OBJECTIVE: To identify baseline characteristics of patients with scleroderma-related interstitial lung disease (SSc-ILD) that could serve as predictors of the most favorable response to 12-month treatment with oral cyclophosphamide (CYC). METHODS: Regression analyses were retrospectively applied to the Scleroderma Lung Study data in order to identify baseline characteristics that correlated with the absolute change in forced vital capacity (FVC) (% predicted values) and the placebo-adjusted change in % predicted FVC over time (the CYC treatment effect). RESULTS: Completion of the CYC arm of the Scleroderma Lung Study was associated with a placebo-adjusted improvement in the % predicted FVC of 2.11% at 12 months, which increased to 4.16% when patients were followed up for another 6 months (P=0.014). Multivariate regression analyses identified the maximal severity of reticular infiltrates (assessed as maximum fibrosis scores) on high-resolution computed tomography (HRCT) at baseline, the modified Rodnan skin thickness score (MRSS) at baseline, and the Mahler baseline dyspnea index as independent correlates of treatment response. When patients were stratified on the basis of whether 50% or more of any lung zone was involved by reticular infiltrates on HRCT and/or whether patients exhibited an MRSS of at least 23, a subgroup of patients emerged in whom there was an average CYC treatment effect of 9.81% at 18 months (P<0.001). Conversely, there was no treatment effect (a -0.58% difference) in patients with less severe HRCT findings and a lower MRSS at baseline. CONCLUSION: A retrospective analysis of the Scleroderma Lung Study data identified the severity of reticular infiltrates on baseline HRCT and the baseline MRSS as patient features that might be predictive of responsiveness to CYC therapy.
RCT Entities:
OBJECTIVE: To identify baseline characteristics of patients with scleroderma-related interstitial lung disease (SSc-ILD) that could serve as predictors of the most favorable response to 12-month treatment with oral cyclophosphamide (CYC). METHODS: Regression analyses were retrospectively applied to the Scleroderma Lung Study data in order to identify baseline characteristics that correlated with the absolute change in forced vital capacity (FVC) (% predicted values) and the placebo-adjusted change in % predicted FVC over time (the CYC treatment effect). RESULTS: Completion of the CYC arm of the Scleroderma Lung Study was associated with a placebo-adjusted improvement in the % predicted FVC of 2.11% at 12 months, which increased to 4.16% when patients were followed up for another 6 months (P=0.014). Multivariate regression analyses identified the maximal severity of reticular infiltrates (assessed as maximum fibrosis scores) on high-resolution computed tomography (HRCT) at baseline, the modified Rodnan skin thickness score (MRSS) at baseline, and the Mahler baseline dyspnea index as independent correlates of treatment response. When patients were stratified on the basis of whether 50% or more of any lung zone was involved by reticular infiltrates on HRCT and/or whether patients exhibited an MRSS of at least 23, a subgroup of patients emerged in whom there was an average CYC treatment effect of 9.81% at 18 months (P<0.001). Conversely, there was no treatment effect (a -0.58% difference) in patients with less severe HRCT findings and a lower MRSS at baseline. CONCLUSION: A retrospective analysis of the Scleroderma Lung Study data identified the severity of reticular infiltrates on baseline HRCT and the baseline MRSS as patient features that might be predictive of responsiveness to CYC therapy.
Authors: Donald P Tashkin; Robert Elashoff; Philip J Clements; Jonathan Goldin; Michael D Roth; Daniel E Furst; Edgar Arriola; Richard Silver; Charlie Strange; Marcy Bolster; James R Seibold; David J Riley; Vivien M Hsu; John Varga; Dean E Schraufnagel; Arthur Theodore; Robert Simms; Robert Wise; Fredrick Wigley; Barbara White; Virginia Steen; Charles Read; Maureen Mayes; Ed Parsley; Kamal Mubarak; M Kari Connolly; Jeffrey Golden; Mitchell Olman; Barri Fessler; Naomi Rothfield; Mark Metersky Journal: N Engl J Med Date: 2006-06-22 Impact factor: 91.245
Authors: Rachel K Hoyles; Ross W Ellis; Jessica Wellsbury; Belinda Lees; Pauline Newlands; Nicole S L Goh; Christopher Roberts; Sujal Desai; Ariane L Herrick; Neil J McHugh; Noeleen M Foley; Stanley B Pearson; Paul Emery; Douglas J Veale; Christopher P Denton; Athol U Wells; Carol M Black; Roland M du Bois Journal: Arthritis Rheum Date: 2006-12
Authors: Shervin Assassi; Roozbeh Sharif; Robert E Lasky; Terry A McNearney; Rosa M Estrada-Y-Martin; Hilda Draeger; Deepthi K Nair; Marvin J Fritzler; John D Reveille; Frank C Arnett; Maureen D Mayes Journal: Arthritis Res Ther Date: 2010-09-02 Impact factor: 5.156
Authors: Nicole S L Goh; Srihari Veeraraghavan; Sujal R Desai; Derek Cramer; David M Hansell; Christopher P Denton; Carol M Black; Roland M du Bois; Athol U Wells Journal: Arthritis Rheum Date: 2007-06
Authors: Elizabeth R Volkmann; Donald P Tashkin; Masataka Kuwana; Ning Li; Michael D Roth; Julio Charles; Faye N Hant; Galina S Bogatkevich; Tanjina Akter; Grace Kim; Jonathan Goldin; Dinesh Khanna; Philip J Clements; Daniel E Furst; Robert M Elashoff; Richard M Silver; Shervin Assassi Journal: Arthritis Rheumatol Date: 2019-11-01 Impact factor: 10.995
Authors: Romy B Christmann; Percival Sampaio-Barros; Giuseppina Stifano; Claudia L Borges; Carlos R de Carvalho; Ronaldo Kairalla; Edwin R Parra; Avrum Spira; Robert Simms; Vera L Capellozzi; Robert Lafyatis Journal: Arthritis Rheumatol Date: 2014-03 Impact factor: 10.995