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Normalisation of biomarkers and improvement in clinical outcomes in patients with Crohn’s Disease treated with risankizumab in the phase 3 ADVANCE, MOTIVATE, and FORTIFY studies
Year: 2022
Source: ECCO'22 Virtual
Authors: Raja Atreya
Created: Tuesday, 24 May 2022, 8:13 PM
Background

The efficacy of risankizumab (RZB), an interleukin 23 p19 inhibitor, in patients with Crohn’s disease (CD) has been reported. Normalisation of high-sensitivity C-reactive protein (hs-CRP) and faecal calprotectin (FCP) are intermediate treatment targets in CD. Here, we evaluated changes in these objective inflammatory biomarkers and clinical outcomes with RZB treatment.

Methods

In 2 phase 3, randomised, double-blind studies (ADVANCE, NCT03105128; MOTIVATE, NCT03104413), patients with moderately to severely active CD received 12-week intravenous (IV) RZB induction therapy or placebo (PBO). Patients with clinical response to RZB IV induction were rerandomised in a 52-week maintenance study (FORTIFY, NCT03105102) to receive subcutaneous (SC) RZB or PBO (ie, RZB withdrawal). Induction analyses included patients who received either 600 mg RZB IV or PBO for 12 weeks. Maintenance analyses included patients who received 360 mg RZB SC every 8 weeks or withdrawal (PBO SC) for 52 weeks. Outcomes assessed were normalisation of hs-CRP and FCP concentrations at week 12 of induction and at week 52 of maintenance in patients with elevated biomarkers at baseline (hs-CRP > 5 mg/L and/or FCP > 250 μg/g), clinical biomarker response (defined as enhanced clinical response [≥ 60% average daily stool frequency (SF) decrease and/or ≥ 35% average daily abdominal pain score (APS) decrease] and ≥ 50% reduction in hs-CRP or FCP), and clinical biomarker remission (defined as clinical remission per CD Activity Index or SF/APS criteria and normal hs-CRP or FCP) during maintenance treatment. Nonresponder imputation was used for missing data.

Results

Greater proportions of patients receiving RZB vs PBO achieved normalisation of hs‑CRP and FCP at the end of the 12-week induction period and the 52-week maintenance period (P < .0001 for all; Table). Among patients with clinical response to RZB IV induction and entered maintenance, rates of clinical biomarker response were maintained through week 52 in patients receiving 360 mg RZB SC and declined over time among patients in the withdrawal (PBO SC) arm (Figure A). Rates of clinical biomarker remission increased over time in patients receiving 360 mg RZB SC. At week 52, clinical remission and normalisation of hs‑CRP or FCP was achieved by 41% of patients receiving RZB vs 28%–29% of patients in the withdrawal (PBO SC) arm (Figure B-C). The safety profile of RZB in CD was previously reported.




Conclusion

Normalisation of objective biomarkers of inflammation in CD was achieved with RZB induction and maintenance therapy. Improvements in both clinical outcomes and biomarker levels were sustained with continuous RZB maintenance therapy and decreased over time in patients discontinuing RZB.

Novel dietary treatments for IBD - how to advise the patient
Year: 2019
Source: 4th D-ECCO Workshop
Authors: Rotem Sigall-Boneh
Created: Wednesday, 5 June 2019, 9:01 PM
Novel dietary treatments for IBD - how to advise the patient
Year: 2019
Source: 4th D-ECCO Workshop
Authors: Rotem Sigall-Boneh
Created: Tuesday, 28 May 2019, 3:32 PM
Files: 1
Nurses role in surgical pathway - A Tandem talk
Year: 2021
Source: 15th N-ECCO Network Meeting
Authors: Karen Kemp, Joy Odita
Created: Friday, 1 October 2021, 12:41 PM
Summary content

1. To understand the role of the IBD nurse in the surgical pathway for patients with IBD
2. To understand the role of the Stoma Care nurse for patients who have stoma formation and pouch surgery
3. Recommendations for care 

Nursing Perspectives: Stoma & Pouch: Part II
Year: 2016
Source: Talking Heads
Authors: Karen Kemp, Kay Greveson
Created: Friday, 22 February 2019, 4:13 PM by ECCO Administrator
Last Modified: Friday, 13 January 2023, 11:59 AM by ECCO Administrator
Nursing roles in IBD management
Year: 2021
Source: 12th N-ECCO School
Authors: Ana Ibarra
Created: Friday, 1 October 2021, 12:41 PM
Last Modified: Friday, 13 January 2023, 12:25 PM by ECCO Administrator
Summary content

To explore the role and scope of the IBD nurse.
To emphasise the importance of the impact and perspective of IBD in our patients.
To overview the UK IBD standards and how they enhance the provision of quality of care for all patients with IBD.
To provide an overview of the N-ECCO Consensus statements and the different levels in IBD nursing.

Nursing roles in IBD management
Year: 2020
Source: 11th N-ECCO School
Authors: Ana Ibarra
Created: Tuesday, 23 June 2020, 5:40 PM
Last Modified: Friday, 13 January 2023, 12:26 PM by ECCO Administrator
Nursing roles in IBD management
Year: 2022
Source: 13th N-ECCO School
Authors: Ana Ibarra
Created: Tuesday, 24 May 2022, 8:13 PM
Summary content

To explore the role and scope of the IBD nurse.
To emphasise the importance of the impact and perspective of IBD in our patients.
To overview the UK IBD standards and how they enhance the provision of quality of care for all patients with IBD.
To provide an overview of the N-ECCO Consensus statements and the different levels in IBD nursing.

Nursing roles in IBD management
Year: 2017
Source: 8th N-ECCO School
Authors: Chauhan U.
Last Modified: Wednesday, 15 March 2017, 1:56 PM by Vesna Babaja
Crohn's disease, Patient reported outcomes, Quality of life (IBDQ), IBD Nurse, MDT
Files: 1
Nursing roles in IBD management
Year: 2020
Source: 11th N-ECCO School
Authors: Ana Ibarra
Created: Tuesday, 23 June 2020, 4:58 PM
Last Modified: Monday, 31 May 2021, 5:26 PM by ECCO Administrator
Files: 1
Nursing roles in IBD management
Year: 2018
Source: 9th N-ECCO School
Authors: Moortgat Liesbeth
Created: Tuesday, 8 May 2018, 11:36 AM
Files: 1
Nursing roles in IBD management
Year: 2019
Source: 10th N-ECCO School
Authors: Susanna Jäghult
Created: Tuesday, 28 May 2019, 3:32 PM
IBD nurse, MDT
Files: 1
Nutrition and food additives
Year: 2017
Source: ECCO'17 Barcelona
Authors: Lees C.
Last Modified: Wednesday, 19 December 2018, 4:34 PM by Julian Nitsov
emulsifiers, food additives
Files: 1
Nutritional assessment
Year: 2021
Source: 6th D-ECCO Workshop
Authors: Emma Halmos
Created: Friday, 1 October 2021, 12:41 PM
Summary content

Educational objectives:
1) To understand the various definitions of malnutrition and how they related to clinical outcomes
2) To learn the various assessment techniques for determining malnutrition, including body composition analyses
3) To learn the emerging point-of-care assessment techniques that may improve clinical assessment and monitoring of malnutrition

Summary:
Malnutrition is very common in IBD patients, but historically, attention has been mostly placed on undernutrition.  It is becoming evident that overnutrition is increasing amongst the IBD population, with similar negative impacts on clinical outcomes.  This presentation will describe various definitions of malnutrition, including protein energy malnutrition, myopenia, sacropenia, myosteatosis, visceral obesity and micronutrient deficiencies and their relevance in predicting clinical outcomes.  Identification of such forms of malnutrition, such as use of imaging for body composition analyses, BMI, bioimpedance, handgrip devices and ultrasound will also be detailed.  In clinical practice, use of BMI has limited value and does not predict poor outcomes.  Nutritional assessment should encompass both detailed body composition analysis, often through imaging that IBD patients already undergo, and cheap, quick and easily applied point-of-care techniques to assess and monitor myopenia, sarcopenia are visceral adiposity.  

Nutritional assessment
Year: 2018
Source: 3rd D-ECCO Workshop
Authors: Gerasimidis Konstantinos
Created: Tuesday, 8 May 2018, 11:36 AM
Files: 1
Nutritional assessment in IBD
Year: 2021
Source: 12th N-ECCO School
Authors: Lihi Godny
Created: Friday, 1 October 2021, 12:41 PM
Summary content

1. To present and discuss the evidence that malnutrition and its various presentations are important in IBD
2. To present and discuss the various approaches for nutritional screening and assessment in routine clinical practice in patients with IBD
3. To discuss the interaction between IBD nurses and dietitians within the setting of a multidisciplinary team
3. To provide practical recommendations for use by nursing staff in routine clinical practice

Nutritional assessment in IBD
Year: 2020
Source: 11th N-ECCO School
Authors: Lihi Godny
Created: Tuesday, 23 June 2020, 5:40 PM
Last Modified: Wednesday, 16 June 2021, 4:43 PM by ECCO Administrator
Nutritional assessment in IBD
Year: 2022
Source: 13th N-ECCO School
Authors: Lihi Godny
Created: Tuesday, 24 May 2022, 8:13 PM
Summary content

Objectives:
•To discuss why should we perform a nutritional assessment in patients with IBD
•To demonstrate how to perform a nutritional assessment
•To emphasize who and when should be screened 
•To understand the importance of working together in a multidisciplinary team

Nutritional assessment in IBD
Year: 2020
Source: 11th N-ECCO School
Authors: Lihi Godny
Created: Tuesday, 23 June 2020, 4:58 PM
Last Modified: Wednesday, 26 May 2021, 2:20 PM by ECCO Administrator
Files: 1
Nutritional assessment in IBD
Year: 2019
Source: 10th N-ECCO School
Authors: Konstantinos Gerasimidis
Created: Tuesday, 28 May 2019, 3:32 PM
Dietary factors, Dietitian
Files: 1