Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study
Background: Since the late ‘90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice.Aim: To investigate the int...
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Frontiers Media S.A.
2020-08-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fmed.2020.00418/full |
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| author | Laixi Xue Laixi Xue K. van Bilsen K. van Bilsen M. W. J. Schreurs M. W. J. Schreurs M. E. J. van Velthoven M. E. J. van Velthoven T. O. Missotten T. O. Missotten A. A. H. J. Thiadens R. W. A. M. Kuijpers R. W. A. M. Kuijpers R. W. A. M. Kuijpers P. van Biezen P. van Biezen V. A. S. H. Dalm V. A. S. H. Dalm V. A. S. H. Dalm J. A. M. van Laar J. A. M. van Laar J. A. M. van Laar M. A. W. Hermans M. A. W. Hermans W. A. Dik W. A. Dik W. A. Dik P. L. A. van Daele P. L. A. van Daele P. L. A. van Daele P. M. van Hagen P. M. van Hagen P. M. van Hagen |
| author_facet | Laixi Xue Laixi Xue K. van Bilsen K. van Bilsen M. W. J. Schreurs M. W. J. Schreurs M. E. J. van Velthoven M. E. J. van Velthoven T. O. Missotten T. O. Missotten A. A. H. J. Thiadens R. W. A. M. Kuijpers R. W. A. M. Kuijpers R. W. A. M. Kuijpers P. van Biezen P. van Biezen V. A. S. H. Dalm V. A. S. H. Dalm V. A. S. H. Dalm J. A. M. van Laar J. A. M. van Laar J. A. M. van Laar M. A. W. Hermans M. A. W. Hermans W. A. Dik W. A. Dik W. A. Dik P. L. A. van Daele P. L. A. van Daele P. L. A. van Daele P. M. van Hagen P. M. van Hagen P. M. van Hagen |
| author_sort | Laixi Xue |
| collection | DOAJ |
| description | Background: Since the late ‘90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice.Aim: To investigate the interchangeability of Remicade® (originator infliximab) and its biosimilar Remsima® in patients with rare immune-mediated inflammatory diseases (IMIDs).Methods: This two-phased prospective open label observational study was designed to monitor the transition from Remicade® to Remsima® in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation.Results: Forty eight patients treated with Remicade® were switched to Remsima® in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n = 17), Behçet's disease (n = 12), non-infectious uveitis (n = 11), and other diagnoses (n = 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n = 7) or adverse events (n = 5) within 2 years; 10 of these patients discontinued Remsima® treatment, one withdrew from the study and one received additional corticosteroid therapy.Conclusions: We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade® to Remsima®. However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade® to Remsima®. The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening. |
| first_indexed | 2024-12-11T09:53:01Z |
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| id | doaj.art-e152d3e8b46f4c7a951758b552d87606 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-12-11T09:53:01Z |
| publishDate | 2020-08-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Medicine |
| spelling | doaj.art-e152d3e8b46f4c7a951758b552d876062022-12-22T01:12:21ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2020-08-01710.3389/fmed.2020.00418534828Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational StudyLaixi Xue0Laixi Xue1K. van Bilsen2K. van Bilsen3M. W. J. Schreurs4M. W. J. Schreurs5M. E. J. van Velthoven6M. E. J. van Velthoven7T. O. Missotten8T. O. Missotten9A. A. H. J. Thiadens10R. W. A. M. Kuijpers11R. W. A. M. Kuijpers12R. W. A. M. Kuijpers13P. van Biezen14P. van Biezen15V. A. S. H. Dalm16V. A. S. H. Dalm17V. A. S. H. Dalm18J. A. M. van Laar19J. A. M. van Laar20J. A. M. van Laar21M. A. W. Hermans22M. A. W. Hermans23W. A. Dik24W. A. Dik25W. A. Dik26P. L. A. van Daele27P. L. A. van Daele28P. L. A. van Daele29P. M. van Hagen30P. M. van Hagen31P. M. van Hagen32Internal Medicine, Erasmus University Rotterdam, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Spaarne Gasthuis Hospital, Haarlem, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Immunology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsThe Rotterdam Eye Hospital, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsThe Rotterdam Eye Hospital, Rotterdam, NetherlandsDepartment of Ophthalmology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsDepartment of Ophthalmology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsDepartment of Ophthalmology, Albert Schweitzer Hospital, Dordrecht, NetherlandsDepartment of Ophthalmology, University Hospital, Vrije Universiteit Brussel, Brussels, BelgiumAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Immunology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Immunology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Immunology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Immunology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsAcademic Center for Rare Immunological Diseases, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Internal Medicine, Division of Clinical Immunology, Erasmus MC, University Medical Center, Rotterdam, NetherlandsDepartment of Immunology, Erasmus MC, University Medical Centre, Rotterdam, NetherlandsBackground: Since the late ‘90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice.Aim: To investigate the interchangeability of Remicade® (originator infliximab) and its biosimilar Remsima® in patients with rare immune-mediated inflammatory diseases (IMIDs).Methods: This two-phased prospective open label observational study was designed to monitor the transition from Remicade® to Remsima® in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation.Results: Forty eight patients treated with Remicade® were switched to Remsima® in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n = 17), Behçet's disease (n = 12), non-infectious uveitis (n = 11), and other diagnoses (n = 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n = 7) or adverse events (n = 5) within 2 years; 10 of these patients discontinued Remsima® treatment, one withdrew from the study and one received additional corticosteroid therapy.Conclusions: We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade® to Remsima®. However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade® to Remsima®. The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening.https://www.frontiersin.org/article/10.3389/fmed.2020.00418/fullinfliximabRemicade®Remsima®CTP 13biosimilarrare or orphan immune-mediated inflammatory diseases (IMIDs) |
| spellingShingle | Laixi Xue Laixi Xue K. van Bilsen K. van Bilsen M. W. J. Schreurs M. W. J. Schreurs M. E. J. van Velthoven M. E. J. van Velthoven T. O. Missotten T. O. Missotten A. A. H. J. Thiadens R. W. A. M. Kuijpers R. W. A. M. Kuijpers R. W. A. M. Kuijpers P. van Biezen P. van Biezen V. A. S. H. Dalm V. A. S. H. Dalm V. A. S. H. Dalm J. A. M. van Laar J. A. M. van Laar J. A. M. van Laar M. A. W. Hermans M. A. W. Hermans W. A. Dik W. A. Dik W. A. Dik P. L. A. van Daele P. L. A. van Daele P. L. A. van Daele P. M. van Hagen P. M. van Hagen P. M. van Hagen Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study Frontiers in Medicine infliximab Remicade® Remsima® CTP 13 biosimilar rare or orphan immune-mediated inflammatory diseases (IMIDs) |
| title | Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study |
| title_full | Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study |
| title_fullStr | Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study |
| title_full_unstemmed | Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study |
| title_short | Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study |
| title_sort | are patients at risk for recurrent disease activity after switching from remicade r to remsima r an observational study |
| topic | infliximab Remicade® Remsima® CTP 13 biosimilar rare or orphan immune-mediated inflammatory diseases (IMIDs) |
| url | https://www.frontiersin.org/article/10.3389/fmed.2020.00418/full |
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