Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study
Carregando...
Citações na Scopus
149
Tipo de produção
article
Data de publicação
2019
Editora
BMJ PUBLISHING GROUP
Indexadores
Título da Revista
ISSN da Revista
Título do Volume
Autores
ELHAI, Muriel
BOUBAYA, Marouane
DISTLER, Oliver
SMITH, Vanessa
MATUCCI-CERINIC, Marco
SANCHO, Juan Jose Alegre
TRUCHETET, Marie-Elise
BRAUN-MOSCOVICI, Yolanda
IANNONE, Florenzo
NOVIKOV, Pavel I.
Autor de Grupo de pesquisa
EUSTAR Network
Editores
Coordenadores
Organizadores
Citação
ANNALS OF THE RHEUMATIC DISEASES, v.78, n.7, p.979-987, 2019
Resumo
Objective To assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice. Methods We performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab. Results 254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47-5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55-1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56-3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83-9.62]; p=0.019 as compared with controls vs 3 [0.66-5.35]; p=0.012). Conclusion Rituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.
Palavras-chave
Referências
- A CR Meet, EFF SAF TOC TREATM S
- Austin PC, 2011, MULTIVAR BEHAV RES, V46, P119, DOI 10.1080/00273171.2011.540480
- Boleto G, SEMIN ARTHRITIS RHEU
- Bosello S, 2010, ARTHRITIS RES THER, V12, DOI 10.1186/ar2965
- Bosello SL, 2015, SEMIN ARTHRITIS RHEU, V44, P428, DOI 10.1016/j.semarthrit.2014.09.002
- Daoussis D, 2017, SEMIN ARTHRITIS RHEU, V46, P625, DOI 10.1016/j.semarthrit.2016.10.003
- Daoussis D, 2012, ARTHRITIS RES THER, V14, DOI 10.1186/ar3879
- Daoussis D, 2010, RHEUMATOLOGY, V49, P271, DOI 10.1093/rheumatology/kep093
- Dobrota R, 2016, ANN RHEUM DIS, V75, P1743, DOI 10.1136/annrheumdis-2015-208024
- Elhai M, 2017, ANN RHEUM DIS, V76, P1897, DOI 10.1136/annrheumdis-2017-211448
- Elhai M, 2013, AUTOIMMUN REV, V12, P1052, DOI 10.1016/j.autrev.2013.05.002
- Elhai M, 2012, RHEUMATOLOGY, V51, P1017, DOI 10.1093/rheumatology/ker269
- Fernandez-Codina A, 2018, ARTHRITIS RHEUMATOL, V70, P1820, DOI 10.1002/art.40560
- Frieden TR, 2017, NEW ENGL J MED, V377, P465, DOI 10.1056/NEJMra1614394
- Giuggioli D, 2015, AUTOIMMUN REV, V14, P1072, DOI 10.1016/j.autrev.2015.07.008
- Guillevin L, 2012, RHEUMATOLOGY, V51, P460, DOI 10.1093/rheumatology/ker271
- Hachulla E, 2009, RHEUMATOLOGY, V48, P304, DOI 10.1093/rheumatology/ken488
- Jordan S, 2015, ANN RHEUM DIS, V74, P1188, DOI 10.1136/annrheumdis-2013-204522
- Khanna D, 2017, J SCLERODERMA RELAT, V2, P11, DOI 10.5301/jsrd.5000231
- Kumanovics G, 2017, RHEUMATOLOGY, V56, pV53, DOI 10.1093/rheumatology/kex202
- Lafyatis R, 2009, ARTHRITIS RHEUM, V60, P578, DOI 10.1002/art.24249
- Le Gouellec N, 2017, PLOS ONE, V12, DOI 10.1371/journal.pone.0181692
- Maurer B, 2015, ANN RHEUM DIS, V74, P1124, DOI 10.1136/annrheumdis-2014-205226
- Meier FMP, 2012, ANN RHEUM DIS, V71, P1355, DOI 10.1136/annrheumdis-2011-200742
- Melsens K, 2018, ACTA CLIN BELG, V73, P119, DOI 10.1080/17843286.2017.1372244
- Mitra R, 2016, STAT METHODS MED RES, V25, P188, DOI 10.1177/0962280212445945
- Moazedi-Fuerst FC, 2015, SCAND J RHEUMATOL, V44, P519, DOI 10.3109/03009742.2015.1069888
- Moazedi-Fuerst FC, 2014, SCAND J RHEUMATOL, V43, P257, DOI 10.3109/03009742.2013.869617
- Muangchan C, 2013, CLIN EXP RHEUMATOL, V31, pS122
- Oldroyd AGS, 2018, RHEUMATOLOGY, V57, P1089, DOI 10.1093/rheumatology/key036
- Saketkoo LA, 2018, J RHEUMATOL, V45, P297, DOI 10.3899/jrheum.180062
- Sircar G, 2018, RHEUMATOLOGY, V57, P2106, DOI 10.1093/rheumatology/key213
- Smith V, 2010, ANN RHEUM DIS, V69, P193, DOI 10.1136/ard.2008.095463
- Smith V, 2016, J RHEUMATOL, V43, P995, DOI 10.3899/jrheum.151018
- Smith V, 2013, J RHEUMATOL, V40, P52, DOI 10.3899/jrheum.120778
- STEEN VD, 1982, ANN INTERN MED, V97, P652, DOI 10.7326/0003-4819-97-5-652
- Steen VD, 2001, ARTHRITIS RHEUM, V44, P2828, DOI 10.1002/1529-0131(200112)44:12<2828::AID-ART470>3.0.CO;2-U
- Tashkin DP, 2016, LANCET RESP MED, V4, P708, DOI 10.1016/S2213-2600(16)30152-7
- Thiebaut M, 2018, AUTOIMMUN REV, V17, P582, DOI 10.1016/j.autrev.2017.12.010
- Tyndall AJ, 2010, ANN RHEUM DIS, V69, P1809, DOI 10.1136/ard.2009.114264
- van den Hoogen F, 2013, ANN RHEUM DIS, V72, P1747, DOI 10.1136/annrheumdis-2013-204424
- Varga J, 2017, J SCLERODERMA RELAT, V2, P137, DOI 10.5301/jsrd.5000249
- Vettori S, 2010, SCAND J RHEUMATOL, V39, P485, DOI 10.3109/03009741003781985
- Vilela VS, 2016, REV BRAS REUMATOL, V56, P458, DOI [10.1016/j.rbr.2016.04.001, 10.1016/j.rbre.2016.06.003]
- Volkmann ER, 2016, ANN AM THORAC SOC, V13, P2045, DOI 10.1513/AnnalsATS.201606-426FR
- Wang MTM, 2015, JAMA INTERN MED, V175, P1571, DOI 10.1001/jamainternmed.2015.2147
- White IR, 2011, STAT MED, V30, P377, DOI 10.1002/sim.4067