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. 2025 Dec 1;64(SI):SI184-SI189.
doi: 10.1093/rheumatology/keaf006.

Tocilizumab and rituximab for systemic sclerosis interstitial lung disease: a real-world cohort analysis

Nina R Goldman  1 , Svetlana I Nihtyanova  1   2 , Claire F Beesley  1 , Athol U Wells  3 , Christopher P Denton  1 , Elisabetta A Renzoni  3   4 , Rizgar Mageed  5 , Voon H Ong  1
Affiliations

Tocilizumab and rituximab for systemic sclerosis interstitial lung disease: a real-world cohort analysis

Nina R Goldman et al. Rheumatology (Oxford). .

Abstract

Objectives: SSc-interstitial lung disease (ILD) is one of the leading causes of mortality in SSc. Data from randomized controlled trials (RCTs) support rituximab and tocilizumab monotherapy but there are limited data regarding their use for those who fail standard immunomodulatory therapies.

Methods: SSc patients treated with rituximab or tocilizumab were retrospectively identified in a single centre cohort. Linear mixed effect models were used to analyse before and after treatment lung function trajectory, and identify patient characteristics associated with treatment response.

Results: A total of 127 patients were included for analysis. Fifty-one of 94 (54.2%) and 13 of 33 (39.4%) of the rituximab and tocilizumab cohorts, respectively, were receiving concurrent MMF. Pre-treatment decline in absolute change % forced vital capacity (%FVC)/year and % diffusion capacity for carbon monoxide (%DLCO)/year, respectively, was similar in both cohorts (-3.2% and -4.0% rituximab, and -3.2% and -3.6% tocilizumab). Both treatments resulted in lung function stabilization (%FVC/year and %DLCO/year: 1.2% and +0.2% rituximab cohort, 1.0% and 1.0% tocilizumab cohort). Anti-topoisomerase antibody (ATA)-positive patients had a significant response on %FVC/year to tocilizumab compared with ATA-negative patients. Gender had a significant impact on %FVC/year response to rituximab, with males responding to a greater degree than females. Age, ILD extent and skin subset had no impact on treatment response.

Conclusion: Combination rituximab or tocilizumab with background immunosuppressive therapy is associated with stabilization in lung function trajectory among those who remain refractory to standard immunosuppressives. Specific patient characteristics have an impact on lung function response. Improved FVC response among ATA patients receiving tocilizumab validate data from RCTs.

Keywords: anti-topoisomerase antibody; interstitial lung disease; rituximab; systemic sclerosis; tocilizumab.

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Figures

Figure 1.
Figure 1.
Change in %FVC over time pre and post treatment with rituximab or tocilizumab and interaction of other patient characteristics. Time 0 = time of biologic treatment. aSignificant effect of characteristics on annual rate of change in %FVC pre or post treatment compared with reference group (P-value ≤0.05). (A) Impact of treatment rituximab (RTX) or tocilizumab (TCZ). (B) Male or Female. (C) ATA+ vs ATA–. (D) concurrent MMF at treatment initiation vs other/no concurrent immunosuppression at treatment initiation (IS). Linear mixed model data is provided in Supplementary Tables S3 and S5, available at Rheumatology online. FVC: forced vital capacity; ATA: anti-topoisomerase antibody
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References

    1. Tyndall AJ, Bannert B, Vonk M et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis 2010;69:1809–15. - PubMed
    1. Perelas A, Silver RM, Arrossi AV, Highland KB. Systemic sclerosis-associated interstitial lung disease. Lancet Respir Med 2020;8:304–20. - PubMed
    1. Tashkin DP, Elashoff R, Clements PJ et al. ; Scleroderma Lung Study Research Group. Cyclophosphamide versus placebo in scleroderma lung disease. New Engl J Med 2006;354:2655–66. - PubMed
    1. Tashkin DP, Roth MD, Clements PJ et al. ; Sclerodema Lung Study II Investigators. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial. Lancet Respir Med 2016;4:708–19. - PMC - PubMed
    1. Levin D, Osman M, Durand C et al. Hematopoietic cell transplantation for systemic sclerosis—a review. Cells 2022;11:3912. - PMC - PubMed