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. 2023 Apr 20;13(4):691.
doi: 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)

Margherita Zen  1 , Mariele Gatto  1 , Roberto Depascale  1 , Francesca Regola  2 , Micaela Fredi  2 , Laura Andreoli  2 , Franco Franceschini  2 , Maria Letizia Urban  3 , Giacomo Emmi  3 , Fulvia Ceccarelli  4 , Fabrizio Conti  4 , Alessandra Bortoluzzi  5 , Marcello Govoni  5 , Chiara Tani  6 , Marta Mosca  6 , Tania Ubiali  7 , Maria Gerosa  7 , Enrica P Bozzolo  8 , Valentina Canti  8 , Paolo Cardinaletti  9 , Armando Gabrielli  9 , Giacomo Tanti  10 , Elisa Gremese  10   11 , Ginevra De Marchi  12 , Salvatore De Vita  12 , Serena Fasano  13 , Francesco Ciccia  13 , Giulia Pazzola  14 , Carlo Salvarani  14   15 , Simone Negrini  16 , Andrea Di Matteo  17 , Rossella De Angelis  17 , Giovanni Orsolini  18 , Maurizio Rossini  18 , Paola Faggioli  19 , Antonella Laria  20 , Matteo Piga  21 , Alberto Cauli  21 , Salvatore Scarpato  22 , Francesca Wanda Rossi  23 , Amato De Paulis  23 , Enrico Brunetta  24 , Angela Ceribelli  25   26 , Carlo Selmi  25   26 , Marcella Prete  27 , Vito Racanelli  27 , Angelo Vacca  27 , Elena Bartoloni  28 , Roberto Gerli  28 , Elisabetta Zanatta  1 , Maddalena Larosa  1 , Francesca Saccon  1 , Andrea Doria  1 , Luca Iaccarino  1
Affiliations

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)

Margherita Zen et al. J Pers Med. .

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.

Keywords: Cutaneous LE Area and Severity Index (CLASI); belimumab; disease activity score (DAS)-28; low disease activity; remission; systemic lupus erythematosus.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(A) DAS28 and glucocorticoid intake during the follow-up in patients with joint involvement at different timepoints. (B) CLASI and glucocorticoid intake during the follow-up in patients with skin involvement at different timepoints.
Figure 2
Figure 2
DAS28-20, DAS28-50, DAS28-70, DAS28 remission, and DAS20 LDA in SLE patients on belimumab at different timepoints.
Figure 3
Figure 3
CLASI-20, CLASI-50, CLASI-70, and CLASI remission in SLE patients treated with belimumab at different timepoints.
Figure 4
Figure 4
Trends in daily dose PDN intake during belimumab treatment in patients with joint and skin manifestations at different timepoints.
See this image and copyright information in PMC

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