Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study
Introduction Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a diverse clinical presentation that involves multiple organ systems and may lead to organ damage and increased risk of mortality. SLE is associated with a high burden of disease that can include loss of productivit...
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BMJ Publishing Group
2024-11-01
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| Series: | BMJ Open |
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| author | Marta Mosca Stephanie Chen Heide Stirnadel-Farrant Cathy Emmas Lucy Carty Caroline Seo Alessandro Sorrentino Cassandra Nekeman-Nan Samuel Chen Miina Waratani |
| author_facet | Marta Mosca Stephanie Chen Heide Stirnadel-Farrant Cathy Emmas Lucy Carty Caroline Seo Alessandro Sorrentino Cassandra Nekeman-Nan Samuel Chen Miina Waratani |
| author_sort | Marta Mosca |
| collection | DOAJ |
| description | Introduction Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a diverse clinical presentation that involves multiple organ systems and may lead to organ damage and increased risk of mortality. SLE is associated with a high burden of disease that can include loss of productivity and employment and reduced health-related quality of life. The current standard of care for SLE is primarily based on immunosuppression and glucocorticoids and is associated with risk of toxicities and poor tolerability. Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, was recently approved as a new treatment for patients with moderate-to-severe SLE.Methods and analysis Here, we report the study design of the ongoing, multinational Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) that includes 3-years of follow-up beginning with the first infusion of anifrolumab and 1 year of retrospective baseline data. ASTER aims to enrol 500 adult patients receiving anifrolumab for SLE in Europe and Canada. The key study objective is to describe the real-world effectiveness of anifrolumab in routine clinical practice, including clinician-reported disease activity and patient-reported outcomes collected via mobile application. This mobile application also includes a medication diary, where patients report their prescription and non-prescription medication use for SLE on a weekly basis; these data will lend insights on treatment patterns for the study population.Ethics and dissemination The design of the ASTER study was informed through consultations with patients with SLE who provided important insights to help maximise patient engagement, retention and the collection of key, patient-relevant endpoints. ASTER enrolment began in February 2023 and the study is expected to finish in 2029.Trial registration number NCT05637112. |
| format | Article |
| id | doaj-art-53cc07162f044e72ac199ef6a00dc6a8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-53cc07162f044e72ac199ef6a00dc6a82024-11-30T10:30:08ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-086055Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness studyMarta Mosca0Stephanie Chen1Heide Stirnadel-Farrant2Cathy Emmas3Lucy Carty4Caroline Seo5Alessandro Sorrentino6Cassandra Nekeman-Nan7Samuel Chen8Miina Waratani9Department of Clinical and Experimental Medicine, University of Pisa, Pisa, ItalyBioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, USAOncology Outcomes Research, Global Medical Affairs, AstraZeneca, Cambridge, UKRespiratory & Immunology Evidence, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UKBiostatistics, AstraZeneca, Cambridge, UKPatient Centered Science, BioPharmaceuticals Medical Evidence, AstraZeneca, Gaithersburg, Maryland, USAGlobal Medical Affairs, Respiratory & Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UKCVRM Evidence, BioPharmaceuticals Medical, AstraZeneca, Mölndal, SwedenEvidence Delivery, BioPharmaceuticals Medical, AstraZeneca, Mölndal, SwedenImmunology, AstraZeneca, Cambridge, UKIntroduction Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a diverse clinical presentation that involves multiple organ systems and may lead to organ damage and increased risk of mortality. SLE is associated with a high burden of disease that can include loss of productivity and employment and reduced health-related quality of life. The current standard of care for SLE is primarily based on immunosuppression and glucocorticoids and is associated with risk of toxicities and poor tolerability. Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, was recently approved as a new treatment for patients with moderate-to-severe SLE.Methods and analysis Here, we report the study design of the ongoing, multinational Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) that includes 3-years of follow-up beginning with the first infusion of anifrolumab and 1 year of retrospective baseline data. ASTER aims to enrol 500 adult patients receiving anifrolumab for SLE in Europe and Canada. The key study objective is to describe the real-world effectiveness of anifrolumab in routine clinical practice, including clinician-reported disease activity and patient-reported outcomes collected via mobile application. This mobile application also includes a medication diary, where patients report their prescription and non-prescription medication use for SLE on a weekly basis; these data will lend insights on treatment patterns for the study population.Ethics and dissemination The design of the ASTER study was informed through consultations with patients with SLE who provided important insights to help maximise patient engagement, retention and the collection of key, patient-relevant endpoints. ASTER enrolment began in February 2023 and the study is expected to finish in 2029.Trial registration number NCT05637112.https://bmjopen.bmj.com/content/14/11/e086055.full |
| spellingShingle | Marta Mosca Stephanie Chen Heide Stirnadel-Farrant Cathy Emmas Lucy Carty Caroline Seo Alessandro Sorrentino Cassandra Nekeman-Nan Samuel Chen Miina Waratani Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study BMJ Open |
| title | Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study |
| title_full | Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study |
| title_fullStr | Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study |
| title_full_unstemmed | Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study |
| title_short | Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study |
| title_sort | anifrolumab study for treatment effectiveness in the real world aster among patients with systemic lupus erythematosus protocol for an international observational effectiveness study |
| url | https://bmjopen.bmj.com/content/14/11/e086055.full |
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