Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 245.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Deprecated: Implicit conversion from float 245.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534
Warning: imagejpeg(C:\Inetpub\vhosts\kidney.de\httpdocs\phplern\29644080
.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Lupus+Sci+Med
2018 ; 5
(1
): e000252
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Safety, tolerability and pharmacokinetics of subcutaneous and intravenous
anifrolumab in healthy volunteers
#MMPMID29644080
Tummala R
; Rouse T
; Berglind A
; Santiago L
Lupus Sci Med
2018[]; 5
(1
): e000252
PMID29644080
show ga
OBJECTIVES: To compare the pharmacokinetics (PK), safety and tolerability of
subcutaneous (SC) and intravenous anifrolumab, an anti-type I interferon receptor
monoclonal antibody in development for SLE, in healthy volunteers. METHODS: In
this Phase I randomised, placebo-controlled study, 30 adults were assigned to
three treatment cohorts (anifrolumab 300?mg SC (n=6), anifrolumab 300?mg
intravenous (n=6), anifrolumab 600?mg SC (n=6)) and placebo (n=4/cohort). Serial
blood samples were collected up to Day 84 to measure anifrolumab concentrations
and antidrug antibodies (ADAs). PK parameters were estimated by noncompartmental
analysis. RESULTS: Maximum serum concentrations in SC cohorts occurred after 4-7
days. Anifrolumab serum concentrations were below the limit of detection in all
individuals by Day 84. Exposure to SC anifrolumab increased dose proportionally
from 300?mg to 600?mg based on area under the serum concentration-time curve.
Anifrolumab 300?mg SC exposure reached 87% of the intravenous exposure.
Anifrolumab 300?mg SC and placebo administration elicited minimal injection-site
reactions. Transient injection-site induration occurred in five of six
individuals after anifrolumab 600?mg SC and two of four individuals after
placebo. Transient, mild to moderate injection-site induration and pruritus
occurred simultaneously in two of six individuals after anifrolumab 600?mg SC.
Adverse events were reported by 50% (n=9) of anifrolumab-treated individuals and
33% (n=4) of placebo-treated individuals. ADAs were detected in only one
individual in the anifrolumab 300-mg intravenous group at the Day 84 assessment.
CONCLUSION: Anifrolumab 300-mg SC exposure was 87% of intravenous administration,
with single SC anifrolumab administrations well tolerated in healthy volunteers.