Jonas Halfvarson1, Jonas F Ludvigsson2,3,4, Anders Forss5, Mark Clements2, Pär Myrelid6, Hans Strid7, Charlotte Söderman8, Agnieszka Wagner9, David Andersson10, Fredrik Hjelm11, Ola Olén12,13. 1. Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. 2. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, 171 77, Stockholm, Sweden. 3. Department of Paediatrics, Örebro University Hospital, Örebro, Sweden. 4. Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA. 5. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, 171 77, Stockholm, Sweden. anders.forss@ki.se. 6. Department of Biomedical and Clinical Sciences, Division of Surgery, Linköping University Hospital, Linköping University, Linköping, Sweden. 7. Department of Internal Medicine, Södra Älvsborg Hospital, Borås, Sweden. 8. Medical Department, Capio St Göran Hospital, Stockholm, Sweden. 9. Department of Internal Medicine, Blekinge Hospital, Karlskrona, Sweden. 10. Department of Internal Medicine, Danderyd University Hospital, Stockholm, Sweden. 11. Janssen Cilag AB, Solna, Sweden. 12. Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 13. Sachs' Children and Youth Hospital, Stockholm South General Hospital, Stockholm, Sweden.
Abstract
BACKGROUND: Prospectively and systematically collected long-term real-world clinical data on ustekinumab (anti-interleukin-12/23) are still scarce. AIMS: To assess the long-term effectiveness of ustekinumab in patients with active Crohn's disease (CD). METHODS: This is a prospective multicenter study of adult patients with CD initiating ustekinumab according to recommended doses at 20 Swedish hospitals. The primary outcome was clinical remission (Harvey-Bradshaw Index (HBI) ≤ 4 points) at weeks 52 and 104. Secondary outcomes included clinical response (≥ 3-point-decrease in HBI among patients with initial HBI ≥ 5 points), treatment retention, and biomarkers (C-reactive protein (CRP), hemoglobin, fecal-calprotectin) at weeks 52 and 104 compared to baseline. We also reported Health-related Quality of Life (HRQoL) measures. RESULTS: Of 114 included patients, 107 (94%) had previously failed ≥ 1 and 58 (51%) ≥ 2 anti-tumor necrosis factor agents. Forty (35%) had failed anti-integrin agents. Ustekinumab retention rates at weeks 52 and 104 were 70% (n = 80/114) and 61% (n = 69/114), respectively. Clinical response was seen in 36% (n = 25/69) and 29% (n = 20/69) of the patients, and remission was achieved in 32% (n = 31/96) and 29% (n = 28/96) at weeks 52 and 104, respectively. Median HBI and CRP levels decreased significantly at both timepoints as compared to baseline. Significant improvements were also observed in HRQoL. Adverse events were reported in 11% (n = 13/114) of the patients, including five cases of severe adverse events. No malignancies were observed. CONCLUSIONS: In this nationwide prospective real-world 104-week-follow-up study of adult patients with active CD, ustekinumab was associated with long-term clinical effectiveness and improvement in HRQoL measures when used in routine clinical care.
BACKGROUND: Prospectively and systematically collected long-term real-world clinical data on ustekinumab (anti-interleukin-12/23) are still scarce. AIMS: To assess the long-term effectiveness of ustekinumab in patients with active Crohn's disease (CD). METHODS: This is a prospective multicenter study of adult patients with CD initiating ustekinumab according to recommended doses at 20 Swedish hospitals. The primary outcome was clinical remission (Harvey-Bradshaw Index (HBI) ≤ 4 points) at weeks 52 and 104. Secondary outcomes included clinical response (≥ 3-point-decrease in HBI among patients with initial HBI ≥ 5 points), treatment retention, and biomarkers (C-reactive protein (CRP), hemoglobin, fecal-calprotectin) at weeks 52 and 104 compared to baseline. We also reported Health-related Quality of Life (HRQoL) measures. RESULTS: Of 114 included patients, 107 (94%) had previously failed ≥ 1 and 58 (51%) ≥ 2 anti-tumor necrosis factor agents. Forty (35%) had failed anti-integrin agents. Ustekinumab retention rates at weeks 52 and 104 were 70% (n = 80/114) and 61% (n = 69/114), respectively. Clinical response was seen in 36% (n = 25/69) and 29% (n = 20/69) of the patients, and remission was achieved in 32% (n = 31/96) and 29% (n = 28/96) at weeks 52 and 104, respectively. Median HBI and CRP levels decreased significantly at both timepoints as compared to baseline. Significant improvements were also observed in HRQoL. Adverse events were reported in 11% (n = 13/114) of the patients, including five cases of severe adverse events. No malignancies were observed. CONCLUSIONS: In this nationwide prospective real-world 104-week-follow-up study of adult patients with active CD, ustekinumab was associated with long-term clinical effectiveness and improvement in HRQoL measures when used in routine clinical care.
Authors: Marisa Iborra; Belén Beltrán; Agnes Fernández-Clotet; Eva Iglesias-Flores; Pablo Navarro; Montserrat Rivero; Ana Gutiérrez; Mónica Sierra-Ausin; Francisco Mesonero; Rocío Ferreiro-Iglesias; Joaquín Hinojosa; Xavier Calvet; Beatriz Sicilia; Carlos González-Muñoza; Beatriz Antolín; María González-Vivo; Ana Y Carbajo; Santiago García-López; Albert Martín-Cardona; Gerard Surís; María Dolores Martin-Arranz; Ruth de Francisco; Fiorella Cañete; Eugeni Domènech; Pilar Nos Journal: Aliment Pharmacol Ther Date: 2020-08-08 Impact factor: 8.171