Background: Belimumab is the unique biologic therapy available for patients with SLE. Objectives: To investigate effectiveness and safety of belimumab in SLE patients in clinical practice. Methods: 458 active SLE patients (ACR criteria) from 24 Italian Centers, mean±SD age 43.5±11.3 years; mean±SD disease duration 12.3±8.7 years, were treated with belimumab (10 mg/kg day 0, 14, 28 and then every 28 days), as add-on therapy. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24H proteinuria, CLASI, PGA, Fatigue (VAS 0-10) were recorded at baseline and every 6 months. Flares were defined according to SFI. Response was evaluated according to SRI-4. Statistics were performed by pairs Ttest, chi-square test and multiple logistic regression (SPSS, version 22.0). Results: Mean±SD follow-up was 21.2±15.3 months (range 3-60). Most common features treated with belimumab were articular in 67%, mucocutaneous in 55%, and renal in 17% of cases. Improvement of clinical and serological variables, including daily prednisone dosage, was observed (Table). SRI-4 is summarized in the Figure. At the end of follow-up 293 patients (66%) were still on belimumab. Most common cause of discontinuation were inadequate response (36%), AEs (31%), and pregnancy (8%). Mean number of flare during belimumab treatment compared with the corresponding period before belimumab initiation decreased (p<0.001). SLEDAI-2K 10 was an independent predictor of response by logistic regression at month 12 and 24 (p=0.003 and p=0.025). 9,998 infusions were analyzed. 784 AEs were observed in 330 patients, SAEs were 43 in 36 patients. No severe infusion reactions were observed; 16 patients had infective SAEs, and 22 non infective SAEs. Conclusion: We confirmed the effectiveness, the steroid sparing effect and good safety profile of belimumab in our cohort.

Effectiveness and safety of belimumab in patients with active systemic lupus erythematosus: results from a large, nationwide, multicentric study / Iaccarino, Luca; Saccon, Francesca; Mathieu, Alessandro; Piga, Matteo; Ceribelli, Angela; Selmi, Carlo; Cardinaletti, Paolo; Gabrielli, Armando; DI Matteo, Andrea; De Angelis, Rossella; Faggioli, Paola; Laria, Antonella; Fredi, Micaela; Regola, Francesca; Andreoli, Laura; Pazzola, Giulia; Salvarani, Carlo; Puppo, Francesco; Negrini, Simone; Prete, Marcella; Racanelli, Vito; Gremese, Elisa; Gerosa, Maria; Ubiali, Tania; Bozzolo, Enrica; Canti, Valentina; Conti, Fabrizio; Ceccarelli, Fulvia; Bartoloni Bocci, Elena; Gerli, Roberto; Lobasso, Antonio; De Paulis, Amato; De Marchi, Ginevra; De Vita, Salvatore; Bortoluzzi, Alessandra; Govoni, Marcello; Benvenuti, Francesco; Zen, Margherita; Mosca, Marta; Tani, Chiara; Rossini, Maurizio; Orsolini, Giovanni; Gatto, Mariele; Scarpato, Salvatore; Brunetta, Enrico; Zumbo, Aurora; Valentini, Gabriele; Fasano, Serena; Emmi, Giacomo; Letizia Urban, Maria; Tanti, Giacomo; Tincani, Angela; Doria, Andrea. - In: ANNALS OF THE RHEUMATIC DISEASES. THE EULAR JOURNAL. - ISSN 1792-328X. - 78:2(2019), pp. 778-779. (Intervento presentato al convegno EULAR tenutosi a --- nel ---) [10.1136/annrheumdis-2019-eular.3635].

Effectiveness and safety of belimumab in patients with active systemic lupus erythematosus: results from a large, nationwide, multicentric study

Vito Racanelli;
2019-01-01

Abstract

Background: Belimumab is the unique biologic therapy available for patients with SLE. Objectives: To investigate effectiveness and safety of belimumab in SLE patients in clinical practice. Methods: 458 active SLE patients (ACR criteria) from 24 Italian Centers, mean±SD age 43.5±11.3 years; mean±SD disease duration 12.3±8.7 years, were treated with belimumab (10 mg/kg day 0, 14, 28 and then every 28 days), as add-on therapy. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24H proteinuria, CLASI, PGA, Fatigue (VAS 0-10) were recorded at baseline and every 6 months. Flares were defined according to SFI. Response was evaluated according to SRI-4. Statistics were performed by pairs Ttest, chi-square test and multiple logistic regression (SPSS, version 22.0). Results: Mean±SD follow-up was 21.2±15.3 months (range 3-60). Most common features treated with belimumab were articular in 67%, mucocutaneous in 55%, and renal in 17% of cases. Improvement of clinical and serological variables, including daily prednisone dosage, was observed (Table). SRI-4 is summarized in the Figure. At the end of follow-up 293 patients (66%) were still on belimumab. Most common cause of discontinuation were inadequate response (36%), AEs (31%), and pregnancy (8%). Mean number of flare during belimumab treatment compared with the corresponding period before belimumab initiation decreased (p<0.001). SLEDAI-2K 10 was an independent predictor of response by logistic regression at month 12 and 24 (p=0.003 and p=0.025). 9,998 infusions were analyzed. 784 AEs were observed in 330 patients, SAEs were 43 in 36 patients. No severe infusion reactions were observed; 16 patients had infective SAEs, and 22 non infective SAEs. Conclusion: We confirmed the effectiveness, the steroid sparing effect and good safety profile of belimumab in our cohort.
2019
2019
Athènes CCM Middle East
Athènes CCM Middle East
Effectiveness and safety of belimumab in patients with active systemic lupus erythematosus: results from a large, nationwide, multicentric study / Iaccarino, Luca; Saccon, Francesca; Mathieu, Alessandro; Piga, Matteo; Ceribelli, Angela; Selmi, Carlo; Cardinaletti, Paolo; Gabrielli, Armando; DI Matteo, Andrea; De Angelis, Rossella; Faggioli, Paola; Laria, Antonella; Fredi, Micaela; Regola, Francesca; Andreoli, Laura; Pazzola, Giulia; Salvarani, Carlo; Puppo, Francesco; Negrini, Simone; Prete, Marcella; Racanelli, Vito; Gremese, Elisa; Gerosa, Maria; Ubiali, Tania; Bozzolo, Enrica; Canti, Valentina; Conti, Fabrizio; Ceccarelli, Fulvia; Bartoloni Bocci, Elena; Gerli, Roberto; Lobasso, Antonio; De Paulis, Amato; De Marchi, Ginevra; De Vita, Salvatore; Bortoluzzi, Alessandra; Govoni, Marcello; Benvenuti, Francesco; Zen, Margherita; Mosca, Marta; Tani, Chiara; Rossini, Maurizio; Orsolini, Giovanni; Gatto, Mariele; Scarpato, Salvatore; Brunetta, Enrico; Zumbo, Aurora; Valentini, Gabriele; Fasano, Serena; Emmi, Giacomo; Letizia Urban, Maria; Tanti, Giacomo; Tincani, Angela; Doria, Andrea. - In: ANNALS OF THE RHEUMATIC DISEASES. THE EULAR JOURNAL. - ISSN 1792-328X. - 78:2(2019), pp. 778-779. (Intervento presentato al convegno EULAR tenutosi a --- nel ---) [10.1136/annrheumdis-2019-eular.3635].
Iaccarino, Luca; Saccon, Francesca; Mathieu, Alessandro; Piga, Matteo; Ceribelli, Angela; Selmi, Carlo; Cardinaletti, Paolo; Gabrielli, Armando; DI Ma...espandi
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