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)

Author:

Zen Margherita1ORCID,Gatto Mariele1ORCID,Depascale Roberto1,Regola Francesca2ORCID,Fredi Micaela2,Andreoli Laura2ORCID,Franceschini Franco2ORCID,Urban Maria Letizia3,Emmi Giacomo3,Ceccarelli Fulvia4,Conti Fabrizio4,Bortoluzzi Alessandra5,Govoni Marcello5ORCID,Tani Chiara6,Mosca Marta6,Ubiali Tania7ORCID,Gerosa Maria7,Bozzolo Enrica P.8,Canti Valentina8,Cardinaletti Paolo9,Gabrielli Armando9,Tanti Giacomo10,Gremese Elisa1011,De Marchi Ginevra12ORCID,De Vita Salvatore12,Fasano Serena13ORCID,Ciccia Francesco13ORCID,Pazzola Giulia14,Salvarani Carlo1415,Negrini Simone16ORCID,Di Matteo Andrea17,De Angelis Rossella17ORCID,Orsolini Giovanni18,Rossini Maurizio18ORCID,Faggioli Paola19,Laria Antonella20,Piga Matteo21ORCID,Cauli Alberto21,Scarpato Salvatore22,Rossi Francesca Wanda23,De Paulis Amato23,Brunetta Enrico24,Ceribelli Angela2526,Selmi Carlo2526ORCID,Prete Marcella27,Racanelli Vito27ORCID,Vacca Angelo27ORCID,Bartoloni Elena28ORCID,Gerli Roberto28,Zanatta Elisabetta1,Larosa Maddalena1,Saccon Francesca1,Doria Andrea1ORCID,Iaccarino Luca1

Affiliation:

1. Rheumatology Unit, Department of Medicine-DIMED, University of Padova, Via Giustiniani, 2, 35128 Padova, Italy

2. ASST Spedali Civili di Brescia, Department of Clinical and Experimental Sciences, Rheumatology and Clinical Immunology, 25123 Brescia, Italy

3. Department of Experimental and Clinical Medicine, University of Florence, 50139 Firenze, Italy

4. Dipartimento Universitario di Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari (SCIAC) ‘Sapienza’ University, 00185 Rome, Italy

5. Rheumatology Unit, Azienda Ospedaliero-Universitaria S. Anna—Ferrara, University of Ferrara, 44121 Ferrara, Italy

6. Rheumatology, University of Pisa, 56124 Pisa, Italy

7. Clinical Rheumatology Unit Milano, ASST Gaetano Pini, Department of Clinical Sciences and Community Health, Lombardia, 20129 Milan, Italy

8. Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, 20100 Milan, Italy

9. Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, 60121 Ancona, Italy

10. Division of Rheumatology, Università Cattolica del Sacro Cuore Sede di Roma, 00168 Rome, Italy

11. Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli-IRCCS, 00168 Rome, Italy

12. Rheumatology Unit, University of Udine, Medical Area, 33100 Udine, Italy

13. Deparment of Precision Medicine Napoli, Università degli Studi della Campania Luigi Vanvitelli, 81100 Caserta, Italy

14. Azienda USL-IRCCS di Reggio Emilia, 42123 Reggio Emilia, Italy

15. Rheumatology Unit, University of Modena and Reggio Emilia, 41125 Reggio Emilia, Italy

16. Internal Medicine Unit, Department of Internal Medicine, Università degli Studi di Genova, 16146 Genoa, Italy

17. Deparment of Clinical and Experimental Sciences, Università Politecnica delle Marche, Rheumatology Clinic, 60131 Ancona, Italy

18. Unit of Rheumatology, University of di Verona, 37134 Verona, Italy

19. ASST OVEST Milanese Presidio di Legnano, 20025 Legnano, Italy

20. ASST OVEST Milanese Presidio di Magenta, 20013 Magenta, Italy

21. Rheumatology Unit, AOU University Clinic, University of Cagliari, 09124 Cagliari, Italy

22. Rheumatology, Ospedale M. Scarlato, Scafati, 84018 Salerno, Italy

23. Dipartimento di Scienze Mediche, Traslazionali e Centro di Ricerca Immunologia Base e Clinica (CISI), University of Napoli Federico II, 80131 Napoli, Italy

24. IRCCS Humanitas Research Hospital, Milan, Italy, 20089 Milan, Italy

25. Department of Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, 20089 Milan, Italy

26. Department of Biomedical Sciences, Humanitas University, 20133 Milan, Italy

27. Unit of Internal Medicine, Department of Biomedical Sciences and Human Oncology, University of Bari, 70125 Bari, Italy

28. Rheumatology Unit, Department of Medicine, University of Perugia, 06121 Perugia, Italy

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.

Publisher

MDPI AG

Subject

Medicine (miscellaneous)

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