Advanced search
1 file | 875.56 KB

Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis

(2018) ACTA CLINICA BELGICA. 73(2). p.119-125
Author
Organization
Abstract
OBJECTIVES: Following results in open-label studies of rituximab in patients with systemic sclerosis, a Belgian three-centre initiative was launched to explore safety and efficacy of rituximab in early, diffuse cutaneous systemic sclerosis (dcSSc). METHODS: Open-label study of 17 patients with early dcSSc, treated with two courses of rituximab, at month 0 and 6. Clinical examination, lung function testing, echocardiography, disease activity score (DAS) and functional status were performed at baseline and over 24 months of follow-up. RESULTS: Modified Rodnan skin score (MRSS) changed significantly over time, with a mean of 25.5 (standard deviation [SD] 6.0) at baseline to 12.6 (SD 5.1) at month 24 (Mixed Model Analysis [MMA] p < 0.0001), which is a decrease of 51% at month 24 vs. baseline. DAS showed significant decrease over the total study period, with a score of 4.1 (SD 1.7) at baseline to 1.5 (SD 1.8) at month 24 (MMA p < 0.0001). Additionally, this was significant at all time points vs. baseline, both for MRSS and DAS. Internal organ status remained clinically stable throughout the study period. No statistically significant differences compared to baseline were found at the follow-up time points. Seven serious adverse events took place, all except for one, considered unrelated to study medication. CONCLUSIONS: This is the first multicentre Belgian collaboration investigating potential efficacy of rituximab in early dcSSc. Rituximab appears to be safe and tolerable and it may have beneficial effects on skin involvement, on overall disease activity and on stabilization of internal organ status in early dcSSc.
Keywords
Systemic sclerosis, anti-CD20 therapy, clinical outcome, clinical trial, early severe diffuse scleroderma, rituximab

Downloads

  • (...).pdf
    • full text
    • |
    • UGent only
    • |
    • PDF
    • |
    • 875.56 KB

Citation

Please use this url to cite or link to this publication:

Chicago
Melsens, Karin, Els Vandecasteele, Ellen Deschepper, Valérie Badot, Daniel Blockmans, Guy Brusselle, Ellen De Langhe, et al. 2018. “Two Years Follow-up of an Open-label Pilot Study of Treatment with Rituximab in Patients with Early Diffuse Cutaneous Systemic Sclerosis.” Acta Clinica Belgica 73 (2): 119–125.
APA
Melsens, K., Vandecasteele, E., Deschepper, E., Badot, V., Blockmans, D., Brusselle, G., De Langhe, E., et al. (2018). Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis. ACTA CLINICA BELGICA, 73(2), 119–125.
Vancouver
1.
Melsens K, Vandecasteele E, Deschepper E, Badot V, Blockmans D, Brusselle G, et al. Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis. ACTA CLINICA BELGICA. 2018;73(2):119–25.
MLA
Melsens, Karin, Els Vandecasteele, Ellen Deschepper, et al. “Two Years Follow-up of an Open-label Pilot Study of Treatment with Rituximab in Patients with Early Diffuse Cutaneous Systemic Sclerosis.” ACTA CLINICA BELGICA 73.2 (2018): 119–125. Print.
@article{8539382,
  abstract     = {OBJECTIVES: Following results in open-label studies of rituximab in patients with systemic sclerosis, a Belgian three-centre initiative was launched to explore safety and efficacy of rituximab in early, diffuse cutaneous systemic sclerosis (dcSSc).
METHODS: Open-label study of 17 patients with early dcSSc, treated with two courses of rituximab, at month 0 and 6. Clinical examination, lung function testing, echocardiography, disease activity score (DAS) and functional status were performed at baseline and over 24 months of follow-up.
RESULTS: Modified Rodnan skin score (MRSS) changed significantly over time, with a mean of 25.5 (standard deviation [SD] 6.0) at baseline to 12.6 (SD 5.1) at month 24 (Mixed Model Analysis [MMA] p {\textlangle} 0.0001), which is a decrease of 51\% at month 24 vs. baseline. DAS showed significant decrease over the total study period, with a score of 4.1 (SD 1.7) at baseline to 1.5 (SD 1.8) at month 24 (MMA p {\textlangle} 0.0001). Additionally, this was significant at all time points vs. baseline, both for MRSS and DAS. Internal organ status remained clinically stable throughout the study period. No statistically significant differences compared to baseline were found at the follow-up time points. Seven serious adverse events took place, all except for one, considered unrelated to study medication.
CONCLUSIONS: This is the first multicentre Belgian collaboration investigating potential efficacy of rituximab in early dcSSc. Rituximab appears to be safe and tolerable and it may have beneficial effects on skin involvement, on overall disease activity and on stabilization of internal organ status in early dcSSc.},
  author       = {Melsens, Karin and Vandecasteele, Els and Deschepper, Ellen and Badot, Val{\'e}rie and Blockmans, Daniel and Brusselle, Guy and De Langhe, Ellen and De Pauw, Michel and Debusschere, Claire and Decuman, Saskia and Deroo, Liselotte and Houssiau, Fr{\'e}d{\'e}ric and Lenaerts, Jan and PIETTE, YVES and Thevissen, Kristof and Vanthuyne, Marie and Westhovens, Ren{\'e} and Wijnant, Sara and De Keyser, Filip and Smith, Vanessa},
  issn         = {1784-3286},
  journal      = {ACTA CLINICA BELGICA},
  language     = {eng},
  number       = {2},
  pages        = {119--125},
  title        = {Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis},
  url          = {http://dx.doi.org/10.1080/17843286.2017.1372244},
  volume       = {73},
  year         = {2018},
}

Altmetric
View in Altmetric
Web of Science
Times cited: