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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.
Rationale and background:
Tofacitinib, an inhibitor of the Janus kinase (JAK) family of kinases, was approved in the European Union (EU) in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Malignancy excluding non-melanoma skin cancer (NMSC) is an important potential risk and venous thromboembolism (VTE) is an important identified risk associated with the use of tofacitinib, and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events, as well as other potential safety events of interest, that may be associated with tofacitinib treatment. Pfizer will implement a post approval, active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform.
Research question:
What are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care, as compared to the incidence rates in patients with UC treated with other approved systemic agents, and patients with UC naïve to biologics and immunomodulators/immunosuppressants (hereafter referred to as immunosuppressants)?
Study design:
This is an active cohort study of adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
Variables:
The study variables include baseline patient characteristics (i.e., clinical and demographic characteristics, comorbidities, and current and past therapies), the primary outcomes of interest, and other safety events of interest.
Data sources:UR-CARE will be used as the only data source.
Study size:
This study is descriptive, and all eligible patients in UR-CARE registry during the study period who have consented to participate in the study will be included, with no upper limit on the sample size.
Data analysis:
All statistical analysis will be performed by GETECCU using SAS software v9.4, SAS Institute Inc, Cary, NC, USA. Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Tofacitinib cohort): | Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025 | ||
| Cohort 2 (Biologics cohort): |
| ||
| Cohort 3 (Immunosuppressants cohort): |
| ||
| Cohort 4 (Naïve cohort): |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Malignancy excluding non-melanoma skin cancer (NMSC) | Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE]) | deep venous thrombosis [DVT] and pulmonary embolism [PE]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Non melanoma skin cancer (NMSC) | Non melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva MarÃa RodrÃguez | Contact | +34 691 08 42 07 | secretariacientifica1@geteccu.org | |
| Manuel MD Barreiro, PhD | Contact | manubarreiro@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manuel MD Barreiro, PhD | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda General Hospital | Recruiting | Bonheiden | 28202 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23604131 | Background | Burisch J, Pedersen N, Cukovic-Cavka S, Brinar M, Kaimakliotis I, Duricova D, Shonova O, Vind I, Avnstrom S, Thorsgaard N, Andersen V, Krabbe S, Dahlerup JF, Salupere R, Nielsen KR, Olsen J, Manninen P, Collin P, Tsianos EV, Katsanos KH, Ladefoged K, Lakatos L, Bjornsson E, Ragnarsson G, Bailey Y, Odes S, Schwartz D, Martinato M, Lupinacci G, Milla M, De Padova A, D'Inca R, Beltrami M, Kupcinskas L, Kiudelis G, Turcan S, Tighineanu O, Mihu I, Magro F, Barros LF, Goldis A, Lazar D, Belousova E, Nikulina I, Hernandez V, Martinez-Ares D, Almer S, Zhulina Y, Halfvarson J, Arebi N, Sebastian S, Lakatos PL, Langholz E, Munkholm P; EpiCom-group. East-West gradient in the incidence of inflammatory bowel disease in Europe: the ECCO-EpiCom inception cohort. Gut. 2014 Apr;63(4):588-97. doi: 10.1136/gutjnl-2013-304636. Epub 2013 Apr 20. | |
| 23491313 |
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| from 01 July 2018 through to 31 March 2025 |
| Lung cancer | Lung cancer. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Lymphoma | Lymphoma (including 3 main subtypes Hodgkin's lymphoma, non-Hodgkin's lymphoma, and chronic lymphocytic lymphoma). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Serious infections | Serious infections. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Opportunistic infections (e.g., tuberculosis) | Opportunistic infections (e.g., tuberculosis). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Herpes zoster(HZ) | Herpes zoster(HZ). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Major adverse cardiac events (MACE) | Major adverse cardiac events (MACE) | from 01 July 2018 through to 31 March 2025 |
| Myocardial infarction (MI) | Myocardial infarction (MI). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Progressive multifocal leukoencephalopathy (PML) | Progressive multifocal leukoencephalopathy (PML). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Gastrointestinal (GI) perforations | Gastrointestinal (GI) perforations. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| Fractures | Fractures. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| All-cause mortality | All-cause mortality | from 01 July 2018 through to 31 March 2025 |
| surgery for Ulcerative colitis (UC) | surgery for Ulcerative colitis (UC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event. | from 01 July 2018 through to 31 March 2025 |
| AZ Delta vzw | Recruiting | Roeselare | 8800 | Belgium |
|
| Acibadem City Clinic Tokuda University Hospital | Recruiting | Sofia | 1407 | Bulgaria |
|
| General Hospital of Athens "Evangelismos" | Recruiting | Ellinikó | Attica | 16777 | Greece |
|
| Lithuanian University of Life Sciences | Not yet recruiting | Kaunas | 44307 | Lithuania |
|
| Background |
| Sjoberg D, Holmstrom T, Larsson M, Nielsen AL, Holmquist L, Ekbom A, Ronnblom A. Incidence and natural history of ulcerative colitis in the Uppsala Region of Sweden 2005-2009 - results from the IBD cohort of the Uppsala Region (ICURE). J Crohns Colitis. 2013 Oct;7(9):e351-7. doi: 10.1016/j.crohns.2013.02.006. Epub 2013 Mar 9. |
| 22001864 | Background | Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14. |
| 24127738 | Background | Busch K, Ludvigsson JF, Ekstrom-Smedby K, Ekbom A, Askling J, Neovius M. Nationwide prevalence of inflammatory bowel disease in Sweden: a population-based register study. Aliment Pharmacol Ther. 2014 Jan;39(1):57-68. doi: 10.1111/apt.12528. Epub 2013 Oct 16. |
| Background | The Committee for Medicinal Products for Human Use. Guideline on the development of new medicinal products for the treatment of ulcerative colitis. CHMP/EWP/18463/2006 Revision 1. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf |
| 30639677 | Background | Coward S, Clement F, Benchimol EI, Bernstein CN, Avina-Zubieta JA, Bitton A, Carroll MW, Hazlewood G, Jacobson K, Jelinski S, Deardon R, Jones JL, Kuenzig ME, Leddin D, McBrien KA, Murthy SK, Nguyen GC, Otley AR, Panaccione R, Rezaie A, Rosenfeld G, Pena-Sanchez JN, Singh H, Targownik LE, Kaplan GG. Past and Future Burden of Inflammatory Bowel Diseases Based on Modeling of Population-Based Data. Gastroenterology. 2019 Apr;156(5):1345-1353.e4. doi: 10.1053/j.gastro.2019.01.002. Epub 2019 Jan 10. |
| 27787492 | Background | Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3. |
| 29102619 | Background | Everhov AH, Halfvarson J, Myrelid P, Sachs MC, Nordenvall C, Soderling J, Ekbom A, Neovius M, Ludvigsson JF, Askling J, Olen O. Incidence and Treatment of Patients Diagnosed With Inflammatory Bowel Diseases at 60 Years or Older in Sweden. Gastroenterology. 2018 Feb;154(3):518-528.e15. doi: 10.1053/j.gastro.2017.10.034. Epub 2017 Nov 2. |
| Background | Khalili, H., Söderling, J., Everhov, Å. H., et al. 15 - Health Care Use, Work Loss, and Total Costs in Incident and Prevelant Ulcerative Colitis: Results from a Nationwide Study in Sweden. Gastroenterology 2018, 154(Supplement 1), S-5-5. http://doi.org/10.1016/S0016-5085(18)30504-3 |
| 22894574 | Background | Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168. |
| 16530532 | Background | Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006 Mar;130(3):940-87. doi: 10.1053/j.gastro.2006.01.048. No abstract available. |
| 26135040 | Background | McAuliffe ME, Lanes S, Leach T, Parikh A, Faich G, Porter J, Holick C, Esposito D, Zhao Y, Fox I. Occurrence of adverse events among patients with inflammatory bowel disease in the HealthCore Integrated Research Database. Curr Med Res Opin. 2015;31(9):1655-64. doi: 10.1185/03007995.2015.1065242. Epub 2015 Aug 20. |
| 30929112 | Background | Ludvigsson JF, Svedberg P, Olen O, Bruze G, Neovius M. The longitudinal integrated database for health insurance and labour market studies (LISA) and its use in medical research. Eur J Epidemiol. 2019 Apr;34(4):423-437. doi: 10.1007/s10654-019-00511-8. Epub 2019 Mar 30. |
| 31219157 | Background | Biemans VBC, van der Meulen-de Jong AE, van der Woude CJ, Lowenberg M, Dijkstra G, Oldenburg B, de Boer NKH, van der Marel S, Bodelier AGL, Jansen JM, Haans JJL, Theeuwen R, de Jong D, Pierik MJ, Hoentjen F. Ustekinumab for Crohn's Disease: Results of the ICC Registry, a Nationwide Prospective Observational Cohort Study. J Crohns Colitis. 2020 Jan 1;14(1):33-45. doi: 10.1093/ecco-jcc/jjz119. |
| 32674882 | Background | Zabana Y, Panes J, Nos P, Gomollon F, Esteve M, Garcia-Sanchez V, Gisbert JP, Barreiro-de-Acosta M, Domenech E; en representacion de GETECCU. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol. 2020 Nov;43(9):551-558. doi: 10.1016/j.gastrohep.2020.05.007. Epub 2020 Jul 14. English, Spanish. |
| 32563061 | Background | Murthy SK, Robertson McCurdy AB, Carrier M, McCurdy JD. Venous thromboembolic events in inflammatory bowel diseases: A review of current evidence and guidance on risk in the post-hospitalization setting. Thromb Res. 2020 Oct;194:26-32. doi: 10.1016/j.thromres.2020.06.005. Epub 2020 Jun 3. |
| 22020901 | Background | Curtis JR, Chen SY, Werther W, John A, Johnson DA. Validation of ICD-9-CM codes to identify gastrointestinal perforation events in administrative claims data among hospitalized rheumatoid arthritis patients. Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1150-8. doi: 10.1002/pds.2215. Epub 2011 Aug 27. |
| Background | Brooke, H. L., Holzmann, M. J., Olen, O., et al. Enhancing evidence-based medicine: Twelve tips for conducting register-based research. MedEdPublish 2016; 5(2). http://doi.org/10.15694/mep.2016.000071 |
| 11241255 | Background | Bernstein CN, Blanchard JF, Kliewer E, Wajda A. Cancer risk in patients with inflammatory bowel disease: a population-based study. Cancer. 2001 Feb 15;91(4):854-62. doi: 10.1002/1097-0142(20010215)91:43.0.co;2-z. |
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| 27170593 | Background | van den Heuvel TR, Wintjens DS, Jeuring SF, Wassink MH, Romberg-Camps MJ, Oostenbrug LE, Sanduleanu S, Hameeteman WH, Zeegers MP, Masclee AA, Jonkers DM, Pierik MJ. Inflammatory bowel disease, cancer and medication: Cancer risk in the Dutch population-based IBDSL cohort. Int J Cancer. 2016 Sep 15;139(6):1270-80. doi: 10.1002/ijc.30183. Epub 2016 May 31. |
| 24685910 | Background | Mercer LK, Lunt M, Low AL, Dixon WG, Watson KD, Symmons DP, Hyrich KL; BSRBR Control Centre Consortium. Risk of solid cancer in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Ann Rheum Dis. 2015 Jun;74(6):1087-93. doi: 10.1136/annrheumdis-2013-204851. Epub 2014 Mar 31. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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