Meta-analysisindependent cross-checkabstract checked★ key study I-SRC-101 in-depth review
Stopping steroids after a kidney transplant while other anti-rejection drugs continue
Steroid avoidance or withdrawal for kidney transplant recipients.
Overview
Oliveras L et al.. Cochrane Database Syst Rev 2026 · PMID 42187003 · DOI 10.1002/14651858.CD005632.pub4
Across 53 trials, stopping or avoiding steroids did not clearly change graft loss in the first year; avoiding steroids slightly raised acute rejection in some regimens.
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?
Find out whether steroids can be left out after a kidney transplant
- How was the study done?
Cochrane review of randomised trials
- How many people, animals or samples were studied?
53 trials, 8317 recipients
- What was actually found?
Similar short-term graft survival; more acute rejection with steroid avoidance unless combined with modern drugs; less post-transplant diabetes
- How large was the observed effect?
BPAR RR 1.58 (avoidance); graft loss RR 1.19 (withdrawal, CI 0.72-1.96)
- What do the results mean in everyday life?
Doctors can sometimes stop cortisone, but only while other anti-rejection drugs continue
- What are the study's limitations?
Low certainty; mostly unblinded trials
- What does it say about Elawady's specific claim?
Supports only steroid withdrawal under specialist care, not stopping all drugs
- Do the results apply to Germany and Europe?
High
- What can explicitly not be concluded from this study?
Whether stopping all anti-rejection drugs is safe (not studied)
Scientific in-depth review
1. Full reference
- Authors
- Oliveras L et al.
- Journal
- Cochrane Database Syst Rev
- Year
- 2026
- Identifier
- PMID 42187003 DOI 10.1002/14651858.CD005632.pub4
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works record checked
- Retracted
- no
- Corrections
Update of earlier version: doi: 10.1002/14651858.CD005632.pub3
- Extent checked
- abstract only
- Conflicts of interest and funding
Funding: Rio Hortega predoctoral fellowship (Instituto de Salud Carlos III) for the first author. One author (JP) declared speaker fees from several pharmaceutical companies and authored included trials but did not take part in eligibility, extraction, risk-of-bias or GRADE decisions for them.
2. Research question
What are the benefits and harms of steroid avoidance or withdrawal in kidney-transplant recipients?
3. Study design and population
- Study design
- Meta-analysis – Cochrane systematic review and meta-analysis of randomised and quasi-randomised trials (update; GRADE)
- Population
Kidney-transplant recipients (adults; three trials in children)
- Country
International
- Period
Searches to 29 April 2025
- Sample size
53 studies, 8317 randomised recipients
- Inclusion and exclusion criteria
RCTs and quasi-RCTs of steroid avoidance or withdrawal versus steroid maintenance
4. Methods and endpoints
- Exposure / intervention
Steroid avoidance (no steroids after the first days) or steroid withdrawal (stopping later) while other immunosuppressants continue
- Comparator
Steroid maintenance
- Endpoints
Death, graft loss, biopsy-proven acute rejection (BPAR), post-transplant diabetes, infection, cardiovascular events
- Statistical methods
Random-effects meta-analysis, risk ratios with 95% CI; RoB 1; GRADE
5. Actual results
- Results
Steroid avoidance vs maintenance: BPAR up to 1 year RR 1.58 (1.11-2.25; low certainty); death 1-5 years RR 0.61 (0.39-0.96; low); graft loss up to 1 year RR 0.95 (0.62-1.46; moderate); post-transplant diabetes RR 0.70 (0.59-0.84; low). Steroid withdrawal vs maintenance: death up to 1 year RR 0.69 (0.35-1.37; low); graft loss up to 1 year RR 1.19 (0.72-1.96; moderate); BPAR up to 1 year RR 1.41 (0.89-2.23; low); post-transplant diabetes RR 0.82 (0.55-1.21; moderate).
- Absolute risks
Not reported in the abstract.
- Authors' conclusion
No evidence of a difference in death or graft loss up to one year with steroid avoidance or withdrawal; avoidance may increase acute rejection unless combined with tacrolimus, an antimetabolite and induction therapy; avoidance may reduce post-transplant diabetes.
6. Strengths
- Cochrane methods, 53 RCTs, GRADE
- Most recent synthesis (2026 update)
7. Weaknesses
- Overall certainty low (risk of bias, imprecision)
- Only 5 of 53 studies blinded
- All regimens continued other immunosuppressants; complete withdrawal of all drugs was not studied
8. Risk of bias
- Orienting tool
- AMSTAR 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Well-conducted Cochrane review; the underlying trials have mostly unclear or high risk of bias.
9. Assessment of the statistical interpretation
Ratio CIs are log-symmetric (checked in stats/C-SRC-46_transplant.py). The withdrawal comparisons have wide CIs that include clinically important harm (graft loss RR up to 1.96).
10. Relevance to the specific claim
Shows that the only well-studied form of 'stopping' in kidney transplantation is stopping or avoiding steroids while tacrolimus/ciclosporin and mycophenolate are continued. It does not support stopping all immunosuppression.
11. Independent contrary findings
CTOT-09 (I-SRC-102) shows that stopping the calcineurin inhibitor leads to rejection and donor-specific antibodies.
12. Transferability to Germany and Europe
Directly applicable; European centres use steroid-sparing regimens in selected patients.
13. Overall methodological judgement
High-quality synthesis supporting a narrow part of the claim (steroids can be stopped in selected patients under supervision) and not the claim as stated (all drugs stopped).
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | indirect |
| 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 graft survival beyond 5 years with steroid-free regimens.