Highly selective tyrosine kinase 2 inhibition with zasocitinib
(TAK-279) improves outcomes in patients with active psoriatic
arthritis: a randomised phase 2b study

J 2025

Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study

KIVITZ, Alan; Xenofon BARALIAKOS; Elena Tomaselli MUENSTERMAN; Arthur KAVANAUGH; van der Heijde DESIREE et al.

Základní údaje

Originální název

Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study

Autoři

Vydání

Annals of the Rheumatic Diseases, London, ELSEVIER, 2025, 0003-4967

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: 20.600 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14160/25:00143929

Organizační jednotka

Farmaceutická fakulta

Klíčová slova anglicky

Psoriatic arthritis; Adults; Middle aged; Aged; Zasocitinib; Protein kinase inhibitors; Antirheumatic agents; Randomized controlled trial; Double-blind method; Phase 2 clinical trial; Disease activity;

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 10. 3. 2026 12:40, Mgr. Irena Doubková

Anotace

V originále

Objectives: To assess the efficacy, safety, and tolerability of the investigational, oral, allosteric, highly selective, and potent tyrosine kinase 2 inhibitor zasocitinib (TAK-279) in patients with active psoriatic arthritis (PsA). Methods: In this phase 2b, randomised, multicentre, double-blind, placebo-controlled, multiple-dose study, patients (>= 18 years, with PsA symptoms for >= 6 months) received 30 mg, 15 mg, or 5 mg zasocitinib or placebo (1:1:1:1) once daily for 12 weeks, with a 4-week safety follow-up. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12. Secondary efficacy endpoints included ACR50 response, ACR70 response, Psoriasis Area and Severity Index (PASI) 75 response among those with >= 3% body surface area at baseline and minimal disease activity (MDA) at week 12. Results: Overall, 290 patients (mean [SD] age, 49.9 [11.6] years; 57.2% female) received treatment. At week 12, 30 mg or 15 mg zasocitinib treatment resulted in significantly higher ACR20 responses (54.2%; P = .002 and 53.3%; P = .002, respectively) than placebo (29.2%). A numerically higher number of ACR50 responses were achieved at week 12 with 30 mg (26.4%; nominal P = .009) or 15 mg (26.7%; nominal P = .005) zasocitinib than placebo (9.7%). In addition, 30 mg zasocitinib demonstrated a numerically higher number of ACR70 responses (13.9% versus 5.6%, respectively; nominal P = .158), PASI 75 responses (45.7% versus 15.4%, respectively; nominal P = .002), and MDA (29.2% versus 12.5%, respectively; nominal P = .014) at week 12 versus placebo. In this small study of limited duration, most adverse events were mild/moderate and were more frequently observed in the higher dose group. In this small sample size, no new safety signals or clear dose-dependent laboratory parameter changes were identified. Conclusions: Here, 30 mg and 15 mg zasocitinib demonstrated efficacy across core domains in patients with active PsA with no new safety signals. These findings will be confirmed in ongoing larger studies of longer duration.

Citovat

KIVITZ, Alan; Xenofon BARALIAKOS; Elena Tomaselli MUENSTERMAN; Arthur KAVANAUGH; van der Heijde DESIREE; Piotr A KLIMIUK; Guillermo VALENZUELA; Eva DOKOUPILOVÁ; Gabrielle POIRIER; Bhaskar SRIVASTAVA; Sue DASEN; Xinyan ZHANG; Ting HONG; Jingjing CHEN; Peter POTHULA; Haoling Holly WENG; Mona TRIVEDI a Apinya LERTRATANAKUL. Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study. Annals of the Rheumatic Diseases. London: ELSEVIER, 2025, roč. 84, č. 10, s. 1660-1674. ISSN 0003-4967. Dostupné z: https://doi.org/10.1016/j.ard.2025.05.023.

@article{2559465,
   author = {Kivitz, Alan and Baraliakos, Xenofon and Muensterman, Elena Tomaselli and Kavanaugh, Arthur and Desiree, van der Heijde and Klimiuk, Piotr A and Valenzuela, Guillermo and Dokoupilová, Eva and Poirier, Gabrielle and Srivastava, Bhaskar and Dasen, Sue and Zhang, Xinyan and Hong, Ting and Chen, Jingjing and Pothula, Peter and Weng, Haoling Holly and Trivedi, Mona and Lertratanakul, Apinya},
   article_location = {London},
   article_number = {10},
   doi = {https://doi.org/10.1016/j.ard.2025.05.023},
   keywords = {Psoriatic arthritis; Adults; Middle aged; Aged; Zasocitinib; Protein kinase inhibitors; Antirheumatic agents; Randomized controlled trial; Double-blind method; Phase 2 clinical trial; Disease activity;},
   language = {eng},
   issn = {0003-4967},
   journal = {Annals of the Rheumatic Diseases},
   title = {Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study},
   url = {https://www.sciencedirect.com/science/article/pii/S0003496725010416?pes=vor&utm_source=clarivate&getft_integrator=clarivate},
   volume = {84},
   year = {2025}
}

TY  - JOUR
ID  - 2559465
AU  - Kivitz, Alan - Baraliakos, Xenofon - Muensterman, Elena Tomaselli - Kavanaugh, Arthur - Desiree, van der Heijde - Klimiuk, Piotr A - Valenzuela, Guillermo - Dokoupilová, Eva - Poirier, Gabrielle - Srivastava, Bhaskar - Dasen, Sue - Zhang, Xinyan - Hong, Ting - Chen, Jingjing - Pothula, Peter - Weng, Haoling Holly - Trivedi, Mona - Lertratanakul, Apinya
PY  - 2025
TI  - Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study
JF  - Annals of the Rheumatic Diseases
VL  - 84
IS  - 10
SP  - 1660-1674
EP  - 1660-1674
PB  - ELSEVIER
SN  - 00034967
KW  - Psoriatic arthritis
KW  - Adults
KW  - Middle aged
KW  - Aged
KW  - Zasocitinib
KW  - Protein kinase inhibitors
KW  - Antirheumatic agents
KW  - Randomized controlled trial
KW  - Double-blind method
KW  - Phase 2 clinical trial
KW  - Disease activity;
UR  - https://www.sciencedirect.com/science/article/pii/S0003496725010416?pes=vor&utm_source=clarivate&getft_integrator=clarivate
N2  - Objectives: To assess the efficacy, safety, and tolerability of the investigational, oral, allosteric, highly selective, and potent tyrosine kinase 2 inhibitor zasocitinib (TAK-279) in patients with active psoriatic arthritis (PsA). Methods: In this phase 2b, randomised, multicentre, double-blind, placebo-controlled, multiple-dose study, patients (>= 18 years, with PsA symptoms for >= 6 months) received 30 mg, 15 mg, or 5 mg zasocitinib or placebo (1:1:1:1) once daily for 12 weeks, with a 4-week safety follow-up. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12. Secondary efficacy endpoints included ACR50 response, ACR70 response, Psoriasis Area and Severity Index (PASI) 75 response among those with >= 3% body surface area at baseline and minimal disease activity (MDA) at week 12. Results: Overall, 290 patients (mean [SD] age, 49.9 [11.6] years; 57.2% female) received treatment. At week 12, 30 mg or 15 mg zasocitinib treatment resulted in significantly higher ACR20 responses (54.2%; P = .002 and 53.3%; P = .002, respectively) than placebo (29.2%). A numerically higher number of ACR50 responses were achieved at week 12 with 30 mg (26.4%; nominal P = .009) or 15 mg (26.7%; nominal P = .005) zasocitinib than placebo (9.7%). In addition, 30 mg zasocitinib demonstrated a numerically higher number of ACR70 responses (13.9% versus 5.6%, respectively; nominal P = .158), PASI 75 responses (45.7% versus 15.4%, respectively; nominal P = .002), and MDA (29.2% versus 12.5%, respectively; nominal P = .014) at week 12 versus placebo. In this small study of limited duration, most adverse events were mild/moderate and were more frequently observed in the higher dose group. In this small sample size, no new safety signals or clear dose-dependent laboratory parameter changes were identified. Conclusions: Here, 30 mg and 15 mg zasocitinib demonstrated efficacy across core domains in patients with active PsA with no new safety signals. These findings will be confirmed in ongoing larger studies of longer duration.
ER  -

KIVITZ, Alan; Xenofon BARALIAKOS; Elena Tomaselli MUENSTERMAN; Arthur KAVANAUGH; van der Heijde DESIREE; Piotr A KLIMIUK; Guillermo VALENZUELA; Eva DOKOUPILOVÁ; Gabrielle POIRIER; Bhaskar SRIVASTAVA; Sue DASEN; Xinyan ZHANG; Ting HONG; Jingjing CHEN; Peter POTHULA; Haoling Holly WENG; Mona TRIVEDI a Apinya LERTRATANAKUL. Highly selective tyrosine kinase 2 inhibition with zasocitinib (TAK-279) improves outcomes in patients with active psoriatic arthritis: a randomised phase 2b study. \textit{Annals of the Rheumatic Diseases}. London: ELSEVIER, 2025, roč.~84, č.~10, s.~1660-1674. ISSN~0003-4967. Dostupné z: https://doi.org/10.1016/j.ard.2025.05.023.

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