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

J 2024

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

DEODHAR, Atul; Jerzy SUPRONIK; Alan KIVITZ; Guillermo VALENZUELA; Karen KAPUR et al.

Základní údaje

Originální název

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

Autoři

DEODHAR, Atul; Jerzy SUPRONIK; Alan KIVITZ; Guillermo VALENZUELA; Karen KAPUR; Susanne ROHRER; Eva DOKOUPILOVÁ; Hanno B RICHARDS a Karel PAVELKA

Vydání

ARTHRITIS & RHEUMATOLOGY, HOBOKEN, WILEY, 2024, 2326-5191

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30226 Rheumatology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 10.900

Kód RIV

RIV/00216224:14160/24:00139082

Organizační jednotka

Farmaceutická fakulta

DOI

https://doi.org/10.1002/art.42993

UT WoS

001346128700001

EID Scopus

2-s2.0-85208040404

Klíčová slova anglicky

adult; axial spondyloarthritis; clinical trial; controlled study; double blind procedure; drug therapy; female; human; intravenous drug administration; male; middle aged; phase 3 clinical trial; randomized controlled trial; treatment outcome

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 17. 3. 2025 09:50, Ing. Richard Heger, Ph.D.

Anotace

V originále

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.

Citovat

DEODHAR, Atul; Jerzy SUPRONIK; Alan KIVITZ; Guillermo VALENZUELA; Karen KAPUR; Susanne ROHRER; Eva DOKOUPILOVÁ; Hanno B RICHARDS a Karel PAVELKA. Efficacy and Safety of Intravenous Secukinumab in Patients With Active Axial Spondyloarthritis: Results From a Randomized, Placebo-Controlled, Phase 3 Study. ARTHRITIS & RHEUMATOLOGY. HOBOKEN: WILEY, 2024, roč. 77, č. 2, s. 163-170. ISSN 2326-5191. Dostupné z: https://doi.org/10.1002/art.42993.

@article{2484658,
   author = {Deodhar, Atul and Supronik, Jerzy and Kivitz, Alan and Valenzuela, Guillermo and Kapur, Karen and Rohrer, Susanne and Dokoupilová, Eva and Richards, Hanno B and Pavelka, Karel},
   article_location = {HOBOKEN},
   article_number = {2},
   doi = {https://doi.org/10.1002/art.42993},
   keywords = {adult; axial spondyloarthritis; clinical trial; controlled study; double blind procedure; drug therapy; female; human; intravenous drug administration; male; middle aged; phase 3 clinical trial; randomized controlled trial; treatment outcome},
   language = {eng},
   issn = {2326-5191},
   journal = {ARTHRITIS & RHEUMATOLOGY},
   title = {Efficacy and Safety of Intravenous Secukinumab in Patients With Active Axial Spondyloarthritis: Results From a Randomized, Placebo-Controlled, Phase 3 Study},
   url = {https://www.webofscience.com/wos/woscc/full-record/WOS:001346128700001},
   volume = {77},
   year = {2024}
}

TY  - JOUR
ID  - 2484658
AU  - Deodhar, Atul - Supronik, Jerzy - Kivitz, Alan - Valenzuela, Guillermo - Kapur, Karen - Rohrer, Susanne - Dokoupilová, Eva - Richards, Hanno B - Pavelka, Karel
PY  - 2024
TI  - Efficacy and Safety of Intravenous Secukinumab in Patients With Active Axial Spondyloarthritis: Results From a Randomized, Placebo-Controlled, Phase 3 Study
JF  - ARTHRITIS & RHEUMATOLOGY
VL  - 77
IS  - 2
SP  - 163-170
EP  - 163-170
PB  - WILEY
SN  - 23265191
KW  - adult
KW  - axial spondyloarthritis
KW  - clinical trial
KW  - controlled study
KW  - double blind procedure
KW  - drug therapy
KW  - female
KW  - human
KW  - intravenous drug administration
KW  - male
KW  - middle aged
KW  - phase 3 clinical trial
KW  - randomized controlled trial
KW  - treatment outcome
UR  - https://www.webofscience.com/wos/woscc/full-record/WOS:001346128700001
N2  - 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.
ER  -

DEODHAR, Atul; Jerzy SUPRONIK; Alan KIVITZ; Guillermo VALENZUELA; Karen KAPUR; Susanne ROHRER; Eva DOKOUPILOVÁ; Hanno B RICHARDS a Karel PAVELKA. Efficacy and Safety of Intravenous Secukinumab in Patients With Active Axial Spondyloarthritis: Results From a Randomized, Placebo-Controlled, Phase 3 Study. \textit{ARTHRITIS \&{}amp; RHEUMATOLOGY}. HOBOKEN: WILEY, 2024, roč.~77, č.~2, s.~163-170. ISSN~2326-5191. Dostupné z: https://doi.org/10.1002/art.42993.

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