Ruperto, Nicolino, Brunner, Hermine, I, Ramanan, Athimalaipet, V, Horneff, Gerd, Cuttica, Ruben, Henrickson, Michael, Anton, Jordi, Lucica Boteanu, Alina, Calvo Penades, Inmaculada, Minden, Kirsten, Schmeling, Heinrike, Hufnagel, Markus, Weiss, Jennifer E., Pardeo, Manuela, Nanda, Kabita, Roth, Johannes, Rubio-Perez, Nadina, Hsu, Joy C., Wimalasundera, Sunethra, Wells, Chris, Bharucha, Kamal, Douglass, Wendy, Bao, Min, Mallalieu, Navita L., Martini, Alberto, Lovell, Daniel and De Benedetti, Fabrizio (2021). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. RHEUMATOLOGY, 60 (10). S. 4568 - 4581. OXFORD: OXFORD UNIV PRESS. ISSN 1462-0332

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Abstract

Objectives. To determine s.c. tocilizumab (s.c.-TCZ) dosing regimens for systemic JIA (sJIA) and polyarticular JIA (pJIA). Methods. In two 52-week phase 1 b trials, s.c.-TCZ (162 mg/dose) was administered to sJIA patients every week or every 2 weeks (every 10 days before interim analysis) and to pJIA patients every 2 weeks or every 3 weeks with body weight >= 30 kg or <30 kg, respectively. Primary end points were pharmacokinetics, pharmacodynamics and safety; efficacy was exploratory. Comparisons were made to data from phase 3 trials with i.v. tocilizumab (i.v.-TCZ) in sJIA and pJIA. Results. Study participants were 51 sJIA patients and 52 pJIA patients aged 1-17 years who received s.c.-TCZ. Steady-state minimum TCZ concentration (C-trough) >5th percentile of that achieved with i.v.-TCZ was achieved by 49 (96%) sJIA and 52 (100%) pJIA patients. In both populations, pharmacodynamic markers of disease were similar between body weight groups. Improvements in Juvenile Arthritis DAS-71 were comparable between s.c.-TCZ and i.v.-TCZ. By week 52, 53% of sJIA patients and 31% of pJIA patients achieved clinical remission on treatment. Safety was consistent with that of i.v.-TCZ except for injection site reactions, reported by 41.2% and 28.8% of sJIA and pJIA patients, respectively. Infections were reported in 78.4% and 69.2% of patients, respectively. Two sJIA patients died; both deaths were considered to be related to TCZ. Conclusion. s.c.-TCZ provides exposure and risk/benefit profiles similar to those of i.v.-TCZ. S.c. administration provides an alternative administration route that is more convenient for patients and caregivers and that has potential for in-home use.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Ruperto, NicolinoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brunner, Hermine, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ramanan, Athimalaipet, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Horneff, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cuttica, RubenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henrickson, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anton, JordiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lucica Boteanu, AlinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Calvo Penades, InmaculadaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Minden, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmeling, HeinrikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hufnagel, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weiss, Jennifer E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pardeo, ManuelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nanda, KabitaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roth, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubio-Perez, NadinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hsu, Joy C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wimalasundera, SunethraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wells, ChrisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bharucha, KamalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Douglass, WendyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bao, MinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mallalieu, Navita L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martini, AlbertoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lovell, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Benedetti, FabrizioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-606080
DOI: 10.1093/rheumatology/keab047
Journal or Publication Title: RHEUMATOLOGY
Volume: 60
Number: 10
Page Range: S. 4568 - 4581
Date: 2021
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1462-0332
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INTERLEUKIN-6 RECEPTOR INHIBITION; RHEUMATOID-ARTHRITIS; DISEASE-ACTIVITY; DEFINING CRITERIA; JOINT INVOLVEMENT; SOLUBLE IL-6; PREFERENCES; COMBINATION; EFFICACY; ANTIBODYMultiple languages
RheumatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60608

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