment of Pediatric Inflammatory Bowel Disease: A Decade of JPGN Contributions. Wolters Kluwer Health Adis (ESP), 2014.
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title = "Safety and efficacy of adalimumab in pediatric patients with crohn disease",
abstract = "Objectives: Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumor necrosis factor-a inhibitor to infliximab. To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients with CD. Our aim was 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 with CD received adalimumab for a 33-month period. Of those, 14 patients had adequate follow-up, 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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Wyneski, MJ, Green, A, Kay, M, Wyllie, R & Mahajan, L 2014, Safety and efficacy of adalimumab in pediatric patients with crohn disease. in Biologic Treatment of Pediatric Inflammatory Bowel Disease: A Decade of JPGN Contributions. Wolters Kluwer Health Adis (ESP).

Safety and efficacy of adalimumab in pediatric patients with crohn disease. / Wyneski, Matthew J.; Green, Alex; Kay, Marsha; Wyllie, Robert; Mahajan, Lori.

Biologic Treatment of Pediatric Inflammatory Bowel Disease: A Decade of JPGN Contributions. Wolters Kluwer Health Adis (ESP), 2014.

Research output: Chapter in Book/Report/Conference proceedingChapter

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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 tumor necrosis factor-a inhibitor to infliximab. To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients with CD. Our aim was 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 with CD received adalimumab for a 33-month period. Of those, 14 patients had adequate follow-up, 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 tumor necrosis factor-a inhibitor to infliximab. To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients with CD. Our aim was 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 with CD received adalimumab for a 33-month period. Of those, 14 patients had adequate follow-up, 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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KW - Crohn disease

KW - Inflammatory bowel disease

KW - Infliximab

KW - Infusion reaction

KW - Tumor necrosis factor-α

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Wyneski MJ, Green A, Kay M, Wyllie R, Mahajan L. Safety and efficacy of adalimumab in pediatric patients with crohn disease. In Biologic Treatment of Pediatric Inflammatory Bowel Disease: A Decade of JPGN Contributions. Wolters Kluwer Health Adis (ESP). 2014