RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE
Therapy for systemic lupus erythematosus (SLE) remains challenging. The long-term use of glucocorticoids (GC) and cytostatics considerably improves life expectancy, but at the same time favors the development of irreversible organ damages. To evaluate the efficacy of belimumab (BLM), a biological ag...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
IMA PRESS LLC
2016-03-01
|
| Series: | Научно-практическая ревматология |
| Subjects: | |
| Online Access: | https://rsp.mediar-press.net/rsp/article/view/2166 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1839568403364315136 |
|---|---|
| author | E. A. Aseeva S. K. Soloviev A. A. Mesnyankina T. M. Reshetnyak N. E. Lopatina S. I. Glukhova E. L. Nasonov |
| author_facet | E. A. Aseeva S. K. Soloviev A. A. Mesnyankina T. M. Reshetnyak N. E. Lopatina S. I. Glukhova E. L. Nasonov |
| author_sort | E. A. Aseeva |
| collection | DOAJ |
| description | Therapy for systemic lupus erythematosus (SLE) remains challenging. The long-term use of glucocorticoids (GC) and cytostatics considerably improves life expectancy, but at the same time favors the development of irreversible organ damages. To evaluate the efficacy of belimumab (BLM), a biological agent, that blocks B-lymphocyte-stimulating factor registered for the treatment of active SLE, is an important task of the practice of rheumatology.Objective: to evaluate the efficacy and safety of BLM in patients with high and moderate SLE activity.Subjects and methods. The investigation enrolled 16 patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score of 6 to 19, who were positive for antinuclear factor (100%) and had low complement levels and high anti-native DNA antibodies (81%). BLM was used as monthly intravenous infusions at a dose of 10 mg/kg. The efficiency and safety of the therapy were evaluated monthly and 1 year after the initiation of treatment with BLM; SLE activity was estimated using SLEDAI-2K; a physician’s global assessment of disease activity on a visual analogue scale (VAS); anti-DNA antibody level changes, complement levels, a GC dose, damage index, and adverse events were determined.Results and discussion. BLM therapy proved to be effective in 62% of cases at 1 year after therapy initiation. At 1 month, SLE activity significantly decreased with SLEDAI-2K score diminishment from 9.31±3.21 to 6.25±2.80 in the entire group (p < 0.04). Over a month, the physician’s global assessment of disease activity significantly reduced from 19.25±6.60 to 13.68±3.97 mm (р<0.01) and reached minimum (8.28±6.87 mm) by 10 months of therapy. There was a significant decrease in anti-DNA antibodies and an increase in complement C4 level at 5 and 3 months of therapy, respectively. Six of the 10 patients who had received a complete cycle of BLM therapy achieved remission at 12 months. The dose of GC was significantly reduced at 6 months of therapy. Adverse events were rare. BLM was discontinued because of its inadequate efficacy in 4 patients.Conclusion. Twelve-month therapy with BLM is effective in patients with high and moderate SLE activity according to SLEDAI-2K and with high immunological activity. The use of BLM in SLE contributes to a GC dose reduction and fails to cause serious adverse events. |
| format | Article |
| id | doaj-art-b4f861faab294ba3a3d6ba52c1ca8da6 |
| institution | Matheson Library |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| publishDate | 2016-03-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj-art-b4f861faab294ba3a3d6ba52c1ca8da62025-08-04T17:03:56ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922016-03-01541313710.14412/1995-4484-2016-31-372045RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICEE. A. Aseeva0S. K. Soloviev1A. A. Mesnyankina2T. M. Reshetnyak3N. E. Lopatina4S. I. Glukhova5E. L. Nasonov6V.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of RheumatologyV.A. Nasonova Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University, Ministry of Health of RussiaTherapy for systemic lupus erythematosus (SLE) remains challenging. The long-term use of glucocorticoids (GC) and cytostatics considerably improves life expectancy, but at the same time favors the development of irreversible organ damages. To evaluate the efficacy of belimumab (BLM), a biological agent, that blocks B-lymphocyte-stimulating factor registered for the treatment of active SLE, is an important task of the practice of rheumatology.Objective: to evaluate the efficacy and safety of BLM in patients with high and moderate SLE activity.Subjects and methods. The investigation enrolled 16 patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score of 6 to 19, who were positive for antinuclear factor (100%) and had low complement levels and high anti-native DNA antibodies (81%). BLM was used as monthly intravenous infusions at a dose of 10 mg/kg. The efficiency and safety of the therapy were evaluated monthly and 1 year after the initiation of treatment with BLM; SLE activity was estimated using SLEDAI-2K; a physician’s global assessment of disease activity on a visual analogue scale (VAS); anti-DNA antibody level changes, complement levels, a GC dose, damage index, and adverse events were determined.Results and discussion. BLM therapy proved to be effective in 62% of cases at 1 year after therapy initiation. At 1 month, SLE activity significantly decreased with SLEDAI-2K score diminishment from 9.31±3.21 to 6.25±2.80 in the entire group (p < 0.04). Over a month, the physician’s global assessment of disease activity significantly reduced from 19.25±6.60 to 13.68±3.97 mm (р<0.01) and reached minimum (8.28±6.87 mm) by 10 months of therapy. There was a significant decrease in anti-DNA antibodies and an increase in complement C4 level at 5 and 3 months of therapy, respectively. Six of the 10 patients who had received a complete cycle of BLM therapy achieved remission at 12 months. The dose of GC was significantly reduced at 6 months of therapy. Adverse events were rare. BLM was discontinued because of its inadequate efficacy in 4 patients.Conclusion. Twelve-month therapy with BLM is effective in patients with high and moderate SLE activity according to SLEDAI-2K and with high immunological activity. The use of BLM in SLE contributes to a GC dose reduction and fails to cause serious adverse events.https://rsp.mediar-press.net/rsp/article/view/2166systemic lupus erythematosusbelimumabefficacysafety |
| spellingShingle | E. A. Aseeva S. K. Soloviev A. A. Mesnyankina T. M. Reshetnyak N. E. Lopatina S. I. Glukhova E. L. Nasonov RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE Научно-практическая ревматология systemic lupus erythematosus belimumab efficacy safety |
| title | RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE |
| title_full | RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE |
| title_fullStr | RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE |
| title_full_unstemmed | RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE |
| title_short | RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE |
| title_sort | results of an observational prospective study of the efficacy and safety of belimumab benlysta r in systemic lupus erythematosus in real clinical practice |
| topic | systemic lupus erythematosus belimumab efficacy safety |
| url | https://rsp.mediar-press.net/rsp/article/view/2166 |
| work_keys_str_mv | AT eaaseeva resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice AT sksoloviev resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice AT aamesnyankina resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice AT tmreshetnyak resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice AT nelopatina resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice AT siglukhova resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice AT elnasonov resultsofanobservationalprospectivestudyoftheefficacyandsafetyofbelimumabbenlystainsystemiclupuserythematosusinrealclinicalpractice |