TY - JOUR
T1 - Capturing biologic treatment for IBD in the Swedish Prescribed Drug Register and the Swedish National Patient Register–a validation study
AU - Bröms, Gabriella
AU - Söderling, Jonas
AU - Sachs, Michael C.
AU - Halfvarson, Jonas
AU - Myrelid, Par
AU - Ludvigsson, Jonas F.
AU - Everhov, Åsa H.
AU - Olén, Ola
AU - SWIBREG Study Group
A2 - Hjortswang, Henrik
A2 - Björk, Jan
A2 - Grip, Olof
A2 - Andersson, Marie
N1 - 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.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - anti-TNF
KW - biologics
KW - Crohn’s disease
KW - IBD
KW - IBD unclassified
KW - ulcerative colitis
KW - validation
U2 - 10.1080/00365521.2021.1884894
DO - 10.1080/00365521.2021.1884894
M3 - Article
C2 - 33632044
AN - SCOPUS:85101634978
SN - 0036-5521
VL - 56
SP - 410
EP - 421
JO - Scandinavian Journal of Gastroenterology
JF - Scandinavian Journal of Gastroenterology
IS - 4
ER -