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Karlqvist, S. (2024). Clinical aspects of biological treatment in inflammatory bowel disease. (Doctoral dissertation). Örebro: Örebro University
Open this publication in new window or tab >>Clinical aspects of biological treatment in inflammatory bowel disease
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Inflammatory bowel disease (IBD) including its main subtypes, Crohn’s disease and ulcerative colitis, is a chronic and recurrent inflammatory condition that affects the entire gastrointestinal system. Biological treatment has revolutionized the therapeutic armamentarium in the past two decades. The growing number of therapeutic options advocates for head-to-head comparisons, evaluation in clinical practice and assessment of safety. Therefore, this thesis aims to evaluate different facets of biological treatment in real-world cohorts.

In Paper I, we examined the potential effectiveness of golimumab in Crohn’s disease using data from The Swedish National Quality Register for Inflammatory Bowel Disease (SWIBREG). The findings indicate a drug retention rate of 35% after a median follow-up of 89 (IQR: 32–158) weeks. Paper II constituted a prospective, multicentre, observational cohort study investigating the effectiveness of vedolizumab and its impact on quality of life in a Swedish clinical setting. The percentage of patients in clinical remission after 52 weeks was 41% for Crohn's disease and 47% for ulcerative colitis. Improvements in biochemical markers and health-related quality of life measures were observed at 12 and 52 weeks in both subtypes of IBD. In Paper III, second-line biological treatments were compared in propensity score-matched cohorts based on combined data from multiple high-quality Swedish nationwide registers. The effectiveness and safety of secondline anti-TNF and vedolizumab were similar at 12 months in Crohn’s disease (n=198) and ulcerative colitis (n=202). Based on propensity score-matched data from nationwide health registers, Paper IV showed that vedolizumab was associated with higher hazard ratios of serious infections than anti-TNF in Crohn’s disease but not in ulcerative colitis.

To conclude, this thesis suggests that golimumab might have a role in treating Crohn’s disease. It also increased knowledge about the real-world effectiveness of vedolizumab. Lastly, the thesis underscored aspects of efficacy and safety when contrasting vedolizumab with anti-TNF.

Place, publisher, year, edition, pages
Örebro: Örebro University, 2024. p. 108
Series
Örebro Studies in Medicine, ISSN 1652-4063 ; 290
Keywords
ulcerative colitis, Crohn’s disease, anti-TNF, vedolizumab, comparative effectiveness, serious infections, inflammatory bowel disease, clinical aspects, register-based studies
National Category
General Practice
Identifiers
urn:nbn:se:oru:diva-111283 (URN)9789175295527 (ISBN)9789175295534 (ISBN)
Public defence
2024-04-26, Örebro universitet, Campus USÖ, Tidefeltsalen, Södra Grev Rosengatan 32, Örebro, 09:00 (English)
Opponent
Supervisors
Available from: 2024-02-01 Created: 2024-02-01 Last updated: 2024-04-30Bibliographically approved
Karlqvist, S., Sachs, M., Eriksson, C., Cao, Y., Montgomery, S., Ludvigsson, J. F., . . . Halfvarson, J. (2024). Comparative risk of serious infection with vedolizumab vs anti-TNF in Inflammatory Bowel Disease: Results from nationwide Swedish registers. Paper presented at 19th Congress of ECCO, Stockholm, Sweden, February 21-24, 2024. Journal of Crohn's & Colitis, 18(Suppl. 1), I1291-I1293, Article ID P680.
Open this publication in new window or tab >>Comparative risk of serious infection with vedolizumab vs anti-TNF in Inflammatory Bowel Disease: Results from nationwide Swedish registers
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2024 (English)In: Journal of Crohn's & Colitis, ISSN 1873-9946, E-ISSN 1876-4479, Vol. 18, no Suppl. 1, p. I1291-I1293, article id P680Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: The real-world comparative safety of vedolizumab in inflammatory bowel disease (IBD) remains uncertain. We aimed to assess the risk of serious infection in IBD patients treated with vedolizumab, compared to (i) those treated with anti-tumour necrosis factor (TNF) treatment and (ii) the general population.

Methods: In this nationwide cohort study, treatment episodes were identified from Swedish health registers (from 1 May 2014 – 31 December 2020). Patients were considered exposed from initiation of treatment until 90 days after discontinuation of treatment. We used Cox regression with propensity score-matched cohorts to estimate hazard ratios (HRs) for incident serious infection, defined as infection requiring hospital admission.

Results: After propensity score matching, the cohorts were not materially different at baseline with regard to demographic, disease and treatment characteristics (Table 1). During 1376 treatment-episodes in patients with Crohn’s disease, there were 5.18 (95%CI: 3.98-6.63) serious infections per 100 person-years (PY) with vedolizumab vs 3.54 (95%CI: 2.50-4.85) per 100 PY with anti-TNF; HR 1.72 (95%CI: 1.12-2.65; Figure 1A). When examining site-specific infections in Crohn’s disease, vedolizumab was associated with an HR of 2.47 (95% CI: 0.96-6.39) for serious gastrointestinal infections. Compared to the rate of 0.75 (95%CI: 0.59-0.92) serious infections per 100 PY in the general population, vedolizumab demonstrated an increased HR of 7.00 (95%CI: 5.04-9.72).

Across 1294 episodes among patients with ulcerative colitis there were 3.74 (95%CI: 2.66-5.11) serious infections per 100 PY with vedolizumab vs 3.42 (95%CI: 2.31-4.89) per 100 PY with anti-TNF, corresponding to HRs of 0.80 (95%CI: 0.47-1.36, Figure 1B) within the initial 1.1 years of treatment and 2.03 (95%CI: 0.65-6.32) after 1.1 years (follow-up truncated due to non-proportional hazards). In ulcerative colitis, there was no statistically significant association between vedolizumab treatment and any of the site-specific serious infections. Compared to the rate of 0.69 (95%CI: 0.53-0.87) serious infections per 100 PY in the general population, vedolizumab showed an increased HR of 5.45 (95%CI: 3.67-8.11).

Conclusion: Vedolizumab was associated with higher hazard ratios of serious infections compared to anti-TNF in Crohn’s disease, but not in ulcerative colitis. Nonetheless, in both IBD subtypes vedolizumab exhibited increased hazard ratios compared to the general population. These results underscore the importance of heightened clinical awareness of infections in vedolizumab-treated patients and may help clinicians understanding the optimal positioning of vedolizumab.

Place, publisher, year, edition, pages
Oxford University Press, 2024
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-113289 (URN)10.1093/ecco-jcc/jjad212.0810 (DOI)001189928901172 ()
Conference
19th Congress of ECCO, Stockholm, Sweden, February 21-24, 2024
Available from: 2024-04-19 Created: 2024-04-19 Last updated: 2025-02-11Bibliographically approved
Visuri, I., Eriksson, C., Karlqvist, S., Lykiardopoulos, B., Karlén, P., Grip, O., . . . Halfvarson, J. (2023). Long-term outcomes of vedolizumab in inflammatory bowel disease: the Swedish prospective multicentre SVEAH extension study. Therapeutic Advances in Gastroenterology, 16, Article ID 17562848231174953.
Open this publication in new window or tab >>Long-term outcomes of vedolizumab in inflammatory bowel disease: the Swedish prospective multicentre SVEAH extension study
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2023 (English)In: Therapeutic Advances in Gastroenterology, ISSN 1756-283X, E-ISSN 1756-2848, Vol. 16, article id 17562848231174953Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Real-world data on long-term outcomes of vedolizumab (VDZ) are scarce.

OBJECTIVE: To assess long-term outcomes (up to 3 years) of VDZ in treating inflammatory bowel disease (IBD).

DESIGN: A nationwide, prospective multicentre extension of a Swedish observational study on VDZ assessing Effectiveness And Healthcare resource utilization in patients with IBD (SVEAH).

METHODS: After re-consent, data of patients with Crohn's disease (CD) (n = 68) and ulcerative colitis (UC) (n = 46) treated with VDZ were prospectively recorded using an electronic case report form integrated with the Swedish IBD Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey-Bradshaw Index ⩽4 in CD and partial Mayo score ⩽2 in UC) at 104 and 156 weeks in patients with a response and/or remission 12 weeks after starting VDZ. Secondary outcomes included health-related quality of life (HRQoL) and biochemical outcomes.

RESULTS: VDZ continuation rates were high at weeks 104 and 156, 88% and 84%, respectively, for CD and 87% and 78%, respectively, for UC. Of the 53 CD patients with a response/remission at 12 weeks, 40 (75%) patients were in remission at 104 weeks and 42 (79%) patients at 156 weeks. For UC, these numbers were 25/31 (81%) and 22/31 (71%), respectively. Improvements were seen in the Short Health Scale (p < 0.01 for each dimension; CD, n = 51; UC, n = 33) and the EuroQol 5-Dimensions, 5-levels index value (p < 0.01; CD, n = 39; UC, n = 30). Median plasma-C-reactive protein concentrations (mg/L) decreased from 5 at baseline to 4 in CD (p = 0.01, n = 53) and from 5 to 4 in UC (p = 0.03, n = 34) at 156 weeks. Correspondingly, median faecal-calprotectin (µg/g) decreased from 641 to 114 in CD patients (p < 0.01, n = 26) and from 387 to 37 in UC patients (p = 0.02, n = 17).

CONCLUSION: VDZ demonstrated high continuation rates and was associated with improvements in clinical outcomes, HRQoL measures and inflammatory markers at 2 and 3 years after treatment initiation in this prospective national SVEAH extension study.

REGISTRATION: ENCePP registration number: EUPAS22735.

Place, publisher, year, edition, pages
Sage Publications, 2023
Keywords
Crohn’s disease, inflammatory bowel disease, real-world data, ulcerative colitis, vedolizumab
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-106367 (URN)10.1177/17562848231174953 (DOI)001005230800001 ()37274297 (PubMedID)2-s2.0-85161292810 (Scopus ID)
Note

Funding agencies:

Takeda Pharmaceutical Company Ltd EUPAS22735

Swedish government's agreement on medical training and research OLL-836791 OLL-934569 OLL-929900 OLL-960775

 

Available from: 2023-06-26 Created: 2023-06-26 Last updated: 2025-02-11Bibliographically approved
Eriksson, C., Söderling, J., Karlqvist, S., Bröms, G., Everhov, Å. H., Bergemalm, D., . . . Halfvarson, J. (2023). Ustekinumab Versus Anti-tumour Necrosis Factor Alpha Agents as Second-Line Biologics in Crohn's Disease. Digestive Diseases and Sciences, 68(7), 3119-3128
Open this publication in new window or tab >>Ustekinumab Versus Anti-tumour Necrosis Factor Alpha Agents as Second-Line Biologics in Crohn's Disease
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2023 (English)In: Digestive Diseases and Sciences, ISSN 0163-2116, E-ISSN 1573-2568, Vol. 68, no 7, p. 3119-3128Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: There are little data on positioning biologics in Crohn's disease (CD). AIMS: We aimed to assess the comparative effectiveness and safety of ustekinumab vs tumour necrosis factor-alpha (anti-TNF) agents after first-line treatment with anti-TNF in CD.

METHODS: We used Swedish nationwide registers to identify patients with CD, exposed to anti-TNF who initiated second-line biologic treatment with ustekinumab or second-line anti-TNF therapy. Nearest neighbour 1:1 propensity score matching (PSM) was used to balance the groups. The primary outcome was 3-year drug survival used as a proxy for effectiveness. Secondary outcomes included drug survival without hospital admission, CD-related surgery, antibiotics, hospitalization due to infection and exposure to corticosteroids.

RESULTS: Some 312 patients remained after PSM. Drug survival at 3 years was 35% (95% CI 26-44%) in ustekinumab compared to 36% (95% CI 28-44%) in anti-TNF-treated patients (p = 0.72). No statistically significant differences were observed between the groups in 3-year survival without hospital admission (72% vs 70%, p = 0.99), surgery (87% vs 92%, p = 0.17), hospital admission due to infection (92% vs 92%, p = 0.31) or prescription of antibiotics (49% vs 50%, p = 0.56). The proportion of patients continuing second-line biologic therapy did not differ by reason for ending first-line anti-TNF (lack of response vs intolerance) or by type of first-line anti-TNF (adalimumab vs infliximab).

CONCLUSION: Based on data from Swedish routine care, no clinically relevant differences in effectiveness or safety of second-line ustekinumab vs anti-TNF treatment were observed in patients with CD with prior exposure to anti-TNF.

Place, publisher, year, edition, pages
Springer-Verlag New York, 2023
Keywords
Anti-TNF, Comparative effectiveness, Comparative safety, Crohn’s disease, Population-based study, Ustekinumab
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-105110 (URN)10.1007/s10620-023-07897-2 (DOI)000952916200002 ()36929241 (PubMedID)2-s2.0-85150157990 (Scopus ID)
Funder
Örebro UniversityRegion Örebro County, OLL-836791Swedish Society of Medicine, SLS-789611Stockholm County Council, 20170720 20190638Karolinska Institute, 20170720 20190638Swedish Research Council, 2020-02002
Note

Funding agencies:

Johnson & Johnson USA Janssen Biotech Inc CNTO1275CRD0005

Stockholm Region Clinical Postdoctoral Researcher Grant

Strategic Research Area Epidemiology program at Karolinska Institutet

 

Available from: 2023-03-22 Created: 2023-03-22 Last updated: 2025-02-11Bibliographically approved
Rundquist, S., Sachs, M. C., Eriksson, C., Olén, O., Montgomery, S. & Halfvarson, J. (2021). Drug survival of anti-TNF agents compared with vedolizumab as a second-line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers. Alimentary Pharmacology and Therapeutics, 53(4), 471-483
Open this publication in new window or tab >>Drug survival of anti-TNF agents compared with vedolizumab as a second-line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers
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2021 (English)In: Alimentary Pharmacology and Therapeutics, ISSN 0269-2813, E-ISSN 1365-2036, Vol. 53, no 4, p. 471-483Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Comparisons of second-line anti-tumour necrosis factor (TNF) agents and vedolizumab are sparse.

AIM: To evaluate the effectiveness of anti-TNF agents compared to vedolizumab as second-line biologics in inflammatory bowel disease (IBD).

METHODS: A propensity score-matched cohort was created using Swedish nationwide registers. Patients with Crohn's disease or ulcerative colitis, exposed to first-line anti-TNF treatment, who initiated a second anti-TNF agent or vedolizumab in 2014-2016 (N = 1363) were included. The primary outcome was drug survival at 12 months. Secondarily, we assessed survival without IBD-related hospitalisation, IBD-related surgery, antibiotics, or hospitalisation because of infection, and also corticosteroid exposure.

RESULTS: After 1:1 propensity score matching, 400 patients (Crohn's disease, N = 198; ulcerative colitis, N = 202) remained. For Crohn's disease, drug survival was 73% in the vedolizumab group vs 74% in the anti-TNF group (difference: 1 percentage point; 95% confidence interval [CI]:-11-13; P = 0.87). Survival without IBD-related hospitalisation (82% vs 88%), surgery (82% vs 89%), antibiotics (65% vs 71%), hospitalisation due to infection (95% vs 88%) and corticosteroids (58% vs 48%) were not statistically significantly different between groups. For ulcerative colitis, drug survival was 69% in the vedolizumab group vs 62% in the anti-TNF group (difference: -7 percentage points; 95% CI: -20 to 6; P = 0.30). Vedolizumab-treated patients had lower survival without IBD-related hospitalisation (82% vs 93%, P = 0.02). Survival without colectomy (93% vs 97%), antibiotics (81% vs 70%), hospitalisation due to infection (92% vs 92%) and corticosteroids (58% vs 48%) were not statistically significantly different.

CONCLUSIONS: Based on Swedish clinical practice, the effectiveness and safety of second-line anti-TNF and vedolizumab at 12 months appeared largely similar.

Place, publisher, year, edition, pages
Blackwell Science Ltd., 2021
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-88172 (URN)10.1111/apt.16193 (DOI)000600055200001 ()33340426 (PubMedID)2-s2.0-85100804411 (Scopus ID)
Note

Funding Agency:

Takeda Pharma AB IISR-2017-101937

Available from: 2020-12-22 Created: 2020-12-22 Last updated: 2025-02-11Bibliographically approved
Rundquist, S., Sachs, M. C., Eriksson, C., Olén, O., Montgomery, S. & Halfvarson, J. (2021). Editorial: anti-TNF agents against vedolizumab as a second-line treatment? Not surprising tie game-authors' reply. Alimentary Pharmacology and Therapeutics, 53(5), 642-643
Open this publication in new window or tab >>Editorial: anti-TNF agents against vedolizumab as a second-line treatment? Not surprising tie game-authors' reply
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2021 (English)In: Alimentary Pharmacology and Therapeutics, ISSN 0269-2813, E-ISSN 1365-2036, Vol. 53, no 5, p. 642-643Article in journal, Editorial material (Refereed) Published
Place, publisher, year, edition, pages
Blackwell Science Ltd., 2021
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-89515 (URN)10.1111/apt.16241 (DOI)000616662800013 ()33566420 (PubMedID)2-s2.0-85100748822 (Scopus ID)
Available from: 2021-02-11 Created: 2021-02-11 Last updated: 2025-02-11Bibliographically approved
Rundquist, S., Sachs, M. C., Eriksson, C., Olén, O., Montgomery, S. & Halfvarson, J. (2021). Letter: vedolizumab or a second anti-TNF-no difference in efficacy for primary biologic failures with IBD. Authors' reply [Letter to the editor]. Alimentary Pharmacology and Therapeutics, 53(9), 1046-1047
Open this publication in new window or tab >>Letter: vedolizumab or a second anti-TNF-no difference in efficacy for primary biologic failures with IBD. Authors' reply
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2021 (English)In: Alimentary Pharmacology and Therapeutics, ISSN 0269-2813, E-ISSN 1365-2036, Vol. 53, no 9, p. 1046-1047Article in journal, Letter (Refereed) Published
Place, publisher, year, edition, pages
Blackwell Science Ltd., 2021
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-90998 (URN)10.1111/apt.16352 (DOI)000637878000012 ()33831234 (PubMedID)2-s2.0-85104045363 (Scopus ID)
Available from: 2021-04-14 Created: 2021-04-14 Last updated: 2025-02-11Bibliographically approved
Eriksson, C., Rundquist, S., Lykiardopoulos, V., Udumyan, R., Karlén, P., Grip, O., . . . Halfvarson, J. (2021). Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study. Therapeutic Advances in Gastroenterology, 14, Article ID 17562848211023386.
Open this publication in new window or tab >>Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study
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2021 (English)In: Therapeutic Advances in Gastroenterology, ISSN 1756-283X, E-ISSN 1756-2848, Vol. 14, article id 17562848211023386Article in journal (Refereed) Published
Abstract [en]

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD).

Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn's disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL).

Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn's disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn's disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn's disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn's disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn's disease and ulcerative colitis patients (p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52.

Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

Place, publisher, year, edition, pages
Sage Publications, 2021
Keywords
Crohn’s disease, inflammatory bowel disease, ulcerative colitis, vedolizumab
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-93482 (URN)10.1177/17562848211023386 (DOI)000687984600001 ()34276808 (PubMedID)2-s2.0-85109172373 (Scopus ID)
Note

Funding agency:

Takeda Pharmaceutical Company Ltd EUPAS22735

Available from: 2021-08-12 Created: 2021-08-12 Last updated: 2025-02-11Bibliographically approved
Rundquist, S., Sachs, M., Eriksson, C., Olén, O., Montgomery, S. & Halfvarson, J. (2020). Effectiveness of anti-TNF vs. vedolizumab as a second biologic in IBD: results from national Swedish registers. Journal of Crohn's & Colitis, 14(Suppl. 1), S317-S318
Open this publication in new window or tab >>Effectiveness of anti-TNF vs. vedolizumab as a second biologic in IBD: results from national Swedish registers
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2020 (English)In: Journal of Crohn's & Colitis, ISSN 1873-9946, E-ISSN 1876-4479, Vol. 14, no Suppl. 1, p. S317-S318Article in journal, Meeting abstract (Other academic) Published
Place, publisher, year, edition, pages
Oxford University Press, 2020
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-81139 (URN)10.1093/ecco-jcc/jjz203.456 (DOI)000518803401226 ()
Available from: 2020-04-14 Created: 2020-04-14 Last updated: 2025-02-11Bibliographically approved
Eriksson, C., Rundquist, S., Lykiardopoulos, V., Udumyan, R., Karlén, P., Grip, O., . . . Halfvarson, J. (2020). Real-world effectiveness of vedolizumab in ulcerative colitis: Week 52 results from the Swedish multi-centre, prospective, observational SVEAH UC study. Journal of Crohn's & Colitis, 14(Suppl. 1), S576-S577
Open this publication in new window or tab >>Real-world effectiveness of vedolizumab in ulcerative colitis: Week 52 results from the Swedish multi-centre, prospective, observational SVEAH UC study
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2020 (English)In: Journal of Crohn's & Colitis, ISSN 1873-9946, E-ISSN 1876-4479, Vol. 14, no Suppl. 1, p. S576-S577Article in journal, Meeting abstract (Other academic) Published
Place, publisher, year, edition, pages
Oxford University Press, 2020
National Category
Gastroenterology and Hepatology
Identifiers
urn:nbn:se:oru:diva-81134 (URN)10.1093/ecco-jcc/jjz203.842 (DOI)000518803403006 ()
Available from: 2020-04-14 Created: 2020-04-14 Last updated: 2025-02-11Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-4923-3169

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