Early clinical response associates with long-term outcomes with ixekizumab in radiographic axial spondyloarthritis.

Background: The Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology recommendations for axial spondyloarthritis (axSpA) management include patient assessment for biological disease-modifying antirheumatic drug (bDMARD) treatment response after at least 12 weeks of treatment. The current treat-to-target strategy for axSpA is to achieve inactive disease (ID; Axial Spondyloarthritis Disease Activity Score (ASDAS) <1.3) or at least low disease activity (LDA; 1.3≤ASDAS<2.1).To investigate the association between treatment response at week 12 and/or week 24 and attainment of the ASDAS<2.1 treat-to-target recommendation at week 52 in bDMARD-naïve patients with radiographic (r-)axSpA treated with ixekizumab (IXE).
Methods: This post hoc analysis included patients randomly assigned to IXE 80 mg every 4 weeks from COAST-V (NCT02696785), a phase 3 trial in bDMARD-naïve patients with r-axSpA. The proportion of patients who achieved ASDAS<2.1 at week 52 was measured among those who attained or not clinically important improvement (CII, ∆ASDAS≥1.1) response, and among those with ID, LDA and high or very high disease activity at week 12 and/or week 24. Non-response was assumed for missing data.
Results: Amongst 81 patients, 47 (58.0%) achieved ASDAS CII at week 12, with 70.2% (n=33) achieving ASDAS<2.1 at week 52. At week 24, 52 (64.2%) patients achieved ASDAS CII, with 71.2% (n=37) achieving ASDAS<2.1 at week 52. Of the 24 patients who did not achieve ASDAS CII at either week 12 or week 24, 5 (20.8%) achieved ASDAS<2.1 at week 52.
Conclusion: This analysis reinforces the current recommendation that continuing treatment in those achieving ASDAS CII at week 12 and/or week 24 increases the likelihood of obtaining ID/LDA at week 52.
Trial Registration Number: NCT02696785.
Competing Interests: Competing interests: SR has received speaker and/or consultation fees and/or research support/grants from AbbVie, Eli Lilly and Company, Galapagos NV, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi and UCB Pharma. CL has received speaker and/or consultation fees and/or research support/grants from AbbVie, Amgen, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly and Company, Galapagos NV, Merck Sharp & Dohme, Novartis, Pfizer and Roche. LB has received speaker and/or consultation fees and/or research support/grants from Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Sanofi, Eli Lilly and Company, Gilead, JAMP Pharma, Fresenius Kabi, Teva, Organon and Sandoz. PW has received consulting payments, research funding, and/or honoraria from Abbvie, Amgen, Novartis, Eli Lilly and Company, Sanofi-Genzyme, SetPoint, Sun Pharma, Viela Bio, RegenLab, Paradigm, AstraZeneca, Janssen, Horizon and LG Chem. TP is an employee and shareholder of Eli Lilly and Company. RB is an employee and shareholder of Eli Lilly and Company. SL-L is a former employee of Eli Lilly and Company. BJ is an employee and shareholder of Eli Lilly and Company. MJN has received speaker and/or consultation fees and/or research support/grants from AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, Novartis and Pfizer and has received grant and/or research support from Novartis. JC-CW has received speaker and/or consultation fees and/or research support/grants from AbbVie, Bristol Myers Squibb, Celgene, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Novartis, Pfizer, Sanofi-Aventis, TSH Biopharm and UCB Pharma.
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