Herrick, Ariane L., Pan, Xiaoyan, Peytrignet, Sebastien, Lunt, Mark ORCID: 0000-0002-2391-5575, Hesselstrand, Roger, Mouthon, Luc, Silman, Alan, Brown, Edith, Czirjak, Laszlo, Distler, Joerg H. W., Distler, Oliver ORCID: 0000-0002-0546-8310, Fligelstone, Kim, Gregory, William J., Ochiel, Rachel, Vonk, Madelon, Ancuta, Codrina, Ong, Voon H., Farge, Dominique, Hudson, Marie, Matucci-Cerinic, Marco, Balbir-Gurman, Alexandra, Midtvedt, Oyvind, Jordan, Alison C., Jobanputra, Paresh ORCID: 0000-0002-2712-667X, Stevens, Wendy, Moinzadeh, Pia, Hall, Frances C., Agard, Christian, Anderson, Marina E., Diot, Elisabeth, Madhok, Rajan, Akil, Mohammed, Buch, Maya H., Chung, Lorinda, Damjanov, Nemanja, Gunawardena, Harsha, Lanyon, Peter ORCID: 0000-0002-9855-6802, Ahmad, Yasmeen, Chakravarty, Kuntal, Jacobsen, Soren ORCID: 0000-0002-5654-4993, MacGregor, Alexander J., McHugh, Neil, Mueller-Ladner, Ulf, Riemekasten, Gabriela, Becker, Michael, Roddy, Janet, Carreira, Patricia E., Fauchais, Anne Laure, Hachulla, Eric, Hamilton, Jennifer, Inanc, Murat, McLaren, John S., van Laar, Jacob M., Pathare, Sanjay, Proudman, Susannah, Rudin, Anna, Sahhar, Joanne, Coppere, Brigitte, Serratrice, Christine, Sheeran, Tom, Veale, Douglas J., Grange, Claire, Trad, Georges-Selim and Denton, Christopher P. (2017). Treatment outcome in early diffuse cutaneous systemic sclerosis: the European Scleroderma Observational Study (ESOS). Ann. Rheum. Dis., 76 (7). S. 1207 - 1219. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2060

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Abstract

Objectives The rarity of early diffuse cutaneous systemic sclerosis (dcSSc) makes randomised controlled trials very difficult. We aimed to use an observational approach to compare effectiveness of currently used treatment approaches. Methods This was a prospective, observational cohort study of early dcSSc (within three years of onset of skin thickening). Clinicians selected one of four protocols for each patient: methotrexate, mycophenolate mofetil (MMF), cyclophosphamide or 'no immunosuppressant'. Patients were assessed three-monthly for up to 24 months. The primary outcome was the change in modified Rodnan skin score (mRSS). Confounding by indication at baseline was accounted for using inverse probability of treatment (IPT) weights. As a secondary outcome, an IPT-weighted Cox model was used to test for differences in survival. Results Of 326 patients recruited from 50 centres, 65 were prescribed methotrexate, 118 MMF, 87 cyclophosphamide and 56 no immunosuppressant. 276 (84.7%) patients completed 12 and 234 (71.7%) 24 months follow-up (or reached last visit date). There were statistically significant reductions in mRSS at 12 months in all groups: -4.0 (-5.2 to -2.7) units for methotrexate, -4.1 (-5.3 to -2.9) for MMF, -3.3 (-4.9 to -1.7) for cyclophosphamide and -2.2 (-4.0 to -0.3) for no immunosuppressant (p value for between-group differences=0.346). There were no statistically significant differences in survival between protocols before (p=0.389) or after weighting (p=0.440), but survival was poorest in the no immunosuppressant group (84.0%) at 24 months. Conclusions These findings may support using immunosuppressants for early dcSSc but suggest that overall benefit is modest over 12 months and that better treatments are needed.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Herrick, Ariane L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pan, XiaoyanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peytrignet, SebastienUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lunt, MarkUNSPECIFIEDorcid.org/0000-0002-2391-5575UNSPECIFIED
Hesselstrand, RogerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mouthon, LucUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Silman, AlanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brown, EdithUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Czirjak, LaszloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Distler, Joerg H. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Distler, OliverUNSPECIFIEDorcid.org/0000-0002-0546-8310UNSPECIFIED
Fligelstone, KimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gregory, William J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ochiel, RachelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vonk, MadelonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ancuta, CodrinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ong, Voon H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Farge, DominiqueUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hudson, MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Matucci-Cerinic, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balbir-Gurman, AlexandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Midtvedt, OyvindUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jordan, Alison C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jobanputra, PareshUNSPECIFIEDorcid.org/0000-0002-2712-667XUNSPECIFIED
Stevens, WendyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moinzadeh, PiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hall, Frances C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Agard, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anderson, Marina E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Diot, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Madhok, RajanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Akil, MohammedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buch, Maya H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chung, LorindaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Damjanov, NemanjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gunawardena, HarshaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lanyon, PeterUNSPECIFIEDorcid.org/0000-0002-9855-6802UNSPECIFIED
Ahmad, YasmeenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chakravarty, KuntalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jacobsen, SorenUNSPECIFIEDorcid.org/0000-0002-5654-4993UNSPECIFIED
MacGregor, Alexander J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McHugh, NeilUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller-Ladner, UlfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Riemekasten, GabrielaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Becker, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roddy, JanetUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carreira, Patricia E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fauchais, Anne LaureUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hachulla, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hamilton, JenniferUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Inanc, MuratUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McLaren, John S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Laar, Jacob M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pathare, SanjayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Proudman, SusannahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rudin, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sahhar, JoanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Coppere, BrigitteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Serratrice, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sheeran, TomUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Veale, Douglas J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grange, ClaireUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trad, Georges-SelimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Denton, Christopher P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-226993
DOI: 10.1136/annrheumdis-2016-210503
Journal or Publication Title: Ann. Rheum. Dis.
Volume: 76
Number: 7
Page Range: S. 1207 - 1219
Date: 2017
Publisher: BMJ PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1468-2060
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
HEALTH-ASSESSMENT QUESTIONNAIRE; SKIN THICKNESS SCORE; PROPENSITY SCORE; CYCLOPHOSPHAMIDE; PLACEBO; TRIALS; SURVIVAL; THERAPYMultiple languages
RheumatologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22699

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