Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial

Dinesh Khanna; Christopher P. Denton; Angelika Jahreis; Jacob M. van Laar; Tracy M. Frech; Marina E. Anderson; Murray Baron; Lorinda Chung; Gerhard Fierlbeck; Santhanam Lakshminarayanan; Yannick Allanore; Janet E. Pope; Gabriela Riemekasten; Virginia Steen; Ulf Müller-Ladner; Robert Lafyatis; Giuseppina Stifano; Helen Spotswood; Haiyin Chen-Harris; Sebastian Dziadek; Alyssa Morimoto; Thierry Sornasse; Jeffrey Siegel; Daniel E. Furst

doi:10.1016/S0140-6736(16)00232-4

Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial

Dinesh Khanna^*, Christopher P. Denton, Angelika Jahreis, Jacob M. van Laar, Tracy M. Frech, Marina E. Anderson, Murray Baron, Lorinda Chung, Gerhard Fierlbeck, Santhanam Lakshminarayanan, Yannick Allanore, Janet E. Pope, Gabriela Riemekasten, Virginia Steen, Ulf Müller-Ladner, Robert Lafyatis, Giuseppina Stifano, Helen Spotswood, Haiyin Chen-Harris, Sebastian DziadekAlyssa Morimoto, Thierry Sornasse, Jeffrey Siegel, Daniel E. Furst

^*Korrespondierende/r Autor/-in für diese Arbeit

Klinik für Rheumatologie und klinische Immunologie

606 Zitate (Scopus)

Abstract

Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind, placebo-controlled study at 35 hospitals in Canada, France, Germany, the UK, and the USA. We enrolled adults with progressive systemic sclerosis of 5 or fewer years' duration from first non-Raynaud's sign or symptom. Patients were randomly assigned (1:1) to weekly subcutaneous tocilizumab 162 mg or placebo. The primary endpoint was the difference in mean change from baseline in modified Rodnan skin score at 24 weeks. This study is registered with ClinicalTrials.gov, number NCT01532869. Findings We enrolled 87 patients: 43 assigned to tocilizumab and 44 assigned to placebo. The least squares mean change in modified Rodnan skin score at 24 weeks was −3·92 in the tocilizumab group and −1·22 in the placebo group (difference −2·70, 95% CI −5·85 to 0·45; p=0·0915). The least squares mean change at 48 weeks was −6·33 in the tocilizumab group and −2·77 in the placebo group (treatment difference −3·55, 95% CI −7·23 to 0·12; p=0·0579). In one of several exploratory analyses, fewer patients in the tocilizumab group than in the placebo group had a decline in percent predicted forced vital capacity at 48 weeks (p=0·0373). However, we detected no significant difference in disability, fatigue, itching, or patient or clinician global disease severity. 42 (98%) of 43 patients in the tocilizumab group versus 40 (91%) of 44 in the placebo group had adverse events. 14 (33%) versus 15 (34%) had serious adverse events. Serious infections were more common in the tocilizumab group (seven [16%] of 43 patients) than in the placebo group (two [5%] of 44). One patient died in relation to tocilizumab treatment. Interpretation Tocilizumab was not associated with a significant reduction in skin thickening. However, the difference was greater in the tocilizumab group than in the placebo group and we found some evidence of less decline in forced vital capacity. The efficacy and safety of tocilizumab should be investigated in a phase 3 trial before definitive conclusions can be made about its risks and benefits. Funding F Hoffmann-La Roche, Genentech.

Originalsprache	Englisch
Zeitschrift	The Lancet
Jahrgang	387
Ausgabenummer	10038
Seiten (von - bis)	2630-2640
Seitenumfang	11
ISSN	0140-6736
DOIs	https://doi.org/10.1016/S0140-6736(16)00232-4
Publikationsstatus	Veröffentlicht - 25.06.2016

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DK has received grants from Bristol-Myers Squibb, Genentech/Roche, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Patient-Centered Outcomes Research Institute, and the Scleroderma Foundation; and consultancy fees from Actelion, Bayer, Cytori, EMD Serono (Merck), Genkyotex, Gilead, GlaxoSmithKline, Genentech/Roche, Sanofi-Aventis, and Seattle Genetics. CPD has received grants from CSL Behring and GlaxoSmithKline (paid to his institution); consultancy fees from GlaxoSmithKline and Roche (paid to his institution); consultancy fees from Merck-Serono; and speaker fees from Actelion and Bayer. AJ is an employee of and owns stock options in Genentech and has been issued a patent for subcutaneously administered tocilizumab (US 8580264 B2). JMvL has received honoraria from Merck Sharp & Dohme, Pfizer, Roche, and Eli Lilly. MEA has received advisory board and related fees from Actelion and honoraria from Actelion and Bristol-Myers Squibb and has served as principal investigator of clinical trials for Actelion and Roche. LC has served on an advisory board for Gilead and a data monitoring committee for Cytori. YA has received grants from Bristol-Myers Squibb, Roche/Genentech, Inventiva, Pfizer, Sanofi, and Servier; and personal fees from Actelion, Bayer, Roche/Genentech, Inventiva, Medac, Pfizer, Sanofi, Servier, and UCB. JEP has received research and consulting fees from Roche and consulting fees from Actelion, Bayer, Biogen, Celgene, and Genentech. GR has received honoraria for lectures and advisory boards from Actelion, Bayer, GlaxoSmithKline, Pfizer, and Roche. VS has received a grant and advisory board fees from Roche. UM-L has received grants and speaker or advisory board fees from Roche and Chugai. RL has received grants from Shire, Sanofi, Regeneron, Genentech, UCB, Human Genome Sciences, Precision Dermatology, Biogen, Bristol-Myers Squibb, Inception, Stromedix, Pfizer, Boston University, Bristol-Myers Squibb, and PRISM; and consultancy fees from Shire, Sanofi, Regeneron, Roche/Genentech, Biogen, Lycera, Novartis, Celgene, Bristol-Myers Squibb, Amira, Celdara, Celltex, Dart Therapeutics, Idera, Inception, Intermune, Medimmune, Precision Dermatology, Promedior, Zwitter, PRISM, UCB, Actelion, EMD Serono, Akros, Extera, Reneo, Scholar Rock, and Merck. HS is an employee of Roche Products and owns stock in Roche. HC-H is an employee of Genentech. SD is an employee of Roche Diagnostics/F Hoffmann-La Roche. AM and JS are employees of Genentech. TS is an employee of Genentech, and holds stocks, stock options, or bond holdings in Genentech. DEF has received grants from AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, National Institutes of Health, Novartis, Pfizer, Roche/Genentech, UCB; consultancy fees from AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GlaxoSmith Kline, National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, UCB; and speaker fees from AbbVie, Actelion, and UCB. The remaining authors declare no competing interests.

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SDG 3 – Gesundheit und Wohlergehen

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Forschungsschwerpunkt: Infektion und Entzündung - Zentrum für Infektions- und Entzündungsforschung Lübeck (ZIEL)

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10.1016/S0140-6736(16)00232-4

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Khanna, D., Denton, C. P., Jahreis, A., van Laar, J. M., Frech, T. M., Anderson, M. E., Baron, M., Chung, L., Fierlbeck, G., Lakshminarayanan, S., Allanore, Y., Pope, J. E., Riemekasten, G., Steen, V., Müller-Ladner, U., Lafyatis, R., Stifano, G., Spotswood, H., Chen-Harris, H., ... Furst, D. E. (2016). Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. The Lancet, 387(10038), 2630-2640. https://doi.org/10.1016/S0140-6736(16)00232-4

@article{3baa804a1d4245f68e71ffeb23f88faf,

title = "Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial",

abstract = "Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind, placebo-controlled study at 35 hospitals in Canada, France, Germany, the UK, and the USA. We enrolled adults with progressive systemic sclerosis of 5 or fewer years' duration from first non-Raynaud's sign or symptom. Patients were randomly assigned (1:1) to weekly subcutaneous tocilizumab 162 mg or placebo. The primary endpoint was the difference in mean change from baseline in modified Rodnan skin score at 24 weeks. This study is registered with ClinicalTrials.gov, number NCT01532869. Findings We enrolled 87 patients: 43 assigned to tocilizumab and 44 assigned to placebo. The least squares mean change in modified Rodnan skin score at 24 weeks was −3·92 in the tocilizumab group and −1·22 in the placebo group (difference −2·70, 95\% CI −5·85 to 0·45; p=0·0915). The least squares mean change at 48 weeks was −6·33 in the tocilizumab group and −2·77 in the placebo group (treatment difference −3·55, 95\% CI −7·23 to 0·12; p=0·0579). In one of several exploratory analyses, fewer patients in the tocilizumab group than in the placebo group had a decline in percent predicted forced vital capacity at 48 weeks (p=0·0373). However, we detected no significant difference in disability, fatigue, itching, or patient or clinician global disease severity. 42 (98\%) of 43 patients in the tocilizumab group versus 40 (91\%) of 44 in the placebo group had adverse events. 14 (33\%) versus 15 (34\%) had serious adverse events. Serious infections were more common in the tocilizumab group (seven [16\%] of 43 patients) than in the placebo group (two [5\%] of 44). One patient died in relation to tocilizumab treatment. Interpretation Tocilizumab was not associated with a significant reduction in skin thickening. However, the difference was greater in the tocilizumab group than in the placebo group and we found some evidence of less decline in forced vital capacity. The efficacy and safety of tocilizumab should be investigated in a phase 3 trial before definitive conclusions can be made about its risks and benefits. Funding F Hoffmann-La Roche, Genentech.",

author = "Dinesh Khanna and Denton, \{Christopher P.\} and Angelika Jahreis and \{van Laar\}, \{Jacob M.\} and Frech, \{Tracy M.\} and Anderson, \{Marina E.\} and Murray Baron and Lorinda Chung and Gerhard Fierlbeck and Santhanam Lakshminarayanan and Yannick Allanore and Pope, \{Janet E.\} and Gabriela Riemekasten and Virginia Steen and Ulf M{\"u}ller-Ladner and Robert Lafyatis and Giuseppina Stifano and Helen Spotswood and Haiyin Chen-Harris and Sebastian Dziadek and Alyssa Morimoto and Thierry Sornasse and Jeffrey Siegel and Furst, \{Daniel E.\}",

note = "Funding Information: DK has received grants from Bristol-Myers Squibb, Genentech/Roche, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Patient-Centered Outcomes Research Institute, and the Scleroderma Foundation; and consultancy fees from Actelion, Bayer, Cytori, EMD Serono (Merck), Genkyotex, Gilead, GlaxoSmithKline, Genentech/Roche, Sanofi-Aventis, and Seattle Genetics. CPD has received grants from CSL Behring and GlaxoSmithKline (paid to his institution); consultancy fees from GlaxoSmithKline and Roche (paid to his institution); consultancy fees from Merck-Serono; and speaker fees from Actelion and Bayer. AJ is an employee of and owns stock options in Genentech and has been issued a patent for subcutaneously administered tocilizumab (US 8580264 B2). JMvL has received honoraria from Merck Sharp \& Dohme, Pfizer, Roche, and Eli Lilly. MEA has received advisory board and related fees from Actelion and honoraria from Actelion and Bristol-Myers Squibb and has served as principal investigator of clinical trials for Actelion and Roche. LC has served on an advisory board for Gilead and a data monitoring committee for Cytori. YA has received grants from Bristol-Myers Squibb, Roche/Genentech, Inventiva, Pfizer, Sanofi, and Servier; and personal fees from Actelion, Bayer, Roche/Genentech, Inventiva, Medac, Pfizer, Sanofi, Servier, and UCB. JEP has received research and consulting fees from Roche and consulting fees from Actelion, Bayer, Biogen, Celgene, and Genentech. GR has received honoraria for lectures and advisory boards from Actelion, Bayer, GlaxoSmithKline, Pfizer, and Roche. VS has received a grant and advisory board fees from Roche. UM-L has received grants and speaker or advisory board fees from Roche and Chugai. RL has received grants from Shire, Sanofi, Regeneron, Genentech, UCB, Human Genome Sciences, Precision Dermatology, Biogen, Bristol-Myers Squibb, Inception, Stromedix, Pfizer, Boston University, Bristol-Myers Squibb, and PRISM; and consultancy fees from Shire, Sanofi, Regeneron, Roche/Genentech, Biogen, Lycera, Novartis, Celgene, Bristol-Myers Squibb, Amira, Celdara, Celltex, Dart Therapeutics, Idera, Inception, Intermune, Medimmune, Precision Dermatology, Promedior, Zwitter, PRISM, UCB, Actelion, EMD Serono, Akros, Extera, Reneo, Scholar Rock, and Merck. HS is an employee of Roche Products and owns stock in Roche. HC-H is an employee of Genentech. SD is an employee of Roche Diagnostics/F Hoffmann-La Roche. AM and JS are employees of Genentech. TS is an employee of Genentech, and holds stocks, stock options, or bond holdings in Genentech. DEF has received grants from AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, National Institutes of Health, Novartis, Pfizer, Roche/Genentech, UCB; consultancy fees from AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GlaxoSmith Kline, National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, UCB; and speaker fees from AbbVie, Actelion, and UCB. The remaining authors declare no competing interests. Publisher Copyright: {\textcopyright} 2016 Elsevier Ltd Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2016",

month = jun,

day = "25",

doi = "10.1016/S0140-6736(16)00232-4",

language = "English",

volume = "387",

pages = "2630--2640",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "10038",

}

Khanna, D, Denton, CP, Jahreis, A, van Laar, JM, Frech, TM, Anderson, ME, Baron, M, Chung, L, Fierlbeck, G, Lakshminarayanan, S, Allanore, Y, Pope, JE, Riemekasten, G, Steen, V, Müller-Ladner, U, Lafyatis, R, Stifano, G, Spotswood, H, Chen-Harris, H, Dziadek, S, Morimoto, A, Sornasse, T, Siegel, J & Furst, DE 2016, 'Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial', The Lancet, Jg. 387, Nr. 10038, S. 2630-2640. https://doi.org/10.1016/S0140-6736(16)00232-4

Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. / Khanna, Dinesh; Denton, Christopher P.; Jahreis, Angelika et al.
in: The Lancet, Jahrgang 387, Nr. 10038, 25.06.2016, S. 2630-2640.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial

AU - Khanna, Dinesh

AU - Denton, Christopher P.

AU - Jahreis, Angelika

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 - Lafyatis, Robert

AU - Stifano, Giuseppina

AU - Spotswood, Helen

AU - Chen-Harris, Haiyin

AU - Dziadek, Sebastian

AU - Morimoto, Alyssa

AU - Sornasse, Thierry

AU - Siegel, Jeffrey

AU - Furst, Daniel E.

N1 - Funding Information: DK has received grants from Bristol-Myers Squibb, Genentech/Roche, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Patient-Centered Outcomes Research Institute, and the Scleroderma Foundation; and consultancy fees from Actelion, Bayer, Cytori, EMD Serono (Merck), Genkyotex, Gilead, GlaxoSmithKline, Genentech/Roche, Sanofi-Aventis, and Seattle Genetics. CPD has received grants from CSL Behring and GlaxoSmithKline (paid to his institution); consultancy fees from GlaxoSmithKline and Roche (paid to his institution); consultancy fees from Merck-Serono; and speaker fees from Actelion and Bayer. AJ is an employee of and owns stock options in Genentech and has been issued a patent for subcutaneously administered tocilizumab (US 8580264 B2). JMvL has received honoraria from Merck Sharp & Dohme, Pfizer, Roche, and Eli Lilly. MEA has received advisory board and related fees from Actelion and honoraria from Actelion and Bristol-Myers Squibb and has served as principal investigator of clinical trials for Actelion and Roche. LC has served on an advisory board for Gilead and a data monitoring committee for Cytori. YA has received grants from Bristol-Myers Squibb, Roche/Genentech, Inventiva, Pfizer, Sanofi, and Servier; and personal fees from Actelion, Bayer, Roche/Genentech, Inventiva, Medac, Pfizer, Sanofi, Servier, and UCB. JEP has received research and consulting fees from Roche and consulting fees from Actelion, Bayer, Biogen, Celgene, and Genentech. GR has received honoraria for lectures and advisory boards from Actelion, Bayer, GlaxoSmithKline, Pfizer, and Roche. VS has received a grant and advisory board fees from Roche. UM-L has received grants and speaker or advisory board fees from Roche and Chugai. RL has received grants from Shire, Sanofi, Regeneron, Genentech, UCB, Human Genome Sciences, Precision Dermatology, Biogen, Bristol-Myers Squibb, Inception, Stromedix, Pfizer, Boston University, Bristol-Myers Squibb, and PRISM; and consultancy fees from Shire, Sanofi, Regeneron, Roche/Genentech, Biogen, Lycera, Novartis, Celgene, Bristol-Myers Squibb, Amira, Celdara, Celltex, Dart Therapeutics, Idera, Inception, Intermune, Medimmune, Precision Dermatology, Promedior, Zwitter, PRISM, UCB, Actelion, EMD Serono, Akros, Extera, Reneo, Scholar Rock, and Merck. HS is an employee of Roche Products and owns stock in Roche. HC-H is an employee of Genentech. SD is an employee of Roche Diagnostics/F Hoffmann-La Roche. AM and JS are employees of Genentech. TS is an employee of Genentech, and holds stocks, stock options, or bond holdings in Genentech. DEF has received grants from AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, National Institutes of Health, Novartis, Pfizer, Roche/Genentech, UCB; consultancy fees from AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GlaxoSmith Kline, National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, UCB; and speaker fees from AbbVie, Actelion, and UCB. The remaining authors declare no competing interests. Publisher Copyright: © 2016 Elsevier Ltd Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2016/6/25

Y1 - 2016/6/25

N2 - Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind, placebo-controlled study at 35 hospitals in Canada, France, Germany, the UK, and the USA. We enrolled adults with progressive systemic sclerosis of 5 or fewer years' duration from first non-Raynaud's sign or symptom. Patients were randomly assigned (1:1) to weekly subcutaneous tocilizumab 162 mg or placebo. The primary endpoint was the difference in mean change from baseline in modified Rodnan skin score at 24 weeks. This study is registered with ClinicalTrials.gov, number NCT01532869. Findings We enrolled 87 patients: 43 assigned to tocilizumab and 44 assigned to placebo. The least squares mean change in modified Rodnan skin score at 24 weeks was −3·92 in the tocilizumab group and −1·22 in the placebo group (difference −2·70, 95% CI −5·85 to 0·45; p=0·0915). The least squares mean change at 48 weeks was −6·33 in the tocilizumab group and −2·77 in the placebo group (treatment difference −3·55, 95% CI −7·23 to 0·12; p=0·0579). In one of several exploratory analyses, fewer patients in the tocilizumab group than in the placebo group had a decline in percent predicted forced vital capacity at 48 weeks (p=0·0373). However, we detected no significant difference in disability, fatigue, itching, or patient or clinician global disease severity. 42 (98%) of 43 patients in the tocilizumab group versus 40 (91%) of 44 in the placebo group had adverse events. 14 (33%) versus 15 (34%) had serious adverse events. Serious infections were more common in the tocilizumab group (seven [16%] of 43 patients) than in the placebo group (two [5%] of 44). One patient died in relation to tocilizumab treatment. Interpretation Tocilizumab was not associated with a significant reduction in skin thickening. However, the difference was greater in the tocilizumab group than in the placebo group and we found some evidence of less decline in forced vital capacity. The efficacy and safety of tocilizumab should be investigated in a phase 3 trial before definitive conclusions can be made about its risks and benefits. Funding F Hoffmann-La Roche, Genentech.

AB - Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind, placebo-controlled study at 35 hospitals in Canada, France, Germany, the UK, and the USA. We enrolled adults with progressive systemic sclerosis of 5 or fewer years' duration from first non-Raynaud's sign or symptom. Patients were randomly assigned (1:1) to weekly subcutaneous tocilizumab 162 mg or placebo. The primary endpoint was the difference in mean change from baseline in modified Rodnan skin score at 24 weeks. This study is registered with ClinicalTrials.gov, number NCT01532869. Findings We enrolled 87 patients: 43 assigned to tocilizumab and 44 assigned to placebo. The least squares mean change in modified Rodnan skin score at 24 weeks was −3·92 in the tocilizumab group and −1·22 in the placebo group (difference −2·70, 95% CI −5·85 to 0·45; p=0·0915). The least squares mean change at 48 weeks was −6·33 in the tocilizumab group and −2·77 in the placebo group (treatment difference −3·55, 95% CI −7·23 to 0·12; p=0·0579). In one of several exploratory analyses, fewer patients in the tocilizumab group than in the placebo group had a decline in percent predicted forced vital capacity at 48 weeks (p=0·0373). However, we detected no significant difference in disability, fatigue, itching, or patient or clinician global disease severity. 42 (98%) of 43 patients in the tocilizumab group versus 40 (91%) of 44 in the placebo group had adverse events. 14 (33%) versus 15 (34%) had serious adverse events. Serious infections were more common in the tocilizumab group (seven [16%] of 43 patients) than in the placebo group (two [5%] of 44). One patient died in relation to tocilizumab treatment. Interpretation Tocilizumab was not associated with a significant reduction in skin thickening. However, the difference was greater in the tocilizumab group than in the placebo group and we found some evidence of less decline in forced vital capacity. The efficacy and safety of tocilizumab should be investigated in a phase 3 trial before definitive conclusions can be made about its risks and benefits. Funding F Hoffmann-La Roche, Genentech.

UR - https://www.scopus.com/pages/publications/84978920193

U2 - 10.1016/S0140-6736(16)00232-4

DO - 10.1016/S0140-6736(16)00232-4

M3 - Journal articles

C2 - 27156934

AN - SCOPUS:84978920193

SN - 0140-6736

VL - 387

SP - 2630

EP - 2640

JO - The Lancet

JF - The Lancet

IS - 10038

ER -

Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial

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