Trial reportCanadian journal of gastroenterology = Journal canadien de gastroenterologie2011
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.
Trial report in Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Work Productivity Impairment in Persons with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis.Journal of Crohn's & colitis · 2024Pooled it
- Pooled it
- Article
- Single-Cell Transcriptomic and Targeted Genomic Profiling Adjusted for Inflammation and Therapy Bias RevealPharmaceutics · 2024Article
- Choosing Therapy for Moderate to Severe Crohn's Disease.Journal of the Canadian Association of Gastroenterology · 2024Article
- Where Are We and Where to Next?-The Future of Perianal Crohn's Disease Management.Journal of clinical medicine · 2023Review
- Exploring work productivity loss in patients with inflammatory bowel disease.Future science OA · 2023Article
- Impact of Biological Therapies and Tofacitinib on Real-world Work Impairment in Inflammatory Bowel Disease Patients: A Prospective Study.Inflammatory bowel diseases · 2022Article
- Article
- Under the Umbrella of Clinical Pharmacology: Inflammatory Bowel Disease, Infliximab and Adalimumab, and a Bridge to an Era of Biosimilars.Pharmaceutics · 2022Review
- Systematic review and meta-analysis: evaluating response to empiric anti-TNF dose intensification for secondary loss of response in Crohn's disease.Therapeutic advances in gastroenterology · 2022Article
- Primary Failure to an Anti-TNF Agent in Inflammatory Bowel Disease: Switch (to a Second Anti-TNF Agent) or Swap (for Another Mechanism of Action)?Journal of clinical medicine · 2021Review
- Omics data integration identifies ELOVL7 and MMD gene regions as novel loci for adalimumab response in patients with Crohn's disease.Scientific reports · 2021Article
- Body Weight as a Determining Factor in the Predominance of Adverse Drug Reactions Induced by Fixed-Dose Adalimumab Injections in Female Patients in a Korean Hospital Setting.Journal of clinical medicine · 2020Article
- Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis.Advances in therapy · 2020Article
- Work Loss in Relation to Pharmacological and Surgical Treatment for Crohn's Disease: A Population-Based Cohort Study.Clinical epidemiology · 2020Article
- Efficacy and Safety of Adalimumab by Disease Duration: Analysis of Pooled Data From Crohn's Disease Studies.Journal of Crohn's & colitis · 2019Article
- Impact of Adalimumab Patient Support Program's Care Coach Calls on Clinical Outcomes in Patients with Crohn's Disease in Canada: An Observational Retrospective Cohort Study.Journal of the Canadian Association of Gastroenterology · 2018Article
- Clinical Benefit of Long-Term Adalimumab Treatment in Patients With Crohn's Disease Following Loss of Response or Intolerance to Infliximab: 96-Week Efficacy Data From GAIN/ADHERE Trials.Journal of Crohn's & colitis · 2018Article
- Pharmacological Approach to the Management of Crohn's Disease Patients with Perianal Disease.Drugs · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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.
methodsPatients 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.
resultsOf 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.
conclusionsAdalimumab 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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Registered trials
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