EFFICACY AND SAFETY OF BELIMUMAB IN PATIENTS WITH LUPUS NEPHRITIS IN REAL-LIFE SETTING: RESULTS FROM A LARGE, NATIONWIDE, MULTICENTRIC, PROSPECTIVE COHORT
F. Saccon1, M. Gatto2, M. Zen2, M. Fredi3, F. Regola3, F. Franceschini3, A. Tincani3, G. Emmi4, F. Ceccarelli5, F. Conti5, A. Bortoluzzi6, M. Govoni6, M. Mosca7, C. Tani7, M. Gerosa8, T. Ubiali8, E. Bozzolo9, G. A. Ramirez9, L. Moroni9, A. Gabrielli10, P. Cardinaletti10, E. Gremese11, G. Tanti12, S. De Vita13, G. De Marchi13, S. Fasano14, F. Ciccia14, G. Pazzola15, C. Salvarani15, G. Orsolini16, M. Rossini16, P. Faggioli17, A. Laria18, S. Scarpato19, A. De Paulis20, E. Brunetta21, E. Bartoloni Bocci22, R. Gerli22, F. Benvenuti1, L. Iaccarino2, A. Doria2, on behalf of BeRLiSS Study Group
1University of Padua, Division of Rheumatology, Department of Medicine DIMED, Padua, Italy
1University of Padua, Division of Rheumatology, Department of Medicine DIMED, Padua, Italy
3ASST Spedali Civili di Brescia, Department of Clinical and Experimental Sciences, Brescia, Italy
4University of Firenze, Department of Experimental and Clinical Medicine, Firenze, Italy
5Sapienza University of Roma, Dipartimento Universitario di Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari (SCIAC), Rome, Italy
6University of Ferrara, Rheumatology Unit, Ferrara, Italy
7University of Pisa, Rheumatology, Pisa, Italy
8Milan ASST Gaetano Pini, Department of Clinical Sciences and Community Health, Milan, Italy
9Milan San Raffele, Medicina Generale e delle Cure Avanzate, Milan, Italy
10Università Politecnica delle Marche, Dipartimento di Scienze Cliniche e Molecolari, Ancona, Italy
11Rome Fondazione Policlinico Universitario A. Gemelli-IRCCS, Division of Rheumatology, Rome, Italy
12Università Cattolica del Sacro Cuore Sede di Roma, Division of Rheumatology, Rome, Italy
13University of Udine, Rheumatology Unit, Udine, Italy
14Università degli Studi della Campania Luigi Vanvitelli, Deparment of Precision Medicine, Naples, Italy
15Reggio Emilia, Division of Rheumatology, Reggio Emilia, Italy
16University of di Verona, Unit of Rheumatology, Verona, Italy
17ASST OVEST Milanese presidio di Legnano, Rheumatology Unit, Legnano, Italy
18ASST OVEST Milanese presidio di Magenta, Division of Rheumatology, Magenta, Italy
19Salerno Ospedale M. Scarlato, Rheumatology, Salerno, Italy
20University of Napoli Federico II, Dipartimento di Scienze Mediche Traslazionali e Centro di Ricerca Immunologia Base e Clinica (CISI), Naples, Italy
21Istituto Clinico Humanitas, Rheumatology, Milan, Italy
22University of Perugia, Department of Medicine, Perugia, Italy
Background: LN is still a severe manifestation of Systemic lupus erythematosus (SLE) and multitarget therapy is needed to control the disease especially in refractory cases.
Objectives: To evaluate renal response in SLE patients with glomerulonephritis (GN) treated with Belimumab in real-life setting.
Methods: Patients with proteinuria >0.5 g/24 h and/or active sediment at baseline enrolled in a multicentre Italian cohort of SLE patients (BeRLiSS study), treated with monthly iv Belimumab 10 mg/kg plus standard of care were considered in this study.
Complete renal response (CRR
) was defined as proteinuria <0.5 g/24 h, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m
2
and no rescue therapy.
Primary efficacy renal response (PERR
) was defined as proteinuria ≤0.7 g/24 h, eGFR ≥60ml/min/1.73m
2
and no rescue therapy. Prevalence and predictive factors of CRR and PERR at 12 and 24 months after Belimumab initiation were analyzed by multivariate logistic regression analysis.
Results: A total of 91 patients were considered in this study, 79 female, mean age 40.51±9.03 years, mean disease duration 12.18±8.15 years, median follow-up time after Belimumab initiation 22 months. Twenty patients had baseline proteinuria ≥0.5 <1 g/day, 17 ≥1 <2 g/day, 13 ≥2 g/day. Belimumab was started at GN onset in 20 (22%) patients and at the time of a renal flare in all other cases. Seventy-five patients underwent a renal biopsy: 1 class I, 4 class II, 14 class III, 47 class IV and 9 class V. Baseline serum creatinine was 82.44±29.26 umol/L; 15 patients showed eGFR<60ml/min/1.73m
2
at baseline. Immunosuppresants were taken by 70 (76.9%) patients: 47 micofenolate, 15 azathioprine and 5 ciclosporine. Sixty patients (65.9%) were on antimalarials. During follow-up 34 (37.4%) patients achieved CRR. Among them 5 (14.7%) patients relapsed and 29 (85.3%) patients maintained remission. Mean time to achieved CRR was 9.71±5.91 months.
High levels of baseline proteinuria were a negative independent predictor of CRR and PERR at 6 months (OR 0.044 CI95% 0.006-0.320
p=0.002
and OR 0.232 CI95% 0.091-0.596
p=0.002
) and 12 months (OR 0.029 CI95% 0.002-0.556
p=0.019
and OR 0.056 CI95% 0.009-0.327
p=0.001
). High levels of baseline creatinine were a negative independent predictor of renal response. Renal response at 6 months was a strong predictive factor of renal response at 12 and 24 months.
Conclusion: Belimumab is an effective add-on therapy in the treatment of GN in real-life practice setting.
Disclosure of Interests: None declared
Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 594
Session: SLE, Sjögren’s and APS – treatment
(POSTERS only)
