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Early response predicts long-term outcome among ixekizumab-treated patients with radiographic axial spondyloarthritis

Presenter: Sofia Ramiro, consultant rheumatologist and senior researcher, Leiden University Medical Center and Zuyderland Medical Center, Netherlands

How do early disease activity and early clinical response associate with long-term outcomes with ixekizumab in radiographic axial spondyloarthritis? Abstract 0520. Presented Nov 12, 2203.


In patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab, achieving an early response was associated with achieving a target of remission or at least low disease activity in the long term, according to a post hoc analysis of a phase 3 trial presented at ACR Convergence 2023.

Patients with r-axSpA who achieved a response at week 12 or 24, as measured by a clinically important improvement in the Ankylosing Spondylitis Disease Activity Score (ASDAS-CII), had a higher likelihood of attaining the treatment target of inactive disease or low disease activity at week 52, said investigator Sofia Ramiro of Leiden University Medical Center and Zuyderland Medical Center, Netherlands.

“In short, early response predicts long-term response,” Dr Ramiro said in an interview with the Cleveland Clinic Journal of Medicine.

This analysis reinforces the current Assessment of Spondyloarthritis International Society-European League Against Rheumatism (ASAS-EULAR) and treat-to-target recommendations, she added. “In other words, patients achieving an ASDAS-CII at an early time point were highly likely to reach the inactive or low disease activity target after a year of treatment.”

The ASAS-EULAR recommendations for axSpA management recommend assessment for biological disease-modifying anti-rheumatic drug (DMARD) treatment response after at least 12 weeks of treatment, Dr Ramiro and co-authors wrote in a report on their post hoc study, which was presented as a poster at the ACR meeting.

The recommended treatment target is either inactive disease or low disease activity, collectively defined as an ASDAS score below 2.1, they added.

So in the present post hoc analysis, Dr Ramiro and co-authors sought to assess the link between treatment response at week 12 or 24 and attainment of an ASDAS score below 2.1 in patients with r-axSpA treated with ixekizumab as part of the phase 3 COAST-V study. They included 81 biologic DMARD-naive patients who had been randomly assigned to receive ixekizumab 80 mg every 4 weeks.

At week 12, 34 of the 81 patients (42%) had inactive disease or low disease activity status. And by week 52, most of these patients met the target ASDAS score below 2.1. That including 85% of the patients with low disease activity at week 12 and 100% of those with inactive disease at week 12.

Also at week 12, 47 patients achieved an ASDAS-CII. Of those patients, 33 (70%) had inactive disease or low disease activity at week 52.

Similarly, between 81% and 94% of patients who met other clinical response measures at week 12 ended up with an ASDAS score greater than 2.1 at week 52. That included those who at week 12 had a major improvement in ASDAS (ASDAS-MI), a 50% or greater improvement in the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI 50), or achievement of BASDAI score less than 4.

Looking at week 24 outcomes, there were 37 patients (46%) with inactive disease or low disease activity at that time point. Of those individuals, 29 (78%) had already reached an ASDAS of less than 2.1 at week 12. Moreover, most of these patients also had an ASDAS less than 2.1 at week 52, including 79% of those with low disease activity and 100% of those with inactive disease.

In addition, an ASDAS-CII at week 24 was seen in 52 patients, of whom 37 (71%) had inactive or low disease activity at week 52. And similar to week 12, 80% to 89% of these patients achieved the clinical response measures of ASDAS-MI, BASDAI 50, or BASDAI less than 4.

Patients who did not achieve an ASDAS of less than 2.1 at week 12 were more often older, female, and had a longer duration of symptoms versus those patients who did achieve the ASDAS below 2.1, Dr Ramiro reported.

Disclosures:

Sofia Ramiro reported disclosures related to AbbVie, Eli Lilly, Galapagos Pharma, MSD, Novartis, Pfizer, Sanofi, and UCB Pharma.

References:

Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis 2023; 82(1):19-34. doi:10.1136/ard-2022-223296

Smolen JS, Schöls M, Braun J, et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force [published correction appears in Ann Rheum Dis. 2018 Mar;77(3):472]. Ann Rheum Dis 2018; 77(1):3-17. doi:10.1136/annrheumdis-2017-211734

Machado PM, Landewé R, Heijde DV; Assessment of SpondyloArthritis international Society (ASAS). Ankylosing Spondylitis Disease Activity Score (ASDAS): 2018 update of the nomenclature for disease activity states. Ann Rheum Dis 2018; 77(10):1539-1540. doi:10.1136/annrheumdis-2018-213184

Dougados M, Wei JC, Landewé R, et al. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W) [published correction appears in Ann Rheum Dis. 2020 Jun;79(6):e75]. Ann Rheum Dis 2020; 79(2):176-185. doi:10.1136/annrheumdis-2019-216118

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