Taina Sipponen1, Clas-Göran Af Björkesten1, Taru Hallinen2, Tuire Ilus3, Erkki Soini2, Anja Eberl1, Mikko Heikura4, Mikko Kellokumpu5, Ritva Koskela6, Christian Nielsen7, Heikki Nuutinen8, Markku Heikkinen9, Ulla-Maija Suhonen10, Jyrki Tillonen11, E Christina M Wennerström12,13, Andras Borsi14, Minni R Koivunen15. 1. Gastroenterology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. 2. ESiOR Oy, Kuopio, Finland. 3. Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland. 4. Department of Gastroenterology, North Karelia Central Hospital, Joensuu, Finland. 5. Department of Internal Medicine, Lapland Central Hospital, Rovaniemi, Finland. 6. Department of Medicine, Division of Gastroenterology, Oulu University Hospital, Oulu, Finland. 7. Department of Internal Medicine, Vaasa Central Hospital, Vaasa, Finland. 8. Division of Gastroenterology, Department of Medicine, Turku University Hospital, Turku, Finland. 9. Department of Internal Medicine, Kuopio University Hospital, Kuopio, Finland. 10. Department of Internal Medicine, Kainuu Central Hospital, Kajaani, Finland. 11. Department of Internal Medicine, Päijät-Häme Central Hospital, Lahti, Finland. 12. Medical Affairs, Janssen Cilag AB, Solna, Sweden. 13. Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark. 14. Janssen Cilag Limited, EMEA HEMAR, High Wycombe, United Kingdom. 15. Medical Affairs, Espoo, Finland.
Abstract
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.
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.