Risk of Inflammatory Bowel Disease After Anti-CD20 Treatment in Multiple Sclerosis.
8 affiliations
- 1Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden.
- 2Department of Neurology, Danderyd Hospital, Stockholm, Sweden.
- 3Division of Clinical Epidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
- 4Sachs' Children and Youth Hospital, Stockholm South General Hospital, Stockholm, Sweden.
- 5Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
- 6Centre for Digestive Health, Department of Gastroenterology, Dermatovenereology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
- 7Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
- 8Sahlgrenska University Hospital, Department of Neurology, Region Västra Götaland, Gothenburg, Sweden.
Abstract
Importance
Anti-CD20 biologics are widely used as disease-modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS), but recent reports have raised concerns about an increased risk of inflammatory bowel disease (IBD) during treatment. This study aimed to assess treatment-associated IBD risk in individuals with RRMS.Objective
To compare the risk of new-onset IBD across different therapies for RRMS and relative to the general population.Design, setting, and participants
This was a population-based cohort study conducted in Sweden. Through the Swedish MS register, initiations of rituximab, natalizumab, dimethyl fumarate, and fingolimod were identified between January 1, 2011, and December 31, 2023, in individuals with RRMS aged 18 to 55 years with at least 10 years of lookback time (5 years for dispensed drugs) and no evidence of previous IBD. These initiations were matched with general population comparator episodes selected from the Swedish population.Exposures
Rituximab, comparator DMTs (natalizumab, dimethyl fumarate, fingolimod), or general population comparator.Main outcomes and measures
New-onset IBD, defined as 2 or more records on separate dates with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, codes K50 (Crohn disease), K51 (ulcerative colitis), and/or K52.3 (indeterminate colitis).Results
Among the 13 748 therapy episodes (6481 rituximab, 2976 natalizumab, 2767 dimethyl fumarate, 1524 fingolimod) in 9251 individuals (range in mean ages of the exposure groups, 35-38 years) and 61 065 matched general population episodes, 164 IBD events occurred during follow-up (40 with rituximab, 4 with comparator DMTs, and 120 in the general population). The crude incidence rate of IBD was 110 (95% CI, 76-147) per 100 000 person-years for rituximab, 13 (95% CI, 3-30) for the comparator DMTs, and 41 (95% CI, 34-48) for the general population. After adjustment for demographics and MS characteristics, the hazard ratio for the comparator DMTs vs rituximab was 0.10 (95% CI, 0.04-0.22). In the rituximab group, 62% of IBD events were classified as Crohn disease compared with 29% in the general population. The number needed to harm for rituximab vs the comparator DMTs was 131 (95% CI, 93-228) at 5 years, after full adjustment.Conclusions and relevance
Results of this cohort study show that rituximab was associated with an increased risk of IBD compared with other modern MS therapies, after adjustment for differences in characteristics at therapy start. Clinicians and individuals with MS should consider IBD risk in treatment decisions and remain vigilant for gastrointestinal symptoms during anti-CD20 therapy.
Related
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BibTeX
@article{kallin2026risk,
title = {{Risk of Inflammatory Bowel Disease After Anti-CD20 Treatment in Multiple Sclerosis.}},
author = {Sandra Kallin and Anders Svenningsson and Ola Olén and Charlotte Hedin and Jan Lycke and Peter Alping},
journal = {JAMA neurology},
year = {2026},
month = oct,
doi = {10.1001/jamaneurol.2026.3439},
url = {https://europepmc.org/article/MED/42911175},
note = {CC BY},
}
RIS
TY - JOUR
TI - Risk of Inflammatory Bowel Disease After Anti-CD20 Treatment in Multiple Sclerosis.
AU - Sandra Kallin
AU - Anders Svenningsson
AU - Ola Olén
AU - Charlotte Hedin
AU - Jan Lycke
AU - Peter Alping
PY - 2026
DA - 2026/10/22
JO - JAMA neurology
DO - 10.1001/jamaneurol.2026.3439
UR - https://europepmc.org/article/MED/42911175
AB - Importance Anti-CD20 biologics are widely used as disease-modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS), but recent reports have raised concerns about an increased risk of inflammatory bowel disease (IBD) during treatment. This study aimed to assess treatment-associated IBD risk in individuals with RRMS.Objective To compare the risk of new-onset IBD across different therapies for RRMS and relative to the general population.Design, setting, and participants This was a population-based cohort study conducted in Sweden. Through the Swedish MS register, initiations of rituximab, natalizumab, dimethyl fumarate, and fingolimod were identified between January 1, 2011, and December 31, 2023, in individuals with RRMS aged 18 to 55 years with at least 10 years of lookback time (5 years for dispensed drugs) and no evidence of previous IBD. These initiations were matched with general population comparator episodes selected from the Swedish population.Exposures Rituximab, comparator DMTs (natalizumab, dimethyl fumarate, fingolimod), or general population comparator.Main outcomes and measures New-onset IBD, defined as 2 or more records on separate dates with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, codes K50 (Crohn disease), K51 (ulcerative colitis), and/or K52.3 (indeterminate colitis).Results Among the 13 748 therapy episodes (6481 rituximab, 2976 natalizumab, 2767 dimethyl fumarate, 1524 fingolimod) in 9251 individuals (range in mean ages of the exposure groups, 35-38 years) and 61 065 matched general population episodes, 164 IBD events occurred during follow-up (40 with rituximab, 4 with comparator DMTs, and 120 in the general population). The crude incidence rate of IBD was 110 (95% CI, 76-147) per 100 000 person-years for rituximab, 13 (95% CI, 3-30) for the comparator DMTs, and 41 (95% CI, 34-48) for the general population. After adjustment for demographics and MS characteristics, the hazard ratio for the comparator DMTs vs rituximab was 0.10 (95% CI, 0.04-0.22). In the rituximab group, 62% of IBD events were classified as Crohn disease compared with 29% in the general population. The number needed to harm for rituximab vs the comparator DMTs was 131 (95% CI, 93-228) at 5 years, after full adjustment.Conclusions and relevance Results of this cohort study show that rituximab was associated with an increased risk of IBD compared with other modern MS therapies, after adjustment for differences in characteristics at therapy start. Clinicians and individuals with MS should consider IBD risk in treatment decisions and remain vigilant for gastrointestinal symptoms during anti-CD20 therapy.
SN - 2168-6149
SN - 2168-6157
ER -