Naomi Schlesinger, Md, Dirk F. Moore, Phd, Sir Marc Feldmann AC, MB BS, PHD, FRCPATH, FRCP
Affiliation(s):
University of Utah School Of Medicine
Objectives: This study aimed to demonstrate that targeting tumor necrosis factor (TNF) using etanercept 50 mg subcutaneous injection is efficacious for gout flares. Methods The study was designed as a pilot 14-day, randomized, double-blind study comparing etanercept 50 mg subcutaneous to triamcinolone (TA) 40mg intramuscular injections for flares. It aimed to show that patients treated with etanercept do not have worse pain at 72 hours compared to TA. Statistical analysis- means of continuous variables between arms were compared via Student's t-test or Wilcoxon rank-sum test.
Results: Covid-19 dramatically impacted the study. Five patients were enrolled and randomized before the sponsor terminated the study early due to the pandemic. All five patients were male, ages: 28-55. Two patients were randomly assigned to the TA arm and three to the etanercept arm. The mean baseline VAS in the TA arm was 6, and in the etanercept arm, 7.7. The mean VAS at 72 hours in the TA arm was 1.5, and in the etanercept arm, 4 (p= 1). All four patients completing the study, regardless of the assigned arm, experienced statistically less pain on day 7 (p=0.035) and 14 (p= 0.018) compared to day 0. Baseline CRP levels decreased by day 7(p = 0.0098).
Conclusion: Etanercept provided equivalent pain relief as compared to TA at 72 hours. TA and etanercept-treated patients experienced less pain by day seven regardless of the assigned arm (p=0.035). Etanercept may be effective for gout flares when conventional therapy is unsuitable or ineffective. Larger studies are warranted.