Retrospective evaluation of the safety and effect of adalimumab therapy (RESEAT) in pediatric crohns disease

Joel R. Rosh, Trudy Lerer, James Markowitz, Sri R. Goli, Petar Mamula, Joshua D. Noe, Marian Pfefferkorn, Kathleen T. Kelleher, Anne M. Griffiths, Subra Kugathasan, David Keljo, Maria Oliva-Hemker, Wallace Crandall, Ryan S. Carvalho, David R. MacK, Jeffrey S. Hyams

Research output: Contribution to journalArticle

93 Citations (Scopus)

Abstract

OBJECTIVES: Adalimumab, an anti-tumor necrosis factor immunoglobulin-1 antibody, is increasingly being reported as a potential treatment option for children with moderate-to-severe Crohns disease (CD). The aim of this study was to characterize common indications, safety, tolerability, and clinical response to adalimumab in pediatric CD in a large, multicenter, patient cohort. METHODS: Data were obtained using a retrospective, uncontrolled chart review at 12 sites of the Pediatric Inflammatory Bowel Disease Collaborative Research Group. Clinical, laboratory, and demographic data were obtained for CD patients who received at least one dose of adalimumab. Indication for adalimumab, concomitant medications, and clinical outcome at 3, 6, and 12 months for each patient were recorded using physician global assessment (PGA) and Pediatric CD Activity Index scores. Serious adverse events were identified. RESULTS: A total of 115 patients (54% female) received at least one dose of adalimumab. The mean age at the diagnosis of CD was 11.13.1 years, with the first adalimumab dose administered at 4.72.8 years after diagnosis. The most common dosing frequency was every other week with induction doses of 160/80 mg in 19%, 80/40 mg in 44%, and 40/40 mg in 15% of patients. Maintenance dosing was 40 mg every other week in 88% of patients. Mean follow-up after initial adalimumab dose was 108.6 months. Infliximab treatment preceded adalimumab in 95% of patients, with a mean of 12 infliximab infusions (range: 1-44). Infliximab discontinuation was due to loss of response (47%), infusion reaction or infliximab intolerance (45%), or preference for a subcutaneous medication (9%). Concomitant medications at the commencement of adalimumab were corticosteroids (38%), azathioprine/6- mercaptopurine (41%), and methotrexate (23%). Clinical response measured by PGA at 3, 6, and 12 months was 65, 71, and 70%, respectively, with steroid-free remission at 3, 6, and 12 months of 22, 33, and 42%, respectively. There were no malignancies, serious infections, or deaths in the study subjects. CONCLUSIONS: Adalimumab was a well-tolerated and effective rescue therapy for moderate-to-severe pediatric CD patients previously treated with infliximab. Adalimumab demonstrated a steroid-sparing effect, and 70% of patients achieved rapid response that was sustained through 12 months.

Original languageEnglish
Pages (from-to)3042-3049
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume104
Issue number12
DOIs
StatePublished - Dec 2009

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Safety
Therapeutics
Crohn Disease
Pediatric Crohn's disease
Adalimumab
Steroids
Physicians
6-Mercaptopurine
Azathioprine
Inflammatory Bowel Diseases
Methotrexate
Immunoglobulins
Adrenal Cortex Hormones
Tumor Necrosis Factor-alpha
Maintenance
Demography
Infliximab
Pediatrics
Antibodies
Infection

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Rosh, J. R., Lerer, T., Markowitz, J., Goli, S. R., Mamula, P., Noe, J. D., ... Hyams, J. S. (2009). Retrospective evaluation of the safety and effect of adalimumab therapy (RESEAT) in pediatric crohns disease. American Journal of Gastroenterology, 104(12), 3042-3049. https://doi.org/10.1038/ajg.2009.493

Retrospective evaluation of the safety and effect of adalimumab therapy (RESEAT) in pediatric crohns disease. / Rosh, Joel R.; Lerer, Trudy; Markowitz, James; Goli, Sri R.; Mamula, Petar; Noe, Joshua D.; Pfefferkorn, Marian; Kelleher, Kathleen T.; Griffiths, Anne M.; Kugathasan, Subra; Keljo, David; Oliva-Hemker, Maria; Crandall, Wallace; Carvalho, Ryan S.; MacK, David R.; Hyams, Jeffrey S.

In: American Journal of Gastroenterology, Vol. 104, No. 12, 12.2009, p. 3042-3049.

Research output: Contribution to journalArticle

Rosh, JR, Lerer, T, Markowitz, J, Goli, SR, Mamula, P, Noe, JD, Pfefferkorn, M, Kelleher, KT, Griffiths, AM, Kugathasan, S, Keljo, D, Oliva-Hemker, M, Crandall, W, Carvalho, RS, MacK, DR & Hyams, JS 2009, 'Retrospective evaluation of the safety and effect of adalimumab therapy (RESEAT) in pediatric crohns disease', American Journal of Gastroenterology, vol. 104, no. 12, pp. 3042-3049. https://doi.org/10.1038/ajg.2009.493
Rosh, Joel R. ; Lerer, Trudy ; Markowitz, James ; Goli, Sri R. ; Mamula, Petar ; Noe, Joshua D. ; Pfefferkorn, Marian ; Kelleher, Kathleen T. ; Griffiths, Anne M. ; Kugathasan, Subra ; Keljo, David ; Oliva-Hemker, Maria ; Crandall, Wallace ; Carvalho, Ryan S. ; MacK, David R. ; Hyams, Jeffrey S. / Retrospective evaluation of the safety and effect of adalimumab therapy (RESEAT) in pediatric crohns disease. In: American Journal of Gastroenterology. 2009 ; Vol. 104, No. 12. pp. 3042-3049.
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T1 - Retrospective evaluation of the safety and effect of adalimumab therapy (RESEAT) in pediatric crohns disease

AU - Rosh, Joel R.

AU - Lerer, Trudy

AU - Markowitz, James

AU - Goli, Sri R.

AU - Mamula, Petar

AU - Noe, Joshua D.

AU - Pfefferkorn, Marian

AU - Kelleher, Kathleen T.

AU - Griffiths, Anne M.

AU - Kugathasan, Subra

AU - Keljo, David

AU - Oliva-Hemker, Maria

AU - Crandall, Wallace

AU - Carvalho, Ryan S.

AU - MacK, David R.

AU - Hyams, Jeffrey S.

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N2 - OBJECTIVES: Adalimumab, an anti-tumor necrosis factor immunoglobulin-1 antibody, is increasingly being reported as a potential treatment option for children with moderate-to-severe Crohns disease (CD). The aim of this study was to characterize common indications, safety, tolerability, and clinical response to adalimumab in pediatric CD in a large, multicenter, patient cohort. METHODS: Data were obtained using a retrospective, uncontrolled chart review at 12 sites of the Pediatric Inflammatory Bowel Disease Collaborative Research Group. Clinical, laboratory, and demographic data were obtained for CD patients who received at least one dose of adalimumab. Indication for adalimumab, concomitant medications, and clinical outcome at 3, 6, and 12 months for each patient were recorded using physician global assessment (PGA) and Pediatric CD Activity Index scores. Serious adverse events were identified. RESULTS: A total of 115 patients (54% female) received at least one dose of adalimumab. The mean age at the diagnosis of CD was 11.13.1 years, with the first adalimumab dose administered at 4.72.8 years after diagnosis. The most common dosing frequency was every other week with induction doses of 160/80 mg in 19%, 80/40 mg in 44%, and 40/40 mg in 15% of patients. Maintenance dosing was 40 mg every other week in 88% of patients. Mean follow-up after initial adalimumab dose was 108.6 months. Infliximab treatment preceded adalimumab in 95% of patients, with a mean of 12 infliximab infusions (range: 1-44). Infliximab discontinuation was due to loss of response (47%), infusion reaction or infliximab intolerance (45%), or preference for a subcutaneous medication (9%). Concomitant medications at the commencement of adalimumab were corticosteroids (38%), azathioprine/6- mercaptopurine (41%), and methotrexate (23%). Clinical response measured by PGA at 3, 6, and 12 months was 65, 71, and 70%, respectively, with steroid-free remission at 3, 6, and 12 months of 22, 33, and 42%, respectively. There were no malignancies, serious infections, or deaths in the study subjects. CONCLUSIONS: Adalimumab was a well-tolerated and effective rescue therapy for moderate-to-severe pediatric CD patients previously treated with infliximab. Adalimumab demonstrated a steroid-sparing effect, and 70% of patients achieved rapid response that was sustained through 12 months.

AB - OBJECTIVES: Adalimumab, an anti-tumor necrosis factor immunoglobulin-1 antibody, is increasingly being reported as a potential treatment option for children with moderate-to-severe Crohns disease (CD). The aim of this study was to characterize common indications, safety, tolerability, and clinical response to adalimumab in pediatric CD in a large, multicenter, patient cohort. METHODS: Data were obtained using a retrospective, uncontrolled chart review at 12 sites of the Pediatric Inflammatory Bowel Disease Collaborative Research Group. Clinical, laboratory, and demographic data were obtained for CD patients who received at least one dose of adalimumab. Indication for adalimumab, concomitant medications, and clinical outcome at 3, 6, and 12 months for each patient were recorded using physician global assessment (PGA) and Pediatric CD Activity Index scores. Serious adverse events were identified. RESULTS: A total of 115 patients (54% female) received at least one dose of adalimumab. The mean age at the diagnosis of CD was 11.13.1 years, with the first adalimumab dose administered at 4.72.8 years after diagnosis. The most common dosing frequency was every other week with induction doses of 160/80 mg in 19%, 80/40 mg in 44%, and 40/40 mg in 15% of patients. Maintenance dosing was 40 mg every other week in 88% of patients. Mean follow-up after initial adalimumab dose was 108.6 months. Infliximab treatment preceded adalimumab in 95% of patients, with a mean of 12 infliximab infusions (range: 1-44). Infliximab discontinuation was due to loss of response (47%), infusion reaction or infliximab intolerance (45%), or preference for a subcutaneous medication (9%). Concomitant medications at the commencement of adalimumab were corticosteroids (38%), azathioprine/6- mercaptopurine (41%), and methotrexate (23%). Clinical response measured by PGA at 3, 6, and 12 months was 65, 71, and 70%, respectively, with steroid-free remission at 3, 6, and 12 months of 22, 33, and 42%, respectively. There were no malignancies, serious infections, or deaths in the study subjects. CONCLUSIONS: Adalimumab was a well-tolerated and effective rescue therapy for moderate-to-severe pediatric CD patients previously treated with infliximab. Adalimumab demonstrated a steroid-sparing effect, and 70% of patients achieved rapid response that was sustained through 12 months.

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