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Capturing biologic treatment for IBD in the Swedish Prescribed Drug Register and the Swedish National Patient Register–a validation study

Bröms, Gabriella ; Söderling, Jonas ; Sachs, Michael C. ; Halfvarson, Jonas ; Myrelid, Par ; Ludvigsson, Jonas F. ; Everhov, Åsa H. and Olén, Ola (2021) In Scandinavian Journal of Gastroenterology 56(4). p.410-421
Abstract

Background: It is not known to what extent biologic treatment for IBD is captured in the Swedish Prescribed Drug Register (PDR) and the National Patient Register (NPR). Methods: A cross-sectional study from July 2005 until 2017, comparing data on biologic treatment in the PDR and the NPR with medical records. We assessed the proportion of started treatment episodes in the medical records that were found in the PDR/NPR ever, within +/− one year and within +/− three months; for any biologic drug, per specific drug (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), by calendar period (2005–2008, 2009–2012, and 2013–2017) and by study center. For adalimumab, we assessed the validity of end of treatment episodes. Results: Medical... (More)

Background: It is not known to what extent biologic treatment for IBD is captured in the Swedish Prescribed Drug Register (PDR) and the National Patient Register (NPR). Methods: A cross-sectional study from July 2005 until 2017, comparing data on biologic treatment in the PDR and the NPR with medical records. We assessed the proportion of started treatment episodes in the medical records that were found in the PDR/NPR ever, within +/− one year and within +/− three months; for any biologic drug, per specific drug (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), by calendar period (2005–2008, 2009–2012, and 2013–2017) and by study center. For adalimumab, we assessed the validity of end of treatment episodes. Results: Medical records of 1361 patients and 2323 treatment episodes with any biologic were reviewed and 80.1% (95% CI: 78.4–81.7) were ever captured in the PDR/NPR in. A time window of +/− one year or +/− three months reduced the sensitivity to 63.3% (95% CI: 61.3–65.3) and 52.6% (95% CI: 50.5–54.6), respectively. The sensitivity was high (>85%) for the prescribed injection drugs adalimumab, golimumab, and ustekinumab for all time windows and for adalimumab end of treatment, while considerably lower for the infusion drugs infliximab and vedolizumab. Conclusions: The PDR and the NPR are reliable data sources on treatment with injection biologics in patients with IBD in Sweden. Infliximab and vedolizumab are poorly captured, why PDR/NPR data should only be used after careful consideration of their limitations or complemented by other data sources, e.g., the disease-specific quality register SWIBREG.

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author
; ; ; ; ; ; and
contributor
Hjortswang, Henrik ; Björk, Jan ; LU and LU
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
anti-TNF, biologics, Crohn’s disease, IBD, IBD unclassified, ulcerative colitis, validation
in
Scandinavian Journal of Gastroenterology
volume
56
issue
4
pages
410 - 421
publisher
Taylor & Francis
external identifiers
  • scopus:85101634978
  • pmid:33632044
ISSN
0036-5521
DOI
10.1080/00365521.2021.1884894
language
English
LU publication?
yes
additional info
Funding Information: Dr. Halfvarson served as speaker and/or advisory board member for AbbVie, Celgene, Celltrion, Dr Falk Pharma and the Falk Foundation, Ferring, Hospira, Janssen, MEDA, Medivir, MSD, Novartis, Olink Proteomics, Pfizer, Prometheus Laboratories, Sandoz, Shire, Takeda, Thermo Fisher Scientific, Tillotts Pharma, Vifor Pharma, UCB and received grant support from Janssen, MSD and Takeda. Funding Information: The authors acknowledge the reviewers of medical records; Anna Fr?borg, Emelie M?rdberg, Helena K Ohlsson, Ida Holm, Johan Weiber, Johanna Engstr?m, Lars Becker, Natalia Mouratidou and Per Olsson. The authors also acknowledge Anders Jacobsson, statistician at the National Board of Health and Welfare for valuable input through personal communication. Collaborators as part of the SWIBREG study group Henrik Hjortswang Jan Bj?rk Olof Grip Martin Rejler Ulrika Lorentzon Fagerberg Caroline Nordenvall Hans Strid Michael Eberhardson Susanna J?ghult Marie Andersson Pontus Karling Malin Olsson Per Hellstr?m Jonas Bengtson Funding Information: Dr. Bröms has been involved in post-marketing pregnancy safety studies at Karolinska Institutet partly financed by Janssen and Pfizer. Funding Information: Dr. Everhov has participated in projects at Karolinska Institutet partly financed by investigator-initiated grants from Janssen and Ferring. Publisher Copyright: © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
id
0d53efb6-89c5-4683-9f53-cbd287d778fd
date added to LUP
2021-06-16 11:19:39
date last changed
2024-07-13 15:00:59
@article{0d53efb6-89c5-4683-9f53-cbd287d778fd,
  abstract     = {{<p>Background: It is not known to what extent biologic treatment for IBD is captured in the Swedish Prescribed Drug Register (PDR) and the National Patient Register (NPR). Methods: A cross-sectional study from July 2005 until 2017, comparing data on biologic treatment in the PDR and the NPR with medical records. We assessed the proportion of started treatment episodes in the medical records that were found in the PDR/NPR ever, within +/− one year and within +/− three months; for any biologic drug, per specific drug (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), by calendar period (2005–2008, 2009–2012, and 2013–2017) and by study center. For adalimumab, we assessed the validity of end of treatment episodes. Results: Medical records of 1361 patients and 2323 treatment episodes with any biologic were reviewed and 80.1% (95% CI: 78.4–81.7) were ever captured in the PDR/NPR in. A time window of +/− one year or +/− three months reduced the sensitivity to 63.3% (95% CI: 61.3–65.3) and 52.6% (95% CI: 50.5–54.6), respectively. The sensitivity was high (&gt;85%) for the prescribed injection drugs adalimumab, golimumab, and ustekinumab for all time windows and for adalimumab end of treatment, while considerably lower for the infusion drugs infliximab and vedolizumab. Conclusions: The PDR and the NPR are reliable data sources on treatment with injection biologics in patients with IBD in Sweden. Infliximab and vedolizumab are poorly captured, why PDR/NPR data should only be used after careful consideration of their limitations or complemented by other data sources, e.g., the disease-specific quality register SWIBREG.</p>}},
  author       = {{Bröms, Gabriella and Söderling, Jonas and Sachs, Michael C. and Halfvarson, Jonas and Myrelid, Par and Ludvigsson, Jonas F. and Everhov, Åsa H. and Olén, Ola}},
  issn         = {{0036-5521}},
  keywords     = {{anti-TNF; biologics; Crohn’s disease; IBD; IBD unclassified; ulcerative colitis; validation}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{410--421}},
  publisher    = {{Taylor & Francis}},
  series       = {{Scandinavian Journal of Gastroenterology}},
  title        = {{Capturing biologic treatment for IBD in the Swedish Prescribed Drug Register and the Swedish National Patient Register–a validation study}},
  url          = {{http://dx.doi.org/10.1080/00365521.2021.1884894}},
  doi          = {{10.1080/00365521.2021.1884894}},
  volume       = {{56}},
  year         = {{2021}},
}