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      An Australian Real-World Study of Treatment Persistence of Ustekinumab in Crohn’s Disease

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          Abstract

          Introduction

          Real-world treatment persistence to ustekinumab for Crohn’s disease (CD) was studied using Australian Pharmaceutical Benefits Scheme (PBS) data. Demographic and treatment pattern characteristics were also investigated.

          Methods

          Our retrospective cohort analysis included PBS 10% sample data for ustekinumab from September 2017 to March 2020, and for other biologics from October 2007 to capture earlier line(s) of therapy. Included patients received ustekinumab for CD prescribed by a gastroenterologist. Treatment persistence overall and by prior biologic experience, mono- or combination therapy, sex and age were estimated using Kaplan–Meier methods. A Cox proportional hazards regression analysis was performed to assess the effect of age, sex and line of therapy on persistence.

          Results

          Data were available for 301 patients. Of these, 58.8% were female and 76.7% were aged 26–65 years. Median follow-up from first ustekinumab dispense was 16 months. Median persistence to ustekinumab had not been reached. Twelve-month persistence to ustekinumab was 82.6% (95% CI 78.1–87.5%). Patients receiving ustekinumab as their first biologic therapy had 12-month persistence of 88.0% (80.8–95.9%) compared to 80.6% (75.0–86.6%) for patients who had previously received other biologic therapies (p=0.059). The adjusted analysis showed a trend to longer persistence for patients receiving ustekinumab as their first biologic therapy compared to biologic experienced patients (HR 1.86 (95% CI 0.95–3.63), p=0.070). Males had higher persistence to ustekinumab than females (HR 0.36 (0.20–0.66), p<0.001). Receiving ustekinumab as a monotherapy or in combination with azathioprine, mercaptopurine, 5ASAs, methotrexate, or corticosteroids had no effect on persistence (p=0.22).

          Conclusion

          In an Australian real-world setting, persistence to ustekinumab was demonstrated to be over 80% at 12 months. Use as monotherapy or in combination with other therapy for CD did not affect persistence. Differences in treatment persistence by gender and previous biologic use warrant further investigation as further long-term data becomes available.

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          Most cited references19

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          British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

          Ulcerative colitis and Crohn’s disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn’s and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn’s disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn’s disease, including patients, their families and friends.
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            ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment

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              The Australian Pharmaceutical Benefits Scheme data collection: a practical guide for researchers

              Background The Pharmaceutical Benefits Scheme (PBS) is Australia’s national drug subsidy program. This paper provides a practical guide to researchers using PBS data to examine prescribed medicine use. Findings Excerpts of the PBS data collection are available in a variety of formats. We describe the core components of four publicly available extracts (the Australian Statistics on Medicines, PBS statistics online, section 85 extract, under co-payment extract). We also detail common analytical challenges and key issues regarding the interpretation of utilisation using the PBS collection and its various extracts. Conclusions Research using routinely collected data is increasing internationally. PBS data are a valuable resource for Australian pharmacoepidemiological and pharmaceutical policy research. A detailed knowledge of the PBS, the nuances of data capture, and the extracts available for research purposes are necessary to ensure robust methodology, interpretation, and translation of study findings into policy and practice.
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                Author and article information

                Journal
                Biologics
                Biologics
                btt
                btt
                Biologics : Targets & Therapy
                Dove
                1177-5475
                1177-5491
                16 June 2021
                2021
                : 15
                : 237-245
                Affiliations
                [1 ]Janssen-Cilag Pty Ltd , Sydney, NSW, Australia
                [2 ]Prospection Pty Ltd , Sydney, NSW, Australia
                Author notes
                Correspondence: Tzu Hsiang Chien Janssen Australia and New Zealand (Janssen-Cilag Pty Ltd) , 66 Waterloo Road, Macquarie Park, NSW, 2113, AustraliaTel +61 (0)400 919 282 Email tchien1@ITS.JNJ.com
                Author information
                http://orcid.org/0000-0002-7730-6310
                http://orcid.org/0000-0001-7221-6423
                Article
                310076
                10.2147/BTT.S310076
                8215905
                34163137
                3fdfc674-2a87-496f-a0c2-58f1398c87d4
                © 2021 Chien et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 08 March 2021
                : 31 May 2021
                Page count
                Figures: 4, Tables: 4, References: 20, Pages: 9
                Funding
                Funded by: Janssen-Cilag Pty Ltd;
                This study was funded by Janssen-Cilag Pty Ltd, the manufacturer of ustekinumab.
                Categories
                Original Research

                Molecular medicine
                persistence,durability,real-world data,crohn’s disease,ustekinumab
                Molecular medicine
                persistence, durability, real-world data, crohn’s disease, ustekinumab

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