Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years

C. Charles-Schoeman, JT. Giles, NE. Lane, E. Choy, DE. Furst, J. Vencovský, AG. Wilson, GR. Burmester, D. Coombs, SK. Penn, N. Khan, JB. Yee, K. Rahawi, IB. McInnes

. 2024 ; 11 (1) : 157-175. [pub] 20240105

Status neindexováno Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc24005914

INTRODUCTION: Upadacitinib (UPA) is a Janus kinase inhibitor that has demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA) with an acceptable safety profile. We investigated laboratory parameter changes in UPA RA clinical trials. METHODS: Pooled data from six randomized trials in the SELECT phase 3 program were included. Key laboratory parameters and safety data were measured for UPA 15 and 30 mg once daily (QD), adalimumab (ADA) 40 mg every other week + methotrexate (MTX), and MTX monotherapy. Exposure-adjusted event rates (EAERs) of adverse events were calculated. RESULTS: A total of 3209 patients receiving UPA 15 mg QD (10 782.7 patient-years [PY]), 1204 patients receiving UPA 30 mg QD (3162.5 PY), 579 patients receiving ADA + MTX (1573.2 PY), and 314 patients receiving MTX monotherapy (865.1 PY) were included, representing up to 6.5 years of total exposure. Decreases in mean levels of hemoglobin, neutrophils, and lymphocytes, and increases in mean levels of liver enzymes and creatinine phosphokinase were observed with UPA, with grade 3 or 4 changes observed in some patients. Mean low- and high-density lipoprotein cholesterol ratios remained stable for patients receiving UPA 15 mg QD. EAERs of anemia and neutropenia occurred at generally consistent rates between UPA and active comparators (3.1-4.3 and 1.7-5.0 events [E]/100 PY across treatment groups, respectively). Rates of hepatic disorder were higher with MTX monotherapy, UPA 15 mg and UPA 30 mg (10.8, 9.7, and 11.0 E/100 PY, respectively) versus ADA + MTX (6.4 E/100 PY). Rates of lymphopenia were highest with MTX monotherapy (3.2 E/100 PY). Treatment discontinuations due to laboratory-related events were rare, occurring in 1.1% and 2.2% of patients treated with UPA 15 and 30 mg QD, respectively. CONCLUSIONS: The results of this integrated long-term analysis of laboratory parameters continue to support an acceptable safety profile of UPA 15 mg QD for moderate-to-severe RA.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc24005914
003      
CZ-PrNML
005      
20240412130903.0
007      
ta
008      
240405s2024 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1007/s40744-023-00624-3 $2 doi
035    __
$a (PubMed)38180720
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Charles-Schoeman, Christina $u University of California, 1000 Veteran Avenue, Rm 32-59, Los Angeles, CA, 90095, USA. ccharles@mednet.ucla.edu $1 https://orcid.org/0000000217687019
245    10
$a Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years / $c C. Charles-Schoeman, JT. Giles, NE. Lane, E. Choy, DE. Furst, J. Vencovský, AG. Wilson, GR. Burmester, D. Coombs, SK. Penn, N. Khan, JB. Yee, K. Rahawi, IB. McInnes
520    9_
$a INTRODUCTION: Upadacitinib (UPA) is a Janus kinase inhibitor that has demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA) with an acceptable safety profile. We investigated laboratory parameter changes in UPA RA clinical trials. METHODS: Pooled data from six randomized trials in the SELECT phase 3 program were included. Key laboratory parameters and safety data were measured for UPA 15 and 30 mg once daily (QD), adalimumab (ADA) 40 mg every other week + methotrexate (MTX), and MTX monotherapy. Exposure-adjusted event rates (EAERs) of adverse events were calculated. RESULTS: A total of 3209 patients receiving UPA 15 mg QD (10 782.7 patient-years [PY]), 1204 patients receiving UPA 30 mg QD (3162.5 PY), 579 patients receiving ADA + MTX (1573.2 PY), and 314 patients receiving MTX monotherapy (865.1 PY) were included, representing up to 6.5 years of total exposure. Decreases in mean levels of hemoglobin, neutrophils, and lymphocytes, and increases in mean levels of liver enzymes and creatinine phosphokinase were observed with UPA, with grade 3 or 4 changes observed in some patients. Mean low- and high-density lipoprotein cholesterol ratios remained stable for patients receiving UPA 15 mg QD. EAERs of anemia and neutropenia occurred at generally consistent rates between UPA and active comparators (3.1-4.3 and 1.7-5.0 events [E]/100 PY across treatment groups, respectively). Rates of hepatic disorder were higher with MTX monotherapy, UPA 15 mg and UPA 30 mg (10.8, 9.7, and 11.0 E/100 PY, respectively) versus ADA + MTX (6.4 E/100 PY). Rates of lymphopenia were highest with MTX monotherapy (3.2 E/100 PY). Treatment discontinuations due to laboratory-related events were rare, occurring in 1.1% and 2.2% of patients treated with UPA 15 and 30 mg QD, respectively. CONCLUSIONS: The results of this integrated long-term analysis of laboratory parameters continue to support an acceptable safety profile of UPA 15 mg QD for moderate-to-severe RA.
590    __
$a NEINDEXOVÁNO
655    _2
$a časopisecké články $7 D016428
700    1_
$a Giles, Jon T $u Columbia University, New York, NY, USA $1 https://orcid.org/0000000287920402
700    1_
$a Lane, Nancy E $u University of California Davis, Sacramento, CA, USA $1 https://orcid.org/0000000201772198
700    1_
$a Choy, Ernest $u CREATE Centre, Cardiff University, Cardiff, UK $1 https://orcid.org/0000000344598609
700    1_
$a Furst, Daniel E $u Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA $1 https://orcid.org/0000000240187629
700    1_
$a Vencovský, Jiří $u Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic $u Institute of Rheumatology, Na Slupi 4, 12850, Prague, Czech Republic $1 https://orcid.org/0000000208510713 $7 jo20000080529
700    1_
$a Wilson, Anthony G $u Center for Arthritis Research, Conway Institute, University College Dublin, Dublin, Ireland $1 https://orcid.org/0000000348553926
700    1_
$a Burmester, Gerd R $u Charité-Universitätsmedizin Berlin, Berlin, Germany $1 https://orcid.org/0000000175181131
700    1_
$a Coombs, Derek $u AbbVie Inc., North Chicago, IL, USA
700    1_
$a Penn, Sara K $u AbbVie Inc., North Chicago, IL, USA
700    1_
$a Khan, Nasser $u AbbVie Inc., North Chicago, IL, USA
700    1_
$a Yee, Jillian B $u AbbVie Inc., North Chicago, IL, USA
700    1_
$a Rahawi, Kassim $u AbbVie Inc., North Chicago, IL, USA
700    1_
$a McInnes, Iain B $u College of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, UK $1 https://orcid.org/0000000264624280
773    0_
$w MED00207609 $t Rheumatology and therapy $x 2198-6576 $g Roč. 11, č. 1 (2024), s. 157-175
856    41
$u https://pubmed.ncbi.nlm.nih.gov/38180720 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20240405 $b ABA008
991    __
$a 20240412130856 $b ABA008
999    __
$a ok $b bmc $g 2076066 $s 1215676
BAS    __
$a 3
BAS    __
$a PreBMC-PubMed-not-MEDLINE
BMC    __
$a 2024 $b 11 $c 1 $d 157-175 $e 20240105 $i 2198-6576 $m Rheumatology and therapy $n Rheumatol Ther $x MED00207609
LZP    __
$a Pubmed-20240405

Najít záznam

Citační ukazatele

Možnosti archivace