James O. Lindsay
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View article: Efficacy and safety of risankizumab in patients with moderately to severely active Crohn’s disease: interim results from the SEQUENCE open-label extension study
Efficacy and safety of risankizumab in patients with moderately to severely active Crohn’s disease: interim results from the SEQUENCE open-label extension study Open
Background and Aims Risankizumab, a selective interleukin-23 p19 inhibitor, is approved to treat moderately to severely active Crohn’s disease (CD) in adults. We report interim results from part 2 of the ongoing SEQUENCE trial evaluating l…
View article: A FoodSafeR perspective on emerging food safety hazards and associated risks
A FoodSafeR perspective on emerging food safety hazards and associated risks Open
The recently launched FoodSafeR initiative is a cooperative and coordinated approach to the identification, assessment, and management of emerging food security challenges and associated risks—both chemical and microbial. The FoodSafeR con…
View article: Assessment of PredictSURE IBD Assay in a Multinational Cohort of Patients With Inflammatory Bowel Disease
Assessment of PredictSURE IBD Assay in a Multinational Cohort of Patients With Inflammatory Bowel Disease Open
Background and Aims PredictSURE IBD is a prognostic blood test that classifies newly diagnosed, treatment‐naïve Inflammatory Bowel Disease (IBD) patients into ‘IBDhi’ (high‐risk) or ‘IBDlo’ (low‐risk) groups (risk of future aggressive dise…
View article: Effects of Stress, Vagal Nerve Stimulation and Disease Activity on Circulating Cytokines, Quantified by an Ultrasensitive Technique, in Ulcerative Colitis: A Pilot Study
Effects of Stress, Vagal Nerve Stimulation and Disease Activity on Circulating Cytokines, Quantified by an Ultrasensitive Technique, in Ulcerative Colitis: A Pilot Study Open
Aims The utility of circulating cytokine concentrations in ulcerative colitis is limited due to poor assay sensitivity. We aimed to examine the relationship of circulating cytokine concentrations, when measured by ultrasensitive detection,…
View article: Extended Risankizumab Treatment in Patients With Crohn’s Disease Who Did Not Achieve Clinical Response to Induction Treatment
Extended Risankizumab Treatment in Patients With Crohn’s Disease Who Did Not Achieve Clinical Response to Induction Treatment Open
gov: MOTIVATE (Number: NCT03104413), ADVANCE (Number: NCT03105128), and FORTIFY (Number: NCT03105102).
View article: P0722 Efficacy and Safety of Risankizumab in Patients With Moderate to Severe Crohn’s Disease: Results From the One-Year SEQUENCE Open-Label Long-Term Extension
P0722 Efficacy and Safety of Risankizumab in Patients With Moderate to Severe Crohn’s Disease: Results From the One-Year SEQUENCE Open-Label Long-Term Extension Open
Background Part 2 of the ongoing SEQUENCE study examines the long-term efficacy and safety of risankizumab (RZB), an interleukin-23 p19 inhibitor, in patients (pts) with moderate to severe Crohn’s disease (CD). Here, we report the 1-year r…
View article: Impact of pain, fatigue and bowel incontinence on the quality of life of people living with inflammatory bowel disease: A UK cross‐sectional survey
Impact of pain, fatigue and bowel incontinence on the quality of life of people living with inflammatory bowel disease: A UK cross‐sectional survey Open
Background and Aims People with inflammatory bowel disease (IBD) often experience pain, fatigue and bowel incontinence and are at an increased risk of anxiety and depression. Our aim was to assess the impact of these symptoms on health‐rel…
View article: Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn’s Disease
Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn’s Disease Open
In this head-to-head clinical trial of risankizumab and ustekinumab involving patients with moderate-to-severe Crohn's disease who had had unacceptable side effects with anti-TNF therapy or an inadequate response to such therapy, risankizu…
View article: Recommendations for Broadening Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials
Recommendations for Broadening Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials Open
Background Clinical trial recruitment for patients with inflammatory bowel disease [IBD] has become more challenging over time. We aimed to develop recommendations for broadening IBD clinical trial eligibility, to improve the inclusion of …
View article: The role of circulating T cells with a tissue resident phenotype (ex-TRM) in health and disease
The role of circulating T cells with a tissue resident phenotype (ex-TRM) in health and disease Open
Tissue-resident memory T cells (T RM ) are long-lived memory lymphocytes that persist in non-lymphoid tissues and provide the first line of defence against invading pathogens. They adapt to their environment in a tissue-specific manner, ex…
View article: Single cell sequencing data identify distinct B cell and fibroblast populations in stricturing Crohn's disease
Single cell sequencing data identify distinct B cell and fibroblast populations in stricturing Crohn's disease Open
Single cell RNA sequencing of human full thickness Crohn's disease (CD) small bowel resection specimens was used to identify potential therapeutic targets for stricturing (S) CD. Using an unbiased approach, 16 cell lineages were assigned w…
View article: Defining predictors of responsiveness to advanced therapies in Crohn’s disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine
Defining predictors of responsiveness to advanced therapies in Crohn’s disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine Open
Introduction Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic dev…
View article: Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn’s Disease Regardless of Prior Biologic Exposure
Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn’s Disease Regardless of Prior Biologic Exposure Open
gov: NCT03345849, NCT03345836, NCT03345823.
View article: Ultra-processed foods and food additives in gut health and disease
Ultra-processed foods and food additives in gut health and disease Open
Ultra-processed foods (UPFs) and food additives have become ubiquitous components of the modern human diet. There is increasing evidence of an association between diets rich in UPFs and gut disease, including inflammatory bowel disease, co…
View article: Safety and efficacy of autologous haematopoietic stem-cell transplantation with low-dose cyclophosphamide mobilisation and reduced intensity conditioning versus standard of care in refractory Crohn's disease (ASTIClite): an open-label, multicentre, randomised controlled trial
Safety and efficacy of autologous haematopoietic stem-cell transplantation with low-dose cyclophosphamide mobilisation and reduced intensity conditioning versus standard of care in refractory Crohn's disease (ASTIClite): an open-label, multicentre, randomised controlled trial Open
Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
View article: OP01 PROFILE: a multi-centre, randomised, open-label, biomarker-stratified clinical trial of treatment strategies for patients with newly-diagnosed Crohn’s disease
OP01 PROFILE: a multi-centre, randomised, open-label, biomarker-stratified clinical trial of treatment strategies for patients with newly-diagnosed Crohn’s disease Open
Background Clinical outcomes differ substantially between patients with Crohn’s disease and there is variability in how newly-diagnosed patients are managed. Recent interest has focused on developing biomarkers to predict outcomes and guid…
View article: OP36 Risankizumab Versus Ustekinumab for the Achievement of Clinical Outcomes and Symptom Improvement in Patients With Moderate To Severe Crohn’s Disease: Results From the Phase 3b SEQUENCE Trial
OP36 Risankizumab Versus Ustekinumab for the Achievement of Clinical Outcomes and Symptom Improvement in Patients With Moderate To Severe Crohn’s Disease: Results From the Phase 3b SEQUENCE Trial Open
Background The efficacy and safety of risankizumab (RZB) and ustekinumab (UST) in patients (pts) with moderate to severe Crohn's disease (CD) refractory to prior anti-tumour necrosis factor (TNF)α therapy were compared in the SEQUENCE head…
View article: IL-21 conditions antigen-presenting human γδ T-cells to promote IL-10 expression in naïve and memory CD4+ T-cells
IL-21 conditions antigen-presenting human γδ T-cells to promote IL-10 expression in naïve and memory CD4+ T-cells Open
Direct interaction between T-cells exerts a major influence on tissue immunity and inflammation across multiple body sites including the human gut, which is highly enriched in ‘unconventional’ lymphocytes such as γδ T-cells. We previously …
View article: Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies
Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies Open
Background Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association …
View article: P509 Upadacitinib improves symptomatic responses in patients with moderately to severely active Crohn’s disease
P509 Upadacitinib improves symptomatic responses in patients with moderately to severely active Crohn’s disease Open
Background Upadacitinib (UPA), an oral Janus kinase inhibitor approved for the treatment of moderately to severely active Crohn’s disease (CD), has demonstrated the ability to provide rapid symptom relief within the first week of induction…
View article: P1009 Efficacy and safety of 4 years of continuous ozanimod treatment: an interim analysis of the True North open-label extension study
P1009 Efficacy and safety of 4 years of continuous ozanimod treatment: an interim analysis of the True North open-label extension study Open
Background The phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod (OZA) over 52 wk in patients (pts) with moderately to severely active ulcerative colitis (UC); the ongoing TN open-label extension (OLE) is asses…
View article: DOP53 Long-term Efficacy and Safety of Risankizumab in Patients With Moderate to Severe Crohn's Disease up to 3 Years of Treatment: Results From the FORTIFY Open-Label Long-term Extension
DOP53 Long-term Efficacy and Safety of Risankizumab in Patients With Moderate to Severe Crohn's Disease up to 3 Years of Treatment: Results From the FORTIFY Open-Label Long-term Extension Open
Background The ongoing FORTIFY maintenance open-label extension (OLE) substudy evaluates the long-term efficacy and safety of risankizumab (RZB), a p19 interleukin-23 inhibitor, for treatment of moderate to severe Crohn’s disease (CD). Her…
View article: P145 Phagocyte responses to gut-derived C. albicans are modified in inflammatory bowel disease
P145 Phagocyte responses to gut-derived C. albicans are modified in inflammatory bowel disease Open
Background Fungi are a key component of the human gut microbiota and have been strongly implicated in the pathogenesis of inflammatory bowel disease (IBD). Candida albicans typically exists as a commensal yeast within healthy hosts but can…
View article: Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn’s disease: the ASTIClite RCT
Autologous stem cell transplantation with low-dose cyclophosphamide to improve mucosal healing in adults with refractory Crohn’s disease: the ASTIClite RCT Open
Some text in this abstract has been reproduced from Lindsay J, Din S, Hawkey C, Hind D, Irving P, Lobo A, et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation…
View article: Epigenetic and Metabolic Reprogramming of Fibroblasts in Crohn’s Disease Strictures Reveals Histone Deacetylases as Therapeutic Targets
Epigenetic and Metabolic Reprogramming of Fibroblasts in Crohn’s Disease Strictures Reveals Histone Deacetylases as Therapeutic Targets Open
Background and Aims No effective therapeutic intervention exists for intestinal fibrosis in Crohn’s disease [CD]. We characterized fibroblast subtypes, epigenetic and metabolic changes, and signalling pathways in CD fibrosis to inform futu…
View article: Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study
Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study Open
Background and Aims SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis. Met…
View article: Efficacy and safety of upadacitinib for 16‐week extended induction and 52‐week maintenance therapy in patients with moderately to severely active ulcerative colitis
Efficacy and safety of upadacitinib for 16‐week extended induction and 52‐week maintenance therapy in patients with moderately to severely active ulcerative colitis Open
Summary Background Upadacitinib is an oral, selective Janus kinase inhibitor. Aim To assess the efficacy and safety of upadacitinib in patients with moderate‐to‐severe ulcerative colitis following 16‐week extended induction therapy, and 52…