Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus

The aim – evaluation of the efficacy and safety of anifrolumab (AFM) therapy in patients with severe and moderate systemic lupus erythematosus (SLE) in real clinical practice.Material and methods. A prospective observational study (6 months) involving 14 patients with SLE (13 women and 1 man; mean a...

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Main Authors: E. V. Bolotova, E. V. Jakovleva, E. K. Ilinykh, Т. A. Rassovskaya
Format: Article
Language:Russian
Published: IMA PRESS LLC 2025-03-01
Series:Научно-практическая ревматология
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Online Access:https://rsp.mediar-press.net/rsp/article/view/3698
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author E. V. Bolotova
E. V. Jakovleva
E. K. Ilinykh
Т. A. Rassovskaya
author_facet E. V. Bolotova
E. V. Jakovleva
E. K. Ilinykh
Т. A. Rassovskaya
author_sort E. V. Bolotova
collection DOAJ
description The aim – evaluation of the efficacy and safety of anifrolumab (AFM) therapy in patients with severe and moderate systemic lupus erythematosus (SLE) in real clinical practice.Material and methods. A prospective observational study (6 months) involving 14 patients with SLE (13 women and 1 man; mean age 37.5±14 years) treated in the rheumatology department of the Research Institute – Krasnodar Regional Clinical Hospital named after Professor S.V. Ochapovsky. All patients included in the study were prescribed anifrolumab (Safnelo) 300 mg parenterally once every 4 weeks.Results. Already after 3 months, regression of skin rashes was noted in all patients according to the CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) 10.0 [4.0; 11.0] vs 2.0 [2.0; 4.0] (p=0.013). Against the background of AFM therapy, relief of articular syndrome was noted in 90% of patients in the form of a decrease in the number of painful joints 1.5 (0.0; 10.0) vs 0.5 (0.0; 4.0) (p=0.041). Three months after the start of AFM therapy, a decrease in the SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index 2000) activity index was registered in all patients. Its median decreased from 8.0 [6.0; 8.0] to 5.0 [4.0; 7.0] (p=0.007), and after 6 months – to 2.0 [0.0; 6.0] (p=0.005). Six months after the initiation of AFM therapy, 2 (16%) patients managed to achieve a decrease in SLEDAI-2K to 0, which corresponds to the indicators of clinical and laboratory remission of SLE. The criteria for low LLDAS (Lupus Low Disease Activity State) activity after 6 months of therapy were met by 8 (66%) out of 12 patients. Against the background of AFM therapy, positive dynamics of immunological activity was noted after 3 months – a decrease in the level of anti-dsDNA by 37%, the titer of ANF by 33%. Positive dynamics of hematological syndrome was observed against the background of AFM therapy. By the 3rd month of therapy, the proportion of patients with leukopenia less than 4×109/l decreased from 21% to 0%, with lymphopenia less than 1×109/l from 21% to 16%, with thrombocytopenia less than 100×109/l from 8% to 0%, with hemolytic anemia from 8% to 0%. According to the LupusQol questionnaire, which assesses the quality of life associated with the disease, positive dynamics were recorded on all scales 6 months after the start of AFM treatment. Addition of AFM to standard therapy allowed to reduce the dose of glucocorticosteroids by 33% after 3 months from initiation and by 50% after 6 months.Conclusions. Anifrolumab is a highly effective drug for the treatment of patients with severe and moderate systemic lupus erythematosus, has a favorable tolerability and safety profile.
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spelling doaj-art-bc7531e0e0ac4862bc4cc3cab0e549312025-08-20T03:59:31ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922025-03-01631646910.47360/1995-4484-2025-64-693045Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosusE. V. Bolotova0E. V. Jakovleva1E. K. Ilinykh2Т. A. Rassovskaya3Kuban State Medical UniversityResearch Institute – Krasnodar Regional Clinical Hospital named after Professor S.V. OchapovskyResearch Institute – Krasnodar Regional Clinical Hospital named after Professor S.V. OchapovskyResearch Institute – Krasnodar Regional Clinical Hospital named after Professor S.V. OchapovskyThe aim – evaluation of the efficacy and safety of anifrolumab (AFM) therapy in patients with severe and moderate systemic lupus erythematosus (SLE) in real clinical practice.Material and methods. A prospective observational study (6 months) involving 14 patients with SLE (13 women and 1 man; mean age 37.5±14 years) treated in the rheumatology department of the Research Institute – Krasnodar Regional Clinical Hospital named after Professor S.V. Ochapovsky. All patients included in the study were prescribed anifrolumab (Safnelo) 300 mg parenterally once every 4 weeks.Results. Already after 3 months, regression of skin rashes was noted in all patients according to the CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) 10.0 [4.0; 11.0] vs 2.0 [2.0; 4.0] (p=0.013). Against the background of AFM therapy, relief of articular syndrome was noted in 90% of patients in the form of a decrease in the number of painful joints 1.5 (0.0; 10.0) vs 0.5 (0.0; 4.0) (p=0.041). Three months after the start of AFM therapy, a decrease in the SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index 2000) activity index was registered in all patients. Its median decreased from 8.0 [6.0; 8.0] to 5.0 [4.0; 7.0] (p=0.007), and after 6 months – to 2.0 [0.0; 6.0] (p=0.005). Six months after the initiation of AFM therapy, 2 (16%) patients managed to achieve a decrease in SLEDAI-2K to 0, which corresponds to the indicators of clinical and laboratory remission of SLE. The criteria for low LLDAS (Lupus Low Disease Activity State) activity after 6 months of therapy were met by 8 (66%) out of 12 patients. Against the background of AFM therapy, positive dynamics of immunological activity was noted after 3 months – a decrease in the level of anti-dsDNA by 37%, the titer of ANF by 33%. Positive dynamics of hematological syndrome was observed against the background of AFM therapy. By the 3rd month of therapy, the proportion of patients with leukopenia less than 4×109/l decreased from 21% to 0%, with lymphopenia less than 1×109/l from 21% to 16%, with thrombocytopenia less than 100×109/l from 8% to 0%, with hemolytic anemia from 8% to 0%. According to the LupusQol questionnaire, which assesses the quality of life associated with the disease, positive dynamics were recorded on all scales 6 months after the start of AFM treatment. Addition of AFM to standard therapy allowed to reduce the dose of glucocorticosteroids by 33% after 3 months from initiation and by 50% after 6 months.Conclusions. Anifrolumab is a highly effective drug for the treatment of patients with severe and moderate systemic lupus erythematosus, has a favorable tolerability and safety profile.https://rsp.mediar-press.net/rsp/article/view/3698systemic lupus erythematosusanifrolumab (safnelo)interferon receptor type i inhibitorgenetically engineered biological drug
spellingShingle E. V. Bolotova
E. V. Jakovleva
E. K. Ilinykh
Т. A. Rassovskaya
Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus
Научно-практическая ревматология
systemic lupus erythematosus
anifrolumab (safnelo)
interferon receptor type i inhibitor
genetically engineered biological drug
title Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus
title_full Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus
title_fullStr Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus
title_full_unstemmed Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus
title_short Experience of using Anifrolumab in the treatment of patients with systemic lupus erythematosus
title_sort experience of using anifrolumab in the treatment of patients with systemic lupus erythematosus
topic systemic lupus erythematosus
anifrolumab (safnelo)
interferon receptor type i inhibitor
genetically engineered biological drug
url https://rsp.mediar-press.net/rsp/article/view/3698
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AT evjakovleva experienceofusinganifrolumabinthetreatmentofpatientswithsystemiclupuserythematosus
AT ekilinykh experienceofusinganifrolumabinthetreatmentofpatientswithsystemiclupuserythematosus
AT tarassovskaya experienceofusinganifrolumabinthetreatmentofpatientswithsystemiclupuserythematosus