ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 769

Response to Belimumab in SLE Patients with High Disease Activity: Data from a Multicentric Clinical-Practice Based Study Cohort

Luca Iaccarino1, Silvano Bettio2, Rossella Reggia3, Giacomo Emmi4, Fulvia Ceccarelli5, Chiara Tani6, Maria Gerosa7, Marcello Govoni8, Alesandra Bortoluzzi9, Salvatore De Vita10, Ginevra De Marchi11, Rossella De Angelis12, Andrea Di Matteo12, Carlo Salvarani13, Giulia Pazzola13, Elena Bartoloni-Bocci14, Laura Andreoli15, Margherita Zen16, Fabrizio Conti17, Marta Mosca6, Pier Luigi Meroni18, Roberto Gerli14, Angela Tincani19, Andrea Doria20 and Lorenzo Emmi21, 1Department of Medicine-DIMED, University of Padova, Padova, Italy, 2Rheumatology Unit, Univeristy of Padova, Padova, Italy, 3Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy, 4Medical Pathology, Careggi University Hospital, Firenze, Italy, 5Sapienza University of Rome, Rome, Italy, 6Rheumatology Unit, University of Pisa, Pisa, Italy, 7University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy, 8Medical Sciences, UOC of Rheumatology, University Hospital S. Anna, Cona Ferrara, Italy, 9UOC of Rheumatology, University Hospital S. Anna, Cona Ferrara, Italy, 10Clinic of Rheumatology, Department of Medical and Biological Sciences, University Hospital "Santa Maria della Misericordia", Udine, Italy, Udine, Italy, 11Rheumatology Clinic, DSMB, University of Udine, Udine, Italy, 12Polytechnic university of Marche, Rheumatologic Clinic, Iesi, Italy, 13Rheumatology Unit, Internal Medicine Department, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy, 14Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy, 15University of Brescia, Spedali Civili, Brescia, Italy, 16Division of Rheumatology, University of Padova, Padova, Italy, 17Rheumatology Unit, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy, 18Rheumatology Department, University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy, 19Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia, Italy, 20Rheumatology Unit, Department of Medicine - DIMED, University of Padova, Padova, Italy, 21Internal Interdisciplinary Medicine Center for Autoimmune Systemic Diseases, Lupus Clinic,, Internal Interdisciplinary Medicine Center for Autoimmune Systemic Diseases, Lupus Clinic, AOU Careggi, Florence, Italy

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Sunday, November 13, 2016

Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster I: Clinical Trial Design and Current Therapies

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: To investigate effectiveness and identify predictors of response to belimumab in patients with active SLE in clinical practice setting.

Methods: One hundred eighty eight active SLE (ACR criteria) patients with positive anti-dsDNA antibody and low C3 and/or C4, from 11 Italian prospective lupus cohorts, were treated with belimumab (10 mg/kg day 0, 14, 28 and then every 28 days), as add-on therapy. They were 174 (92.6%) females, mean age 40.7+-10.1 years, mean disease duration 12.7±8.5 years. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-hours proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity) were recorded at baseline, at month 12 and 24. Anti-dsDNA levels were measured by ELISA in 98 patients, IIF in 62 patients, Farr assay in 28 patients. The following variables were included in the univariate and multivariate analysis to determine baseline predictors of response (according to SLE Responder Index-4, SRI-4) at 12 and 24 months: gender, age, disease duration, disease activity pattern (relapsing remitting or chronic active), SLEDAI-2K ≥10, prednisone dose >7,5 mg/day, concomitant immunosuppressants (yes/no), polyarthritis, skin rash, glomerulonephritis (GN), hematologic involvement. Pattern of disease activity was identify as chronic active disease in patients with a SLEDAI-2K ≥2 excluding serology in at least two out of the three annual visits and relapsing-remitting disease in patients with a SLEDAI-2K ≥2 excluding serology in one out of three annual visits. Statistics were performed by pairs T-test, chi-square test and multiple logistic regression analysis using SPSS package (version 22.0).

Results: Mean follow-up period was 17.5+-10.6 months (range 3-36). Active manifestations which required the use of belimumab were polyarthritis in 45.7%, skin rash in 26.1%, GN in 13.8%, and hematologic involvement in 14.4% of cases. Clinical and serological variables at baseline and after 12 and 24 months of follow-up are reported in Table.  SRI-4 was achieved by 71.3% and 68.7% of patients at 12 and 24 months, respectively. Baseline independent predictors of response by logistic regression at month 12 were: SLEDAI-2K ≥10 (OR 25.8, 4.19-159.2) and polyarthritis (OR 8.33, 1.88-36.78). Predictors at month 24 were: SLEDAI-2K ≥10 (OR 12.11, 1.63-89.80), polyarthritis (OR 32.56, 2.94-360.56), and prednisone dose >7.5 mg/day (OR 7.88, 1.02-61.48).  Discontinuation was observed in 49 patients (26.1%) after 9±7 months of follow-up. Twenty seven patients (55.1%) discontinued for disease activity, 13 (26.5%) for adverse events, 5 (10.2%) for pregnancy. Retention rate was 89.4% at 6 months, 81.4% at 12 months, 76.1% at 18 months, 75.0%  at 24 months.

Conclusion: SLEDAI ≥10, polyarthritis and prednisone dose >7,5 mg/day at baseline were the best predictors of response in our cohort of patient with active SLE. Casella di testo: Baseline 12 months 24 months Patients (n.) 188 74 52 SLEDAI-2K 8.3±3.3 4.2±2.7 p=0.063 4.0±2.8 p<0.001 Anti-dsDNA (ELISA, KIU/L) 376.1±768.2 153.2±210.3 p=0.003 124.8±145.7 p=0.054 Anti-dsDNA (Farr method, IU/mL) 97.1±194.4 33.4±65.3 p=0.782 23.0±23.5 p=n.s C3 (g/l) 0.71±0.21 0.79±0.19 P<0.001 0.83±0.20 p<0.001 C4 (g/l) 0.11±0.06 0.15±0.07 P<0.001 0.16±0.07 p<0.001 Prednisone daily dose (mg/day) 11.1±7.6 5.0±2.9 p=0.004 4.2±3.8 p<0.001 DAS-28 4.2±1.1 2.2±1.0 p=0.014 1.8±1.0 p<0.001 CLASIa 5.5±4.4 1.4±2.9 p<0.001 1.8±2.8 p=0.005 24-hours proteinuria (g) 1.1±0.74 0.64±0.54 p=0.056 0.53±0.61 p=0.045 Table. Variation of clinical and serologic disease activity variables at 12 and 24 months of follow-up in 188 patients with active SLE and high disease activity treated with belimuma p calculated using pair T-test CLASI: Cutaneous Lupus erythematosus Area and Severity Index Activity    

Disclosure: L. Iaccarino, None; S. Bettio, None; R. Reggia, None; G. Emmi, None; F. Ceccarelli, None; C. Tani, None; M. Gerosa, None; M. Govoni, None; A. Bortoluzzi, None; S. De Vita, None; G. De Marchi, None; R. De Angelis, None; A. Di Matteo, None; C. Salvarani, None; G. Pazzola, None; E. Bartoloni-Bocci, None; L. Andreoli, None; M. Zen, None; F. Conti, None; M. Mosca, None; P. L. Meroni, None; R. Gerli, None; A. Tincani, None; A. Doria, None; L. Emmi, None.

To cite this abstract in AMA style:

Iaccarino L, Bettio S, Reggia R, Emmi G, Ceccarelli F, Tani C, Gerosa M, Govoni M, Bortoluzzi A, De Vita S, De Marchi G, De Angelis R, Di Matteo A, Salvarani C, Pazzola G, Bartoloni-Bocci E, Andreoli L, Zen M, Conti F, Mosca M, Meroni PL, Gerli R, Tincani A, Doria A, Emmi L. Response to Belimumab in SLE Patients with High Disease Activity: Data from a Multicentric Clinical-Practice Based Study Cohort [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/response-to-belimumab-in-sle-patients-with-high-disease-activity-data-from-a-multicentric-clinical-practice-based-study-cohort/. Accessed .

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