Patients with ankylosing spondylitis (AS) who achieve the Assessment of Spondyloarthritis International Society 40 (ASAS40) end point have less spinal pain at night, less fatigue, better sleep, and improved quality of life, according to research results published in Rheumatology and Therapy.
The results also indicated that patients with AS treated with ixekizumab had significantly greater improvements in the 4 ASAS treatment response domains compared with those treated with placebo.
The study included participants with AS from the COAST-V (n=341) trial who had never taken biologic disease-modifying antirheumatic drugs (bDMARD) (naive), and from the COAST-W (n=316), which included participants who had taken tumor necrosis factor inhibitors (TNFi) (experienced). In COAST-V, participants were randomized 1:1:1:1 to receive subcutaneous injections of 80 mg ixekizumab every 2 weeks (n=83), 80 mg ixekizumab every 4 weeks (n=81), 40 mg adalimumab every 2 weeks (n=90), or placebo every 2 weeks (n=87). In COAST-W, participants were randomized 1:1:1 to receive subcutaneous injections of 80 mg ixekizumab every 2 weeks (n=98), 80 mg ixekizumab every 4 weeks (n=114), or placebo every 2 weeks (n=104).
Over 16 weeks, the researchers collected data for the ASAS treatment response domains and other outcomes. They used a mixed-effects model for repeated measures to compare results between the treatment groups.
The results indicated that participants treated with ixekizumab had significantly greater improvements in all 4 ASAS treatment response domains and other outcomes compared with those who received placebo (P <.05). These results were consistent among participants who were bDMARD-naive and TNFi-experienced.
The researchers found that participants who achieved ASAS40 reported better outcomes in all domains compared with nonresponders. Compared with ASAS20 nonresponders, participants who achieved ASAS40 had significantly greater mean changes in spinal pain at night (1.0 vs 5.1 for bDMARD-naive; 0.5 vs 5.4 for TNFi-experienced), fatigue (0.6 vs 3.8 for bDMARD-naive; 0.2 vs 3.9 for TNFi-experienced), sleep quality (1.1 vs 4.0 for bDMARD-naive; 0.8 vs 4.9 for TNFi-experienced), and Short Form 36-Item Physical Component Summary (2.6 vs 11.6 for bDMARD-naive; 1.2 vs 12.6 for TNFi-experienced; P <.0001).
“By translating achievement of ASAS40 into clinical measures commonly used in clinical practice, we aimed to provide physicians with scientific data that will support a better understanding of the relevance of an ASAS40 level of response from the perspective of the signs and symptoms reported by patients,” the researchers wrote.
Disclosures: Sponsorship for this study and article processing charges were funded by Eli Lilly and Company. All authors had full access to all of the data in this study and they take complete responsibility for the integrity of the data and the accuracy of the data analysis.
Mease P, Walsh JA, Baraliakos X, et al. Translating improvements with ixekizumab in clinical trial outcomes into clinical practice: ASAS40, pain, fatigue, and sleep in ankylosing spondylitis [published online June 28, 2019]. Rheumatol Ther. doi:10.1007/s40744-019-0165-3