Treatment outcome in early diffuse cutaneous systemic sclerosis: the European Scleroderma Observational Study (ESOS)

Autor: Herrick, A, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Mouthon, L, Silman, A, Brown, E, Czirják, L, Distler, J, Distler, O, Fligelstone, K, Gregory, W, Ochiel, R, Vonk, M, Ancuţa, C, Ong, V, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, A, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, F, Agard, C, Anderson, M, Diot, E, Madhok, R, Akil, M, Buch, M, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, Macgregor, A, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, P, Fauchais, A, Hachulla, E, Hamilton, J, İnanç, M, McLaren, J, Van Laar, J, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, D, Grange, C, Trad, G, Denton, C
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Adult
Male
Methotrexate/therapeutic use
RNA Polymerase III/immunology
Antibodies
Antinuclear/immunology
Systemic Sclerosis
Severity of Illness Index
Cohort Studies
Early Medical Intervention
Journal Article
Humans
Prospective Studies
Cyclophosphamide
Autoantibodies
Nuclear Proteins
RNA Polymerase III
Mycophenolic Acid/therapeutic use
Clinical and Epidemiological Research
Middle Aged
Mycophenolic Acid
Scleroderma
Diffuse/drug therapy
Treatment
Europe
Survival Rate
Methotrexate
Treatment Outcome
DNA Topoisomerases
Type I
Cyclophosphamide/therapeutic use
Antibodies
Antinuclear
Scleroderma
Diffuse
Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5]
Immunosuppressive Agents/therapeutic use
Nuclear Proteins/immunology
Female
Autoantibodies/immunology
Immunosuppressive Agents
Zdroj: Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid
Consejería de Sanidad de la Comunidad de Madrid
Annals of the Rheumatic Diseases, 76, 7, pp. 1207-1218
Annals of the Rheumatic Diseases
Herrick, A L, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Mouthon, L, Silman, A, Brown, E, Czirják, L, Distler, J H W, Distler, O, Fligelstone, K, Gregory, W J, Ochiel, R, Vonk, M, Ancuţa, C, Ong, V H, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, A C, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, F C, Agard, C, Anderson, M E, Diot, E, Madhok, R, Akil, M, Buch, M H, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, A J, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, P E, Fauchais, A L, Hachulla, E, Hamilton, J, Inanc, M, McLaren, J S, van Laar, J M, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, D J, Grange, C, Trad, G-S & Denton, C P 2017, ' Treatment outcome in early diffuse cutaneous systemic sclerosis : the European Scleroderma Observational Study (ESOS) ', Annals of the Rheumatic Diseases, vol. 76, no. 7, pp. 1207-1218 . https://doi.org/10.1136/annrheumdis-2016-210503
Annals of the Rheumatic Diseases, 76, 1207-1218
Annals of the rheumatic diseases
Herrick, A L, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Mouthon, L, Silman, A, Brown, E, Czirják, L, Distler, J H W, Distler, O, Fligelstone, K, Gregory, W J, Ochiel, R, Vonk, M, Ancuţa, C, Ong, V H, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, A C, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, F C, Agard, C, Anderson, M E, Diot, E, Madhok, R, Akil, M, Buch, M H, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, A J, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, P E, Fauchais, A L, Hachulla, E, Hamilton, J, İnanç, M, McLaren, J S, van Laar, J M, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, D J, Grange, C, Trad, G-S & Denton, C P 2017, ' Treatment outcome in early diffuse cutaneous systemic sclerosis : the European Scleroderma Observational Study (ESOS) ', Annals of the Rheumatic Diseases, vol. 76, no. 7, pp. 1207-1218 . https://doi.org/10.1136/annrheumdis-2016-210503
Herrick, A, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Luc Mouthon, P, Silman, A, Brown, E, Czirják, L, Distler, J H, Distler, O, Fligelstone, K, Gregory, W J, Ochiel, R, Vonk, M C, Ancuţa, C, Ong, V H, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, A C, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, F C, Agard, C, Anderson, M E, Diot, E, Madhok, R, Akil, M, Buch, M, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, A J, McHugh, N J, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, P E, Fauchais, A L, Hachulla, E, Hamilton, J, Inanç, M, McLaren, J S, van Laar, J M, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, D J, Grange, C, Trad, G-S & Denton, C P 2017, ' Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis : The European Scleroderma Observational Study [ESOS] ', Annals of the rheumatic diseases, vol. 76, pp. 1207-1218 . https://doi.org/10.1136/annrheumdis-2016-210503
ISSN: 0003-4967
1207-1218
DOI: 10.1136/annrheumdis-2016-210503
Popis: 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. Trial Registration Number: NCT02339441.
Databáze: OpenAIRE
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