A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease
Abstract Objectives Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long term efficacy and safety of RTX in SSc compared to standard treatment. Methods Fifty one patients with SSc-associated interstitial lung disease...
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| creator | Daoussis, Dimitrios, M.D Melissaropoulos, Konstantinos, M.D Sakellaropoulos, Georgios Antonopoulos, Ioannis, M.D Markatseli, Theodora E., M.D Simopoulou, Theodora, M.D Georgiou, Panagiotis, M.D Andonopoulos, Andrew P., M.D Drosos, Alexandros A., M.D Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK) Liossis, Stamatis-Nick, M.D |
| description | Abstract Objectives Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long term efficacy and safety of RTX in SSc compared to standard treatment. Methods Fifty one patients with SSc-associated interstitial lung disease were recruited and treated with RTX (n=33) or conventional treatment (n=18). Median follow-up was 4 years (range 1-7). Conventional treatment consisted of azathioprine (n=2), methotrexate (n=6) and mycophenolate mofetil (n=10). Results Patients in the RTX group showed an increase in FVC at 2 years (mean ± SD of FVC: 80.60 ± 21.21 vs 86.90 ± 20.56 at baseline vs 2 years, respectively, p =0.041 compared to baseline). In sharp contrast, patients in the control group had no change in FVC during the first 2 years of follow up. At the 7 year time point the remaining patients in the RTX group (n=5) had higher FVC compared to baseline (mean ± SD of FVC: 91.60 ± 14.81, p =0.158 compared to baseline) in contrast to patients in the control group (n=9) where FVC deteriorated ( p |
| doi_str_mv | 10.1016/j.semarthrit.2016.10.003 |
| format | Article |
| fullrecord | <record><control><sourceid>elsevier</sourceid><recordid>TN_cdi_elsevier_clinicalkeyesjournals_1_s2_0_S0049017216303444</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0049017216303444</els_id><sourcerecordid>1_s2_0_S0049017216303444</sourcerecordid><originalsourceid>FETCH-elsevier_clinicalkeyesjournals_1_s2_0_S00490172163034443</originalsourceid><addsrcrecordid>eNqlj0tOxDAQRL0AieFzhz7AJNhJlBEbJEAg1jD7yON0SAfHjtydgdyDA5ORuAGrUpWeqlRKgdG50aa-HXLG0SbpE0lerMka51qXZ2qjdXWXabMrLtQl86C1MbXebdTPA4yzF8ocBsG0hThhyLw9oN-Ci-NkkxU6IrDM7QKxg8cV9R5anDwKxQDSY7LTAl8kPbyRzN802gN0MQEvLDiSA3YeU2TizDJHR1awBTotspCQ9eDn8AEtMVrGa3XeWc9486dX6v7lef_0muFqjoSpcZ4COes_cUEe4pzCyjWm4aLRzfvp7OmrqUtdVlVV_rvgF7-nc0A</addsrcrecordid><sourcetype>Publisher</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease</title><source>Elsevier ScienceDirect Journals</source><creator>Daoussis, Dimitrios, M.D ; Melissaropoulos, Konstantinos, M.D ; Sakellaropoulos, Georgios ; Antonopoulos, Ioannis, M.D ; Markatseli, Theodora E., M.D ; Simopoulou, Theodora, M.D ; Georgiou, Panagiotis, M.D ; Andonopoulos, Andrew P., M.D ; Drosos, Alexandros A., M.D ; Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK) ; Liossis, Stamatis-Nick, M.D</creator><creatorcontrib>Daoussis, Dimitrios, M.D ; Melissaropoulos, Konstantinos, M.D ; Sakellaropoulos, Georgios ; Antonopoulos, Ioannis, M.D ; Markatseli, Theodora E., M.D ; Simopoulou, Theodora, M.D ; Georgiou, Panagiotis, M.D ; Andonopoulos, Andrew P., M.D ; Drosos, Alexandros A., M.D ; Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK) ; Liossis, Stamatis-Nick, M.D</creatorcontrib><description>Abstract Objectives Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long term efficacy and safety of RTX in SSc compared to standard treatment. Methods Fifty one patients with SSc-associated interstitial lung disease were recruited and treated with RTX (n=33) or conventional treatment (n=18). Median follow-up was 4 years (range 1-7). Conventional treatment consisted of azathioprine (n=2), methotrexate (n=6) and mycophenolate mofetil (n=10). Results Patients in the RTX group showed an increase in FVC at 2 years (mean ± SD of FVC: 80.60 ± 21.21 vs 86.90 ± 20.56 at baseline vs 2 years, respectively, p =0.041 compared to baseline). In sharp contrast, patients in the control group had no change in FVC during the first 2 years of follow up. At the 7 year time point the remaining patients in the RTX group (n=5) had higher FVC compared to baseline (mean ± SD of FVC: 91.60 ± 14.81, p =0.158 compared to baseline) in contrast to patients in the control group (n=9) where FVC deteriorated ( p <0.01, compared to baseline). Direct comparison between the 2 groups showed a significant benefit for the RTX group in FVC ( p =0.013). Improvement of skin thickening was found in both the RTX and the standard treatment group, however, direct comparison between groups strongly favored RTX at all time points. Adverse events were comparable between groups. Conclusions Our data indicate that RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Randomized controlled studies are highly needed.</description><identifier>ISSN: 0049-0172</identifier><identifier>DOI: 10.1016/j.semarthrit.2016.10.003</identifier><language>eng</language><subject>Rheumatology</subject><ispartof>Seminars in arthritis and rheumatism, 2016</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,4010,27904,27905,27906</link.rule.ids></links><search><creatorcontrib>Daoussis, Dimitrios, M.D</creatorcontrib><creatorcontrib>Melissaropoulos, Konstantinos, M.D</creatorcontrib><creatorcontrib>Sakellaropoulos, Georgios</creatorcontrib><creatorcontrib>Antonopoulos, Ioannis, M.D</creatorcontrib><creatorcontrib>Markatseli, Theodora E., M.D</creatorcontrib><creatorcontrib>Simopoulou, Theodora, M.D</creatorcontrib><creatorcontrib>Georgiou, Panagiotis, M.D</creatorcontrib><creatorcontrib>Andonopoulos, Andrew P., M.D</creatorcontrib><creatorcontrib>Drosos, Alexandros A., M.D</creatorcontrib><creatorcontrib>Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK)</creatorcontrib><creatorcontrib>Liossis, Stamatis-Nick, M.D</creatorcontrib><title>A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease</title><title>Seminars in arthritis and rheumatism</title><description>Abstract Objectives Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long term efficacy and safety of RTX in SSc compared to standard treatment. Methods Fifty one patients with SSc-associated interstitial lung disease were recruited and treated with RTX (n=33) or conventional treatment (n=18). Median follow-up was 4 years (range 1-7). Conventional treatment consisted of azathioprine (n=2), methotrexate (n=6) and mycophenolate mofetil (n=10). Results Patients in the RTX group showed an increase in FVC at 2 years (mean ± SD of FVC: 80.60 ± 21.21 vs 86.90 ± 20.56 at baseline vs 2 years, respectively, p =0.041 compared to baseline). In sharp contrast, patients in the control group had no change in FVC during the first 2 years of follow up. At the 7 year time point the remaining patients in the RTX group (n=5) had higher FVC compared to baseline (mean ± SD of FVC: 91.60 ± 14.81, p =0.158 compared to baseline) in contrast to patients in the control group (n=9) where FVC deteriorated ( p <0.01, compared to baseline). Direct comparison between the 2 groups showed a significant benefit for the RTX group in FVC ( p =0.013). Improvement of skin thickening was found in both the RTX and the standard treatment group, however, direct comparison between groups strongly favored RTX at all time points. Adverse events were comparable between groups. Conclusions Our data indicate that RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Randomized controlled studies are highly needed.</description><subject>Rheumatology</subject><issn>0049-0172</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid/><recordid>eNqlj0tOxDAQRL0AieFzhz7AJNhJlBEbJEAg1jD7yON0SAfHjtydgdyDA5ORuAGrUpWeqlRKgdG50aa-HXLG0SbpE0lerMka51qXZ2qjdXWXabMrLtQl86C1MbXebdTPA4yzF8ocBsG0hThhyLw9oN-Ci-NkkxU6IrDM7QKxg8cV9R5anDwKxQDSY7LTAl8kPbyRzN802gN0MQEvLDiSA3YeU2TizDJHR1awBTotspCQ9eDn8AEtMVrGa3XeWc9486dX6v7lef_0muFqjoSpcZ4COes_cUEe4pzCyjWm4aLRzfvp7OmrqUtdVlVV_rvgF7-nc0A</recordid><startdate>2016</startdate><enddate>2016</enddate><creator>Daoussis, Dimitrios, M.D</creator><creator>Melissaropoulos, Konstantinos, M.D</creator><creator>Sakellaropoulos, Georgios</creator><creator>Antonopoulos, Ioannis, M.D</creator><creator>Markatseli, Theodora E., M.D</creator><creator>Simopoulou, Theodora, M.D</creator><creator>Georgiou, Panagiotis, M.D</creator><creator>Andonopoulos, Andrew P., M.D</creator><creator>Drosos, Alexandros A., M.D</creator><creator>Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK)</creator><creator>Liossis, Stamatis-Nick, M.D</creator><scope/></search><sort><creationdate>2016</creationdate><title>A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease</title><author>Daoussis, Dimitrios, M.D ; Melissaropoulos, Konstantinos, M.D ; Sakellaropoulos, Georgios ; Antonopoulos, Ioannis, M.D ; Markatseli, Theodora E., M.D ; Simopoulou, Theodora, M.D ; Georgiou, Panagiotis, M.D ; Andonopoulos, Andrew P., M.D ; Drosos, Alexandros A., M.D ; Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK) ; Liossis, Stamatis-Nick, M.D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-elsevier_clinicalkeyesjournals_1_s2_0_S00490172163034443</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Rheumatology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Daoussis, Dimitrios, M.D</creatorcontrib><creatorcontrib>Melissaropoulos, Konstantinos, M.D</creatorcontrib><creatorcontrib>Sakellaropoulos, Georgios</creatorcontrib><creatorcontrib>Antonopoulos, Ioannis, M.D</creatorcontrib><creatorcontrib>Markatseli, Theodora E., M.D</creatorcontrib><creatorcontrib>Simopoulou, Theodora, M.D</creatorcontrib><creatorcontrib>Georgiou, Panagiotis, M.D</creatorcontrib><creatorcontrib>Andonopoulos, Andrew P., M.D</creatorcontrib><creatorcontrib>Drosos, Alexandros A., M.D</creatorcontrib><creatorcontrib>Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK)</creatorcontrib><creatorcontrib>Liossis, Stamatis-Nick, M.D</creatorcontrib><jtitle>Seminars in arthritis and rheumatism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Daoussis, Dimitrios, M.D</au><au>Melissaropoulos, Konstantinos, M.D</au><au>Sakellaropoulos, Georgios</au><au>Antonopoulos, Ioannis, M.D</au><au>Markatseli, Theodora E., M.D</au><au>Simopoulou, Theodora, M.D</au><au>Georgiou, Panagiotis, M.D</au><au>Andonopoulos, Andrew P., M.D</au><au>Drosos, Alexandros A., M.D</au><au>Sakkas, Lazaros, M.D., DM, PhD(UK), FRCP(UK)</au><au>Liossis, Stamatis-Nick, M.D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease</atitle><jtitle>Seminars in arthritis and rheumatism</jtitle><date>2016</date><risdate>2016</risdate><issn>0049-0172</issn><abstract>Abstract Objectives Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long term efficacy and safety of RTX in SSc compared to standard treatment. Methods Fifty one patients with SSc-associated interstitial lung disease were recruited and treated with RTX (n=33) or conventional treatment (n=18). Median follow-up was 4 years (range 1-7). Conventional treatment consisted of azathioprine (n=2), methotrexate (n=6) and mycophenolate mofetil (n=10). Results Patients in the RTX group showed an increase in FVC at 2 years (mean ± SD of FVC: 80.60 ± 21.21 vs 86.90 ± 20.56 at baseline vs 2 years, respectively, p =0.041 compared to baseline). In sharp contrast, patients in the control group had no change in FVC during the first 2 years of follow up. At the 7 year time point the remaining patients in the RTX group (n=5) had higher FVC compared to baseline (mean ± SD of FVC: 91.60 ± 14.81, p =0.158 compared to baseline) in contrast to patients in the control group (n=9) where FVC deteriorated ( p <0.01, compared to baseline). Direct comparison between the 2 groups showed a significant benefit for the RTX group in FVC ( p =0.013). Improvement of skin thickening was found in both the RTX and the standard treatment group, however, direct comparison between groups strongly favored RTX at all time points. Adverse events were comparable between groups. Conclusions Our data indicate that RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Randomized controlled studies are highly needed.</abstract><doi>10.1016/j.semarthrit.2016.10.003</doi></addata></record> |
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| title | A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease |
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