Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease

Results of the adalimumab in Canadian subjects with moderate to severe Crohn's diseaSe (ACCESS) trial

Remo Panaccione, Edward Vincent Loftus, Jr, David Binion, Kevin McHugh, Shamsul Alam, Naijun Chen, Benoit̂ Gueŕette, Parvez Mulani, Jingdong Chao

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn's disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy. METHODS: Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada. RESULTS: Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients. CONCLUSIONS: Adalimumab therapy induced and sustained steroidfree remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.

Original languageEnglish (US)
Pages (from-to)419-425
Number of pages7
JournalCanadian Journal of Gastroenterology
Volume25
Issue number8
StatePublished - Aug 2011

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Crohn Disease
Safety
Necrosis
Fistula
Adalimumab
Therapeutics
Canada
Maintenance
Quality of Life
Infliximab

Keywords

  • Adalimumab
  • Crohn's disease
  • Fistula
  • Quality of life
  • Steroid-free remission
  • Work productivity

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease : Results of the adalimumab in Canadian subjects with moderate to severe Crohn's diseaSe (ACCESS) trial. / Panaccione, Remo; Loftus, Jr, Edward Vincent; Binion, David; McHugh, Kevin; Alam, Shamsul; Chen, Naijun; Gueŕette, Benoit̂; Mulani, Parvez; Chao, Jingdong.

In: Canadian Journal of Gastroenterology, Vol. 25, No. 8, 08.2011, p. 419-425.

Research output: Contribution to journalArticle

Panaccione, Remo ; Loftus, Jr, Edward Vincent ; Binion, David ; McHugh, Kevin ; Alam, Shamsul ; Chen, Naijun ; Gueŕette, Benoit̂ ; Mulani, Parvez ; Chao, Jingdong. / Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease : Results of the adalimumab in Canadian subjects with moderate to severe Crohn's diseaSe (ACCESS) trial. In: Canadian Journal of Gastroenterology. 2011 ; Vol. 25, No. 8. pp. 419-425.
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T1 - Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease

T2 - Results of the adalimumab in Canadian subjects with moderate to severe Crohn's diseaSe (ACCESS) trial

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AU - Loftus, Jr, Edward Vincent

AU - Binion, David

AU - McHugh, Kevin

AU - Alam, Shamsul

AU - Chen, Naijun

AU - Gueŕette, Benoit̂

AU - Mulani, Parvez

AU - Chao, Jingdong

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N2 - OBJECTIVE: To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn's disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy. METHODS: Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada. RESULTS: Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients. CONCLUSIONS: Adalimumab therapy induced and sustained steroidfree remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.

AB - OBJECTIVE: To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn's disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy. METHODS: Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada. RESULTS: Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients. CONCLUSIONS: Adalimumab therapy induced and sustained steroidfree remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.

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KW - Quality of life

KW - Steroid-free remission

KW - Work productivity

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