Gregor Novak

ORCID: 0000-0002-9110-9188
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About
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Research Areas
  • Inflammatory Bowel Disease
  • Microscopic Colitis
  • Immunodeficiency and Autoimmune Disorders
  • Biosimilars and Bioanalytical Methods
  • Mycobacterium research and diagnosis
  • Liver Diseases and Immunity
  • Autoimmune and Inflammatory Disorders
  • Autoimmune Bullous Skin Diseases
  • Eosinophilic Esophagitis
  • Tuberculosis Research and Epidemiology
  • Chronic Lymphocytic Leukemia Research
  • Celiac Disease Research and Management
  • Urticaria and Related Conditions
  • Monoclonal and Polyclonal Antibodies Research
  • Pharmaceutical studies and practices
  • Pneumothorax, Barotrauma, Emphysema
  • Potassium and Related Disorders
  • School Health and Nursing Education
  • Helicobacter pylori-related gastroenterology studies
  • Dermatology and Skin Diseases
  • Diagnosis and treatment of tuberculosis
  • Hemoglobinopathies and Related Disorders
  • Drug Transport and Resistance Mechanisms
  • Antifungal resistance and susceptibility
  • Systemic Lupus Erythematosus Research

Ljubljana University Medical Centre
2017-2025

University of Ljubljana
2019-2025

GTx (United States)
2023

Robarts Clinical Trials
2017-2019

Western University
2017

Amsterdam UMC Location University of Amsterdam
2017

University of Amsterdam
2017

Abstract Background The association between therapeutic outcomes and serum levels associated with the use of subcutaneous (SC) IFX CT-P13 in patients inflammatory bowel disease [IBD] has been poorly studied. We aimed to define SC-IFX thresholds outcomes. Methods Patients receiving who had at least one drug monitoring [TDM] were enrolled. Therapeutic assessed as follows: clinical remission [HBI <5, SCCAI ≤2]; fecal calprotectin [FCAL] [<250 mg/g]; C-reactive protein [CRP] [CRP...

10.1093/ecco-jcc/jjae190.1238 article EN Journal of Crohn s and Colitis 2025-01-01

Objective Endoscopic and histologic healing in ulcerative colitis (UC) is hypothesized to progress proximally distally, with of the distal rectosigmoid occurring last. However, this has not been empirically verified. Methods We performed a prospective cohort study patients pancolonic UC commencing treatment tumor necrosis factor (TNF) antagonist or vedolizumab. Four biopsies were obtained from each five colonic segments at colonoscopy, both baseline 16–24 weeks after initiation. Independent,...

10.1097/meg.0000000000002922 article EN European Journal of Gastroenterology & Hepatology 2025-01-29

Background Real-word comparisons between first-line biologicals in inflammatory bowel disease (IBD) are scarce. Aims The aim of this study is to compare drug persistence and patient reported outcome-2 (PRO-2) remission rates biological classes [anti-tumor necrosis factor (TNF) agents vs anti-integrin vedolizumab IL-12/23 inhibitor ustekinumab] real life cohort. Methods Individual level data 946 adults (588 Crohn’s 358 ulcerative colitis) were retrieved from UR-CARE IBD platform. Adjusted...

10.1097/meg.0000000000002940 article EN European Journal of Gastroenterology & Hepatology 2025-02-06

A prospective trial suggests target infliximab trough levels of 3-7 μg/mL, yet data on additional therapeutic benefits and safety higher are scarce.To explore whether high (≥7 μg/mL) more effective still safe.In this cohort study 183 patients (109 Crohn's disease 74 ulcerative colitis) maintenance treatment at a tertiary referral center we correlated fecal calprotectin C-reactive protein to (426 samples) different time points during treatment. Rates infections were compared in quadrimesters...

10.1080/00365521.2018.1486882 article EN Scandinavian Journal of Gastroenterology 2018-07-10

Summary Background Combination treatment with azathioprine for 6‐12 months is the preferred strategy starting infliximab due to improved pharmacokinetics. However, optimised monotherapy proactive dose escalations in case of low trough levels a safer but under‐studied alternative. Aim To compare clinical success and consumption combination vs strategies. Methods We studied both strategies 149 patients (94 Crohn's disease; 55 ulcerative colitis) undergoing intensive drug monitoring assisted...

10.1111/apt.15179 article EN Alimentary Pharmacology & Therapeutics 2019-02-19

Abstract Background Prediction of endoscopic postoperative recurrence (POR) and prophylactic treatment based on clinical risk profile have thus far been inconclusive. This study aimed to examine the association between development POR in a Crohn’s disease population without identify individual factors POR. Methods Medical records 142 patients with during follow-up after ileocecal or ileocolonic resection at 3 referral centers were reviewed. Endoscopic was defined as modified Rutgeerts score...

10.1093/ibd/izab044 article EN cc-by-nc Inflammatory Bowel Diseases 2021-03-30

The relationship between vedolizumab trough levels and combined endoscopic clinical remission is unknown.To compare in patients with without within the first year of treatment.We prospectively collected 51 consecutive (28 Crohn's disease (CD) 23 ulcerative colitis (UC)) before all infusions up to week 22, at weeks 38 54, concentrations measured after study completion. Centrally read endoscopy was performed a median 46 weeks. primary outcome (CD: Simple score for CD (SES-CD) < 4 ulceration;...

10.1177/2050640619840211 article EN United European Gastroenterology Journal 2019-03-20

The appropriate location for biopsy procurement relative to an ulcer in active Crohn's disease is unknown.To explore the relationship between location, histological activity, proinflammatory gene expression and presence of inflammatory cells.Fifty-one patients with ulcers >0.5 cm diameter colon and/or ileum were prospectively enrolled at three centres. Biopsies obtained from 0 mm, 7 8 mm 21 24 edge largest ulcer. Histological activity was blindly assessed Global Disease Activity Score,...

10.1111/apt.15250 article EN Alimentary Pharmacology & Therapeutics 2019-04-15

Ustekinumab is a monoclonal antibody used in Crohn's disease (CD). Dose optimization case of non-response and the role pharmacokinetic-pharmacodynamic (PK-PD) monitoring remain unresolved dilemmas clinical practice. We aimed to develop population PK-PD model for ustekinumab CD simulate efficacy alternative dosing regimens. included 57 patients recorded their characteristics during 32 weeks after starting with therapy. Serum concentration was prospectively measured fecal calprotectin (FC)...

10.3390/pharmaceutics13101587 article EN cc-by Pharmaceutics 2021-09-30

Objectives Some patients with Crohn’s disease do not achieve remission the approved maintenance dosing of ustekinumab every 8 weeks, possibly due to insufficient drug exposure. We aimed study exposure–response relationship for endoscopic and biomarker normalization dose escalation 4 weeks. Methods Out 135 consecutive patients, 44 active despite standard [at least one C-reactive protein (CRP) &gt;5 mg/L, fecal calprotectin &gt;100 mg/kg, simple score (SES) &gt;3] underwent Subsequent (SES-CD...

10.1097/meg.0000000000002275 article EN European Journal of Gastroenterology & Hepatology 2021-08-16

Background and Objectives: The subcutaneous (SC) formulation of vedolizumab has proven to be effective for the maintenance remission after intravenous induction. Little is known about efficacy switching from treatment SC. We aimed assess real-world SC impact a baseline regimen. Materials Methods: In this observational cohort study, adult patients with inflammatory bowel disease who were switched enrolled. Patients induction (every 8 weeks or every 4 weeks) included. dosing was 108 mg 2...

10.3390/medicina60020296 article EN cc-by Medicina 2024-02-09

Background In 2018, the European Medicines Agency (EMA) replaced a fixed 50 mg every 4-week maintenance regimen of golimumab for ulcerative colitis (UC) patients weighing &lt;80 kg with new, flexible dosing that allows reactive dose optimization to 100 if clinically needed. We analyzed endoscopic remission rates and pharmacokinetics this new in real-life settings. Methods prospectively recruited 30 consecutive (17 body weight kg) UC who received EMA label. The primary endpoint was (Mayo ≤1)...

10.1097/meg.0000000000001843 article EN European Journal of Gastroenterology & Hepatology 2020-08-14

Some of the most ambitious young physicians strive not only for perfection in acquiring clinical skills but are also working hard to become researchers. Because our workload is substantial even if we involved ‘routine practice', taking one step further toward research usually demands a lot enthusiasm and devotion free time. For some from countries without an established network hospitals within country internationally, this path might be steeper. When establishing activities at your...

10.1177/2050640620944713 article EN United European Gastroenterology Journal 2020-07-30

Abstract Background In recent years, there are several new treatment options for inflammatory bowel disease (IBD). Tumour necrosis factor α inhibitors have been joined by novel advanced therapies (vedolizumab, ustekinumab (UST) and Janus kinase inhibitors). These drugs mostly used as second-line treatments after tumor inhibitors, with subsequent poorer efficacy. There few data available on the efficacy of first-line UST. The aim our study was to assess UST in biologically naïve patients IBD....

10.1093/ecco-jcc/jjad212.0914 article EN Journal of Crohn s and Colitis 2024-01-01
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