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 V. Loftus, David Binion, Kevin McHugh, Shamsul Alam, Naijun Chen, Benoit̂ Gueŕette, Parvez Mulani, Jingdong Chao
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.
Canadian Journal of Gastroenterology
https://doi.org/10.1155/2011/724813
Steroid-free remission
Work productivity
10.1155/2011/724813
Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.
Adalimumab Medicine & Life Sciences
Crohn Disease Medicine & Life Sciences
Infliximab Medicine & Life Sciences
Necrosis Medicine & Life Sciences
Fistula Medicine & Life Sciences
Patient Reported Outcome Measures Medicine & Life Sciences
Canada Medicine & Life Sciences
Panaccione, R., Loftus, E. V., Binion, D., McHugh, K., Alam, S., Chen, N., Gueŕette, B., Mulani, P., & Chao, J. (2011). 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. Canadian Journal of Gastroenterology, 25(8), 419-425. https://doi.org/10.1155/2011/724813
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, Edward V.; 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.
Panaccione, R, Loftus, EV, Binion, D, McHugh, K, Alam, S, Chen, N, Gueŕette, B, Mulani, P & Chao, J 2011, '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', Canadian Journal of Gastroenterology, vol. 25, no. 8, pp. 419-425. https://doi.org/10.1155/2011/724813
Panaccione R, Loftus EV, Binion D, McHugh K, Alam S, Chen N et al. 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. Canadian Journal of Gastroenterology. 2011 Aug;25(8):419-425. https://doi.org/10.1155/2011/724813
Panaccione, Remo ; Loftus, Edward V. ; 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.
@article{932ecfa00e2a4ab09b0a7862ba0c9aa2,
title = "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",
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.",
keywords = "Adalimumab, Crohn's disease, Fistula, Quality of life, Steroid-free remission, Work productivity",
author = "Remo Panaccione and Loftus, {Edward V.} and David Binion and Kevin McHugh and Shamsul Alam and Naijun Chen and Benoi{\^t} Gue{\'r}ette and Parvez Mulani and Jingdong Chao",
doi = "10.1155/2011/724813",
journal = "Canadian Journal of Gastroenterology and Hepatology",
publisher = "Pulsus Group Inc.",
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
AU - Panaccione, Remo
AU - Loftus, Edward V.
AU - Binion, David
AU - McHugh, Kevin
AU - Alam, Shamsul
AU - Chen, Naijun
AU - Gueŕette, Benoit̂
AU - Mulani, Parvez
AU - Chao, Jingdong
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.
KW - Adalimumab
KW - Crohn's disease
KW - Fistula
KW - Quality of life
KW - Steroid-free remission
KW - Work productivity
U2 - 10.1155/2011/724813
DO - 10.1155/2011/724813
JO - Canadian Journal of Gastroenterology and Hepatology
JF - Canadian Journal of Gastroenterology and Hepatology