Trial reportAlimentary pharmacology & therapeutics2017
Effects of concomitant immunomodulators on the pharmacokinetics, efficacy and safety of adalimumab in patients with Crohn's disease or ulcerative colitis who had failed conventional therapy.
Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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
19 citing papers in PubMed, 55 citations in OpenAlex.
- Significance of measurement of serum trough level and anti-drug antibody of adalimumab as personalised pharmacokinetics in patients with Crohn's disease: a subanalysis of the DIAMOND trial.Alimentary pharmacology & therapeutics · 2017Trial
- Loss of Response to Anti-Tumor Necrosis Factor Alpha Therapy in Patients With Inflammatory Bowel Disease: A Real-World Comparison of Combination Therapy Versus Monotherapy.JGH open : an open access journal of gastroenterology and hepatology · 2026Article
- The Efficacy of Currently Licensed Biologics for Treatment of Ulcerative Colitis: A Literature Review.Cureus · 2023Review
- Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study.Intestinal research · 2022Article
- Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation.Intestinal research · 2022Article
- Serum Adalimumab Levels After Induction Are Associated With Long-Term Remission in Children With Inflammatory Bowel Disease.Frontiers in pediatrics · 2021Article
- Various Forms of Tuberculosis in Patients with Inflammatory Bowel Diseases Treated with Biological Agents.International journal of inflammation · 2021Review
- The shining DIAMOND for evidence-based treatment strategies for Crohn's disease.Journal of gastroenterology · 2020Review
- Impact of immunomodulator use on treatment persistence in patients with ulcerative colitis: A claims database analysis.Journal of gastroenterology and hepatology · 2020Article
- The Evolving Role of Thiopurines in Inflammatory Bowel Disease.Current treatment options in gastroenterology · 2019Review
- The Evolving Role of Thiopurines in Inflammatory Bowel Disease.Current treatment options in gastroenterology · 2019Review
- Canadian Association of Gastroenterology Clinical Practice Guideline for the Management of Luminal Crohn's Disease.Journal of the Canadian Association of Gastroenterology · 2019Article
- Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia.Intestinal research · 2019Review
- Systematic understanding of the mechanism and effects of Arctigenin attenuates inflammation in dextran sulfate sodium-induced acute colitis through suppression of NLRP3 inflammasome by SIRT1.American journal of translational research · 2019Article
- Is there a beneficial effect of adding azathioprine to adalimumab in Crohn's disease patients?Annals of translational medicine · 2018Article
- Interactions Between Thiopurine Metabolites, Adalimumab, and Antibodies Against Adalimumab in Previously Infliximab-Treated Patients with Inflammatory Bowel Disease.Digestive diseases and sciences · 2018Article
- Recent advances and emerging therapies in the non-surgical management of ulcerative colitis.F1000Research · 2018Review
- The benefit of combination therapy depends on disease phenotype and duration in Crohn's disease.Alimentary pharmacology & therapeutics · 2017Article
- Combination Therapy for Inflammatory Bowel Disease.Gastroenterology & hepatology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdalimumab is approved for use in patients with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) who have not achieved disease control with conventional therapies including corticosteroids and/or immunomodulators (IMM).
aimTo analyse six studies that examined efficacy, pharmacokinetics and safety of combination IMM/adalimumab therapy, compared with adalimumab monotherapy in patients with inadequate disease control on conventional therapy.
methodsPatients with moderate to severe CD or UC from randomised, double-blind, placebo-controlled trials were analysed. Adalimumab was added to background therapy; patients were categorised as receiving adalimumab monotherapy (CD induction, n = 245, maintenance, n = 185; UC induction, n = 213, maintenance, n = 157) or combination therapy (CD induction, n = 139, maintenance, n = 139; UC induction, n = 140, maintenance, n = 100) according to baseline immunomodulator use. Efficacy was reported for the intent-to-treat populations from each study, with remission defined as CD activity index <150 for CD and Mayo score ≤2 with no subscore >1 for UC. Safety was assessed via adverse events.
resultsThe proportions of patients achieving remission were similar for adalimumab monotherapy and immunomodulator combination therapy in all studies. Median adalimumab concentrations at week 4 or 8 were numerically but not significantly higher with adalimumab combination therapy vs. monotherapy in the CD and UC studies respectively. Incidence and rate of adverse events was similar for adalimumab monotherapy and combination therapy.
conclusionsPost hoc analysis of six randomised, controlled trials demonstrated no efficacy benefits with immunomodulator/adalimumab combination therapy, compared with adalimumab monotherapy in CD and UC patients with inadequate disease control on conventional therapy; the safety of the two treatment approaches was comparable.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.