Early clinical experience with adalimumab in treatment of inflammatory bowel disease with infliximab-treated and naïve patients

A. Swaminath, Thomas A. Ullman, M. Rosen, L. Mayer, S. Lichtiger, M. T. Abreu

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background: Adalimumab, at an induction dose of 160/80 mg followed by 40 mg every other week is approved for treatment of refractory Crohn's disease (CD) and for patients with loss of response to infliximab. Aim: To evaluate the indications for adalimumab, the proportion of inflammatory bowel disease patients who require dose escalation and to identify whether this strategy is effective in inducing or maintaining remission. Methods: Patients prescribed adalimumab for CD were identified and included for analysis, if they had follow-up of at least 6 weeks. Adalimumab dose was escalated if patients had return of symptoms prior to next dose. Clinical judgment was used to determine severity of disease. A second GI physician confirmed disease severity as determined by the first physician. Results: A total of 48 out of 60 patients met inclusion criteria. Adalimumab was used to treat CD in 47/48 (98%) and ulcerative colitis in one (2%). Most patients had moderate 30/48 (63%) or severe 17/48 (35%) disease. Prior infliximab exposure was present in 42/48 (88%). Adalimumab dose escalation occurred in 14/48 (29%) within an average time of 2.2 months (s.d. 1.5 months). A majority of patients who required dose escalation, nine of 14 (64%) did not improve clinically. Steroids could be discontinued in three of 16 (18.8%). Clinical improvement was noted in 21/48 (43.8%) and one of 48 (2%) patients achieved clinical remission. Adverse drug reactions necessitated drug discontinuation in four of 48 (8%) of patients. Conclusions: This retrospective review from a single academic medical centre suggests that a minority of patients, who cannot be maintained on 40 mg every other week, of adalimumab benefit from an increased dose. This suggests the need for a treatment with an alternative mode of action in anti-TNF failures.

Original languageEnglish (US)
Pages (from-to)273-278
Number of pages6
JournalAlimentary Pharmacology and Therapeutics
Volume29
Issue number3
DOIs
StatePublished - Feb 1 2009
Externally publishedYes

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Inflammatory Bowel Diseases
Crohn Disease
Therapeutics
Adalimumab
Infliximab
Physicians
Drug-Related Side Effects and Adverse Reactions
Ulcerative Colitis
Steroids

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Early clinical experience with adalimumab in treatment of inflammatory bowel disease with infliximab-treated and naïve patients. / Swaminath, A.; Ullman, Thomas A.; Rosen, M.; Mayer, L.; Lichtiger, S.; Abreu, M. T.

In: Alimentary Pharmacology and Therapeutics, Vol. 29, No. 3, 01.02.2009, p. 273-278.

Research output: Contribution to journalArticle

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abstract = "Background: Adalimumab, at an induction dose of 160/80 mg followed by 40 mg every other week is approved for treatment of refractory Crohn's disease (CD) and for patients with loss of response to infliximab. Aim: To evaluate the indications for adalimumab, the proportion of inflammatory bowel disease patients who require dose escalation and to identify whether this strategy is effective in inducing or maintaining remission. Methods: Patients prescribed adalimumab for CD were identified and included for analysis, if they had follow-up of at least 6 weeks. Adalimumab dose was escalated if patients had return of symptoms prior to next dose. Clinical judgment was used to determine severity of disease. A second GI physician confirmed disease severity as determined by the first physician. Results: A total of 48 out of 60 patients met inclusion criteria. Adalimumab was used to treat CD in 47/48 (98{\%}) and ulcerative colitis in one (2{\%}). Most patients had moderate 30/48 (63{\%}) or severe 17/48 (35{\%}) disease. Prior infliximab exposure was present in 42/48 (88{\%}). Adalimumab dose escalation occurred in 14/48 (29{\%}) within an average time of 2.2 months (s.d. 1.5 months). A majority of patients who required dose escalation, nine of 14 (64{\%}) did not improve clinically. Steroids could be discontinued in three of 16 (18.8{\%}). Clinical improvement was noted in 21/48 (43.8{\%}) and one of 48 (2{\%}) patients achieved clinical remission. Adverse drug reactions necessitated drug discontinuation in four of 48 (8{\%}) of patients. Conclusions: This retrospective review from a single academic medical centre suggests that a minority of patients, who cannot be maintained on 40 mg every other week, of adalimumab benefit from an increased dose. This suggests the need for a treatment with an alternative mode of action in anti-TNF failures.",
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