Trial reportJournal of hepatology2024
Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis.
Trial report in Journal of hepatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial
A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Hepatoprotective effects of oyster-derived bioactive compounds in alcoholic liver disease: a systematic review.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026Pooled it
- Beyond corticosteroids: A systematic review of novel therapeutic strategies in severe alcoholic hepatitis and 90-day survival.World journal of gastroenterology · 2025Pooled it
- Assessment of early return to drinking in surviving patients with alcohol-associated hepatitis.Alcohol, clinical & experimental research · 2026Trial
- [Alcohol liver disease: immunoregulatory mechanisms and precision therapeutic targets].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Review
- A Bayesian Optimal Adaptive Clinical Trial Design for Sequentially Integrated Therapies.Statistics in medicine · 2026Article
- Therapeutics for Alcohol-Associated Liver Disease.Annual review of pharmacology and toxicology · 2026Review
- Urine Proteomic Profiling at Admission Reveals Complement Biomarkers Linked to Alcohol-Associated Liver Disease.Alcohol, clinical & experimental research · 2026Article
- Gut-liver axis molecular mechanisms in alcohol-associated liver disease.Alcohol (Fayetteville, N.Y.) · 2026Review
- Natural history and development of a novel composite endpoint in patients with alcohol-associated hepatitis: Data from a prospective multicenter study.Hepatology (Baltimore, Md.) · 2026Observational
- Special Population: A Global Perspective on Metabolic Dysfunction-Associated Alcohol-Related Liver Disease.Clinics in liver disease · 2026Review
- Oxidative Stress and Alcohol-Related Hepatitis: A Role for Future Therapies.Antioxidants (Basel, Switzerland) · 2026Review
- Emerging therapeutic regimens as alternatives to glucocorticoids for severe alcohol-associated hepatitis: a comprehensive review.Clinical and molecular hepatology · 2026Review
- Regulated necrosis at the crossroads of liver inflammation and cancer development.Nature reviews. Gastroenterology & hepatology · 2026Review
- Diacerein improves liver fibrosis, steatosis, and atherosclerosis in ApoE knockout mice.Journal of molecular medicine (Berlin, Germany) · 2026Article
- Lower L-glutamine abundance and higher HSPA8 activity contribute to the mitigation of ethanol-induced liver cell injury by thymol.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Current Clinical Trials for Alcohol-Associated Hepatitis.The American journal of pathology · 2026Review
- Key Experimental Therapeutics and Knowledge Gaps in Metabolic Dysfunction-Associated Steatohepatitis (MASH).Drug design, development and therapy · 2026Review
- Alcohol-related hepatitis induces a specific fibrosis profile through YAP activation in myofibroblasts.JHEP reports : innovation in hepatology · 2025Article
- Infiltrating macrophages replace Kupffer cells and play diverse roles in severe alcohol-associated hepatitis.Cellular & molecular immunology · 2025Article
- Immunological mechanisms and emerging therapeutic targets in alcohol-associated liver disease.Cellular & molecular immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 11 institutions in 2 countries.
Funding
Abstract
BACKGROUND &
aimsSevere alcohol-associated hepatitis (SAH) is associated with high 90-day mortality. Glucocorticoid therapy for 28 days improves 30- but not 90-day survival. We assessed the efficacy and safety of a combination of anakinra, an IL-1 antagonist, plus zinc (A+Z) compared to prednisone using the Day-7 Lille score as a stopping rule in patients with SAH.
methodsIn this phase IIb double-blind randomized trial in adults with SAH and MELD scores of 20-35, participants were randomized to receive either daily anakinra 100 mg subcutaneously for 14 days plus daily zinc sulfate 220 mg orally for 90 days, or daily prednisone 40 mg orally for 30 days. Prednisone or prednisone placebo was stopped if Day-7 Lille score was >0.45. All study drugs were stopped for uncontrolled infection or ≥5 point increase in MELD score. The primary endpoint was overall survival at 90 days.
resultsSeventy-three participants were randomized to prednisone and 74 to A+Z. The trial was stopped early after a prespecified interim analysis showed prednisone was associated with higher 90-day overall survival (90% vs. 70%; hazard ratio for death = 0.34, 95% CI 0.14-0.83, p = 0.018) and transplant-free survival (88% vs. 64%; hazard ratio for transplant or death = 0.30, 95% CI 0.13-0.69, p = 0.004) than A+Z. Acute kidney injury was more frequent with A+Z (45%) than prednisone (22%) (p = 0.001), but rates of infection were similar (31% in A+Z vs. 27% in prednisone, p = 0.389).
conclusionsParticipants with SAH treated with prednisone using the Day-7 Lille score as a stopping rule had significantly higher overall and transplant-free 90-day survival and lower incidence of acute kidney injury than those treated with A+Z. IMPACT AND IMPLICATIONS: There is no approved treatment for severe alcohol-associated hepatitis (SAH). In this double-blind randomized trial, patients with SAH treated with prednisone using the Lille stopping rule on Day 7 had higher 90-day overall and transplant-free survival and lower rates of acute kidney injury compared to patients treated with a combination of anakinra and zinc. The data support continued use of glucocorticoids for patients with SAH, with treatment discontinuation for those with a Lille score >0.45 on Day 7.
trial registrationNCT04072822.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.