Safety and Efficacy of Perispinal Etanercept for Chronic Stroke: A Randomized Clinical Trial.
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BACKGROUND AND OBJECTIVES: Stroke is a leading cause of long-term disability. Etanercept, a competitive tumor necrosis factor-α inhibitor, has been proposed as a potential treatment for post-stroke impairments when given through a perispinal subcutaneous injection. We aimed to evaluate the safety and efficacy of perispinal etanercept in patients with chronic stroke. METHODS: The Perispinal Etanercept for Stroke Outcomes Study was a randomized, double-blind, placebo-controlled, parallel group trial conducted in 3 ambulatory research clinics in Australia and New Zealand. Eligible patients were aged between 18 and 70 years, had a stroke between 1 and 15 years before enrollment, had a modified Rankin Scale score of 2-5, and demonstrated reduced quality of life as assessed by the 36-Item Short Form Survey (SF-36). Patients were randomized in a 1:1 ratio. The primary outcome was the difference in the proportion of participants at day 28 with an improvement of 5 points or more on the SF-36v2 compared with baseline after a single injection of etanercept 25 mg or equivalent placebo. The primary safety outcome was the difference in the proportion over 28 days of serious adverse events after a single injection of etanercept 25 mg or equivalent placebo. The primary outcome and safety were analyzed in the intention-to-treat population. Participants were followed up 56 days after the first injection of perispinal etanercept. RESULTS: Recruitment ceased early because of lack of continued funding. We screened 147 participants, of whom 126 were enrolled and randomized (63 etanercept: 63 placebo; 48 [38%] female, median (interquartile range) age 54.5 (45.0-60.0) years, median time since stroke 3 years). The primary outcome of improvement occurred in 33 of 63 participants (53%) in the etanercept arm and 36 of 63 participants (58%) in the placebo arm (adjusted odds ratio 0.82, 95% CI 0.40-1.67, standardized risk difference -5%, 95% CI -22% to 13%). The proportion of serious adverse events was similar in both treatment arms. DISCUSSION: Perispinal etanercept was safe, but we found no evidence of improvement in quality of life and other efficacy outcomes compared with placebo. TRIAL REGISTRATION INFORMATION: The trial was registered at anzctr.org.au (ACTRN12620001011976) on October 7, 2020. Patients were enrolled between November 4, 2020, and September 1, 2023. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that in patients with imaging-confirmed ischemic or hemorrhagic stroke, perispinal etanercept (25 mg) injection does not improve the patients' quality of life 28 days after injection.