Taina Sipponen, Clas-Göran af Björkesten, Taru Hallinen, Tuire Ilus, Erkki Soini, Anja Eberl, Mikko Heikura, Mikko Kellokumpu, Ritva Koskela, Christian Nielsen, Heikki Nuutinen, Markku Heikkinen, Ulla-Maija Suhonen, Jyrki Tillonen, E. Christina M. Wennerström, Andras Borsi, Minni R. Koivunen & FINUSTE Study group (2021) A nationwide real-world study on dynamic ustekinumab dosing and concomitant medication use among Crohn’s disease patients in Finland, Scandinavian Journal of Gastroenterology, 56:6, 661-670, DOI: 10.1080/00365521.2021.1906315
A nationwide real-world study on dynamic ustekinumab dosing and concomitant medication use among Crohn’s disease patients in Finland
|Author:||Sipponen, Taina1; af Björkesten, Clas-Göran1; Hallinen, Taru2;|
1Gastroenterology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
2ESiOR Oy, Kuopio, Finland
3Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland
4Department of Gastroenterology, North Karelia Central Hospital, Joensuu, Finland
5Department of Internal Medicine, Lapland Central Hospital, Rovaniemi, Finland
6Department of Medicine, Division of Gastroenterology, Oulu University Hospital, Oulu, Finland
7Department of Internal Medicine, Vaasa Central Hospital, Vaasa, Finland
8Division of Gastroenterology, Department of Medicine, Turku University Hospital, Turku, Finland
9Department of Internal Medicine, Kuopio University Hospital, Kuopio, Finland
10Department of Internal Medicine, Kainuu Central Hospital, Kajaani, Finland
11Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland
12Medical Affairs, Janssen Cilag AB, Solna, Sweden
13Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark
14Janssen Cilag Limited, EMEA HEMAR, High Wycombe, United Kingdom
15Medical Affairs, Espoo, Finland
|Online Access:||PDF Full Text (PDF, 2 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2021090945660
|Publish Date:|| 2021-09-09
Background: Real-world evidence to support optimal ustekinumab dosing for refractory Crohn’s disease (CD) patients remains limited. Data from a retrospective nationwide chart review study was utilized to explore ustekinumab dosing dynamics and optimization, identify possible clinical predictors of dose intensification, and to evaluate ustekinumab trough concentrations (TCs) and concomitant medication use in Finland.
Methods: Information gathered from17 Finnish hospitals included clinical chart data from 155 adult CD patients who received intravenous ustekinumab induction during 2017–2018. Data on ustekinumab dosing and TCs, concomitant corticosteroid and immunosuppressant use, and antiustekinumab antibodies were analyzed in a two-year follow-up, subject to availability.
Results: Among 140 patients onustekinumab maintenance therapy, dose optimization was required in 55(39%) of the patients, and 41/47 dose-intensified patients (87%) persisted on ustekinumab. At baseline, dose-intensified patient group had significantly higher C-reactive protein (CRP) levels, and at week 16, significantly lower ustekinumab TCs than in patients without dose intensification. Irrespective of dose optimization, a statistically significant reduction in the use of corticosteroids was observed at both 16 weeks and one year, coupled with an increased proportion of patients on ustekinumab monotherapy. Antiustekinumab antibodies were undetectable in all 28 samples from 25 patients collected throughout the study period.
Conclusions: Nearly a third of all CD patients on ustekinumab maintenance therapy, with a history of treatment-refractory and long-standing disease, required dose intensification. These patients persisted on ustekinumab and had significant reduction of corticosteroid use. Increased baseline CRP was identified as the sole indicator of dose intensification.
Trial registration: EUPAS30920
Scandinavian journal of gastroenterology
|Pages:||661 - 670|
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3121 General medicine, internal medicine and other clinical medicine
This study was supported by Janssen-Cilag Oy (Finland).
© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.