Journalartikel
Autorenliste: Khanna, Dinesh; Denton, Christopher P.; Lin, Celia J. F.; van Laar, Jacob M.; Frech, Tracy M.; Anderson, Marina E.; Baron, Murray; Chung, Lorinda; Fierlbeck, Gerhard; Lakshminarayanan, Santhanam; Allanore, Yannick; Pope, Janet E.; Riemekasten, Gabriela; Steen, Virginia; Mueller-Ladner, Ulf; Spotswood, Helen; Burke, Laura; Siegel, Jeffrey; Jahreis, Angelika; Furst, Daniel E.
Jahr der Veröffentlichung: 2018
Seiten: 212-220
Zeitschrift: Annals of the Rheumatic Diseases
Bandnummer: 77
Heftnummer: 2
ISSN: 0003-4967
eISSN: 1468-2060
Open Access Status: Hybrid
DOI Link: https://doi.org/10.1136/annrheumdis-2017-211682
Verlag: Elsevier
Objectives Assess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study. Methods Patients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96. Results Overall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96. Observed mean (SD (95%CI)) change from baseline in mRSS was -3.1 (6.3 (-5.4 to -0.9)) for placebo and -5.6 (9.1 (-8.9 to-2.4)) for tocilizumab at week 48 and -9.4 (5.6 (-8.9 to -2.4)) for placebo-tocilizumab and -9.1 (8.7 (-12.5 to -5.6)) for continuous-tocilizumab at week 96. Of patients who completed week 96, any decline in %pFVC was observed for 10/24 (42% (95%CI 22% to 63%)) placebo-tocilizumab and 12/26 (46% (95%CI 27% to 67%)) continuous-tocilizumab patients in the open-label period; no patients had >10%absolute decline in %pFVC. Serious infection rates/100 patient-years (95%CI) were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind period by week 48 and 19.6 (7.2 to 42.7) with placebo-tocilizumab and 0.0 (0.0 to 12.2) with continuous-tocilizumab during the open-label period. Conclusions Skin score improvement and FVC stabilisation in the double-blind period were observed in placebo-treated patients who transitioned to tocilizumab and were maintained in the open-label period. Safety data indicated increased serious infections in patients with SSc but no new safety signals with tocilizumab. Trial registration number NCT01532869; Results.
Abstract:
Zitierstile
Harvard-Zitierstil: Khanna, D., Denton, C., Lin, C., van Laar, J., Frech, T., Anderson, M., et al. (2018) Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate), Annals of the Rheumatic Diseases, 77(2), pp. 212-220. https://doi.org/10.1136/annrheumdis-2017-211682
APA-Zitierstil: Khanna, D., Denton, C., Lin, C., van Laar, J., Frech, T., Anderson, M., Baron, M., Chung, L., Fierlbeck, G., Lakshminarayanan, S., Allanore, Y., Pope, J., Riemekasten, G., Steen, V., Mueller-Ladner, U., Spotswood, H., Burke, L., Siegel, J., Jahreis, A., ...Furst, D. (2018). Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Annals of the Rheumatic Diseases. 77(2), 212-220. https://doi.org/10.1136/annrheumdis-2017-211682
Schlagwörter
CLINICAL-TRIAL; DMARDs (biologic); DOUBLE-BLIND; LUNG-DISEASE; PLACEBO; PULSE CYCLOPHOSPHAMIDE; SCLERODERMA; STEM-CELL TRANSPLANTATION; systemic sclerosis (SSc); targeted therapy; TOCILIZUMAB
