Aim: To assess the efficacy of belimumab in joint and skin manifestations in a nationwide cohort of patients with SLE. Methods: All patients with skin and joint involvement enrolled in the BeRLiSS cohort were considered. Belimumab (intravenous, 10 mg/kg) effectiveness in joint and skin manifestations was assessed by DAS28 and CLASI, respectively. Attainment and predictors of DAS28 remission (<2.6) and LDA (≥2.6, ≤3.2), CLASI = 0, 1, and improvement in DAS28 and CLASI indices ≥20%, ≥50%, and ≥70% were evaluated at 6, 12, 24, and 36 months. Results: DAS28 < 2.6 was achieved by 46%, 57%, and 71% of patients at 6, 12, and 24 months, respectively. CLASI = 0 was achieved by 36%, 48%, and 62% of patients at 6, 12, and 24 months, respectively. Belimumab showed a glucocorticoid-sparing effect, being glucocorticoid-free at 8.5%, 15.4%, 25.6%, and 31.6% of patients at 6, 12, 24, and 36 months, respectively. Patients achieving DAS-LDA and CLASI-50 at 6 months had a higher probability of remission at 12 months compared with those who did not (p = 0.034 and p = 0.028, respectively). Conclusions: Belimumab led to clinical improvement in a significant proportion of patients with joint or skin involvement in a real-life setting and was associated with a glucocorticoid-sparing effect. A significant proportion of patients with a partial response at 6 months achieved remission later on during follow-up.

Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study-Joint and Skin (BeRLiSS-JS) / Zen, Margherita; Gatto, Mariele; Depascale, Roberto; Regola, Francesca; Fredi, Micaela; Andreoli, Laura; Franceschini, Franco; Urban, Maria Letizia; Emmi, Giacomo; Ceccarelli, Fulvia; Conti, Fabrizio; Bortoluzzi, Alessandra; Govoni, Marcello; Tani, Chiara; Mosca, Marta; Ubiali, Tania; Gerosa, Maria; Bozzolo, Enrica P; Canti, Valentina; Cardinaletti, Paolo; Gabrielli, Armando; Tanti, Giacomo; Gremese, Elisa; De Marchi, Ginevra; De Vita, Salvatore; Fasano, Serena; Ciccia, Francesco; Pazzola, Giulia; Salvarani, Carlo; Negrini, Simone; Di Matteo, Andrea; De Angelis, Rossella; Orsolini, Giovanni; Rossini, Maurizio; Faggioli, Paola; Laria, Antonella; Piga, Matteo; Cauli, Alberto; Scarpato, Salvatore; Rossi, Francesca Wanda; De Paulis, Amato; Brunetta, Enrico; Ceribelli, Angela; Selmi, Carlo; Prete, Marcella; Racanelli, Vito; Vacca, Angelo; Bartoloni, Elena; Gerli, Roberto; Zanatta, Elisabetta; Larosa, Maddalena; Saccon, Francesca; Doria, Andrea; Iaccarino, Luca. - In: JOURNAL OF PERSONALIZED MEDICINE. - ISSN 2075-4426. - 13:4(2023), p. 691. [10.3390/jpm13040691]

Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study-Joint and Skin (BeRLiSS-JS)

De Angelis, Rossella;Rossi, Francesca Wanda;De Paulis, Amato;
2023

Abstract

Aim: To assess the efficacy of belimumab in joint and skin manifestations in a nationwide cohort of patients with SLE. Methods: All patients with skin and joint involvement enrolled in the BeRLiSS cohort were considered. Belimumab (intravenous, 10 mg/kg) effectiveness in joint and skin manifestations was assessed by DAS28 and CLASI, respectively. Attainment and predictors of DAS28 remission (<2.6) and LDA (≥2.6, ≤3.2), CLASI = 0, 1, and improvement in DAS28 and CLASI indices ≥20%, ≥50%, and ≥70% were evaluated at 6, 12, 24, and 36 months. Results: DAS28 < 2.6 was achieved by 46%, 57%, and 71% of patients at 6, 12, and 24 months, respectively. CLASI = 0 was achieved by 36%, 48%, and 62% of patients at 6, 12, and 24 months, respectively. Belimumab showed a glucocorticoid-sparing effect, being glucocorticoid-free at 8.5%, 15.4%, 25.6%, and 31.6% of patients at 6, 12, 24, and 36 months, respectively. Patients achieving DAS-LDA and CLASI-50 at 6 months had a higher probability of remission at 12 months compared with those who did not (p = 0.034 and p = 0.028, respectively). Conclusions: Belimumab led to clinical improvement in a significant proportion of patients with joint or skin involvement in a real-life setting and was associated with a glucocorticoid-sparing effect. A significant proportion of patients with a partial response at 6 months achieved remission later on during follow-up.
2023
Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study-Joint and Skin (BeRLiSS-JS) / Zen, Margherita; Gatto, Mariele; Depascale, Roberto; Regola, Francesca; Fredi, Micaela; Andreoli, Laura; Franceschini, Franco; Urban, Maria Letizia; Emmi, Giacomo; Ceccarelli, Fulvia; Conti, Fabrizio; Bortoluzzi, Alessandra; Govoni, Marcello; Tani, Chiara; Mosca, Marta; Ubiali, Tania; Gerosa, Maria; Bozzolo, Enrica P; Canti, Valentina; Cardinaletti, Paolo; Gabrielli, Armando; Tanti, Giacomo; Gremese, Elisa; De Marchi, Ginevra; De Vita, Salvatore; Fasano, Serena; Ciccia, Francesco; Pazzola, Giulia; Salvarani, Carlo; Negrini, Simone; Di Matteo, Andrea; De Angelis, Rossella; Orsolini, Giovanni; Rossini, Maurizio; Faggioli, Paola; Laria, Antonella; Piga, Matteo; Cauli, Alberto; Scarpato, Salvatore; Rossi, Francesca Wanda; De Paulis, Amato; Brunetta, Enrico; Ceribelli, Angela; Selmi, Carlo; Prete, Marcella; Racanelli, Vito; Vacca, Angelo; Bartoloni, Elena; Gerli, Roberto; Zanatta, Elisabetta; Larosa, Maddalena; Saccon, Francesca; Doria, Andrea; Iaccarino, Luca. - In: JOURNAL OF PERSONALIZED MEDICINE. - ISSN 2075-4426. - 13:4(2023), p. 691. [10.3390/jpm13040691]
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