Prednisolone
| Evidence Level: L2 | Predicted Indications: 9 |
Table of Contents
- Prednisolone
- Pharmacist Assessment Report
- Prednisolone: From Autoimmune Disease to Alopecia Areata
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Other Predicted Indications (Summary)
- Disclaimer
Prednisolone: From Autoimmune Disease to Alopecia Areata
One-Sentence Summary
Prednisolone is a systemic glucocorticoid originally used for autoimmune and inflammatory conditions, including Crohn disease, adrenocortical insufficiency and acute lymphoblastic leukaemia. The TxGNN model predicts it may be effective for alopecia areata. There are no registered clinical trials, but 20 publications support this direction, including a Cochrane network meta-analysis, a systematic review and one placebo-controlled RCT.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Autoimmune disease, Crohn disease, adrenocortical insufficiency, acute lymphoblastic leukaemia and others (the ARTG entry has no indication text recorded) |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L2 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, prednisolone is a glucocorticoid that suppresses T-cell activation and pro-inflammatory cytokine production. Its efficacy in autoimmune and inflammatory disease is well established.
Alopecia areata is a T-cell-mediated autoimmune condition in which immune privilege of the hair follicle collapses, causing non-scarring hair loss. Because prednisolone targets the same immune-mediated pathology, the prediction is mechanistically plausible. One study also reported that oral pulse steroids altered serum and tissue TNF-α levels in alopecia areata.
There are important limits. Hair loss often relapses after steroids are withdrawn, and long-term systemic use carries significant adverse effects. For this reason, pulse or short-course regimens are generally preferred in the literature.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37870096 | 2023 | Network meta-analysis | Cochrane Database Syst Rev | Compares immunosuppressants, hair growth stimulants and contact immunotherapy for alopecia areata |
| 30191561 | 2019 | Systematic review | Australas J Dermatol | Evaluates RCT evidence for systemic treatments in alopecia areata, totalis and universalis; efficacy evidence is variable |
| 15692475 | 2005 | RCT | J Am Acad Dermatol | Placebo-controlled trial of oral pulse prednisolone in alopecia areata |
| 37992355 | 2023 | Review | Dermatol Pract Concept | Reviews efficacy, relapse rates, side effects and prognostic factors of pulse corticosteroids |
| 36461625 | 2023 | Review | Pediatr Dermatol | Reviews dosing regimens and side effects of pulse corticosteroids in children |
| 21572877 | 2009 | Cohort | Dermato-endocrinology | Medium-dose prednisolone pulse; effective in early stages, but side effects led to discontinuation |
| 28140540 | 2017 | Cohort | J Dtsch Dermatol Ges | Sequential high- then low-dose steroids in severe childhood disease; relapse follows discontinuation |
| 32779249 | 2020 | Retrospective study | J Eur Acad Dermatol Venereol | Continuation rates of azathioprine, methotrexate and cyclosporine as steroid-sparing agents in 138 patients with chronic disease |
| 26179196 | 2015 | Long-term follow-up | Dermatol Ther | Combined oral pulse and topical steroids in 65 children with severe disease |
| 41243342 | 2025 | Case report | J Dermatol Treat | Durable remission with dexamethasone oral mini-pulse when JAK inhibitors were unsuitable |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 13888Y | Predsolone | Tablet 1 mg (oral) | Not recorded in the data compiled for this report |
Safety Considerations
- Disease-based cautions from the knowledge graph (not label text): the data flag hypertension, congestive heart failure, epilepsy, hyperglycaemia, measles, herpes simplex keratitis, hypopituitarism and related pituitary deficiencies, porphyria, and certain urea cycle disorders (such as citrullinaemia and hyperargininaemia).
- Drug interactions (100 interactions recorded; examples from the retrieved list):
- Major: adalimumab.
- Moderate: zidovudine, isotretinoin, acarbose, acebutolol, acetazolamide, ketorolac, ibuprofen, nifedipine, ethinylestradiol, butalbital, albiglutide, aldesleukin, alemtuzumab, aliskiren and tetanus toxoid vaccine.
- Minor: formoterol and salbutamol.
- Literature on alopecia areata also notes relapse after withdrawal and significant systemic adverse effects with long-term use.
Please refer to the TGA-approved Product Information (PI) for full warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Alopecia areata is an immune-mediated condition, and there is a placebo-controlled RCT of oral pulse prednisolone, a Cochrane network meta-analysis and a systematic review. However, there are no registered trials, relapse after withdrawal is common, and long-term systemic steroid toxicity limits use.
To proceed, the following is needed:
- The ARTG approved indication text and the Product Information warnings and contraindications for the Predsolone 1 mg tablet. The 1 mg strength may also be impractical for pulse dosing.
- Detailed mechanism of action data.
- A critical appraisal of the 2005 placebo-controlled RCT (a published critique of this trial exists) and of the Cochrane network meta-analysis, to confirm the strength of prednisolone-specific evidence.
- A defined pulse or short-course regimen, with a relapse-management and steroid-sparing plan.
- A safety monitoring plan covering blood pressure, glucose and growth in children, and review of interacting medicines.
Other Predicted Indications (Summary)
| Rank | Predicted Indication | Score | Evidence Level | Decision | Comment |
|---|---|---|---|---|---|
| 2 | Alopecia mucinosa | 0.9999 | L5 | Hold | Only a cyclosporine case report; no direct prednisolone evidence |
| 3 | Telogen effluvium | 0.9998 | L5 | Hold | No evidence; usually self-resolving |
| 4 | Folliculitis decalvans | 0.9998 | L5 | Hold | One case report of combination therapy; prednisolone’s contribution unclear |
| 5 | Alopecia antibody deficiency | 0.9998 | L5 | Hold | Only an indirect case report |
| 6–9 | Hereditary hypotrichosis with recurrent skin vesicles; alopecia-intellectual disability-hypergonadotropic hypogonadism syndrome; atrichia with papular lesions; prolapse of lacrimal gland | 99.94–0.9998 | L5 | Hold | No evidence; no plausible immune mechanism |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.