Show simple item record

Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigatorâ Initiated, Multicenter, Doubleâ Blind, Randomized, Placeboâ Controlled Trial

dc.contributor.authorKhanna, Dinesh
dc.contributor.authorSpino, Cathie
dc.contributor.authorJohnson, Sindhu
dc.contributor.authorChung, Lorinda
dc.contributor.authorWhitfield, Michael L.
dc.contributor.authorDenton, Christopher P.
dc.contributor.authorBerrocal, Veronica
dc.contributor.authorFranks, Jennifer
dc.contributor.authorMehta, Bhavan
dc.contributor.authorMolitor, Jerry
dc.contributor.authorSteen, Virginia D.
dc.contributor.authorLafyatis, Robert
dc.contributor.authorSimms, Robert W.
dc.contributor.authorGill, Anna
dc.contributor.authorKafaja, Suzanne
dc.contributor.authorFrech, Tracy M.
dc.contributor.authorHsu, Vivien
dc.contributor.authorDomsic, Robyn T.
dc.contributor.authorPope, Janet E.
dc.contributor.authorGordon, Jessica K.
dc.contributor.authorMayes, Maureen D.
dc.contributor.authorSchiopu, Elena
dc.contributor.authorYoung, Amber
dc.contributor.authorSandorfi, Nora
dc.contributor.authorPark, Jane
dc.contributor.authorHant, Faye N.
dc.contributor.authorBernstein, Elana J.
dc.contributor.authorChatterjee, Soumya
dc.contributor.authorCastelino, Flavia V.
dc.contributor.authorAjam, Ali
dc.contributor.authorWang, Yue
dc.contributor.authorWood, Tammara
dc.contributor.authorAllanore, Yannick
dc.contributor.authorMatucci‐cerinic, Marco
dc.contributor.authorDistler, Oliver
dc.contributor.authorSinger, Ora
dc.contributor.authorBush, Erica
dc.contributor.authorFox, David A.
dc.contributor.authorFurst, Daniel E.
dc.date.accessioned2020-01-13T15:16:43Z
dc.date.availableWITHHELD_13_MONTHS
dc.date.available2020-01-13T15:16:43Z
dc.date.issued2020-01
dc.identifier.citationKhanna, Dinesh; Spino, Cathie; Johnson, Sindhu; Chung, Lorinda; Whitfield, Michael L.; Denton, Christopher P.; Berrocal, Veronica; Franks, Jennifer; Mehta, Bhavan; Molitor, Jerry; Steen, Virginia D.; Lafyatis, Robert; Simms, Robert W.; Gill, Anna; Kafaja, Suzanne; Frech, Tracy M.; Hsu, Vivien; Domsic, Robyn T.; Pope, Janet E.; Gordon, Jessica K.; Mayes, Maureen D.; Schiopu, Elena; Young, Amber; Sandorfi, Nora; Park, Jane; Hant, Faye N.; Bernstein, Elana J.; Chatterjee, Soumya; Castelino, Flavia V.; Ajam, Ali; Wang, Yue; Wood, Tammara; Allanore, Yannick; Matucci‐cerinic, Marco ; Distler, Oliver; Singer, Ora; Bush, Erica; Fox, David A.; Furst, Daniel E. (2020). "Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigatorâ Initiated, Multicenter, Doubleâ Blind, Randomized, Placeboâ Controlled Trial." Arthritis & Rheumatology 72(1): 125-136.
dc.identifier.issn2326-5191
dc.identifier.issn2326-5205
dc.identifier.urihttps://hdl.handle.net/2027.42/153066
dc.publisherWiley Periodicals, Inc.
dc.titleAbatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigatorâ Initiated, Multicenter, Doubleâ Blind, Randomized, Placeboâ Controlled Trial
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelRheumatology
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/153066/1/art41055_am.pdf
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/153066/2/art41055.pdf
dc.identifier.doi10.1002/art.41055
dc.identifier.sourceArthritis & Rheumatology
dc.identifier.citedreferenceStifano G, Sornasse T, Rice LM, Na L, Chenâ Harris H, Khanna D, et al. Skin gene expression is prognostic for the trajectory of skin disease in patients with diffuse cutaneous systemic sclerosis. Arthritis Rheumatol 2018; 70: 912 â 9.
dc.identifier.citedreferenceVillela R, Yuen SY, Pope JE, Baron M, and the Canadian Scleroderma Research Group. Assessment of unmet needs and the lack of generalizability in the design of randomized controlled trials for scleroderma treatment. Arthritis Rheum 2008; 59: 706 â 13.
dc.identifier.citedreferenceKhanna D, Lin CJ, Spotswood H, Siegel J, Jahreis A, Denton CP, et al. Evaluation of American College of Rheumatology provisional Composite Response Index in Systemic Sclerosis (ACR CRISS) in a phase 3 randomized controlled trial [abstract]. Arthritis Rheumatol 2018; 70 Suppl 10. URL: https://acrabstracts.org/abstract/evaluation-of-american-college-of-rheumatology-provisional-composite-response-index-in-systemic-sclerosis-acr-criss-in-a-phase-3-randomized-controlled-trial/.
dc.identifier.citedreferenceSpiera R, Hummers L, Chung L, Frech T, Domsic R, Hsu V, et al. Safety and efficacy of lenabasum (JBTâ 101) in diffuse cutaneous systemic sclerosis subjects treated for one year in an openâ label extension of trial JBT101â SScâ 001 [abstract]. Ann Rheum Dis 2018; Suppl 2: 52.
dc.identifier.citedreferenceSargent JL, Milano A, Bhattacharyya S, Varga J, Connolly MK, Chang HY, et al. A TGFβâ responsive gene signature is associated with a subset of diffuse scleroderma with increased disease severity. J Invest Dermatol 2010; 130: 694 â 705.
dc.identifier.citedreferenceFrantz C, Auffray C, Avouac J, Allanore Y. Regulatory T cells in systemic sclerosis. Front Immunol 2018; 9: 2356.
dc.identifier.citedreferenceLangdon K, Haleagrahara N. Regulatory Tâ cell dynamics with abatacept treatment in rheumatoid arthritis. Int Rev Immunol 2018; 37: 206 â 14.
dc.identifier.citedreferenceMerrill JT, Burgosâ Vargas R, Westhovens R, Chalmers A, D’Cruz D, Wallace DJ, et al. The efficacy and safety of abatacept in patients with nonâ lifeâ threatening manifestations of systemic lupus erythematosus: results of a twelveâ month, multicenter, exploratory, phase IIb, randomized, doubleâ blind, placeboâ controlled trial. Arthritis Rheum 2010; 62: 3077 â 87.
dc.identifier.citedreferenceLangford CA, Monach PA, Specks U, Seo P, Cuthbertson D, McAlear CA, et al. An openâ label trial of abatacept (CTLA4â IG) in nonâ severe relapsing granulomatosis with polyangiitis (Wegener’s). Ann Rheum Dis 2014; 73: 1376 â 9.
dc.identifier.citedreferenceKhanna D, Furst DE, Hays RD, Park GS, Wong WK, Seibold JR, et al. Minimally important difference in diffuse systemic sclerosis: results from the Dâ penicillamine study. Ann Rheum Dis 2006; 65: 1325 â 9.
dc.identifier.citedreferenceWiese AB, Berrocal VJ, Furst DE, Seibold JR, Merkel PA, Mayes MD, et al. Correlates and responsiveness to change of measures of skin and musculoskeletal disease in early diffuse systemic sclerosis. Arthritis Care Res (Hoboken) 2014; 66: 1731 â 9.
dc.identifier.citedreferenceHerrick AL, Peytrignet S, Lunt M, Pan X, Hesselstrand R, Mouthon L, et al. Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study. Ann Rheum Dis 2018; 77: 563 â 70.
dc.identifier.citedreferenceShand L, Lunt M, Nihtyanova S, Hoseini M, Silman A, Black CM, et al. Relationship between change in skin score and disease outcome in diffuse cutaneous systemic sclerosis: application of a latent linear trajectory model. Arthritis Rheum 2007; 56: 2422 â 31.
dc.identifier.citedreferenceDenton CP, Khanna D. Systemic sclerosis. Lancet 2017; 390: 1685 â 99.
dc.identifier.citedreferenceKowalâ Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis 2017; 76: 1327 â 39.
dc.identifier.citedreferenceKalogerou A, Gelou E, Mountantonakis S, Settas L, Zafiriou E, Sakkas L. Early T cell activation in the skin from patients with systemic sclerosis. Ann Rheum Dis 2005; 64: 1233 â 5.
dc.identifier.citedreferenceRoumm AD, Whiteside TL, Medsger TA Jr, Rodnan GP. Lymphocytes in the skin of patients with progressive systemic sclerosis: quantification, subtyping, and clinical correlations. Arthritis Rheum 1984; 27: 645 â 53.
dc.identifier.citedreferenceFleischmajer R, Perlish JS, Reeves JR. Cellular infiltrates in scleroderma skin. Arthritis Rheum 1977; 20: 975 â 84.
dc.identifier.citedreferenceAssassi S, Khanna D, Hinchcliff M, Steen VD, Hant F, Gordon JK, et al. Cell type specific gene expression analysis of early systemic sclerosis skin shows a prominent activation pattern of innate and adaptive immune system in the Prospective Registry for Early Systemic Sclerosis (PRESS) cohort [abstract]. Arthritis Rheumatol 2017; 69 Suppl 10. URL: https://acrabstracts.org/abstract/cell-type-specific-gene-expression-analysis-of-early-systemic-sclerosis-skin-shows-a-prominent-activation-pattern-of-innate-and-adaptive-immune-system-in-the-prospective-registry-for-early-system/.
dc.identifier.citedreferencePonsoye M, Frantz C, Ruzehaji N, Nicco C, Elhai M, Ruiz B, et al. Treatment with abatacept prevents experimental dermal fibrosis and induces regression of established inflammationâ driven fibrosis. Ann Rheum Dis 2016; 75: 2142 â 9.
dc.identifier.citedreferenceBoleto G, Guignabert C, Pezet S, Cauvet A, Sadoine J, Tu L, et al. Tâ cell costimulation blockade is effective in experimental digestive and lung tissue fibrosis. Arthritis Res Ther 2018; 20: 197.
dc.identifier.citedreferenceChakravarty EF, Martyanov V, Fiorentino D, Wood TA, Haddon DJ, Jarrell JA, et al. Gene expression changes reflect clinical response in a placeboâ controlled randomized trial of abatacept in patients with diffuse cutaneous systemic sclerosis. Arthritis Res Ther 2015; 17: 159.
dc.identifier.citedreferenceVan den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 2013; 65: 2737 â 47.
dc.identifier.citedreferenceLeRoy EC, Medsger TA Jr. Criteria for the classification of early systemic sclerosis. J Rheumatol 2001; 28: 1573 â 6.
dc.identifier.citedreferenceKhanna D, Furst DE, Clements PJ, Allanore Y, Baron M, Czirjak L, et al. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord 2017; 2: 11 â 8.
dc.identifier.citedreferenceMilano A, Pendergrass SA, Sargent JL, George LK, McCalmont TH, Connolly MK, et al. Molecular subsets in the gene expression signatures of scleroderma skin. PLoS One 2008; 3: e2696.
dc.identifier.citedreferenceKhanna D, Clements PJ, Furst DE, Korn JH, Ellman M, Rothfield N, et al, for the Relaxin Investigators and the Scleroderma Clinical Trials Consortium. Recombinant human relaxin in the treatment of systemic sclerosis with diffuse cutaneous involvement: a randomized, doubleâ blind, placeboâ controlled trial. Arthritis Rheum 2009; 60: 1102 â 11.
dc.identifier.citedreferenceKhanna D, Berrocal VJ, Giannini EH, Seibold JR, Merkel PA, Mayes MD, et al. The American College of Rheumatology provisional Composite Response Index for clinical trials in early diffuse cutaneous Systemic Sclerosis. Arthritis Rheumatol 2016; 68: 299 â 311.
dc.identifier.citedreferenceKhanna D, Clements PJ, Volkmann ER, Wilhalme H, Tseng CH, Furst DE, et al. Minimal clinically important differences for the modified Rodnan skin score: results from the Scleroderma Lung Studies (SLSâ I and SLSâ II). Arthritis Res Ther 2019; 21: 23.
dc.identifier.citedreferenceAmjadi S, Maranian P, Furst DE, Clements PJ, Wong WK, Postlethwaite AE, et al, for the Investigators of the Dâ Penicillamine, Human RecombinantRelaxin, and Oral Bovine Type I Collagen Clinical Trials. Course of the modified Rodnan skin thickness score in systemic sclerosis clinical trials: analysis of three large multicenter, doubleâ blind, randomized controlled trials. Arthritis Rheum 2009; 60: 2490 â 8.
dc.identifier.citedreferenceKhanna D, Lin CJ, Kuwana M, Allanore Y, Batalov A, Butrimiene I, et al. Efficacy and safety of tocilizumab for the treatment of systemic sclerosis: results from a phase 3 randomized controlled trial. Arthritis Rheumatol 2018, 70 Suppl 10. URL: https://acrabstracts.org/abstract/efficacy-and-safety-of-tocilizumab-for-the-treatment-of-systemic-sclerosis-results-from-a-phase-3-randomized-controlled-trial/.
dc.identifier.citedreferenceKhanna D, Denton CP, Jahreis A, van Laar JM, Frech TM, Anderson ME, et al. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. Lancet 2016; 387: 2630 â 40.
dc.identifier.citedreferenceDomsic RT, Rodriguezâ Reyna T, Lucas M, Fertig N, Medsger TA Jr. Skin thickness progression rate: a predictor of mortality and early internal organ involvement in diffuse scleroderma. Ann Rheum Dis 2011; 70: 104 â 9.
dc.identifier.citedreferenceClements PJ, Hurwitz EL, Wong WK, Seibold JR, Mayes M, White B, et al. Skin thickness score as a predictor and correlate of outcome in systemic sclerosis: highâ dose versus lowâ dose penicillamine trial. Arthritis Rheum 2000; 43: 2445 â 54.
dc.owningcollnameInterdisciplinary and Peer-Reviewed


Files in this item

Show simple item record

Remediation of Harmful Language

The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.

Accessibility

If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.