• Je něco špatně v tomto záznamu ?

Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase 3 Study

A. Kivitz, L. Sedova, M. Churchill, R. Kotha, A. Singhal, A. Torres, G. Valenzuela, S. Whelan, T. Dumortier, X. Zhu, R. Martin, L. Pricop

. 2025 ; 77 (2) : 171-179. [pub] 20241017

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze III, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc25010128

Grantová podpora
Novartis Pharmaceuticals Corporation

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of intravenous (IV) secukinumab in patients with active psoriatic arthritis (PsA). METHODS: INVIGORATE-2 (NCT04209205) was a randomized, placebo-controlled, phase 3 trial. Patients with active PsA were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks [q4w]) or placebo. At week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg q4w), and patients who received IV secukinumab continued treatment through week 52. The primary efficacy endpoint was achievement of 50% improvement in American College of Rheumatology response criteria (ACR50) at week 16. Efficacy and safety were evaluated through weeks 52 and 60, respectively. RESULTS: Among 191 patients randomized to IV secukinumab and 190 to placebo/IV secukinumab, 177 (92.7%) and 170 (89.5%) completed the entire study period, respectively. A significantly higher proportion of patients who received IV secukinumab versus placebo achieved ACR50 at week 16 (31.4% vs 6.3%; adjusted P < 0.0001). All secondary efficacy endpoints were met at week 16 (all adjusted P < 0.05 using the predefined hypothesis-testing hierarchy). Patients who switched from placebo to secukinumab at week 16 showed rapid improvements in ACR50 rates; by week 52, both treatment arms experienced similar improvements in efficacy outcomes. No new or unexpected safety signals were observed with receiving IV secukinumab. One death was reported in the placebo group before week 16. CONCLUSION: IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25010128
003      
CZ-PrNML
005      
20250429135403.0
007      
ta
008      
250415s2025 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1002/art.42997 $2 doi
035    __
$a (PubMed)39300596
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Kivitz, Alan $u Altoona Center for Clinical Research, Duncansville, Pennsylvania $1 https://orcid.org/0000000210451310
245    10
$a Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase 3 Study / $c A. Kivitz, L. Sedova, M. Churchill, R. Kotha, A. Singhal, A. Torres, G. Valenzuela, S. Whelan, T. Dumortier, X. Zhu, R. Martin, L. Pricop
520    9_
$a OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of intravenous (IV) secukinumab in patients with active psoriatic arthritis (PsA). METHODS: INVIGORATE-2 (NCT04209205) was a randomized, placebo-controlled, phase 3 trial. Patients with active PsA were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks [q4w]) or placebo. At week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg q4w), and patients who received IV secukinumab continued treatment through week 52. The primary efficacy endpoint was achievement of 50% improvement in American College of Rheumatology response criteria (ACR50) at week 16. Efficacy and safety were evaluated through weeks 52 and 60, respectively. RESULTS: Among 191 patients randomized to IV secukinumab and 190 to placebo/IV secukinumab, 177 (92.7%) and 170 (89.5%) completed the entire study period, respectively. A significantly higher proportion of patients who received IV secukinumab versus placebo achieved ACR50 at week 16 (31.4% vs 6.3%; adjusted P < 0.0001). All secondary efficacy endpoints were met at week 16 (all adjusted P < 0.05 using the predefined hypothesis-testing hierarchy). Patients who switched from placebo to secukinumab at week 16 showed rapid improvements in ACR50 rates; by week 52, both treatment arms experienced similar improvements in efficacy outcomes. No new or unexpected safety signals were observed with receiving IV secukinumab. One death was reported in the placebo group before week 16. CONCLUSION: IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously.
650    _2
$a lidé $7 D006801
650    12
$a psoriatická artritida $x farmakoterapie $7 D015535
650    12
$a humanizované monoklonální protilátky $x aplikace a dávkování $x terapeutické užití $7 D061067
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé středního věku $7 D008875
650    _2
$a dospělí $7 D000328
650    _2
$a výsledek terapie $7 D016896
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a intravenózní podání $7 D061605
650    _2
$a antirevmatika $x terapeutické užití $x aplikace a dávkování $7 D018501
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a multicentrická studie $7 D016448
700    1_
$a Sedova, Liliana $u Institute of Rheumatology and Charles University in Prague, Prague, Czech Republic
700    1_
$a Churchill, Melvin $u Arthritis Center of Nebraska, Lincoln
700    1_
$a Kotha, Roshan $u Sharp Community Medical Group, La Mesa, California
700    1_
$a Singhal, Atul $u SouthWest Arthritis Research Group, Mesquite, Texas
700    1_
$a Torres, Alexander $u Highlands Advanced Rheumatology and Arthritis Center, Avon Park, Florida
700    1_
$a Valenzuela, Guillermo $u Integral Rheumatology & Immunology Specialists, Plantation, Florida
700    1_
$a Whelan, Sarah $u Novartis Ireland Ltd, Dublin, Ireland
700    1_
$a Dumortier, Thomas $u Novartis Pharma AG, Basel, Switzerland
700    1_
$a Zhu, Xuan $u Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
700    1_
$a Martin, Ruvie $u Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
700    1_
$a Pricop, Luminita $u Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
773    0_
$w MED00188151 $t Arthritis & rheumatology $x 2326-5205 $g Roč. 77, č. 2 (2025), s. 171-179
856    41
$u https://pubmed.ncbi.nlm.nih.gov/39300596 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250415 $b ABA008
991    __
$a 20250429135358 $b ABA008
999    __
$a ok $b bmc $g 2311481 $s 1247209
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 77 $c 2 $d 171-179 $e 20241017 $i 2326-5205 $m Arthritis & rheumatology $n Arthritis Rheumatol $x MED00188151
GRA    __
$p Novartis Pharmaceuticals Corporation
LZP    __
$a Pubmed-20250415

Najít záznam

Citační ukazatele

Možnosti archivace