Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review
IntroductionOff-label rituximab is commonly used for patients with systemic lupus erythematosus (SLE) with extrarenal disease activity.MethodsThe outcomes and tolerability of rituximab in adult patients with non-renal SLE treated at our hospital from 2013 to 2020 were described. Patients were follow...
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Frontiers Media S.A.
2023-05-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1159794/full |
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| author | Carla Sans-Pola Carla Sans-Pola Carla Sans-Pola Immaculada Danés Immaculada Danés Immaculada Danés Josep Àngel Bosch Patricia Marrero-Álvarez Josefina Cortés Antònia Agustí Antònia Agustí Antònia Agustí |
| author_facet | Carla Sans-Pola Carla Sans-Pola Carla Sans-Pola Immaculada Danés Immaculada Danés Immaculada Danés Josep Àngel Bosch Patricia Marrero-Álvarez Josefina Cortés Antònia Agustí Antònia Agustí Antònia Agustí |
| author_sort | Carla Sans-Pola |
| collection | DOAJ |
| description | IntroductionOff-label rituximab is commonly used for patients with systemic lupus erythematosus (SLE) with extrarenal disease activity.MethodsThe outcomes and tolerability of rituximab in adult patients with non-renal SLE treated at our hospital from 2013 to 2020 were described. Patients were followed-up until December 2021. Data were retrieved from electronic medical records. Response was classified into complete, partial or no response according to the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2 K)-based definitions.ResultsA total of 44 cycles were administered to 33 patients. Median age was 45 years and 97% were female. Median follow-up was 5.9 years (IQR 3.7–7.2). The most frequent symptoms that motivated rituximab use were thrombocytopenia (30.3%), arthritis (30.3%), neurological manifestations (24.2%) and cutaneous lupus (15.2%). After most treatment cycles a partial remission was achieved. The median SLEDAI-2 K score declined from 9 (IQR 5–13) to 1.5 (IQR 0–4) (p < 0.00001). The median number of flares significantly declined after receiving rituximab. Platelet counts significantly improved in patients with thrombocytopenia and patients with skin disorders or neurological manifestations also had a partial or complete response. Only 50% of patients with a predominant joint involvement had either a complete or a partial response. The median time to relapse after the first cycle was 1.6 years (95% CI, 0.6–3.1). Anti-dsDNA levels decreased significantly after rituximab from a median of 64.3 (IQR 12–373.9) to 32.7 (IQR 10–173), p = 0.00338. The most frequent adverse events were infusion-related reactions (18.2%) and infections (57.6%). All patients needed further treatment to maintain remission or to treat new flares.ConclusionA partial or complete response was documented after most rituximab cycles in patients with non-renal SLE. Patients with thrombocytopenia, neurolupus, and cutaneous lupus had better response than those with a predominant joint involvement. |
| first_indexed | 2024-03-13T09:39:19Z |
| format | Article |
| id | doaj.art-30692b39933c45e0bd29b2dd3809c082 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-13T09:39:19Z |
| publishDate | 2023-05-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Medicine |
| spelling | doaj.art-30692b39933c45e0bd29b2dd3809c0822023-05-25T04:45:46ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-05-011010.3389/fmed.2023.11597941159794Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature reviewCarla Sans-Pola0Carla Sans-Pola1Carla Sans-Pola2Immaculada Danés3Immaculada Danés4Immaculada Danés5Josep Àngel Bosch6Patricia Marrero-Álvarez7Josefina Cortés8Antònia Agustí9Antònia Agustí10Antònia Agustí11Department of Clinical Pharmacology, Vall d’Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, SpainClinical Pharmacology Research Group, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Hospital Universitari, Barcelona, SpainDepartment of Clinical Pharmacology, Vall d’Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, SpainClinical Pharmacology Research Group, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Hospital Universitari, Barcelona, SpainDepartment of Internal Medicine, Universitat Autònoma de Barcelona, Bellaterra, SpainPharmacy Department, Vall d’Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Internal Medicine, Vall d’Hebron Hospital Universitari, Barcelona Hospital Campus, Barcelona, SpainDepartment of Clinical Pharmacology, Vall d’Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, SpainClinical Pharmacology Research Group, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Hospital Universitari, Barcelona, SpainIntroductionOff-label rituximab is commonly used for patients with systemic lupus erythematosus (SLE) with extrarenal disease activity.MethodsThe outcomes and tolerability of rituximab in adult patients with non-renal SLE treated at our hospital from 2013 to 2020 were described. Patients were followed-up until December 2021. Data were retrieved from electronic medical records. Response was classified into complete, partial or no response according to the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2 K)-based definitions.ResultsA total of 44 cycles were administered to 33 patients. Median age was 45 years and 97% were female. Median follow-up was 5.9 years (IQR 3.7–7.2). The most frequent symptoms that motivated rituximab use were thrombocytopenia (30.3%), arthritis (30.3%), neurological manifestations (24.2%) and cutaneous lupus (15.2%). After most treatment cycles a partial remission was achieved. The median SLEDAI-2 K score declined from 9 (IQR 5–13) to 1.5 (IQR 0–4) (p < 0.00001). The median number of flares significantly declined after receiving rituximab. Platelet counts significantly improved in patients with thrombocytopenia and patients with skin disorders or neurological manifestations also had a partial or complete response. Only 50% of patients with a predominant joint involvement had either a complete or a partial response. The median time to relapse after the first cycle was 1.6 years (95% CI, 0.6–3.1). Anti-dsDNA levels decreased significantly after rituximab from a median of 64.3 (IQR 12–373.9) to 32.7 (IQR 10–173), p = 0.00338. The most frequent adverse events were infusion-related reactions (18.2%) and infections (57.6%). All patients needed further treatment to maintain remission or to treat new flares.ConclusionA partial or complete response was documented after most rituximab cycles in patients with non-renal SLE. Patients with thrombocytopenia, neurolupus, and cutaneous lupus had better response than those with a predominant joint involvement.https://www.frontiersin.org/articles/10.3389/fmed.2023.1159794/fullrituximaboff-labelsystemic erythematosus lupusCD20effectiveness |
| spellingShingle | Carla Sans-Pola Carla Sans-Pola Carla Sans-Pola Immaculada Danés Immaculada Danés Immaculada Danés Josep Àngel Bosch Patricia Marrero-Álvarez Josefina Cortés Antònia Agustí Antònia Agustí Antònia Agustí Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review Frontiers in Medicine rituximab off-label systemic erythematosus lupus CD20 effectiveness |
| title | Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review |
| title_full | Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review |
| title_fullStr | Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review |
| title_full_unstemmed | Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review |
| title_short | Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: a retrospective study and literature review |
| title_sort | off label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity a retrospective study and literature review |
| topic | rituximab off-label systemic erythematosus lupus CD20 effectiveness |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1159794/full |
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