TY - JOUR
T1 - Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: Results from the open-label period of a phase II randomised controlled trial (faSScinate)
AU - Khanna, Dinesh
AU - Denton, Christopher P.
AU - Lin, Celia J.F.
AU - Van Laar, Jacob M.
AU - Frech, Tracy M.
AU - Anderson, Marina E.
AU - Baron, Murray
AU - Chung, Lorinda
AU - Fierlbeck, Gerhard
AU - Lakshminarayanan, Santhanam
AU - Allanore, Yannick
AU - Pope, Janet E.
AU - Riemekasten, Gabriela
AU - Steen, Virginia
AU - Müller-Ladner, Ulf
AU - Spotswood, Helen
AU - Burke, Laura
AU - Siegel, Jeffrey
AU - Jahreis, Angelika
AU - Furst, Daniel E.
N1 - Funding Information:
Funding this study was funded by roche. Funding for manuscript preparation was provided by F Hoffmann-La roche Ltd.
Publisher Copyright:
© 2018 Article author(s).
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/2
Y1 - 2018/2
N2 - 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 162 mg 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%)) placebotocilizumab 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.
AB - 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 162 mg 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%)) placebotocilizumab 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.
UR - http://www.scopus.com/inward/record.url?scp=85041502058&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2017-211682
DO - 10.1136/annrheumdis-2017-211682
M3 - Journal articles
C2 - 29066464
AN - SCOPUS:85041502058
SN - 0003-4967
VL - 77
SP - 212
EP - 220
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 2
ER -