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Patient assessments measured fatigue, disease activity, global spinal pain, and spinal pain at night.
Ixekizumab improved symptoms related to radiographic axial spondyloarthritis (r-axSpA), even as early as the first follow-up visit, according to new findings presented at the Clinical Congress of Rheumatology (CCR) East 2020 meeting.
These symptoms typically include fatigue, pain, stiffness, and sleep disturbances, which negatively impact the patient’s health-related quality of life.
Atul Deodhar, MD, MRCP, Professor at the Oregon Health and Science University of Medicine, and colleagues, assessed the data from the COAST-V and COAST-W studies in order to evaluate the high-affinity monoclonal antibody’s impact on r-axSpA symptoms. Both studies were phase 3 randomized controlled trials that originally evaluated the safety and efficacy of the drug in both biological disease-modifying antirheumatic drug (DMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with r-axSpA.
In the COAST-V study, a total of 341 patients were randomized to receive ixekizumab in two different dosing schedules (every 2 or 4 weeks), placebo, or adalimumab for 14 weeks. An extended treatment period with different dosing schedules for each arm was conducted between weeks 16-56.
For the COAST-W study, 316 paritcipants were enrolled and assigned to either one of two dosing schedules for ixekizumab or the placebo group. Similar to the COAST-V study, the double blind period was conducted until week 14 followed by an extended treatment period from week 16 to week 52.
Both studies included patients ≥18, who had an established diagnosis of r-axSpA, a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, and a total back pain score ≥ 4, among other eligibility criteria.
They excluded patients with a serious infection ≤12 weeks prior to enrollment.
Assessments used at baseline and in follow up weeks until week 52 were the Fatigue Numeric Rating Scale, Patient’s Global Assessments of Disease activity, global spinal pain, spinal pain at night, and Jenkins Sleep Evaluation Questionnaire (JSEQ).
Deodhar and colleagues noted that over the course of treatment, patients experienced significant improvements in all measurements and assessments. Furthermore, these reductions were sustained through the extended treatment period.
These improvements for ixekizumab-treated patients were observed at the first post-baseline visit for each assessment. For example, Ixekizumab’s effects on fatigue were reported at week 8, disease activity at week 1, global spinal pain at week 1, and spinal pain at week 1.
JSEQ score improvements were observed at the second post-baseline assessment, or week 16.
Overall, the investigators lauded the drug’s efficacy in reducing r-axSpA-related symptoms and improving patient quality of life.
The study, “Ixekizumab Improves Fatigue, Pain, and Sleep up to 52 Weeks in Patients with Radiographic Axial Spondyloarthritis,” was presented at CCR East 2020.