Publications by authors named "Malcolm Hogan"
Reliability and Responsiveness of Endoscopic Indices for Assessing Crohn's Disease Postoperative Recurrence in the PREVENT trial.
Clin Gastroenterol Hepatol
September 2025
Background And Aims: Assessing endoscopic activity is integral in the management of postoperative Crohn's disease (CD). We aimed to comprehensively characterize the reliability and responsiveness of different endoscopic instruments when used to assess postoperative CD activity.
Methods: Ileocolonoscopy videos (n=70) from the PREVENT trial were reviewed by three blinded central readers.
Background: Plaque psoriasis of the scalp, a common psoriasis location, remains difficult to manage. The comparative efficacy of newer oral agents, such as deucravacitinib, versus traditional first-generation biologics has not been characterized in the treatment of scalp psoriasis. This study indirectly compared the long-term efficacy of deucravacitinib versus that of adalimumab for the treatment of scalp psoriasis.
View Article and Find Full Text PDFDevelopment and External Validation of an Endoscopic and Histologic Pouchitis Assessment Tool: The Atlantic Pouchitis Index.
Clin Gastroenterol Hepatol
July 2025
Background & Aims: No fully validated indices to measure pouchitis activity exist. We aimed to develop and externally validate a novel endoscopic and histologic index.
Methods: Endoscopists and pathologists used 11 (4 endoscopic, 4 histologic, 3 composite) existing indices and items from a prior Research and Development/University of California Los Angeles appropriateness exercise to assess pouchitis disease activity in videos and images from 98 patients with chronic antibiotic-refractory pouchitis who participated in a randomized placebo-controlled alicaforsen trial.
Background & Aims: Approval of new therapies for inflammatory bowel disease (IBD) requires rigorously designed and well-executed randomized controlled trials (RCTs). Corticosteroids remain a cornerstone of IBD induction therapy, and many patients in trials are enrolled while taking corticosteroids. Despite this, approaches to corticosteroid management in RCTs have been highly heterogeneous, often differing from clinical practice.
View Article and Find Full Text PDFBackground & Aims: Understanding placebo rates is critical for efficient clinical trial design. We assessed placebo rates and associated factors using individual patient data from Crohn's disease trials.
Methods: We conducted a meta-analysis of phase 2/3 placebo-controlled trials evaluating advanced therapies in moderate to severe Crohn's disease (2010-2021).
Article Synopsis
- The study compares various scoring systems used to assess disease activity in patients with moderately to severely active ulcerative colitis (UC) after treatment with ustekinumab.
- It utilized data from the phase 3 UNIFI induction trial, calculating the responsiveness of different scores by measuring how much better treated participants performed compared to those receiving a placebo, known as win probability (WinP).
- The findings indicate that the UC-100 score showed the highest responsiveness, but the Mayo Clinic score and its modifications also performed well, suggesting that different scoring methods can be appropriate depending on specific circumstances and evaluation needs.
Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn's Disease Activity.
Clin Gastroenterol Hepatol
September 2024
Background & Aims: The operating properties of histologic indices for evaluating Crohn's disease (CD) activity are poorly characterized. We assessed the reliability and responsiveness of existing histologic indices/items used in CD and ulcerative colitis (UC), in addition to 3 novel items, and developed exploratory ileal, colonic, and colonic-ileal CD instruments.
Methods: Blinded central readers independently reviewed paired baseline and week 12 image sets from the EXTEND trial.
Background & Aims: There is a need to develop safe and effective pharmacologic options for the treatment of celiac disease (CeD); however, consensus on the appropriate design and configuration of randomized controlled trials (RCTs) in this population is lacking.
Methods: A 2-round modified Research and Development/University of California Los Angeles Appropriateness Method study was conducted. Eighteen gastroenterologists (adult and pediatric) and gastrointestinal pathologists voted on statements pertaining to the configuration of CeD RCTs, inclusion and exclusion criteria, gluten challenge, and trial outcomes.
Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis.
Aliment Pharmacol Ther
October 2023
Article Synopsis
- Ulcerative proctitis (UP) is a challenging form of ulcerative colitis with significant symptoms, and the aim of this study was to evaluate the effectiveness of various medical treatments for it.
- The research analyzed 53 randomized controlled trials, focusing mainly on induction and maintenance of clinical remission, with findings indicating that topical 5-aminosalicylic acid (5-ASA) and corticosteroids significantly outperform placebo in treating UP.
- The study concludes that treatments like topical 5-ASA and corticosteroids are effective for active UP, while therapies like tacrolimus and Etrasimod show promise for both induction and maintenance of remission, highlighting the need for more trials specifically targeting UP.
Article Synopsis
- - Deucravacitinib, a TYK2 inhibitor, is approved for treating moderate-to-severe plaque psoriasis and was compared to adalimumab in long-term trials to assess effectiveness.
- - The study involved a comparison of two distinct trials, reweighting participant data to ensure balanced characteristics, focusing on a significant reduction in psoriasis severity scores (PASI).
- - Results indicated that deucravacitinib led to a higher percentage of patients achieving greater reductions in psoriasis severity at week 112 compared to adalimumab, but both treatments showed similar effectiveness at week 52.
Background: Targeting interleukin-23 (IL-23) is an important therapeutic strategy for Crohn's disease (CD).
Aims: This systematic review and meta-analysis assessed the efficacy and safety of selective IL-23p19 and IL-12/23p40 inhibitors in patients with moderate-to-severe CD.
Methods: MEDLINE, Embase, and the Cochrane library (CENTRAL) were searched from inception to May 24, 2023, for randomized, placebo- or active comparator-controlled induction and/or maintenance trials of selective IL-23p19 and IL-12/23p40 inhibitors in pediatric and adult patients with CD.
Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study.
Clin Gastroenterol Hepatol
October 2023
Background And Aims: Endoscopic assessment of disease activity is integral for evaluating treatment response in patients with Crohn's disease (CD). We aimed to define appropriate items for evaluating endoscopic activity and conventions for consistent endoscopic scoring rules in CD.
Methods: A 2-round modified RAND/University of California at Los Angeles Appropriateness Method study was conducted.
Background: Precise estimates of placebo response rates help efficient clinical trial design. In this systematic review and meta-analysis, we assessed contemporary placebo endoscopic and histological response rates in Crohn's disease (CD) clinical trials.
Methods: MEDLINE, EMBASE, and Cochrane CENTRAL were searched from inception to April 2022 to identify placebo-controlled studies of pharmacological interventions for CD.
Background And Aims: Perianal fistulizing disease is a common complication of Crohn's disease [CD], for which new therapies are urgently needed. To assist the design of clinical trials for novel therapeutics, we conducted a systematic review and meta-analysis of randomised controlled trials [RCTs] to quantify placebo rates and identify factors influencing them in perianal CD [pCD].
Methods: We searched MEDLINE, Embase and CENTRAL from inception to June 2021.
Background And Aims: Treatment options for proctitis are limited. To assist trial design for novel therapeutics, we conducted a systematic review and meta-analysis of proctitis randomized controlled trials [RCTs] to quantify placebo rates and identify factors influencing them.
Methods: We searched MEDLINE, EMBASE and CENTRAL from inception to June 2021.
Background And Aims: The NASH Clinical Research Network histologic scoring system, the gold-standard NASH histology assessment for clinical trials, has demonstrated intrarater and interrater variability. An expert panel in a previous systematic Research and Development/University of California Los Angeles (RAND/UCLA) study determined that existing histologic scoring systems do not fully capture NASH disease activity and fibrosis, and standardized definitions of histologic features are needed. We evaluated the reliability of existing and alternate histologic measures and their correlations with a disease activity visual analog scale to propose optimal components for an expanded NAFLD activity score (NAS).
View Article and Find Full Text PDFBackground And Aims: Endoscopic outcomes have become important measures of eosinophilic esophagitis (EoE) disease activity, including as an endpoint in randomized controlled trials (RCTs). We evaluated the operating properties of endoscopic measures for use in EoE RCTs.
Methods: Modified Research and Development/University of California Los Angeles appropriateness methods and a panel of 15 international EoE experts identified endoscopic items and definitions with face validity that were used in a 2-round voting process to define simplified (all items graded as absent or present) and expanded versions (additional grades for edema, furrows, and/or exudates) of the EoE Endoscopic Reference Score (EREFS).
Background: Precision in estimating placebo rates is important for clinical trial design.
Aim: To quantify placebo rates across relevant endpoints in Crohn's disease [CD] trials and identify the factors influencing these rates in a contemporary meta-analysis.
Methods: We searched MEDLINE, EMBASE, and CENTRAL from inception to March 2021.
Background And Aims: We aimed to quantify the magnitude of the association between endoscopic recurrence and clinical recurrence [symptom relapse] in patients with postoperative Crohn's disease.
Methods: Databases were searched to October 2, 2020, for randomised controlled trials [RCTs] and cohort studies of adult patients with Crohn's disease with ileocolonic resection and anastomosis. Summary effect estimates for the association between clinical recurrence and endoscopic recurrence were quantified by risk ratios [RR] and 95% confidence intervals [95% CI].
Background And Aims: Quantifying placebo rates and the factors influencing them are essential to inform trial design. We provide a contemporary summary of clinical, endoscopic, histological and safety placebo rates in induction and maintenance clinical trials of ulcerative colitis, and identify factors influencing them.
Methods: MEDLINE, EMBASE and the Cochrane library were searched from April 2014 to April 2020, updating a prior meta-analysis that searched from inception to April 2014.