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Multicenter Study
. 2020 Aug;72(8):1314-1324.
doi: 10.1002/art.41253. Epub 2020 Jun 12.

Early Disease and Low Baseline Damage as Predictors of Response to Belimumab in Patients With Systemic Lupus Erythematosus in a Real-Life Setting

Mariele Gatto  1 , Francesca Saccon  1 , Margherita Zen  1 , Francesca Regola  2 , Micaela Fredi  2 , Laura Andreoli  2 , Angela Tincani  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 Bozzolo  8 , Valentina Canti  8 , Paolo Cardinaletti  9 , Armando Gabrielli  9 , Giacomo Tanti  10 , Elisa Gremese  11 , Ginevra De Marchi  12 , Salvatore De Vita  12 , Serena Fasano  13 , Francesco Ciccia  13 , Giulia Pazzola  14 , Carlo Salvarani  15 , Simone Negrini  16 , Francesco Puppo  16 , Andrea Di Matteo  9 , Rossella De Angelis  9 , Giovanni Orsolini  17 , Maurizio Rossini  17 , Paola Faggioli  18 , Antonella Laria  18 , Matteo Piga  19 , Alessandro Mathieu  19 , Salvatore Scarpato  20 , Francesca W Rossi  21 , Amato de Paulis  21 , Enrico Brunetta  22 , Angela Ceribelli  23 , Carlo Selmi  24 , Marcella Prete  25 , Vito Racanelli  25 , Angelo Vacca  25 , Elena Bartoloni  26 , Roberto Gerli  26 , Maddalena Larosa  1 , Luca Iaccarino  1 , Andrea Doria  1
Affiliations
Free article
Multicenter Study

Early Disease and Low Baseline Damage as Predictors of Response to Belimumab in Patients With Systemic Lupus Erythematosus in a Real-Life Setting

Mariele Gatto et al. Arthritis Rheumatol. 2020 Aug.
Free article

Abstract

Objective: To investigate predictors of response, remission, low disease activity, damage, and drug discontinuation in patients with systemic lupus erythematosus (SLE) who were treated with belimumab.

Methods: In this retrospective study of a multicenter cohort of SLE patients who received intravenous belimumab, the proportion of patients who achieved remission, low disease activity, and treatment response according to the SLE Responder Index 4 (SRI-4) was determined, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) was used to score disease damage yearly over the follow-up. Predictors of outcomes were analyzed by multivariate logistic regression with the results expressed as odds ratios (ORs) and 95% confidence intervals (95% CIs).

Results: The study included 466 patients with active SLE from 24 Italian centers, with a median follow-up period of 18 months (range 1-60 months). An SRI-4 response was achieved by 49.2%, 61.3%, 69.7%, 69.6%, and 66.7% of patients at 6, 12, 24, 36, and 48 months, respectively. Baseline predictors of response at 6 months included a score of ≥10 on the SLE Disease Activity Index 2000 (SLEDAI-2K) (OR 3.14 [95% CI 2.033-4.860]) and a disease duration of ≤2 years (OR 1.94 [95% CI 1.078-3.473). Baseline predictors of response at 12 months included a score of ≥10 on the SLEDAI-2K (OR 3.48 [95% CI 2.004-6.025]) and an SDI score of 0 (OR 1.74 [95% CI 1.036-2.923]). Baseline predictors of response at 24 months included a score of ≥10 on the SLEDAI-2K (OR 4.25 [95% CI 2.018-8.940]) and a disease duration of ≤2 years (OR 3.79 [95% CI 1.039-13.52]). Baseline predictors of response at 36 months included a score of ≥10 on the SLEDAI-2K (OR 14.59 [95% CI 3.54-59.79) and baseline status of current smoker (OR 0.19 [95% CI 0.039-0.69]). Patients who were in remission for ≥25% of the follow-up period (44.3%) or who had low disease activity for ≥50% of the follow-up period (66.1%) accrued significantly less damage (P = 0.046 and P = 0.007). A baseline SDI score of 0 was an independent predictor of achieving low disease activity in ≥50% of the follow-up period and remission in ≥25% of the follow-up period. Our findings suggest that the lower the baseline damage, the greater the probability of achieving remission over the course of ≥25% of the follow-up. Further, there was a negative association between the number of flares reported prior to belimumab initiation and the frequency of belimumab discontinuation due to inefficacy (P = 0.009).

Conclusion: In patients with active SLE and low damage at baseline, treatment with belimumab early in the disease may lead to favorable outcomes in a real-life setting.

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References

    1. Gatto M, Zen M, Iaccarino L, Doria A. New therapeutic strategies in systemic lupus erythematosus management [review]. Nat Rev Rheumatol 2019;15:30-48.
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