Randomised controlled trialindependent cross-checkabstract only checked I-INTB-10 standard review
Stopping steroids early after transplant, while keeping other drugs
A prospective, randomized, double-blind, placebo-controlled multicenter trial comparing early (7 day) corticosteroid cessation versus long-term, low-dose corticosteroid therapy.
Overview
Woodle ES et al.. Ann Surg 2008 · PMID 18936569 · DOI 10.1097/SLA.0b013e318187d1da
With continued tacrolimus and MMF, early steroid withdrawal gave similar 5-year graft survival but more mild rejection.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test early steroid withdrawal
- How was the study done?
Blinded RCT
- How many people, animals or samples were studied?
386 recipients
- What was actually found?
Similar graft survival; more mild rejection; better metabolic profile
- How large was the observed effect?
rejection 17.8% vs 10.8%
- What do the results mean in everyday life?
Doctors can sometimes drop cortisone after transplant, but the other anti-rejection drugs stay.
- What are the study's limitations?
Selected patients; abstract only
- What does it say about Elawady's specific claim?
Partly supports dropping cortisone; contradicts stopping all immunosuppressants.
- Do the results apply to Germany and Europe?
High
- What can explicitly not be concluded from this study?
Cannot conclude that all immunosuppression can be stopped.
Scientific in-depth review
1. Full reference
- Authors
- Woodle ES et al.
- Journal
- Ann Surg
- Year
- 2008
- Identifier
- PMID 18936569 DOI 10.1097/SLA.0b013e318187d1da
- Verification
- verified – PubMed efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Research Support, Non-U.S. Gov't (publication type); no COI statement in record
2. Research question
Is early corticosteroid withdrawal after kidney transplantation as safe as chronic low-dose prednisone?
3. Study design and population
- Study design
- Randomised controlled trial – Randomised, double-blind, placebo-controlled multicentre trial, 5-year results
- Population
Adult deceased and living donor kidney-transplant recipients without delayed graft function, on tacrolimus/MMF/antibody induction
- Country
not stated in abstract (multicentre)
- Period
5 years
- Sample size
386
- Inclusion and exclusion criteria
No delayed graft function
4. Methods and endpoints
- Exposure / intervention
Corticosteroid withdrawal at day 7 (with continued tacrolimus and MMF)
- Comparator
Prednisone 5 mg/day after month 6
- Endpoints
Composite of death, graft loss, moderate/severe acute rejection; renal function; metabolic outcomes
- Statistical methods
Proportions, Kaplan-Meier
5. Actual results
- Results
At 5 years no differences in the composite (15.7% vs 14.4%), death (5.8% vs 6.7%), death-censored graft loss (5.8% vs 3.6%) or renal function (creatinine 1.5 vs 1.5 mg/dL). Biopsy-confirmed acute rejection 17.8% vs 10.8% (P=0.058; Kaplan-Meier P=0.04), mainly mild steroid-sensitive Banff 1A. Withdrawal improved triglycerides, weight (5.1 vs 7.7 kg gain) and reduced insulin-requiring post-transplant diabetes (3.7% vs 11.6%).
- Absolute risks
Acute rejection 17.8% vs 10.8%
- Authors' conclusion
Early corticosteroid withdrawal under tacrolimus/MMF/antibody induction gives similar long-term graft survival and function and improves cardiovascular risk factors, with more mild acute rejection.
6. Strengths
- Double-blind, placebo-controlled
- 5-year follow-up
7. Weaknesses
- Selected low-risk recipients
- Abstract only read
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Blinded RCT.
9. Assessment of the statistical interpretation
Supports steroid-free maintenance only when other immunosuppressants continue.
10. Relevance to the specific claim
Fair point: cortisone (corticosteroids) can be withdrawn in selected patients under medical supervision; the trial kept tacrolimus and MMF, so it does not support stopping all immunosuppression.
11. Independent contrary findings
More acute rejection without steroids.
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
Shows that reducing steroid exposure is an accepted, evidence-based strategy, not a reason to stop all drugs.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Long-term outcomes beyond 5 years.