Long-term Use of Rituximab in Systemic Sclerosis: A Real-life Italian Multicentre Study

Giacomo De Luca¹, Corrado Campochiaro², Fabio Cacciapaglia³, Nicoletta Del Papa⁴, Elisabetta Zanatta⁵, Paolo Airò⁶, Maria Grazia Lazzaroni⁶, Dilia Giuggioli⁷, Maria De Santis⁸, Gabriella Alonzi⁹, Stefano Stano¹⁰, Marco Binda⁵, Beatrice Moccaldi⁵, Antonio Tonutti¹¹, Florenzo Iannone¹², Maria Antonietta D'Agostino⁹, Lorenzo Dagna¹³, marco Matucci Cerinic¹⁴ and Silvia Bosello¹⁵, ¹Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy, ²IRCCS San Raffaele Hospital, Unit of Immunology, Rheumatology, Allergy and Rare Disease. Vita-Salute San Raffaele University, Milan, Italy, ³Rheumatology Unit, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari, Bari, Italy, ⁴Scleroderma Clinic, Dipartimento di Reumatologia, ASST Gaetano Pini CTO, Milano, Italy, ⁵Rheumatology Unit, Padova University Hospital, Padova, Italy, ⁶Rheumatology and Clinical Immunology, ASST Spedali Civili of Brescia, University of Brescia, Brescia, Italy, ⁷Scleroderma Unit, Rheumatology Unit, University Hospital of Modena and Reggio Emilia, Modena, Italy, ⁸Reumatologia e Immunologia Clinica, IRCCS Humanitas Research Hospital, Humanitas University, Rozzano, Milan, Italy, ⁹Scleroderma Unit, Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, ¹⁰Rheumatology Unit - DiMePRe-J University of Bari, Bari, Italy, ¹¹Humanitas University and Humanitas Research Hospital, Rozzano, Italy, ¹²Rheumatology Unit, Department of Precision and Regenerative Medicine and Ionian Area, University of Bari "Aldo Moro", Bari, Italy, ¹³Department of Internal Medicine, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy, ¹⁴Unit of Immunology, Rheumatology, Allergy and Rare diseases, IRCCS San Raffaele Hospital, Milan, Milan, Italy, ¹⁵Division of Rheumatology - Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy

Meeting: ACR Convergence 2023

Keywords: B-Cell Targets, Systemic sclerosis

Session Information

Date: Monday, November 13, 2023

Title: (1513–1533) Systemic Sclerosis & Related Disorders – Clinical Poster II: Clinical Trial, Treatment & Intervention

Session Type: Poster Session B

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

Background/Purpose: Rituximab(RTX) has been used for the management of systemic sclerosis(SSc). Its efficacy has been recently confirmed in a phase III clinical trial with extension observation up to 48 weeks, but long term data are limited. We analyzed the real life long-term use of RTX in SSc Italian patients.

Methods: SSc patients treated with RTX and with a follow-up ³36 months were included. Disease features at baseline, 6, 12, 24 months and latest available follow-up were analyzed. Persistence of RTX, reasons for RTX introduction and suspension, immunosuppressive therapy (ISTs) modifications, and RTX-related adverse events (AEs) were recorded.

Results: the main characteristics of SSc patients are presented in on Table 1 (median follow-up was 72(52-96) months). RTX was primarily started for lung (38.8%), skin (36.2%), or arthritis (13.8%) worsening (Figure 1A). Patients were treated with RTX for a median of 42.5(26.0-69.7) months: 138 patients(90.8%) were treated with ³1 RTX course. In the entire cohort, mRSS significantly improved both at 6 months and at final follow- (mRSS: 11.9±8.0 and 8.3±7.4 vs 16.5±9.6) and in dcSSc patients with progressive skin involvement (mRSS: 15.6±9.6 and 9.2±7.9 vs 21.0±10.8)(p< 0.001 for all). Mean predicted (%) FVC and DLCO remained stable at 6 months and at final follow-up, both in the entire cohort (FVC: 105.1±84.2 and 87.0±23.5 vs 91.1±49.3; DLCO: 69.4±23.2 and 63.0±26.5 vs 62.1±19.7) and in patients with ILD (FVC: 88.7±38.2 and 82.9±22.5 vs 89.0±54.8; DLCO: 63.8±18.0 and 56.9±18.8 vs 58.7±19.9)(p= ns for all). in 41 patients(27.0%) ILD worsened, defined as a decline in pFVC ≥5% or in pDLCO ≥10% at 12±3 months. During follow-up, in 26 patients (17.1%) RTX was stopped for complete clinical response, especially in dSSc (p< 0.001); median time to discontinuation was 30.0 [24.0-48.0] months. RTX was stopped due to disease progression in 20 patients (13.2%) and due to infections in 5 (3.3%) (Figure 1B-C). AEs were recorded in 42 patients (27.6%)(Figure 1D). Discontinuation for both clinical remission or AEs was not influenced by indication for RTX, disease features or therapeutic scheme (p=ns).

Conclusion: our study shows that in Italian SSc patients, RTX is used as a long-term immunosuppressive drug due to its clinical effectiveness and satisfactory safety profile. The most common reason for RTX suspension was indeed clinical remission, whereas infectious concerns were only marginal.

SD= standard deviasion; n= number; csDMARDs=conventional synthetic disease modifying anti-rheumatic drug. *RTX administered at 1 gr repeated after 15 days in 98.7% of cases.

RTX= rituximab; ILD=interstitial lung disease; MMF=mycophenolate mofetil; csDMARDs= conventional synthetic disease modifying anti-rheumatic drugs.

Disclosures: G. De Luca: Boehringer Ingelheim, 6, Janssen, 6, SOBI, 6; C. Campochiaro: Boehringer Ingelheim, 1, 6, Janssen, 1, 6, Novartis, 1, 6; F. Cacciapaglia: None; N. Del Papa: None; E. Zanatta: None; P. Airò: None; M. Lazzaroni: None; D. Giuggioli: None; M. De Santis: None; G. Alonzi: None; S. Stano: None; M. Binda: None; B. Moccaldi: None; A. Tonutti: None; F. Iannone: Abbvie, 2, 5, BMS, 2, 5, Janssen, 2, 5, Lilly, 2, 5, MSD, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Roche, 2, 5, UCB, 2, 5; M. D'Agostino: None; L. Dagna: AbbVie, 2, AstraZeneca, 2, Biogen, 2, BMS, 2, 5, Boehringer Ingelheim, 2, Celltrion, 5, Eli Lilly, 2, Galapagos, 2, GSK, 1, Janssen, 2, Kiniksa Pharmaceuticals, 2, 5, Novartis, 2, 6, Pfizer, 2, 5, Sobi, 2, 5, 6; m. Matucci Cerinic: accelerong, 2, 6, actelion, 2, 6, bayer, 2, 6, biogen, 2, 6, Boehringer-Ingelheim, 2, 6, Chemomab, 2, 6, corbus, 2, 6, CSL Behring, 2, 6, Eli Lilly, 2, 6, galapagos, 2, 6, Inventiva, 2, 6, Janssen, 2, 6, Merck/MSD, 2, 6, Mitsubishi, 2, 6, Pfizer, 2, 6, regeneron, 2, 6, Roche, 2, 6, samsung, 2, 6; S. Bosello: None.

To cite this abstract in AMA style:

De Luca G, Campochiaro C, Cacciapaglia F, Del Papa N, Zanatta E, Airò P, Lazzaroni M, Giuggioli D, De Santis M, Alonzi G, Stano S, Binda M, Moccaldi B, Tonutti A, Iannone F, D'Agostino M, Dagna L, Matucci Cerinic m, Bosello S. Long-term Use of Rituximab in Systemic Sclerosis: A Real-life Italian Multicentre Study [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/long-term-use-of-rituximab-in-systemic-sclerosis-a-real-life-italian-multicentre-study/. Accessed .

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