Zev Sthoeger1, Margalit Lorber2, Yuval Tal3, Elias Toubi4, Howard Amital5, Shaye Kivity6, Pnina Langevitz6, Ilan Asher1, Daniel Elbirt1, Nancy Agmon Levin7. 1. Department of Internal Medicine B and Clinical Immunology, Allergy and Neve-Or AIDS Center, Kaplan Medical Center, Rehovot, Israel. 2. Allergy and Clinical Immunology Unit, Rambam Medical Center, Haifa, Israel. 3. Allergy and Clinical Immunology Unit, Hadassah Medical Center, Jerusalem, Israel. 4. Allergy and Clinical Immunology Unit, Bnei-Zion Medical Center, Haifa, Israel. 5. Department of Internal Medicine B, Sheba Medical Center, Tel Hashomer, Israel. 6. Department of Rheumatology, Sheba Medical Center, Tel Hashomer, Israel. 7. Department of Allergy and Clinical Immunology Unit, Sheba Medical Center, Tel Hashomer, Israel.
Abstract
BACKGROUND: Anti-BLyS treatment with the human belimumab monoclonal antibody was shown to be a safe and effective therapeutic modality in lupus patients with active disease (i.e., without significant neurological/renal involvement) despite standard treatment. OBJECTIVES: To evaluate the "real-life" safety and efficacy of belimumab added to standard therapy in patents with active lupus in five Israeli medical centers. METHODS: We conducted a retrospective open-labeled study of 36 lupus patients who received belimumab monthly for at least 1 year in addition to standard treatment. Laboratory tests (C3/C4, anti dsDNA autoantibodies, chemistry, urinalysis and complete blood count) were done every 3-4 months. Adverse events were obtained from patients' medical records. Efficacy assessment by the treating physicians was defined as excellent, good/partial, or no response. RESULTS: The study group comprised 36 lupus patients (8 males, 28 females) with a mean age of 41.6 } 12.2 years. Belimumab was given for a mean period of 2.3 } 1.7 years (range 1-7). None of the patients discontinued belimumab due to adverse events. Four patients (11.1%) had an infection related to belimumab. Only 5 patients (13.9%) stopped taking belimumab due to lack of efficacy. The response was excellent in 25 patients (69.5%) and good/partial in the other 6 (16.6%). Concomitantly, serological response (reduction of C3/C4 and anti-dsDNA autoantibodies) was also observed. Moreover, following belimumab treatment, there was a significant reduction in the usage of corticosteroids (from 100% to 27.7%) and immunosuppressive agents (from 83.3% to 8.3%). CONCLUSIONS: Belimumab, in addition to standard therapy, is a safe and effective treatment for active lupus patients.
BACKGROUND: Anti-BLyS treatment with the humanbelimumab monoclonal antibody was shown to be a safe and effective therapeutic modality in lupuspatients with active disease (i.e., without significant neurological/renal involvement) despite standard treatment. OBJECTIVES: To evaluate the "real-life" safety and efficacy of belimumab added to standard therapy in patents with active lupus in five Israeli medical centers. METHODS: We conducted a retrospective open-labeled study of 36 lupuspatients who received belimumab monthly for at least 1 year in addition to standard treatment. Laboratory tests (C3/C4, anti dsDNA autoantibodies, chemistry, urinalysis and complete blood count) were done every 3-4 months. Adverse events were obtained from patients' medical records. Efficacy assessment by the treating physicians was defined as excellent, good/partial, or no response. RESULTS: The study group comprised 36 lupuspatients (8 males, 28 females) with a mean age of 41.6 } 12.2 years. Belimumab was given for a mean period of 2.3 } 1.7 years (range 1-7). None of the patients discontinued belimumab due to adverse events. Four patients (11.1%) had an infection related to belimumab. Only 5 patients (13.9%) stopped taking belimumab due to lack of efficacy. The response was excellent in 25 patients (69.5%) and good/partial in the other 6 (16.6%). Concomitantly, serological response (reduction of C3/C4 and anti-dsDNA autoantibodies) was also observed. Moreover, following belimumab treatment, there was a significant reduction in the usage of corticosteroids (from 100% to 27.7%) and immunosuppressive agents (from 83.3% to 8.3%). CONCLUSIONS:Belimumab, in addition to standard therapy, is a safe and effective treatment for active lupuspatients.
Authors: Christopher F Bell; Julie Priest; Marni Stott-Miller; Hong Kan; Justyna Amelio; Xue Song; Brendan Limone; Virginia Noxon; Karen H Costenbader Journal: Lupus Sci Med Date: 2020-03-26