ECCO IT HUB (= ECCO DATABASE) –  PRIVACY POLICY ACCORDING TO GDPR

ECCO IT HUB consists of the following organisational entities with their registered seat in 1030 Wien, Ungargasse 6/13, and is based on a joint controllership agreement according to Article 26 General Data Protection Regulation (“GDPR”):

• ECCO – European Crohn’s and Colitis Organisation (“ECCO”), registered in the Austrian Register of Associations (ZVR) under the registration number 468755685, as well as its daughter entity:
• OCEAiN – Organisation, Congress, Emotion, Association, iNnovation GmbH (“OCEAiN”)

(together hereafter referred to as “ECCO IT HUB” or “we”).

1. Purpose

ECCO IT HUB solely processes your personal data for the purpose of:

• centralised and up-to-date data administration of ECCO Membership, Congress and event participations as well as stakeholder status in order to avoid scattering loss of up-to-date contact details among the business units of the joint data controllers

• ECCO Membership administration
• ECCO Congress abstract submission system
• ECCO Congress delegate registration
• ECCO Congress faculty registration
• ECCO Congress industry webshop and sponsor & exhibitor administration
• ECCO Virtual Congress – access administration
• ECCO Congress CME accreditation and administration
• ECCO e-Learning access administration
• ECCO Educational Workshop registration
• ECCO supplier and employee contact administration

• facilitating communication among stakeholders of the IBD Community (= the data subjects in the ECCO Database) and making relevant data visible via the ECCO Website and the ECCO App (including the display of names and affiliations of Congress speaker and ECCO Officer and the disclosure of conflicts of interest, names and affiliation)
• Promotion of ECCO Congress and Association activities
• ECCO Congress programme publication
• ECCO Congress abstract publication
• ECCO Virtual Congress platform
• ECCO Congress onsite speaker centre
• ECCO Disclosure policy of potential conflicts of interest
• ECCO Organs communication & meeting organisation
• ECCO General Assembly voting administration
• ECCO Manuscript development (Guidelines, Topical Reviews, Scientific Workshop Papers, Position Statements)
• ECCO e-Learning content development
• ECCO e-Guide content development
• Publication of ECCO News
• ECCO Website security measures and fraud prevention
• the collection and selection process with respect to open research calls, open manuscript-project calls and open calls for positions in ECCO
• Nomination collection for IBD Intensive Course for Trainees and N-ECCO School held at the annual ECCO Congress
• ECCO Organs elections - application collection
• ECCO Fellowships and Grants - application collection
• ECCO Manuscript- application collection (Guidelines, Topical Reviews, Scientific Workshop Papers, Position Statements)
• ECCO CONFER project case proposal collection
• facilitating the whole process of submission, review and publication of scientific abstracts of the annual ECCO Congress as well as facilitating the scientific review of ECCO Fellowships and Grants application
  • ECCO Congress Abstracts – scientific review
  • ECCO Fellowships and Grants – scientific review
• conducting statistical analyses and reports
• ECCO Congress, Membership and project statistics
• ECCO Website statistics for internal market research purposes
• ECCO App statistics
• ECCO Congress industry badge scanners

2. Legal basis of data collection

ECCO IT Hub only processes your personal data as follows:

• We will ask your consent to process your data in the following areas of our Website/App. You may withdraw your consent at any time. The withdrawal of your consent shall not affect the lawfulness of processing based on consent before its withdrawal:
  • ECCO Website cookies
  • ECCO Portal Account set-up
  • ECCO App installation and usage
  • ECCO e-Learning access for non-member health-care professionals until the age of 35
  • ECCO eNewsletter subscription of ECCO Portal Account Holders (without Membership)
  • Replies to open calls of ECCO (ECCO Organs, Manuscripts, Fellowships and Grants, IBD Intensive Course for Trainees, N-ECCO School, CONFER project)
  • ECCO Educational Workshop registration
  • ECCO Congress Abstract submission
  • ECCO Scientific Reviewer status
  • ECCO Congress Faculty invitations (with a separate publication consent for congress material and, for poster presentations, the consent to be contacted by delegates with regards to their poster)
  • Personal contributions to ECCO Virtual Congress
  • Publication of personal disclosure information of potential conflicts of interest, of e-Learning and e-Guide material, of ECCO manuscripts and ECCO News

 

• in performance of our (pre-)contractual obligation
  • ECCO Congress registration
  • ECCO Congress exhibition and sponsorship
  • ECCO supplier and employee contact administration

 

• on legitimate interest according to of Article 6 of the GDPR:
  • ECCO Membership administration for the fulfilment of our association purpose.

 

• Photo policy:
  • Portrait pictures are submitted by data subjects themselves or taken by the ECCO photographer are based on your explicit consent, which can be withdrawn according to point 7 below.
  • As event organisers, ECCO and OCEAiN reserve the right on their legitimate interest to use ECCO Congress photos and film footage of the official ECCO photographers and film team (as also stated in the ECCO Congress registration terms and conditions) as well as to use photos of other ECCO events in which you might be captured.

Should you have a strong objection about a specific item, you can still address ECCO Office as outlined in point 7 below.

These photos and film footage are intended for reporting about the event on the ECCO Website, in the ECCO eNewsletters, in promotional material (such as Congress break slide) and in printing material (such as the ECCO Anniversary Book series). 

3. Data categories: What kind of data?

Your personal data will not be subject to further processing in a way and manner that are incompatible with the intended purposes listed above.

ECCO Website

ECCO IT Hub processes the IP address of ECCO Website visitors and cookie information chosen by you and as explained in the cookies setting banner:

• The IP address is transmitted with every server request. ECCO IT Hub and its provider of statistical services do not store IP addresses permanently, but use them for session identification purposes and to prevent attacks only. The following information will be stored in the server logs: the IP address of the requesting computer, together with the date, time, which file is requested (name and URL), what amount of data is transferred to you, a message as to whether the request was successful, identification data of the browser used and the operating system used, as well as the website from which access was made (if access is via a link).

 

• The ECCO Website uses Matomo Analytics software, which relies on cookies as well. They are stored on your computer and generate information for the analysis of the ECCO webpages used by you (including your IP address in anonymised form), which is stored on a server located in Austria.

 

• During your visit to the ECCO Website, some information is collected and analysed for web controlling purposes. This information is provided by your browser. The following data are collected:
  • Requests (file name of the requested file) (e.g., beispiel.de/index.html)
  • Browser type/browser version (e.g., Internet Explorer 6.0)
  • Browser language (e.g., English)
  • Operating system used (e.g., Windows XP)
  • Inner resolution of browser window
  • Screen resolution
  • JavaScript activation
  • Java on /off
  • Cookies on / off
  • Colour depth
  • Referrer URL (the previously visited web site)
  • Time of access
  • Clicks
  • Total orders, if any
  • Content of forms, if any (in the case of text fields, e.g. name and password, only the information “completed“ or “not completed“ is transmitted)
  • The ECCO Website relies on several so-called cookies, which are small text files that are placed on your computer and saved by your browser ( - access all cookie details under the cookie banner). Cookies cannot be used to identify specific individuals and do not contain personal data. Most of the cookies used are so-called “session cookies” that are deleted at the end of your browser session. In addition, there are some persistent cookies used to recognize you as a returning visitor to the website.

 

ECCO Portal Account Holders in ECCO IT Hub

ECCO IT Hub processes the following personal data as provided by you in setting up an ECCO Portal Account and choosing to participate in further interactions:

• name,
• email
• addresse(s)
• phone number(s)
• postal addresse(s)
• fax
• gender
• date of birth
• age
• profession
• professional specialization
• expertise & particular areas of interest
• HCP (health care professional) status,
• your ECCO Membership status (which may also be published once per year with names per country in the context of the ECCO Congress),
• applications to open calls, event and project participation(s)
• disclosures of potential conflicts of interest,
• reimbursement data,
• portrait pictures and event photos and film footage
• passport details for congress invitation letters.
• In addition, the scientific review process generates a review result for the submitters of abstracts and applications for fellowships and grants which will be stored in connection with the abstract submitted via the submitter’s account.
• The election process generates a ranking result which is kept confidential within ECCO Office archives.

If you participate in the ECCO App and/or an ECCO virtual event, you can choose to share your personal information as well as your opinion in public debates with the other participants.

• The content of all postings and the contribution to public debates is solely your responsibility as participant who chose to actively share information. Neither ECCO or OCEAiN nor their expert volunteers or staff members can be held liable for this posted content, while ECCO and OCEAiN reserve the right to edit, rectify or delete postings of participants for good faith or legal reason.
  • Self-management of consent-based data of ECCO Portal Account used for single-sign on solution in ECCO App: your first name, last name, and email address (= you can reject that the ECCO Portal data is shared with the ECCO App)
  • Self-management of data storage and data subject rights (= the users can delete themselves): social media, website, address, job title, biography, company, country, topics of interest, portrait picture, written chat contributions
  • No data storage; self-management of data subject rights in live engagement (= you can decide themselves when to turn on/off the camera/mic/screen sharing): camera image, audio transmission, image and screen sharing
  • While text postings on the social wall can be deleted by you on your own (= self-management of data subject rights) and with this deletion also the answer comments, you cannot delete on your own your answer-comments to postings.

You may withdraw your consent regarding consent based data at any time. The withdrawal of your consent shall not affect the lawfulness of processing based on consent before its withdrawal.

4. Data received from third parties (Article 14 of the GDPR)

Please note that in the context of the following group registration, nomination and submission processes, ECCO IT HUB received your personal data via the contact person of the respective group registration:

• Membership Group Registrations
  • Source of the data: tour operator agencies booking group memberships
  • Purpose: invitation to pre-paid ECCO Membership
  • Legal Basis: consent of data subject to tour operator agencies booking group registrations; these tour operators are under a contractual obligation with ECCO to collect your consent for this registration in advance.
  • Data categories processed: last name, email address and country

 

• Congress Group Registrations
  • Source of the data: tour operator agencies booking group registrations
  • Purpose: invitation to pre-paid ECCO Congress Registration
  • Legal Basis: consent of data subject to tour operator agencies booking group registrations; these tour operators are under a contractual obligation with OCEAiN to collect your consent for this registration in advance.
  • Data categories processed: last name, email address and country, badge-pick-up and certificates of attendances of their invited delegates in tour operator profile

 

• Nomination process of the candidates for the IBD Intensive Course for Trainees
  • Source of the data: National Representatives of ECCO Country Members
  • Purpose: invitation to free-of-charge educational course at ECCO Congress
  • Legal Basis: consent of data subject to respective ECCO National Representative submitting nominations for this course; legitimate interest of data subject to be admitted to this selective course.
  • Data categories processed: first name, last name, email address, city, country, years of experience, letter of intent

 

• Nomination process of candidates for the N-ECCO School
  • Source of the data: N-ECCO National Representatives of ECCO Country Members
  • Purpose: invitation to free-of-charge educational course at ECCO Congress
  • Legal Basis: consent of data subject to respective ECCO National Representative submitting nominations for this course; legitimate interest of data subject to be admitted to this selective course.
  • Data categories processed: first name, last name, email address, city, country, phone number

 

• Congress Abstract submission process for an author group
  • Source of the data: Abstract submitter
  • Purpose: participation in the abstract selection for Abstract presentations at the ECCO Congress
  • Legal Basis: consent of data subject to submitting author of the author group; legitimate interest of data subject to participate in this scientific abstract selection.
  • Data categories processed: first name, last name, email address, institute, department, city, country, conflicts of interest

Please note that data subjects of such group registrations are contacted by ECCO Office within the first month with full transparency about this general ECCO Privacy Policy outlined here. 

As a data subject, you can address the contact point and data protection officers indicated above as well as the data protection authority indicated below.

5. Data recipients and sub-processors:

• European recipients and sub-processors:

In order to adequately fulfil the intended purposes listed above, ECCO IT Hub contracts primarily data processors based in the European Union – including but not limited to:

• COVR / Netropolix : https://www.netropolix.be/ for the customer management system of the ECCO Database
• SOL4: https://www.sol4.at/ for ECCO Website Support
• Conference Compass: https://www.conferencecompass.com/ for the ECCO App software
• Rapidmail: rapidmail.de for ECCO eNewsletter distribution,
• Viveum: www.viveum.com  as ePayment system on the ECCO Website
• GTN: https://gtn-solutions.com/ as e-Learning platform support

 

In the group registration processes, group leaders have a restricted duplicate-check option via entering the correct email address and name.

• Non-European recipients and sub-processors:

 

• In case applications are submitted to the scientific review in the context of Fellowships and Grants application reviews and the Congress Abstract reviews, this process includes individual experts from outside of Europe.

 

• In case that Educational Workshops take place outside of Europe, the registration lists for this respective Workshop are shared with the local organiser.

 

• The ECCO Virtual Congress and event platform relies on some US-based IT Services such as the Vimeo video player and the Zoom online conference platform as well as on European IT Services with US-based sub-processors such as chat tools (incl. Slido: https://www.sli.do/ and Conference Compass: https://www.conferencecompass.com/  ) and networking tools. Online educational events will rely on a selection of these services as well.

 

• The ECCO Virtual Congress platform - and the online exhibition in particular - also features links to external company websites and chat tools – which are declared as such. This privacy policy and the terms and conditions of the ECCO Virtual Congress do not apply to these external websites, which need to be consulted separately for cookie and data protection policies. These websites are not within the responsibility of ECCO and OCEAiN, who may therefore not be held liable.

 

In case you explicitly consent to badge scanning in the ECCO Congress exhibition or satellite symposia, we transfer your personal data (Name; Contact details) to the exhibition or sponsor companies of the congress, some of which do have their head-quarters in the USA.  The current list of exhibitors can be found on the annual Congress Website (accessible via https://www.ecco-ibd.eu/congresses-and-events.html )  in the exhibitor section. You may withdraw your consent at any time. The withdrawal of your consent shall not affect the lawfulness of processing based on consent before its withdrawal.

6. Data storage time-frame:

ECCO IT Hub of course also observes the principle of storage limitation for personal data.

• IP address of ECCO Website visitors: The server logs are saved in order to be able to check the system security, to administrate the website technically and to be able to optimize the offer. The server logs are stored for the duration of 3 months. After this period the identity of the user can no longer be determined, even by ISPs.
• Anonymised IP address storage in the Matomo Analytics software of the ECCO Website: 24 months
• ECCO IT Hub will process the following data of Portal Account Holders until withdrawal of consent, but not longer than for 7 years:
  • name,
  • email
  • addresse(s)
  • phone number(s)
  • postal addresse(s)
  • fax
  • gender
  • date of birth
  • age
  • profession
  • professional specialization
  • expertise & particular areas of interest
  • HCP (health care professional) status,
  • your ECCO Membership status (which may also be published once per year with names per country in the context of the ECCO Congress),
  • applications to open calls, event and project participation(s)
  • disclosures of potential conflicts of interest,
  • reimbursement data
  • passport details for congress invitation letters.
  • In addition, the scientific review process generates a review result for the submitters of abstracts and applications for fellowships and grants which will be stored in connection with the abstract submitted via the submitter’s account.
  • The election process generates a ranking result which is kept confidential within ECCO Office archives.

• Beyond that time, ECCO IT Hub will only process your data (including photographs and video material) for association archive purposes, or if we are obliged to process your personal data by law.

Personal (non-scientific) supporting documents (such as letters of intent, CVs, publication lists), submitted in the context of applications to open calls, event and project participation(s)are stored not longer than 3 years.

7. Your rights as data subject:

Should you be affected by our processing of personal data, you have the right at any time to request access to, rectification, or erasure of personal data, or restriction of the processing concerning your personal data or to object to processing as well as the right to data portability.

As data subject, you may withdraw your consent for

• ECCO Website cookies (via deinstallation on user side)
• ECCO Portal Account set-up
• ECCO App installation and usage (via deinstallation on user side)
• ECCO e-Learning access for non-member health-care professionals until the age of 35
• ECCO eNewsletter subscription of ECCO Portal Account Holders (without Membership)
• Replies to open calls of ECCO (ECCO Organs, Manuscripts, Fellowships and Grants, IBD Intensive Course for Trainees, N-ECCO School, CONFER project)
• ECCO Educational Workshop registration
• ECCO Congress Abstract submission
• ECCO Scientific Reviewer status
• ECCO Congress Faculty invitations (with a separate publication consent for congress material)
• Personal contributions to ECCO Virtual Congress
• Publication of personal disclosure information of potential conflicts of interest, of e-Learning and e-Guide material, of ECCO manuscripts and ECCO News
• ECCO Congress – Industry Badge Scanner consent
• Portrait pictures (and event photos and film footage)

from ECCO IT HUB to process your personal data at any time under This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it. or by postal mail to ECCO Office, Ungargasse 6/13, A-1030 Vienna, Austria.

Please note that the withdrawal of your consent shall not affect the lawfulness of processing based on consent before its withdrawal, and that in certain circumstances ECCO IT Hub is entitled or else required to process certain forms of personal data for a period extending beyond the withdrawal of consent, either due to our contractual relationship with you, or else due to legal requirements.

According to Art. 13 (2) e GDPR, you are not obliged to agree to the processing of your data. However, please also note

• that in case of the withdrawal of consent you will not be able to benefit or use all functions of ECCO IT Hub;
• that in case of disagreement with the processing of necessary data for (pre-) contractual obligations, the business transaction cannot be implemented;
• that in case you disagree with the legitimate interest according to of Article 6 of the GDPR regarding ECCO Membership, you will not be able to become an ECCO Member.

You directly access and modify your information via your personal log-in under the following link: https://cm.ecco-ibd.eu/cmgateway/member/NW/index.html?module=relationmanager&config=normal#manageprofiles.

In case you believe that the processing of your personal data does not comply with the provisions of data protection, you can – other legal remedies in law courts or under administrative law notwithstanding – make a complaint with a supervisory authority, in particular in the Member State of your habitual residence, place of work or place of the alleged infringement. In Austria, the supervisory authority is the Austrian Data Protection Authority (Österreichische Datenschutzbehörde).

According to Art. 13 (2) f GDPR, ECCO IT HUB does not generate automatic decisions including data profiling.

8. Nature of joint data processing by ECCO and OCEAiN:

The essence of the ECCO IT Hub arrangement according to Article 26 GDPR:

(Updated with JCA revised text per March 15, 2020)

DESCRIPTION OF JOINT DATA PROCESSING OPERATIONS:

The ECCO Database constitutes the core for all projects on the side of ECCO Association as well the side of OCEAiN GmbH, who is in charge of organising the annual ECCO Congress, the e-Learning platform and publishing the ECCO News magazine.

As the ECCO Congress constitutes the annual meeting of the ECCO Members and other stakeholders in the field of inflammatory bowel diseases, the ECCO Database has a significant intersection set of data subjects as the same data subjects can be ECCO Members and Congress Delegates. 

The data subjects in the ECCO Database are health care professionals, pharma industry representatives, patient representatives and students in the field of inflammatory bowel diseases with an interest in both ECCO Association activities and ECCO Congress and e-Learning activities. In addition, the ECCO Database captures press contacts, as well as employees and contact persons of tour operator agencies booking group registrations and of supplier companies, which are contracted to implement projects of ECCO and OCEAiN. 

MEANS OF JOINT DATA PROCESSING OPERATIONS: 

With the increasingly enhanced digitalisation of the joint data processing operations over the past years, the ECCO Website with a Login-Area called the ECCO Portal constitutes the main entrance door to all activities of ECCO and OCEAiN.

The ECCO Portal Account is the “front” side entrance door to and, after personal Login-In, the front side display of the respective personal data-set captured in the ECCO Database.

As soon as an ECCO Portal Account holder applies for ECCO Membership or engages in another activity, joint processing takes place in the ECCO Database: the use of synergy effects in data harmonization also aims to facilitate access of  data subjects to activities within the larger framework of ECCO IT Hub (e.g. distribution of our newsletters, promotion of our Congress and educational/scientific activities, access facilitation via the publisher/distributor of our publications). 

Depending on the status of the data subject (e.g.: Membership status, Congress Registration statutes, Scientific Reviewer Status), the data subject can access various online tools (e.g.: online application process per open call, registration process for workshops or ECCO Congress, industry webshop)  and various levels of online content (e.g.: applications received for internal or scientific review, e-Learning material, meeting documents).

Most of the functionalities are directly provided by the ECCO Database suppliers and do not need data transfers to other suppliers.

The ECCO Website and the ECCO Database are hosted on a rented ECCO Server space in Austria.

Additional Platforms and technology needed are solved with a single-sign on technology with the ECCO Database, which are in particular

• the ePayment tool used to process online credit card payments for ECCO Membership and ECCO Congress Registrations.
• the e-Learning platform which is accessible to all ECCO Members and also to health care professionals as ECCO Portal Account holders without active ECCO Membership up to the age of 35. The single-sign on mechanism is based on an age check, which takes place within the ECCO Database before the access interface is enabled to the e-Learning Platform.
• the ECCO App: upon installation of the ECCO App (offering a dedicated section for ECCO Association and another dedicated section for the annual Congress) on the data subject’s mobile device, first name, last name and email address is shared with the App provider company to allow the single-sign-on mechanism. In case of additional consent of the data subject chosen in  the settings of the App, the personal status (of Membership or Congress Delegates) can be shared in order to be visible for a chat-function tool.

 

In addition, two further joint data processing platforms are used to facilitate project management and communication:

• the ECCO Office inhouse server
• the eNewsletter Mailing Platform

PURPOSE OF JOINT DATA PROCESSING OPERATIONS: please refer to point 1 above.

CATEGORIES OF DATA PROCESSED UNDER THIS AGREEMENT: please refer to point 3 above.

DATA STORAGE LIMITATION: please refer to point 6 above.

ALLOCATION OF DATA PROTECTION TASKS/DUTIES (under Art. 26 GDPR)

The data protection tasks done jointly are

• provision of information according to Article 26 paragraph 2 sentence 2 GDPR
• common contact point for the fulfilment of data subjects’ requests,
• information obligation according to Article 13 / 14 GDPR,
• fulfilment of the request of access,
• fulfilment of the request of rectification,
• fulfilment of the request of erasure and restriction of processing,
• notification to recipients (Article 19 GDPR),
• fulfilment of the request of data portability, processing of withdrawals,
• implementation of technical and organisational measures (Article 32 GDPR),
• review and adaption of technical and organisational measures,
• maintenance of a record of processing activities

 

The data protection tasks done separately are:

• selection and assignment of data processors
• processing of notifiable data breaches

 

CONTACT POINT ACCORDING TO ARTICLE 13, 14 and 26 GDPR:

ECCO Office
Ungargasse 6/13, A-1030 Vienna, Austria.
Tel: +43-(0)1-710 2242-0
Fax: +43-(0)1-710 2242-001

E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Data ProTection Officer ACCORDING TO ARTICLE 37 GDPR:

Knyrim Trieb Rechtsanwälte OG

Mariahilfer Straße 89a, A-1060 Wien

T: +43 1 909 30 70, F: +43 1 9093639

E: This email address is being protected from spambots. You need JavaScript enabled to view it., W: www.kt.at

FN 462250f, HG Wien

Current JCC eTOC

Please find here the JCC eTOC service, the table of contents for each new issue that is always being updated. Don’t miss this excellent tool for keeping up-to-date on newly published articles.

Journal of Crohn's and Colitis Current Issue Unravelling the Smoke Trail: Maternal Smoking, Childhood Exposure, and their Impact on Inflammatory Bowel DiseasesMon, 18 Mar 2024 00:00:00 GMT by The impact of maternal smoking and early life exposure to passive smoking in the development of inflammatory bowel disease [IBD] remains a subject of controversy. In an earlier prospective study in 2007, patients with Crohn’s disease [CD] were more likely to have prenatal smoke exposure than controls (odds ratio [OR] 1.72, 95% confidence interval [CI]; 1.1–2.7) and were also more likely to have passive smoke exposure during childhood, with one or both parents or other household members being smokers [OR 2.04, 95% CI; 1.28–3.31].¹ However, a meta-analysis conducted in 2008 by Jones D et al. found no strong association between childhood or prenatal passive smoke exposure and IBD.² Recently, two noteworthy studies on the impact of maternal smoking during pregnancy [MSDP] and childhood smoking exposure on the development of IBD have been published in the current issue of the journal. The first report, conducted by Linmin Hu et al., is entitled ‘Impact of maternal smoking, offspring smoking, and genetic susceptibility on Crohn’s disease and ulcerative colitis’.³ Another study, titled ‘Tobacco smoke exposure in early childhood and later risk of inflammatory bowel disease’ was conducted by Ida Sigvardsson et al. Both reports emphasise the importance of understanding early life exposure to passive smoking in the development of IBD.⁴Read more Tobacco Smoke Exposure in Early Childhood and Later Risk of Inflammatory Bowel Disease: A Scandinavian Birth Cohort StudyThu, 08 Feb 2024 00:00:00 GMT by

Abstract

Objectives

To examine the association between early-life smoking exposure and later risk of inflammatory bowel disease [IBD].

Methods

We followed 115663 participants from the Norwegian Mother, Father and Child [MoBa] and All Babies in Southeast Sweden [ABIS] cohorts from birth [1997–2009] through 2021. IBD was identified through national patient registers. Validated questionnaire data defined maternal smoking during pregnancy, maternal environmental tobacco smoke [ETS] exposure during pregnancy, and child ETS exposure by ages 12 and 36 months. Cox regression was used to estimate adjusted hazard ratios [aHRs] for sex, maternal age, education level, parental IBD, and origin. Cohort-specific estimates were pooled using a random-effects model.

Results

During 1 987 430 person-years of follow-up, 444 participants developed IBD [ABIS, 112; MoBa, 332]. Any vs no maternal smoking during pregnancy yielded a pooled aHR of 1.30 [95% CI = 0.97–1.74] for offspring IBD. Higher level of maternal smoking during pregnancy (compared with no smoking, average ≥6 cigarettes/day: pooled aHR = 1.60 [95% CI = 1.08–2.38]) was associated with offspring IBD, whereas a lower smoking level was not (average 1–5 cigarettes/day: pooled aHR = 1.09 [95% CI = 0.73–1.64]). Child ETS exposure in the first year of life was associated with later IBD (any vs no ETS, pooled aHR = 1.32 [95% CI = 1.03–1.69]). Estimates observed for child ETS exposure by 36 months were similar but not statistically significant.

Conclusions

In this prospective Scandinavian cohort study, children exposed to higher levels of maternal smoking during pregnancy or ETS during the first year of life were at increased risk of later IBD.Read more Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn’s DiseaseThu, 14 Dec 2023 00:00:00 GMT by

Abstract

Background and Aims

Ontamalimab is a fully human immunoglobulin G2 monoclonal antibody against mucosal addressin cell adhesion molecule-1, developed as treatment for inflammatory bowel disease.

Methods

Six phase 3, multicentre, randomised, double-blind, placebo-controlled clinical trials compared efficacy and safety of ontamalimab [25 mg and 75 mg once every 4 weeks] with placebo in patients with moderate-to-severe ulcerative colitis or Crohn’s disease [two induction studies and one re-randomised maintenance study per condition]. This clinical trial programme was discontinued in 2020 for reasons unrelated to drug safety/efficacy; Crohn’s disease studies are described in the Supplementary data.

Results

The induction [12-week] and maintenance [52-week] studies included 659 and 366 randomised patients, respectively. More patients who received ontamalimab induction than placebo achieved the primary endpoint of clinical remission at Week 12 [25 mg, 18.5% vs 15.8%, p = 0.617, 27.0% vs 12.5%, p = 0.027; 75 mg, 29.8% vs 15.8%, p = 0.018, 29.5% vs 12.5% p = 0.014]; significantly more patients who received ontamalimab maintenance therapy than placebo achieved Week 52 clinical remission [25 mg, 53.5% vs 8.2%, p <0.001; 75 mg, 40.2% vs 12.8%, p <0.001]. Endoscopic improvement was generally significantly different vs placebo [induction: 25 mg, 27.8% vs 21.1%, p = 0.253, 35.1% vs 12.5%, p = 0.001; 75 mg, 41.1% vs 21.1%, p = 0.002, 33.9% vs 12.5%, p = 0.003; maintenance: 25 mg, 56.3% vs 9.6%, p <0.001; 75 mg, 48.8% vs 15.1%, p <0.001]. Adverse event rates were similar between ontamalimab and placebo groups.

Conclusions

Ontamalimab 75 mg was effective, with no safety concerns, as induction and maintenance therapy for patients with moderate-to-severe ulcerative colitis. [NCT03259334; NCT03259308; NCT03290781; NCT03559517; NCT03566823; NCT03627091]Read more Impact of Maternal Smoking, Offspring Smoking, and Genetic Susceptibility on Crohn’s Disease and Ulcerative ColitisFri, 01 Dec 2023 00:00:00 GMT by

Abstract

Background and Aims

The long-term impact of maternal smoking during pregnancy [MSDP] on the risk of Crohn’s disease [CD] and ulcerative colitis [UC] in adult offspring remains uncertain. The present study aimed to investigate the individual and combined effects of early life exposure [MSDP], offspring personal behaviour [smoking], and genetic risk on the development of CD and UC in adult offspring.

Methods

We conducted a prospective cohort study using UK Biobank data, including 334 083 participants recruited between 2006 and 2010, with follow-up until December 31, 2021. Multivariable Cox regression models were used to evaluate the associations of genetic factors, maternal and personal smoking, and their combination with CD and UC.

Results

Participants exposed to MSDP had an 18% increased risk of CD compared to those without MSDP (hazard ratio [HR] = 1.18, 95% confidence interval [CI] = 1.01–1.39). However, no significant association was found between MSDP and UC risk [HR = 1.03, 95% CI = 0.92–1.16]. Personal smoking increased the risk of CD and UC, and had a numerically amplified effect with MSDP. Participants with high genetic risk and MSDP had a 2.01-fold [95% CI = 1.53–2.65] and a 2.45-fold [95% CI = 2.00–2.99] increased risk of CD and UC, respectively, compared to participants without MSDP and with low genetic risk.

Conclusions

Our prospective cohort study provides evidence that MSDP increases the risk of CD in adult offspring, whereas no evidence supports their causal association. Additionally, smoking and genetic susceptibility had a numerically amplified effect with MSDP on CD and UC, but the interaction lacked statistical significance.Read more Improved Clinical Outcomes With Early Anti-Tumour Necrosis Factor Alpha Therapy in Children With Newly Diagnosed Crohn’s Disease: Real-world Data from the International Prospective PIBD-SETQuality Inception Cohort StudyMon, 27 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

Treatment guidelines for paediatric Crohn’s disease [CD] suggest early use of anti-tumour necrosis factor alpha [anti-TNFα] in high-risk individuals. The aim is to evaluate the effect of early anti-TNF in a real-world cohort.

Methods

Children with newly diagnosed CD were prospectively recruited at 28 participating sites of the international observational PIBD-SETQuality study. Outcomes were compared at 3 months, 1 and 2 years between patients receiving early anti-TNF [<90 days after diagnosis] and those not receiving early anti-TNF. Outcomes included sustained steroid-free remission [SSFR] without treatment intensification [specified as SSFR*] and sustained steroid-free mild/inactive disease without treatment intensification [specified as SSFMI*]. Penalised logistic regression model-based standardisation was applied to estimate the relative risks [RR] of early therapy on outcomes. RRs were estimated for high-risk and low-risk patients, based on presence of predictors of poor outcome [POPOs] and disease activity at diagnosis.

Results

In total, 331 children (median age 13.9 years [IQR 12.2–15.3]) were enrolled, with 135 [41%] receiving early anti-TNF. At 1 year, patients on early anti-TNF had higher rates of SSFR* [30% vs 14%, p <0.001] and SSFMI* [69% vs 33%, p <0.001], with RRs of 2.95 [95% CI 1.63-5.36] and 4.67 [95% CI 2.46-8.87], respectively. At 1 year, the RRs for SSFMI* were higher, and statistically significant in high-risk patients, i.e. those with moderate/severe disease compared with mild/inactive disease at diagnosis (5.50 [95% CI 2.51-12.05] vs 2.91 [95% CI 0.92-9.11]), and those with any POPO compared with no POPO (5.05 [95% CI 2.45-10.43] vs 3.41 [95% CI 0.54-21.7]).

Conclusion

In this cohort of children with newly-diagnosed CD, early anti-TNF demonstrated superior effectiveness in high-risk patients.Read more The Role of Platelets and von Willebrand Factor in the Procoagulant Phenotype of Inflammatory Bowel DiseaseMon, 27 Nov 2023 00:00:00 GMT by

Abstract

Aims

Although the risk of thrombosis is well documented for inflammatory bowel disease [IBD] patients, the underlying pathological mechanism seems to be different from other thrombotic conditions. Determining the factors responsible for the increased risk of thrombosis in IBD would help to improve the management of this frequent complication.

Methods

We studied the interplay between platelets, coagulation, and von Willebrand factor [VWF] in 193 IBD patients and in experimental models [acute and chronic] of colitis in wild-type and VWF-deficient mice.

Results

We found a platelet-dependent increase in thrombin generation in IBD patients and in our mouse model of colitis. Agglutinated platelets were present in the blood of patients and mice. Interestingly, we observed not only a significant increase in total VWF antigen, but we were also able to detect the presence of active VWF [VWF in its platelet-binding conformation; 3.2 ± 2.7 μg/mL] in the plasma of 30% of all IBD patients. In healthy controls, active VWF levels were <0.3 μg/mL. This led us to further explore experimental colitis in VWF-deficient mice and we observed that these mice were protected against the procoagulant state triggered by the colitis. Unexpectedly, these mice also showed a significant worsening of colitis severity in both acute and chronic models.

Conclusion

Platelets and VWF [including its active form] appear to be central players in the procoagulant phenotype in IBD. We observed that the role of VWF in haemostasis differs from its role in colonic tissue healing, potentially opening new therapeutic avenues for a life-threatening complication in IBD patients.Read more Histological Image-based Ensemble Model to Identify Myenteric Plexitis and Predict Endoscopic Postoperative Recurrence in Crohn’s Disease: A Multicentre, Retrospective StudyFri, 24 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

Myenteric plexitis is correlated with postoperative recurrence of Crohn’s disease when relying on traditional statistical methods. However, comprehensive assessment of myenteric plexus remains challenging. This study aimed to develop and validate a deep learning system to predict postoperative recurrence through automatic screening and identification of features of the muscular layer and myenteric plexus.

Methods

We retrospectively reviewed 205 patients who underwent bowel resection surgery from two hospitals. Patients were divided into a training cohort [n = 108], an internal validation cohort [n = 47], and an external validation cohort [n = 50]. A total of 190 960 patches from 278 whole-slide images of surgical specimens were analysed using the ResNet50 encoder, and 6144 features were extracted after transfer learning. We used five robust algorithms to construct classification models. The performances of the models were evaluated based on the area under the receiver operating characteristic curve [AUC] in three cohorts.

Results

The stacking model achieved satisfactory accuracy in predicting postoperative recurrence of CD in the training cohort (AUC: 0.980; 95% confidence interval [CI] 0.960–0.999), internal validation cohort [AUC: 0.908; 95% CI 0.823–0.992], and external validation cohort [AUC: 0.868; 95% CI 0.761–0.975]. The accuracy for identifying the severity of myenteric plexitis was 0.833, 0.745, and 0.694 in the training, internal validation and external validation cohorts, respectively.

Conclusions

Our work initially established an interpretable stacking model based on features of the muscular layer and myenteric plexus extracted from histological images to identify the severity of myenteric plexitis and predict postoperative recurrence of CD.Read more Treatment of Antibiotic Refractory Chronic Pouchitis With JAK Inhibitors and S1P Receptor Modulators: An ECCO CONFER Multicentre Case SeriesWed, 15 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

Data regarding the effectiveness and safety of Janus kinase [JAK] inhibitors and sphingosine-1-phosphate [S1P] receptor modulators in antibiotic refractory chronic pouchitis [CARP] are lacking.

Methods

This ECCO-CONFER project retrospectively collected data for JAK inhibitor or S1P receptor modulator treatments for CARP with at least 3 months of follow-up. The outcomes included corticosteroid- and antibiotic-free clinical response and remission at 3 and 12 months, and trends in modified pouchitis disease activity index [mPDAI], endoscopic PDAI, C-reactive protein, and calprotectin.

Results

Seventeen treatments in 15 patients were evaluated. Previous pouchitis treatments included infliximab [5/15], adalimumab [4/15], vedolizumab [9/15], and ustekinumab [5/15]. Pooling data on JAK inhibitors [eight tofacitinib, one filgotinib, and six upadacitinib] after 3 months [T3], steroid- and antibiotic-free clinical response was achieved in 53.3% [8/15], and steroid- and antibiotic-free clinical remission was achieved in 40% [6/15]. Of the patients with at least 12 months of follow-up, steroid- and antibiotic-free clinical response was achieved in 50% [3/6] and remission in one patient [16.7%], endoscopic response in 50% [3/6], and endoscopic remission in 50% [3/6]. Of the two ozanimod treatments at T3, steroid- and antibiotic-free clinical response was achieved in one patient, without remission; both discontinued ozanimod before T12. No side effects were reported.

Conclusions

Small molecules may represent a suitable option for CARP refractory to multiple biologics, deserving further investigation.Read more Kidney Injuries as Extra-intestinal Manifestation of Inflammatory Bowel DiseaseWed, 15 Nov 2023 00:00:00 GMT by As nephrologists who often see patients with inflammatory bowel disease [IBD] at the request of their gastroenterologist, we read with interest the ECCO Guidelines on Extra-Intestinal Manifestations [EIM] in IBD which you recently published.¹ It struck us that the kidney was not even mentioned. Renal involvement was overlooked in a similar way in two other important recent publications about EIM.^2,3Read more Anti-tumor Necrosis Factor Alpha Versus Corticosteroids: A 3-fold Difference in the Occurrence of Venous Thromboembolism in Inflammatory Bowel Disease－A Systematic Review and Meta-analysisSat, 11 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

Patients with inflammatory bowel disease [IBD] have a more than two fold higher risk of venous thromboembolic events [VTE] than the general population. The aetiology is complex, and the role of medication is not precisely defined. We aimed to assess the effects of anti-tumor necrosis factor alpha [anti-TNFα] drugs and conventional anti-inflammatory therapy, namely corticosteroids [CS], immunomodulators [IM], and 5-aminosalicylates [5-ASA] on VTE in IBD.

Methods

A systematic search was performed in five databases on November 22, 2022. We included studies reporting VTE in the distinct categories of medications, determined the proportions, and calculated the odds ratios [OR] with 95% confidence intervals [CI], using the random-effects model. The risk of bias was evaluated with the Joanna Briggs Institute Critical Appraisal Checklist and the Risk of Bias in Non-randomized Studies of Interventions tool.

Results

The quantitative analysis included 16 observational studies, with data from 91 322 IBD patients. Patients receiving anti-TNFα medication had significantly less VTE [proportion: 0.05, CI: 0.02–0.10], than patients treated with CS [proportion: 0.16, CI: 0.07–0.32], with OR = 0.42 [CI: 0.25–0.71]. IMs resulted in similar proportions of VTE compared with biologics [0.05, CI: 0.03–0.10], with OR = 0.94 [CI: 0.67–1.33]. The proportion of patients receiving 5-ASA having VTE was 0.09 [CI: 0.04–0.20], with OR = 1.00 [CI: 0.61–1.62].

Conclusions

Biologics should be preferred over corticosteroids in cases of severe flare-ups and multiple VTE risk factors, as they are associated with reduced odds of these complications. Further studies are needed to validate our data.Read more The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b StudySat, 11 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

NX-13 activation of NLRX1 reduces intracellular reactive oxygen species and decreases inflammation in animal models of colitis. A phase 1a trial demonstrated a gut-selective pharmacokinetic profile with good tolerability. This phase Ib study aimed to evaluate the safety, tolerability, and pharmacokinetics of NX-13 in patients with active ulcerative colitis [UC].

Methods

We conducted a multicentre, randomized, double-blind, placebo-controlled trial of NX-13 in patients with active UC. Patients with a Mayo Clinic Score of 4–10 were randomly assigned [3:3:3:1 ratio] to three NX-13 oral dose groups (250 mg immediate release [IR], 500 mg IR, or 500 mg delayed release [DR], or placebo) once daily for 4 weeks. Safety and pharmacokinetics were the primary and secondary objectives, respectively.

Results

Thirty-eight patients [11 females] were recruited and randomized to placebo [five], NX-13 250 mg IR [11], NX-13 500 mg IR [11], or NX-13 500 mg DR [11] and received at least one dose. There were no serious adverse events or deaths during the trial. One patient [500 mg DR, 1/11] withdrew due to worsening of UC and a second [500 mg IR, 1/11] on the last day of treatment after a panic attack associated with atrial fibrillation. In the efficacy population [36 patients], clinical improvement in rectal bleeding and stool frequency scores relative to placebo were seen as early as week 2 and endoscopic response was seen at week 4.

Conclusions

NX-13 was generally safe and well tolerated with early signs of rapid symptom and endoscopic improvement. This novel mechanism of action warrants further investigation. ClinicalTrials.gov: NCT04862741.Read more Impact of Baseline Corticosteroid Use on the Efficacy and Safety of Upadacitinib in Patients with Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 Clinical Trial ProgrammeMon, 06 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

This post hoc analysis assessed the efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis stratified by corticosteroid use from the ulcerative colitis Phase 3 clinical trial programme.

Methods

Patients were randomised [1:2] to 8 weeks’ placebo or upadacitinib 45 mg once daily; Week 8 responders were re-randomised [1:1:1] to 52 weeks’ placebo or upadacitinib 15 or 30 mg daily. Corticosteroid dose was kept stable during induction but tapered according to a protocol-defined schedule [or investigator discretion] during maintenance Weeks 0–8. Efficacy outcomes and exposure-adjusted, treatment-emergent adverse event [TEAE] rates were assessed for induction and maintenance stratified by corticosteroid use at induction baseline.

Results

Overall, 377/988 [38%] patients were receiving corticosteroids at induction baseline [placebo, n = 133; upadacitinib 45 mg, n = 244] and 252 [37%] of the 681 clinical responders who entered maintenance were on corticosteroids at induction baseline [n = 84 for each treatment]. Similar proportions of patients receiving upadacitinib achieved clinical remission per Adapted Mayo Score with and without baseline corticosteroids at Weeks 8 and 52. The total proportion of patients re-initiating corticosteroids was higher with placebo [24/84;29%] vs upadacitinib 15 mg [16/81; 20%)] and 30 mg [11/81; 14%]. During induction, patients receiving corticosteroids at baseline had higher rates of TEAEs, serious TEAEs, and serious infections vs those not receiving corticosteroids; however, TEAE rates were similar during maintenance after corticosteroid withdrawal.

Conclusions

Upadacitinib is an effective steroid-sparing treatment in patients with moderately to severely active ulcerative colitis. Clinicaltrials.gov identifiers: NCT02819635; NCT03653026Read more Cancer Biology or Ineffective Surveillance? A Multicentre Retrospective Analysis of Colitis-Associated Post-Colonoscopy Colorectal CancersMon, 06 Nov 2023 00:00:00 GMT by

Abstract

Background and Aims

Inflammatory bowel disease [IBD] is associated with high rates of post-colonoscopy colorectal cancer [PCCRC], but further in-depth qualitative analyses are required to determine whether they result from inadequate surveillance or aggressive IBD cancer evolution.

Methods

All IBD patients who had a colorectal cancer [CRC] diagnosed between January 2015 and July 2019 and a recent [<4 years] surveillance colonoscopy at one of four English hospital trusts underwent root cause analyses as recommended by the World Endoscopy Organisation to identify plausible PCCRC causative factors.

Results

In total, 61% [n = 22/36] of the included IBD CRCs were PCCRCs. They developed in patients with high cancer risk factors [77.8%; n = 28/36] requiring annual surveillance, yet 57.1% [n = 20/35] had inappropriately delayed surveillance. Most PCCRCs developed in situations where [i] an endoscopically unresectable lesion was detected [40.9%; n = 9/22], [ii] there was a deviation from the planned management pathway [40.9%; n = 9/22], such as service-, clinician- or patient-related delays in acting on a detected lesion, or [iii] lesions were potentially missed as they were typically located within areas of active inflammation or post-inflammatory change [36.4%; n = 8/22].

Conclusions

IBD PCCRC prevention will require more proactive strategies to reduce endoscopic inflammatory burden, and to improve lesion optical characterization, adherence to recommended surveillance intervals, and patient acceptance of prophylactic colectomy. However, the significant proportion appearing to originate from non-adenomatous-looking mucosa which fail to yield neoplasia on biopsy yet display aggressive cancer evolution highlights the limitations of current surveillance. Emerging molecular biomarkers may play a role in enhancing cancer risk stratification in future clinical practice.Read more Higher Serum Infliximab Concentrations Following Subcutaneous Dosing are Associated with Deep Remission in Patients with Inflammatory Bowel DiseaseThu, 02 Nov 2023 00:00:00 GMT by

Abstract

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].

Results

Of 91 patients identified, 71 qualified for inclusion in the study [70% with CD; 27% with concomitant immunomodulators]. At the time of drug concentration measurement [median 13.5 months after switch], 55 [77%] patients had sustained clinical remission; n = 44 [62%] composite clinical and biomarker remission; n = 40 [56%] biochemical remission; and n = 31 [43%] deep remission. The mean SC-IFX concentrations were significantly higher in patients with sustained clinical remission [p = 0.014]; composite clinical and biomarker remission [p = 0.003]; biochemical remission [p < 0.001]; and deep remission [p < 0.001] compared to patients without having these outcomes. In multivariate analysis, SC-IFX concentration was the only factor independently associated with sustained clinical remission (odds ratio [OR]: 4.7, 95% confidence interval [CI]: 3.1–12.2, p = 0.005); clinical and biomarker remission [OR: 9.21, 95% CI: 6.09–18.7, p = 0.006]; biochemical remission [OR: 37, 95% CI: 14–39.3, p < 0.001]; and deep remission [OR: 29, 95% CI: 15.7–37.4, p < 0.001]. The optimal SC-IFX concentration cut-off associated with deep remission based on ROC analysis was 20 µg/mL [sensitivity: 0.91, specificity: 0.80, accuracy: 0.85]. Combination with an immunomodulator failed to improve SC-IFX pharmacokinetics.

Conclusion

Higher SC-IFX concentrations are associated with higher rates of favourable therapeutic outcomes in IBD patients. Serum SC-IFX concentrations >20 µg/mL were significantly associated with deep remission.Read more