Publications by authors named "Konstantinos Papamichael"

Inflammatory bowel diseases (IBDs) are chronic inflammatory conditions of the gastrointestinal tract, comprising ulcerative colitis (UC) and Crohn's disease (CD). Earlier onset of IBD symptoms has been linked to a higher prevalence of depression and anxiety. Evidence supports that cortisol abnormalities correlate with the development and severity of autoimmune diseases.

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Background: There are limited data on the role of proactive therapeutic drug monitoring (TDM) of ustekinumab (UST) in patients with inflammatory bowel disease (IBD). This study investigated the efficacy and safety of proactive TDM in IBD patients treated with subcutaneous (sc) UST.

Methods: This was a retrospective single-center cohort study.

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Article Synopsis
  • - The study highlights that quick initiation of biologic therapy is crucial for patients with inflammatory bowel disease (IBD), but various factors can delay this process in an outpatient setting.
  • - Researchers analyzed data from 411 patients receiving biologics between March 2019 and September 2020, finding an overall median delay of 20 days, with specific delays varying by medication.
  • - Key factors contributing to delays included being self-identified as Black, living farther from treatment facilities, and not having immediate insurance coverage approval.
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Background: There are limited data regarding therapeutic drug monitoring (TDM) of non-anti-tumor necrosis factor therapy in inflammatory bowel disease (IBD). This study aimed to evaluate the efficacy of proactive TDM in IBD patients treated with intravenous (iv) vedolizumab (VDZ).

Methods: This single-center retrospective cohort study included consecutive IBD patients treated with maintenance iv VDZ therapy undergoing TDM from November 2016 to March 2023.

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This article is the second in a series of two publications on the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of Crohn's disease. The first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations.

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Risankizumab (RZB) is a monoclonal antibody that targets the p19 subunit of interleukin (IL)-23. The ADVANCE and MOTIVATE randomized controlled trials (RCTs) demonstrated that intravenous (IV) RZB compared with placebo led to higher rates of clinical remission and endoscopic response at week 12 in patients with active Crohn's disease (CD). The phase III FORTIFY RCT showed that subcutaneous (SC) RZB was significantly more effective than placebo for achieving clinical remission and endoscopic response as maintenance therapy in patients with moderate-to-severe active CD.

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Article Synopsis
  • * The main treatment for these fistulas is anti-tumor necrosis factor therapy, particularly using infliximab and adalimumab (ADM), with therapeutic drug monitoring (TDM) helping to manage treatment responses.
  • * The study aims to explore how maintenance ADM levels relate to complete fistula healing, seeking to find an ideal ADM concentration threshold for optimal treatment outcomes.
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Background: Infliximab, an anti-tumor necrosis factor monoclonal antibody, has revolutionized the pharmacological management of immune-mediated inflammatory diseases (IMIDs). This position statement critically reviews and examines existing data on therapeutic drug monitoring (TDM) of infliximab in patients with IMIDs. It provides a practical guide on implementing TDM in current clinical practices and outlines priority areas for future research.

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Background: Infliximab (IFX) use is limited by loss of response often due to the development of anti-IFX antibodies and low drug levels.

Methods: We performed a single center prospective observational cohort study of pediatric and young adult subjects with inflammatory bowel disease (IBD) on IFX with over 3 years of follow-up. Infliximab levels (IFXL) and antibodies to infliximab (ATI) were measured throughout the study.

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Article Synopsis
  • Biological therapy is highly effective for moderate to severe inflammatory bowel disease (IBD), but a significant number of patients may not respond initially or may lose their response over time.
  • Factors like body weight, low serum albumin, and immunogenicity can lead to faster drug clearance, impacting treatment outcomes.
  • The review discusses how monitoring drug clearance can guide personalized dosing strategies, although its practical application in clinical settings still needs to be clarified.
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Background: The relationship between subcutaneous infliximab [SC-IFX] concentrations and favourable therapeutic outcomes in patients with Crohn's disease [CD] and ulcerative colitis [UC] remains elusive.

Patients And Methods: This cross-sectional study included consecutive adult patients with inflammatory bowel disease [IBD] treated with SC-IFX at a maintenance dose of 120 mg/2 weeks. Investigated therapeutic outcomes included sustained clinical remission; composite clinical and biomarker remission [clinical remission and C-reactive protein <5 mg/L]; biochemical remission [faecal calprotectin <250 µg/g]; and deep remission [clinical, biological, and biochemical remission].

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Inflammatory bowel disease (IBD) is a chronic disease of the intestines. The pathophysiology of IBD, namely Crohn's disease and ulcerative colitis, is a complex interplay between environmental, genetic, and immune factors. Physicians and patients often seek complementary and alternative medicines (CAMs) as primary and supplementary treatment modalities.

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Unlabelled: Monitoring of anti-drug antibodies in patients on ustekinumab is not routinely recommended in patients with inflammatory bowel disease (IBD) due to low rates of immunogenicity.

Aim Of Study: The purpose of this study was to investigate the relationship between anti-drug antibodies detected by a drug-tolerant assay and loss of response (LOR) to therapy in a cohort of patients with IBD being treated with ustekinumab.

Patients And Methods: This retrospective study consecutively enrolled all adult patients with moderate to severe active IBD who had at least 2 years of follow-up after ustekinumab was initiated.

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Article Synopsis
  • - The study investigates how high levels of visceral adipose tissue (VAT) in patients with inflammatory bowel diseases (IBDs) affect their response to infliximab treatment, particularly in achieving remission.
  • - Researchers measured various parameters, including body composition and infliximab levels, in 142 IBD patients receiving ongoing treatment, aiming to find optimal infliximab cutoffs for remission based on VAT.
  • - Findings indicate that patients with higher VAT need significantly higher infliximab levels (15.3 mcg/mL) for remission compared to those with lower VAT (3.9 mcg/mL), suggesting tailored treatment based on VAT may improve outcomes.
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Article Synopsis
  • Therapeutic drug monitoring (TDM) is a crucial tool for improving therapy outcomes in inflammatory bowel disease (IBD) and other immune-mediated diseases by ensuring optimal drug concentrations.
  • Proactive TDM helps achieve better treatment responses and is particularly important in pediatric patients, with monitoring of drug levels guiding dose adjustments during therapy.
  • While there are still knowledge gaps regarding the use of proactive TDM, current evidence indicates it leads to improved patient outcomes compared to traditional, reactive approaches.
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Background: Pancreatic Exocrine Insufficiency (PEI) is a possible cause of recurrent/persistent symptoms in celiac disease. Although pancreatic enzyme supplementation may be used to treat non-responsive celiac disease (NRCD) in clinical practice, clinical outcomes are variable and there is limited and low quality evidence to support this practice. The aim of this study was to assess the efficacy of pancreatic enzyme supplements (PES) for improvement of gastrointestinal symptoms in NRCD.

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Introduction: Exposure-outcome relationship data show that higher infliximab concentrations are associated with better outcomes in patients with Crohn's disease (CD). However, most of these data were derived from adult patients on maintenance therapy. We aimed to investigate the association of infliximab concentrations during and early after induction therapy of infliximab with short-term and long-term clinical outcomes in a pediatric CD population.

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Article Synopsis
  • - Many patients with inflammatory bowel disease (IBD) are treated with anti-TNF therapies like infliximab (IFX), but around 20% experience a loss of response (LOR) due to the presence of anti-drug antibodies (ADAb).
  • - A systematic review was conducted analyzing 90 publications on monitoring patients with anti-TNF therapy, highlighting that most ADAb detection methods are limited in their ability to work when drug levels are high.
  • - New drug-tolerant assays have been developed to accurately detect ADAb during varying phases of treatment, which can help predict treatment efficacy and issues such as primary non-response or LOR.
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