Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious

H M Lindegaard, P Johansen, G Gröndal, E.C. Jensen, L Juul, A M Schlemmer, B Agular, Inger Marie Jensen Hansen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVES: To investigate the impact of enhanced infusion rate of tocilizumab on the occurrence of infusion reactions, overall safety, and efficacy in rheumatoid arthritis (RA).

METHOD: We conducted a 24-week multicentre, open-label, randomized parallel group study comparing adverse event (AE) and effect profiles following tocilizumab IV 8 mg/kg every 4 weeks over 31 min vs. standard 60-min infusions in patients with RA and an inadequate clinical response to disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-α inhibitors.

RESULTS: A total of 47 patients were enrolled in the study and randomized to fast infusions (n = 25) and controls (n = 22). Incidences of infusion reactions were similar between the two groups, neither of them leading to withdrawal. Likewise, the incidence of additional AEs did not differ between the treatment arms. Two serious adverse events (SAEs) were reported, in the control group. Four patients withdrew due to AEs, two from each arm. Efficacy at week 24 was comparable between groups.

CONCLUSIONS: In RA, monthly tocilizumab infusions of 8 mg/kg provided over 31 or 60 min during 24 weeks did not differ concerning safety or efficacy.

OriginalsprogEngelsk
TidsskriftScandinavian Journal of Rheumatology
Vol/bind45
Udgave nummer4
Sider (fra-til)262-266
Antal sider5
ISSN0300-9742
DOI
StatusUdgivet - 4. jan. 2016

Fingeraftryk

Safety
Antirheumatic Agents
Incidence
Tumor Necrosis Factor-alpha
Control Groups
tocilizumab

Citer dette

Lindegaard, H M ; Johansen, P ; Gröndal, G ; Jensen, E.C. ; Juul, L ; Schlemmer, A M ; Agular, B ; Jensen Hansen, Inger Marie. / Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious. I: Scandinavian Journal of Rheumatology. 2016 ; Bind 45, Nr. 4. s. 262-266.
@article{7cb7a8429ebd471aaaef4d34b9854f9a,
title = "Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious",
abstract = "OBJECTIVES: To investigate the impact of enhanced infusion rate of tocilizumab on the occurrence of infusion reactions, overall safety, and efficacy in rheumatoid arthritis (RA).METHOD: We conducted a 24-week multicentre, open-label, randomized parallel group study comparing adverse event (AE) and effect profiles following tocilizumab IV 8 mg/kg every 4 weeks over 31 min vs. standard 60-min infusions in patients with RA and an inadequate clinical response to disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-α inhibitors.RESULTS: A total of 47 patients were enrolled in the study and randomized to fast infusions (n = 25) and controls (n = 22). Incidences of infusion reactions were similar between the two groups, neither of them leading to withdrawal. Likewise, the incidence of additional AEs did not differ between the treatment arms. Two serious adverse events (SAEs) were reported, in the control group. Four patients withdrew due to AEs, two from each arm. Efficacy at week 24 was comparable between groups.CONCLUSIONS: In RA, monthly tocilizumab infusions of 8 mg/kg provided over 31 or 60 min during 24 weeks did not differ concerning safety or efficacy.",
author = "Lindegaard, {H M} and P Johansen and G Gr{\"o}ndal and E.C. Jensen and L Juul and Schlemmer, {A M} and B Agular and {Jensen Hansen}, {Inger Marie}",
year = "2016",
month = "1",
day = "4",
doi = "10.3109/03009742.2015.1112030",
language = "English",
volume = "45",
pages = "262--266",
journal = "Scandinavian Journal of Rheumatology",
issn = "0300-9742",
publisher = "Taylor & Francis",
number = "4",

}

Lindegaard, HM, Johansen, P, Gröndal, G, Jensen, EC, Juul, L, Schlemmer, AM, Agular, B & Jensen Hansen, IM 2016, 'Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious', Scandinavian Journal of Rheumatology, bind 45, nr. 4, s. 262-266. https://doi.org/10.3109/03009742.2015.1112030

Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious. / Lindegaard, H M; Johansen, P; Gröndal, G; Jensen, E.C.; Juul, L; Schlemmer, A M; Agular, B; Jensen Hansen, Inger Marie.

I: Scandinavian Journal of Rheumatology, Bind 45, Nr. 4, 04.01.2016, s. 262-266.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Doubling the single-dose infusion rate of tocilizumab in rheumatoid arthritis is safe and efficacious

AU - Lindegaard, H M

AU - Johansen, P

AU - Gröndal, G

AU - Jensen, E.C.

AU - Juul, L

AU - Schlemmer, A M

AU - Agular, B

AU - Jensen Hansen, Inger Marie

PY - 2016/1/4

Y1 - 2016/1/4

N2 - OBJECTIVES: To investigate the impact of enhanced infusion rate of tocilizumab on the occurrence of infusion reactions, overall safety, and efficacy in rheumatoid arthritis (RA).METHOD: We conducted a 24-week multicentre, open-label, randomized parallel group study comparing adverse event (AE) and effect profiles following tocilizumab IV 8 mg/kg every 4 weeks over 31 min vs. standard 60-min infusions in patients with RA and an inadequate clinical response to disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-α inhibitors.RESULTS: A total of 47 patients were enrolled in the study and randomized to fast infusions (n = 25) and controls (n = 22). Incidences of infusion reactions were similar between the two groups, neither of them leading to withdrawal. Likewise, the incidence of additional AEs did not differ between the treatment arms. Two serious adverse events (SAEs) were reported, in the control group. Four patients withdrew due to AEs, two from each arm. Efficacy at week 24 was comparable between groups.CONCLUSIONS: In RA, monthly tocilizumab infusions of 8 mg/kg provided over 31 or 60 min during 24 weeks did not differ concerning safety or efficacy.

AB - OBJECTIVES: To investigate the impact of enhanced infusion rate of tocilizumab on the occurrence of infusion reactions, overall safety, and efficacy in rheumatoid arthritis (RA).METHOD: We conducted a 24-week multicentre, open-label, randomized parallel group study comparing adverse event (AE) and effect profiles following tocilizumab IV 8 mg/kg every 4 weeks over 31 min vs. standard 60-min infusions in patients with RA and an inadequate clinical response to disease-modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF)-α inhibitors.RESULTS: A total of 47 patients were enrolled in the study and randomized to fast infusions (n = 25) and controls (n = 22). Incidences of infusion reactions were similar between the two groups, neither of them leading to withdrawal. Likewise, the incidence of additional AEs did not differ between the treatment arms. Two serious adverse events (SAEs) were reported, in the control group. Four patients withdrew due to AEs, two from each arm. Efficacy at week 24 was comparable between groups.CONCLUSIONS: In RA, monthly tocilizumab infusions of 8 mg/kg provided over 31 or 60 min during 24 weeks did not differ concerning safety or efficacy.

U2 - 10.3109/03009742.2015.1112030

DO - 10.3109/03009742.2015.1112030

M3 - Journal article

VL - 45

SP - 262

EP - 266

JO - Scandinavian Journal of Rheumatology

JF - Scandinavian Journal of Rheumatology

SN - 0300-9742

IS - 4

ER -