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.

Basic information

Original name

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

Authors

BEHRENS, Frank (guarantor), Philipp SEWERIN, Miguel Eugenio DE, Yusuf PATEL, Anastas BATALOV, Eva DOKOUPILOVÁ (203 Czech Republic, belonging to the institution), Christine KLEINMOND, Effie POURNARA, Ankita SHEKHAWAT, Claudia JENTZSCH, Annette WIEDON and Xenofon BARALIAKOS

Edition

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

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.500

RIV identification code

RIV/00216224:14160/22:00126122

Organization unit

Faculty of Pharmacy

DOI

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

UT WoS

000789235000001

Keywords in English

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

Abstract

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 and 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, p. 1-11. ISSN 1462-0324. Available from: 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 and 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, p.~1-11. ISSN~1462-0324. Available from: https://dx.doi.org/10.1093/rheumatology/keab784.

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