Treatment options for autoimmune hepatitis: A systematic review of randomized controlled trials
Bibliographic record
Abstract
Background & AimsPredniso(lo)ne with or without azathioprine is considered the mainstay in the treatment of autoimmune hepatitis (AIH), but many therapeutic options are available. The primary objective of this review was to explore the published literature on the optimal induction and subsequent maintenance therapy for AIH.MethodsWe performed a systematic search on electronic databases MEDLINE (1950-07.2009), Web of Science, Cochrane, and the website www.clinicaltrials.gov. Randomized controlled trials (RCTs) on apparent beneficial treatment regimens as induction or maintenance treatment in AIH were included. Pediatric studies were excluded. We calculated relative risks (RR) for comparison of treatment options on the primary outcome measure, which was defined as clinical, biochemical and histological remission.ResultsEleven RCTs were included, of which 7 studies evaluated the induction therapy in AIH patients: 3 treatment naive (n = 253), 2 relapse (n = 53), 2 combination of naive and relapse (n = 110). The remaining 4 studies (n = 162) assessed maintenance therapy. All but one maintenance study (thymostimulin versus no therapy) studied predniso(lo)ne (PRED), azathioprine (AZA) or combination PRED + AZA. We found no differences in primary outcome between induction therapy with PRED and PRED + AZA in treatment naive patients (RR = 0.98; 95% CI 0.65–1.47). AZA monotherapy as induction was considered as not viable because of a high mortality rate (30%). This was similar in AIH patients who relapsed: RR for PRED versus PRED + AZA for inducing remission was not different: 0.71 (95% CI 0.37–1.39). PRED + AZA maintained remission more often than PRED (RR = 1.40; 95% CI 1.13–1.73). Also AZA maintained a higher remission rate than PRED (RR = 1.35; 95% CI 1.07–1.70). Maintenance of remission was not different between PRED + AZA and AZA (RR = 1.06; 95% CI 0.94–1.20).ConclusionsBased on available RCTs, PRED monotherapy and PRED + AZA combination therapy are both viable induction therapies for AIH treatment naives and relapsers, while for maintenance therapy PRED + AZA and AZA therapy are superior to PRED monotherapy. Predniso(lo)ne with or without azathioprine is considered the mainstay in the treatment of autoimmune hepatitis (AIH), but many therapeutic options are available. The primary objective of this review was to explore the published literature on the optimal induction and subsequent maintenance therapy for AIH. We performed a systematic search on electronic databases MEDLINE (1950-07.2009), Web of Science, Cochrane, and the website www.clinicaltrials.gov. Randomized controlled trials (RCTs) on apparent beneficial treatment regimens as induction or maintenance treatment in AIH were included. Pediatric studies were excluded. We calculated relative risks (RR) for comparison of treatment options on the primary outcome measure, which was defined as clinical, biochemical and histological remission. Eleven RCTs were included, of which 7 studies evaluated the induction therapy in AIH patients: 3 treatment naive (n = 253), 2 relapse (n = 53), 2 combination of naive and relapse (n = 110). The remaining 4 studies (n = 162) assessed maintenance therapy. All but one maintenance study (thymostimulin versus no therapy) studied predniso(lo)ne (PRED), azathioprine (AZA) or combination PRED + AZA. We found no differences in primary outcome between induction therapy with PRED and PRED + AZA in treatment naive patients (RR = 0.98; 95% CI 0.65–1.47). AZA monotherapy as induction was considered as not viable because of a high mortality rate (30%). This was similar in AIH patients who relapsed: RR for PRED versus PRED + AZA for inducing remission was not different: 0.71 (95% CI 0.37–1.39). PRED + AZA maintained remission more often than PRED (RR = 1.40; 95% CI 1.13–1.73). Also AZA maintained a higher remission rate than PRED (RR = 1.35; 95% CI 1.07–1.70). Maintenance of remission was not different between PRED + AZA and AZA (RR = 1.06; 95% CI 0.94–1.20). Based on available RCTs, PRED monotherapy and PRED + AZA combination therapy are both viable induction therapies for AIH treatment naives and relapsers, while for maintenance therapy PRED + AZA and AZA therapy are superior to PRED monotherapy.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.014 | 0.044 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.015 | 0.013 |
| Bibliometrics | 0.008 | 0.008 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".