Adalimumab for Crohns disease in clinical practice at Mayo clinic: The first 118 patients

Jason M. Swoger, Edward Vincent Loftus, Jr, William J. Tremaine, William Alvis Faubion, Darrell S. Pardi, Sunanda V. Kane, Karen A. Hanson, W. Scott Harmsen, Alan R. Zinsmeister, William J. Sandborn

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

Background: We sought to assess the effectiveness and safety of adalimumab for the treatment of Crohns disease (CD) in clinical practice. Methods: Demographic, clinical, and treatment data were abstracted from the medical record. The primary outcome was clinical response to induction therapy with adalimumab for CD (complete, partial, or nonresponse). Results: In all, 118 patients were prescribed adalimumab for CD between January 2003 and June 2007. All but five subjects (96%) had received prior infliximab and 50 were on systemic corticosteroids at the time of initial adalimumab dose (44%). A complete response was achieved in 53 patients and 20 patients had no response. The cumulative probability of any response (complete or partial) was 81.3% at 1 year. Dose escalation was required in 59 patients (1-year cumulative probability, 54.0%). Among patients with complete response, 18 lost response during follow-up (1-year cumulative probability, 21.4%). Among 50 patients on corticosteroids at baseline the median daily dose was 20 mg, which decreased to a median of 0 mg during treatment. Sixty-four patients (54%) experienced a total of 117 adverse events. Thirteen patients (11%) experienced 15 serious adverse events. Sixteen patients (14%) discontinued adalimumab due to an adverse event. Conclusions: Adalimumab was both effective and well tolerated for the treatment of CD in this tertiary practice with a high prevalence of past infliximab exposure. This experience largely predates FDA approval of adalimumab for CD. (Inflamm Bowel Dis 2010)

Original languageEnglish (US)
Pages (from-to)1912-1921
Number of pages10
JournalInflammatory Bowel Diseases
Volume16
Issue number11
DOIs
StatePublished - Nov 2010

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Crohn Disease
Adrenal Cortex Hormones
Therapeutics
Adalimumab
Prednisolone
Medical Records
Demography
Safety

Keywords

  • adalimumab
  • anti-tumor necrosis factor antibody
  • biologic therapy
  • Crohns disease
  • inflammatory bowel disease

ASJC Scopus subject areas

  • Gastroenterology
  • Immunology and Allergy

Cite this

Adalimumab for Crohns disease in clinical practice at Mayo clinic : The first 118 patients. / Swoger, Jason M.; Loftus, Jr, Edward Vincent; Tremaine, William J.; Faubion, William Alvis; Pardi, Darrell S.; Kane, Sunanda V.; Hanson, Karen A.; Harmsen, W. Scott; Zinsmeister, Alan R.; Sandborn, William J.

In: Inflammatory Bowel Diseases, Vol. 16, No. 11, 11.2010, p. 1912-1921.

Research output: Contribution to journalArticle

Swoger, JM, Loftus, Jr, EV, Tremaine, WJ, Faubion, WA, Pardi, DS, Kane, SV, Hanson, KA, Harmsen, WS, Zinsmeister, AR & Sandborn, WJ 2010, 'Adalimumab for Crohns disease in clinical practice at Mayo clinic: The first 118 patients', Inflammatory Bowel Diseases, vol. 16, no. 11, pp. 1912-1921. https://doi.org/10.1002/ibd.21272
Swoger, Jason M. ; Loftus, Jr, Edward Vincent ; Tremaine, William J. ; Faubion, William Alvis ; Pardi, Darrell S. ; Kane, Sunanda V. ; Hanson, Karen A. ; Harmsen, W. Scott ; Zinsmeister, Alan R. ; Sandborn, William J. / Adalimumab for Crohns disease in clinical practice at Mayo clinic : The first 118 patients. In: Inflammatory Bowel Diseases. 2010 ; Vol. 16, No. 11. pp. 1912-1921.
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abstract = "Background: We sought to assess the effectiveness and safety of adalimumab for the treatment of Crohns disease (CD) in clinical practice. Methods: Demographic, clinical, and treatment data were abstracted from the medical record. The primary outcome was clinical response to induction therapy with adalimumab for CD (complete, partial, or nonresponse). Results: In all, 118 patients were prescribed adalimumab for CD between January 2003 and June 2007. All but five subjects (96{\%}) had received prior infliximab and 50 were on systemic corticosteroids at the time of initial adalimumab dose (44{\%}). A complete response was achieved in 53 patients and 20 patients had no response. The cumulative probability of any response (complete or partial) was 81.3{\%} at 1 year. Dose escalation was required in 59 patients (1-year cumulative probability, 54.0{\%}). Among patients with complete response, 18 lost response during follow-up (1-year cumulative probability, 21.4{\%}). Among 50 patients on corticosteroids at baseline the median daily dose was 20 mg, which decreased to a median of 0 mg during treatment. Sixty-four patients (54{\%}) experienced a total of 117 adverse events. Thirteen patients (11{\%}) experienced 15 serious adverse events. Sixteen patients (14{\%}) discontinued adalimumab due to an adverse event. Conclusions: Adalimumab was both effective and well tolerated for the treatment of CD in this tertiary practice with a high prevalence of past infliximab exposure. This experience largely predates FDA approval of adalimumab for CD. (Inflamm Bowel Dis 2010)",
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