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Rituximab as a rescue treatment added on mycophenolate mofetil background therapy in progressive systemic sclerosis associated interstitial lung disease unresponsive to conventional immunosuppression

•There is an unmet need for rescue therapies in patients with progressive SSc-ILD who do not respond to conventional immunosuppressants.•The combination of MMF/RTX was able to reverse the decline of lung function parameters in a not negligible proportion of patients with a progressive fibrosing phen...

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Published in:Seminars in arthritis and rheumatism 2020-10, Vol.50 (5), p.977-987
Main Authors: Narváez, Javier, LLuch, Judit, Molina-Molina, Maria, Vicens-Zygmunt, Vanesa, Luburich, Patricio, Yañez, Marcos Anibal, Nolla, Joan M.
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Language:English
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Summary:•There is an unmet need for rescue therapies in patients with progressive SSc-ILD who do not respond to conventional immunosuppressants.•The combination of MMF/RTX was able to reverse the decline of lung function parameters in a not negligible proportion of patients with a progressive fibrosing phenotype, unresponsive to conventional therapy.•Rituximab has a reasonable safety profile. To test whether the use of rituximab (RTX) is effective and safe as a rescue therapy add-on treatment to mycophenolate (MMF) in patients with progressive systemic sclerosis-associated interstitial lung disease (SSc-ILD) in whom conventional immunosuppressants (IS) have failed. Longitudinal retrospective observational study of a cohort of patients with SSc-ILD that started treatment with RTX due to ongoing lung function impairment despite treatment with glucocorticoids and IS (cyclophosphamide and/or MMF). All patients were treated with 2 or more cycles of RTX and evaluated for at least 12 months. Twenty-four patients were included. Before initiation of RTX the mean decline in%pFVC and %pDLCO during the previous 2 years (delta) was −12.9% and −12.5%, respectively. After 1 year of treatment with RTX, a significant improvement in %pFVC (∆+8.8% compared to baseline, 95% CI: −13.7 to −3.9; p = 0.001) and%pDLCO (∆+4.6%, 95% CI: −8.2 to −0.8; p = 0.018) was observed. In addition, there was a significant reduction in the median dose of prednisone and it could be suspended in 25% of patients. At 2 years of treatment, RTX had been discontinued in 9 patients (due to adverse events in 3 cases and inefficacy in 6). In the 15 patients (62.5%) that completed 24 months of therapy, the statistically significant amelioration in pulmonary function test parameters was maintained: ∆%pFVC: +11.1% (95% CI: −17.6 to −4.5; p = 0.003) and ∆%pDLCO: +8.7% (95% CI: −13.9 to −8.3; p = 0.003). Based on our results, RTX's use as an add-on treatment to MMF appears to be effective as a rescue therapy in patients with a more aggressive SSc-ILD phenotype.
ISSN:0049-0172
1532-866X
DOI:10.1016/j.semarthrit.2020.08.004