• Je něco špatně v tomto záznamu ?

Efficacy and Safety of Intravenous Secukinumab in Patients With Active Axial Spondyloarthritis: Results From a Randomized, Placebo-Controlled, Phase 3 Study

A. Deodhar, J. Supronik, A. Kivitz, G. Valenzuela, K. Kapur, S. Rohrer, E. Dokoupilová, HB. Richards, K. Pavelka

. 2025 ; 77 (2) : 163-170. [pub] 20241031

Jazyk angličtina Země Spojené státy americké

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

Perzistentní odkaz   https://www.medvik.cz/link/bmc25010129

Grantová podpora
Novartis Pharmaceuticals Corporation

OBJECTIVE: Our goal was to assess the efficacy and safety of intravenous (IV) secukinumab for the treatment of adults with active axial spondyloarthritis (axSpA) in INVIGORATE-1. METHODS: INVIGORATE-1 (NCT04156620) was a randomized, double-blind, parallel-group, phase 3 trial in patients with active axSpA (either radiographic or nonradiographic). Patients were randomized one to one to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks) or IV placebo for 16 weeks. After week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg every four weeks), and patients randomized to secukinumab continued treatment through week 52. The primary endpoint was the Assessment of SpondyloArthritis International Society (ASAS40) response at week 16. Safety was evaluated through week 60. RESULTS: Among patients initially randomized to IV secukinumab (n = 264) or placebo (n = 262), 86.0% and 88.9% completed the entire 60-week study period, respectively. A higher proportion of patients receiving secukinumab versus placebo met the primary endpoint (ASAS40 response) at week 16 (40.9% vs 22.9%; P < 0.0001). By week 24, patients who switched from placebo to secukinumab at week 16 achieved ASAS40 response rates comparable to those in patients originally randomized to secukinumab. All secondary efficacy endpoints were met at week 16, and responses were sustained through week 52. No new or unexpected safety signals were observed with IV secukinumab. CONCLUSION: IV secukinumab was effective for the treatment of adults with active axSpA over 52 weeks. The safety profile was consistent with that in previous reports on subcutaneous secukinumab.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25010129
003      
CZ-PrNML
005      
20250429135403.0
007      
ta
008      
250415s2025 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1002/art.42993 $2 doi
035    __
$a (PubMed)39300513
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Deodhar, Atul $u Oregon Health and Science University, Portland, Oregon $1 https://orcid.org/0000000221301246
245    10
$a Efficacy and Safety of Intravenous Secukinumab in Patients With Active Axial Spondyloarthritis: Results From a Randomized, Placebo-Controlled, Phase 3 Study / $c A. Deodhar, J. Supronik, A. Kivitz, G. Valenzuela, K. Kapur, S. Rohrer, E. Dokoupilová, HB. Richards, K. Pavelka
520    9_
$a OBJECTIVE: Our goal was to assess the efficacy and safety of intravenous (IV) secukinumab for the treatment of adults with active axial spondyloarthritis (axSpA) in INVIGORATE-1. METHODS: INVIGORATE-1 (NCT04156620) was a randomized, double-blind, parallel-group, phase 3 trial in patients with active axSpA (either radiographic or nonradiographic). Patients were randomized one to one to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks) or IV placebo for 16 weeks. After week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg every four weeks), and patients randomized to secukinumab continued treatment through week 52. The primary endpoint was the Assessment of SpondyloArthritis International Society (ASAS40) response at week 16. Safety was evaluated through week 60. RESULTS: Among patients initially randomized to IV secukinumab (n = 264) or placebo (n = 262), 86.0% and 88.9% completed the entire 60-week study period, respectively. A higher proportion of patients receiving secukinumab versus placebo met the primary endpoint (ASAS40 response) at week 16 (40.9% vs 22.9%; P < 0.0001). By week 24, patients who switched from placebo to secukinumab at week 16 achieved ASAS40 response rates comparable to those in patients originally randomized to secukinumab. All secondary efficacy endpoints were met at week 16, and responses were sustained through week 52. No new or unexpected safety signals were observed with IV secukinumab. CONCLUSION: IV secukinumab was effective for the treatment of adults with active axSpA over 52 weeks. The safety profile was consistent with that in previous reports on subcutaneous secukinumab.
650    _2
$a lidé $7 D006801
650    12
$a humanizované monoklonální protilátky $x aplikace a dávkování $x terapeutické užití $x škodlivé účinky $7 D061067
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a dospělí $7 D000328
650    _2
$a lidé středního věku $7 D008875
650    _2
$a výsledek terapie $7 D016896
650    12
$a axiální spondyloartritida $x farmakoterapie $7 D000089183
650    _2
$a antirevmatika $x aplikace a dávkování $x terapeutické užití $x škodlivé účinky $7 D018501
650    _2
$a intravenózní podání $7 D061605
650    _2
$a monoklonální protilátky $x aplikace a dávkování $x terapeutické užití $x škodlivé účinky $7 D000911
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a klinické zkoušky, fáze III $7 D017428
700    1_
$a Supronik, Jerzy $u NZOZ Centrum Medyczne Artur Racewicz, Bialystok, Poland
700    1_
$a Kivitz, Alan $u Altoona Center for Clinical Research, Duncansville, Pennsylvania
700    1_
$a Valenzuela, Guillermo $u Integral Rheumatology and Immunology Specialists, Plantation, Florida
700    1_
$a Kapur, Karen $u Novartis Pharma AG, Basel, Switzerland
700    1_
$a Rohrer, Susanne $u Novartis Pharma AG, Basel, Switzerland
700    1_
$a Dokoupilová, Eva $u Medical Plus, s.r.o., Uherske Hradiste, Czech Republic, and Masaryk University, Brno, Czech Republic
700    1_
$a Richards, Hanno B $u Novartis Pharma AG, Basel, Switzerland
700    1_
$a Pavelka, Karel $u Charles University, Prague, Czech Republic $1 https://orcid.org/0000000319528422 $7 jn99240000847
773    0_
$w MED00188151 $t Arthritis & rheumatology $x 2326-5205 $g Roč. 77, č. 2 (2025), s. 163-170
856    41
$u https://pubmed.ncbi.nlm.nih.gov/39300513 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250415 $b ABA008
991    __
$a 20250429135359 $b ABA008
999    __
$a ok $b bmc $g 2311482 $s 1247210
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 77 $c 2 $d 163-170 $e 20241031 $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