An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn's disease

William J. Sandborn, Stephen Hanauer, Edward Vincent Loftus, Jr, William J. Tremaine, Sunanda Kane, Russell Cohen, Karen Hanson, Therese Johnson, Debra Schmitt, Resa Jeche

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: We assessed the tolerability and clinical benefit of adalimumab, a human antibody to tumor necrosis factor (TNF), in patients with Crohn's disease who had previously received and responded to the chimeric anti-TNF antibody infliximab, but who no longer had a sustained response and/or tolerance to infliximab. METHODS: A total of 24 patients with Crohn's disease who had lost responsiveness or developed intolerance (acute or delayed infusion reactions) to infliximab were enrolled in a 12-wk uncontrolled trial and treated with subcutaneous adalimumab 80 mg at week 0 and then 40 mg every other week starting at week 2. After week 4, the dose could be escalated to 40 mg weekly in patients who did not achieve clinical remission, complete fistula closure, and complete steroid withdrawal. Outcome measures included the ability to tolerate adalimumab and clinical remission (defined as a Crohn's disease activity index (CDAI) score ≤150 points) and clinical response (defined as a decrease in the CDAI) ≥100 points) in patients who had a baseline CDAI score ≥220. RESULTS: None of the patients experienced acute or delayed hypersensitivity reactions during treatment with adalimumab (including 14 who previously experienced treatment-limiting acute hypersensitivity reactions and 6 who previously experienced delayed hypersensitivity reactions with infliximab). Of 17 patients with baseline CDAI scores ≥220: clinical remission occurred at weeks 4 and 12 in 2 (12%) and 5 (29%), respectively; and clinical response occurred in 7 (41%) and 10 (59%), respectively. Nineteen patients (79%) escalated their dose during weeks 4-6. CONCLUSIONS: Adalimumab is well tolerated and appears to be a clinically beneficial option for patients with Crohn's disease who have previously lost their response to, or cannot tolerate infliximab.

Original languageEnglish (US)
Pages (from-to)1984-1989
Number of pages6
JournalAmerican Journal of Gastroenterology
Volume99
Issue number10
DOIs
StatePublished - Oct 2004

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Crohn Disease
Monoclonal Antibodies
Delayed Hypersensitivity
Tumor Necrosis Factor-alpha
human TNF protein
Adalimumab
Infliximab
Antibodies
Fistula
Hypersensitivity
Steroids
Outcome Assessment (Health Care)
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

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An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn's disease. / Sandborn, William J.; Hanauer, Stephen; Loftus, Jr, Edward Vincent; Tremaine, William J.; Kane, Sunanda; Cohen, Russell; Hanson, Karen; Johnson, Therese; Schmitt, Debra; Jeche, Resa.

In: American Journal of Gastroenterology, Vol. 99, No. 10, 10.2004, p. 1984-1989.

Research output: Contribution to journalArticle

Sandborn, William J. ; Hanauer, Stephen ; Loftus, Jr, Edward Vincent ; Tremaine, William J. ; Kane, Sunanda ; Cohen, Russell ; Hanson, Karen ; Johnson, Therese ; Schmitt, Debra ; Jeche, Resa. / An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn's disease. In: American Journal of Gastroenterology. 2004 ; Vol. 99, No. 10. pp. 1984-1989.
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abstract = "BACKGROUND: We assessed the tolerability and clinical benefit of adalimumab, a human antibody to tumor necrosis factor (TNF), in patients with Crohn's disease who had previously received and responded to the chimeric anti-TNF antibody infliximab, but who no longer had a sustained response and/or tolerance to infliximab. METHODS: A total of 24 patients with Crohn's disease who had lost responsiveness or developed intolerance (acute or delayed infusion reactions) to infliximab were enrolled in a 12-wk uncontrolled trial and treated with subcutaneous adalimumab 80 mg at week 0 and then 40 mg every other week starting at week 2. After week 4, the dose could be escalated to 40 mg weekly in patients who did not achieve clinical remission, complete fistula closure, and complete steroid withdrawal. Outcome measures included the ability to tolerate adalimumab and clinical remission (defined as a Crohn's disease activity index (CDAI) score ≤150 points) and clinical response (defined as a decrease in the CDAI) ≥100 points) in patients who had a baseline CDAI score ≥220. RESULTS: None of the patients experienced acute or delayed hypersensitivity reactions during treatment with adalimumab (including 14 who previously experienced treatment-limiting acute hypersensitivity reactions and 6 who previously experienced delayed hypersensitivity reactions with infliximab). Of 17 patients with baseline CDAI scores ≥220: clinical remission occurred at weeks 4 and 12 in 2 (12{\%}) and 5 (29{\%}), respectively; and clinical response occurred in 7 (41{\%}) and 10 (59{\%}), respectively. Nineteen patients (79{\%}) escalated their dose during weeks 4-6. CONCLUSIONS: Adalimumab is well tolerated and appears to be a clinically beneficial option for patients with Crohn's disease who have previously lost their response to, or cannot tolerate infliximab.",
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AU - Sandborn, William J.

AU - Hanauer, Stephen

AU - Loftus, Jr, Edward Vincent

AU - Tremaine, William J.

AU - Kane, Sunanda

AU - Cohen, Russell

AU - Hanson, Karen

AU - Johnson, Therese

AU - Schmitt, Debra

AU - Jeche, Resa

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N2 - BACKGROUND: We assessed the tolerability and clinical benefit of adalimumab, a human antibody to tumor necrosis factor (TNF), in patients with Crohn's disease who had previously received and responded to the chimeric anti-TNF antibody infliximab, but who no longer had a sustained response and/or tolerance to infliximab. METHODS: A total of 24 patients with Crohn's disease who had lost responsiveness or developed intolerance (acute or delayed infusion reactions) to infliximab were enrolled in a 12-wk uncontrolled trial and treated with subcutaneous adalimumab 80 mg at week 0 and then 40 mg every other week starting at week 2. After week 4, the dose could be escalated to 40 mg weekly in patients who did not achieve clinical remission, complete fistula closure, and complete steroid withdrawal. Outcome measures included the ability to tolerate adalimumab and clinical remission (defined as a Crohn's disease activity index (CDAI) score ≤150 points) and clinical response (defined as a decrease in the CDAI) ≥100 points) in patients who had a baseline CDAI score ≥220. RESULTS: None of the patients experienced acute or delayed hypersensitivity reactions during treatment with adalimumab (including 14 who previously experienced treatment-limiting acute hypersensitivity reactions and 6 who previously experienced delayed hypersensitivity reactions with infliximab). Of 17 patients with baseline CDAI scores ≥220: clinical remission occurred at weeks 4 and 12 in 2 (12%) and 5 (29%), respectively; and clinical response occurred in 7 (41%) and 10 (59%), respectively. Nineteen patients (79%) escalated their dose during weeks 4-6. CONCLUSIONS: Adalimumab is well tolerated and appears to be a clinically beneficial option for patients with Crohn's disease who have previously lost their response to, or cannot tolerate infliximab.

AB - BACKGROUND: We assessed the tolerability and clinical benefit of adalimumab, a human antibody to tumor necrosis factor (TNF), in patients with Crohn's disease who had previously received and responded to the chimeric anti-TNF antibody infliximab, but who no longer had a sustained response and/or tolerance to infliximab. METHODS: A total of 24 patients with Crohn's disease who had lost responsiveness or developed intolerance (acute or delayed infusion reactions) to infliximab were enrolled in a 12-wk uncontrolled trial and treated with subcutaneous adalimumab 80 mg at week 0 and then 40 mg every other week starting at week 2. After week 4, the dose could be escalated to 40 mg weekly in patients who did not achieve clinical remission, complete fistula closure, and complete steroid withdrawal. Outcome measures included the ability to tolerate adalimumab and clinical remission (defined as a Crohn's disease activity index (CDAI) score ≤150 points) and clinical response (defined as a decrease in the CDAI) ≥100 points) in patients who had a baseline CDAI score ≥220. RESULTS: None of the patients experienced acute or delayed hypersensitivity reactions during treatment with adalimumab (including 14 who previously experienced treatment-limiting acute hypersensitivity reactions and 6 who previously experienced delayed hypersensitivity reactions with infliximab). Of 17 patients with baseline CDAI scores ≥220: clinical remission occurred at weeks 4 and 12 in 2 (12%) and 5 (29%), respectively; and clinical response occurred in 7 (41%) and 10 (59%), respectively. Nineteen patients (79%) escalated their dose during weeks 4-6. CONCLUSIONS: Adalimumab is well tolerated and appears to be a clinically beneficial option for patients with Crohn's disease who have previously lost their response to, or cannot tolerate infliximab.

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