Efficacy and safety of secukinumab in patients with
spondyloarthritis and enthesitis at the Achilles tendon:
results from a phase 3b trial

J 2022

Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial

BEHRENS, Frank, Philipp SEWERIN, Miguel Eugenio DE, Yusuf PATEL, Anastas BATALOV et. al.

Základní údaje

Originální název

Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial

Autoři

BEHRENS, Frank (garant), Philipp SEWERIN, Miguel Eugenio DE, Yusuf PATEL, Anastas BATALOV, Eva DOKOUPILOVÁ (203 Česká republika, domácí), Christine KLEINMOND, Effie POURNARA, Ankita SHEKHAWAT, Claudia JENTZSCH, Annette WIEDON a Xenofon BARALIAKOS

Vydání

RHEUMATOLOGY, OXFORD, OXFORD UNIV PRESS, 2022, 1462-0324

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.500

Kód RIV

RIV/00216224:14160/22:00126122

Organizační jednotka

Farmaceutická fakulta

DOI

http://dx.doi.org/10.1093/rheumatology/keab784

UT WoS

000789235000001

Klíčová slova anglicky

spondyloarthritis; Achilles tendon enthesitis; heel enthesitis; pain; bone marrow oedema; biologics; IL-17 inhibitor; imaging outcomes

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 31. 3. 2023 12:21, Mgr. Michal Petr

Anotace

V originále

Objective ACHILLES aimed to demonstrate efficacy of secukinumab on Achilles' tendon enthesitis in spondyloarthritis (SpA) patients. Methods Patients >= 18 years (n = 204) with active PsA or axial SpA and heel enthesitis were randomized 1:1 to secukinumab 150/300 mg or placebo up to week 24, and thereafter placebo patients were switched to secukinumab. Results At week 24, a higher, yet statistically non-significant (P = 0.136), proportion of patients in secukinumab vs placebo reported resolution of Achilles tendon enthesitis in affected foot (42.2% vs 31.4%; odds ratio [OR] = 1.63; 95% CI: 0.87, 3.08). Proportion of patients reporting resolution of enthesitis based on Leeds Enthesitis Index was higher with secukinumab vs placebo (33.3% vs 23.5%; OR = 1.65; 95% CI: 0.85, 3.25) at week 24. Mean change from baseline in heel pain at week 24 was higher in secukinumab patients vs placebo (-2.8 [3.0] vs -1.9 [2.7]). Greater improvements with secukinumab were observed in heel enthesopathy activity and global assessment of disease activity. Imaging evaluation by local reading confirmed heel enthesitis on MRI at screening for all patients. Based on central reading, 56% presented with bone marrow oedema and/or tendinitis; according to Heel Enthesitis MRI Scoring System (HEMRIS) post hoc analysis, 76% had signs of entheseal inflammation while 86% had entheseal inflammation and/or structural changes. Conclusion A substantial proportion of patients showed no signs of inflammation on the centrally read MRIs despite a clinical diagnosis of heel enthesitis, thus highlighting that the discrepancy between the clinical and imaging assessments of enthesitis requires further investigation. Although ACHILLES did not meet the primary end point, the study reported clinically meaningful improvements in patient-related outcomes.

Citovat

BEHRENS, Frank, Philipp SEWERIN, Miguel Eugenio DE, Yusuf PATEL, Anastas BATALOV, Eva DOKOUPILOVÁ, Christine KLEINMOND, Effie POURNARA, Ankita SHEKHAWAT, Claudia JENTZSCH, Annette WIEDON a Xenofon BARALIAKOS. Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial. RHEUMATOLOGY. OXFORD: OXFORD UNIV PRESS, 2022, Neuveden., November, s. 1-11. ISSN 1462-0324. Dostupné z: https://dx.doi.org/10.1093/rheumatology/keab784.

@article{1862882,
   author = {Behrens, Frank and Sewerin, Philipp and de, Miguel Eugenio and Patel, Yusuf and Batalov, Anastas and Dokoupilová, Eva and Kleinmond, Christine and Pournara, Effie and Shekhawat, Ankita and Jentzsch, Claudia and Wiedon, Annette and Baraliakos, Xenofon},
   article_location = {OXFORD},
   article_number = {November},
   doi = {http://dx.doi.org/10.1093/rheumatology/keab784},
   keywords = {spondyloarthritis; Achilles tendon enthesitis; heel enthesitis; pain; bone marrow oedema; biologics; IL-17 inhibitor; imaging outcomes},
   language = {eng},
   issn = {1462-0324},
   journal = {RHEUMATOLOGY},
   title = {Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial},
   url = {https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keab784/6420214},
   volume = {Neuveden.},
   year = {2022}
}

TY  - JOUR
ID  - 1862882
AU  - Behrens, Frank - Sewerin, Philipp - de, Miguel Eugenio - Patel, Yusuf - Batalov, Anastas - Dokoupilová, Eva - Kleinmond, Christine - Pournara, Effie - Shekhawat, Ankita - Jentzsch, Claudia - Wiedon, Annette - Baraliakos, Xenofon
PY  - 2022
TI  - Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial
JF  - RHEUMATOLOGY
VL  - Neuveden.
IS  - November
SP  - 1-11
EP  - 1-11
PB  - OXFORD UNIV PRESS
SN  - 14620324
KW  - spondyloarthritis
KW  - Achilles tendon enthesitis
KW  - heel enthesitis
KW  - pain
KW  - bone marrow oedema
KW  - biologics
KW  - IL-17 inhibitor
KW  - imaging outcomes
UR  - https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keab784/6420214
N2  - Objective ACHILLES aimed to demonstrate efficacy of secukinumab on Achilles' tendon enthesitis in spondyloarthritis (SpA) patients. Methods Patients >= 18 years (n = 204) with active PsA or axial SpA and heel enthesitis were randomized 1:1 to secukinumab 150/300 mg or placebo up to week 24, and thereafter placebo patients were switched to secukinumab. Results At week 24, a higher, yet statistically non-significant (P = 0.136), proportion of patients in secukinumab vs placebo reported resolution of Achilles tendon enthesitis in affected foot (42.2% vs 31.4%; odds ratio [OR] = 1.63; 95% CI: 0.87, 3.08). Proportion of patients reporting resolution of enthesitis based on Leeds Enthesitis Index was higher with secukinumab vs placebo (33.3% vs 23.5%; OR = 1.65; 95% CI: 0.85, 3.25) at week 24. Mean change from baseline in heel pain at week 24 was higher in secukinumab patients vs placebo (-2.8 [3.0] vs -1.9 [2.7]). Greater improvements with secukinumab were observed in heel enthesopathy activity and global assessment of disease activity. Imaging evaluation by local reading confirmed heel enthesitis on MRI at screening for all patients. Based on central reading, 56% presented with bone marrow oedema and/or tendinitis; according to Heel Enthesitis MRI Scoring System (HEMRIS) post hoc analysis, 76% had signs of entheseal inflammation while 86% had entheseal inflammation and/or structural changes. Conclusion A substantial proportion of patients showed no signs of inflammation on the centrally read MRIs despite a clinical diagnosis of heel enthesitis, thus highlighting that the discrepancy between the clinical and imaging assessments of enthesitis requires further investigation. Although ACHILLES did not meet the primary end point, the study reported clinically meaningful improvements in patient-related outcomes.
ER  -

BEHRENS, Frank, Philipp SEWERIN, Miguel Eugenio DE, Yusuf PATEL, Anastas BATALOV, Eva DOKOUPILOVÁ, Christine KLEINMOND, Effie POURNARA, Ankita SHEKHAWAT, Claudia JENTZSCH, Annette WIEDON a Xenofon BARALIAKOS. Efficacy and safety of secukinumab in patients with spondyloarthritis and enthesitis at the Achilles tendon: results from a phase 3b trial. \textit{RHEUMATOLOGY}. OXFORD: OXFORD UNIV PRESS, 2022, Neuveden., November, s.~1-11. ISSN~1462-0324. Dostupné z: https://dx.doi.org/10.1093/rheumatology/keab784.

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