Cohort profile: The Swedish Inception Cohort in inflammatory bowel disease (SIC-IBD)

Abstract

Purpose: There is a need for diagnostic and prognostic biosignatures to improve long-term outcomes in inflammatory bowel disease (IBD). Here, we describe the establishment of the Swedish inception cohort in IBD (SIC-IBD) and demonstrate its potential for the identification of such signatures. Participants: Patients aged 18 years or older with gastrointestinal symptoms who were referred to the gastroenterology unit due to suspected IBD at eight Swedish hospitals between November 2011 and March 2021 were eligible for inclusion. Findings to date: In total, 368 patients with IBD (Crohn's disease, n=143; ulcerative colitis, n=201; IBD-unclassified, n=24) and 168 symptomatic controls were included. In addition, 59 healthy controls without gastrointestinal symptoms were recruited as a second control group. Biospecimens and clinical data were collected at inclusion and in patients with IBD also during follow-up to 10 years. Levels of faecal calprotectin and high-sensitivity C-reactive protein were higher in patients with IBD compared to symptomatic controls and healthy controls. Preliminary results highlight the potential of serum protein signatures and autoantibodies, as well as results from faecal markers, to differentiate between IBD and symptomatic controls in the cohort. During the first year of follow-up, 36% (52/143) of the patients with Crohn's disease, 24% (49/201) with ulcerative colitis and 4% (1/24) with IBD-U experienced an aggressive disease course. Future plans: We have established an inception cohort enabling ongoing initiatives to collect and generate clinical data and multi-omics datasets. The cohort will allow analyses for translation into candidate biosignatures to support clinical decision-making in IBD. Additionally, the data will provide insights into mechanisms of disease pathogenesis.

Competing Interest Statement

DB served as a speaker and/or advisory board member for BMS, Janssen, Pfizer, Pharmacosmos, Sandoz, Takeda and Tillotts Pharma. HS has served as speaker and/or advisory board member for AbbVie Ferring, Janssen, Pfizer, Takeda, Gilead and Tillotts Pharma. AC served as a speaker for Takeda and Ferring. HH has served as a speaker, consultant or advisory board member for AbbVie, Ferring, Fresenius Kabi, Janssen, Norgine, Pfizer, Pharmacosmos, Takeda and Tillotts and has received grant support from AbbVie, Ferring, Takeda, and Tillotts. SA served as a member for Scientific committee/Advisory board of, Janssen, Pharmacosmos, Takeda, as a consultant for Janssen, OrionPharm, Takeda, and as a speaker: Galapagos, Janssen, Tillotts, received research grants from Janssen and OrionPharma. FB has acted as national and/or local principal investigator for clinical trials for Janssen, Ferring and Abbvie. CE received grant support/lecture fee/advisory board from Takeda, Janssen Cilag, Pfizer, Abbvie. OG served as speaker and/or advisory board member for Abbvie, Bristol Mayer Squibb, Eli Lilly, Ferring, Janssen, Pfizer Takeda, Tillotts Pharma and Vifor Pharma. JM has served as a speaker, consultant or advisory board member for AbbVie, Alfasigma, Amgen, Bayer, Biogen, BMS, Eli Lilly, Ferring, Galapagos, Hospira, ITH, Janssen, Lument, MSD, Otsuka, Pfizer, Sandoz, Takeda, Tillotts and UCB; and has received grant support (not for this study) from AbbVie, BMS, Calpro AS, Carbiotix, Ferring, Fresenius Kabi, Pfizer, Svar Life Science and Takeda. MKM has received speaker's fees from Takeda and Janssen. LO has received a financial support for research by Genetic Analysis AS, Biocodex, Danone Research and AstraZeneca and served as Consultant/Advisory Board member for Genetic Analysis AS, and as a speaker for Biocodex, Ferring Pharmaceuticals, Takeda, AbbVie, Novartis, Janssen-Cilag and Meda. MC has received speaker's fees from ViforPharma. She is the national PI for clinical trials for AstraZeneca. CRHH has served as a speaker and/or advisory board member for AstraZeneca, Dr Falk Pharma and the Falk Foundation, Galapagos, Janssen, Pfizer, Takeda, Tillotts Pharma, and received grant support from Tillotts and Takeda. JH served as speaker and/or advisory board member from AbbVie, Alfasigma, Aqilion, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma and the Falk Foundation, Eli Lilly, Ferring, Galapagos, Gilead , Hospira, Index Pharma, Janssen, MEDA, Medivir, Medtronic, Merck, MSD, Novartis, Pfizer, Prometheus Laboratories Inc., Sandoz, Shire, STADA, Takeda, Thermo Fisher Scientific, Tillotts Pharma, Vifor Pharma, UCB and received grant support from Janssen, MSD and Takeda. The remaining authors declare no conflicts of interest.

Funding Statement

This work was supported by the Swedish Foundation for Strategic Research [RB13-0160 to J.H.], the Swedish Research Council [2020-02021 to J.H.], and the Oerebro University Hospital research foundation [OLL-962042, OLL-974710, OLL-986849, OLL-1001470 to J.H.]. The funding sponsors had no role in the study's design; collection, management, analysis, or interpretation of data; in writing of the protocol, or the decision to submit results for publication.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Regional Ethics Committees (Regionala etikprovningsnamnden i Uppsala/ The Swedish Ethical Review Authority) gave ethical approval for this work (Dnr 2010/313). Written informed consent was obtained from all participants before inclusion.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Researchers can apply for access to data and biological specimens by submitting a proposal to the BIO IBD Executive Office (BIO.IBD@oru.se), including a copy of their ethics approval. All proposals will be reviewed by the BIO IBD executive committee based on scientific quality and methodology. This procedure is installed to ensure that the clinical data and biological material are being requested for scientific purposes, in accordance with the informed consent signed by the participants, as the collected data and material cannot be used by purely commercial parties. Additionally, any transfer of data or biological material must comply with Swedish law and the European Union (EU) General Data Protection Regulation (GDPR).

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