Budesonide
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Budesonide: From Crohn’s Disease and Asthma to Atopic Eczema
One-Sentence Summary
Budesonide is a glucocorticoid originally used for Crohn’s disease, inflammatory bowel disease, asthma and allergic rhinitis. The TxGNN model predicts it may be effective for atopic eczema (top-ranked prediction), but no clinical trials are registered and the available literature is indirect, so the evidence is limited to model prediction and a preclinical formulation study.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Crohn’s disease, inflammatory bowel disease, Crohn’s colitis, asthma, allergic rhinitis (the approved indication text for the Australian listing is not available) |
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 0.9996 |
| Evidence Level | L5 |
| 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 | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, budesonide is a potent glucocorticoid, and its efficacy in inflammatory conditions of the gut and airways is established. Mechanistically, its anti-inflammatory and immunosuppressive activity (reduced Th2 cytokine signalling and eosinophil suppression) may be applicable to atopic skin inflammation.
Topical corticosteroids are already standard care for eczema, so the biological rationale is plausible. However, the prediction is not specific to budesonide. No budesonide-specific clinical trials are registered for this indication. The only budesonide-specific therapeutic item is a preclinical formulation study of budesonide-loaded nanoparticle hydrogels for atopic dermatitis. Other retrieved literature concerns eosinophilic esophagitis, corticosteroid allergy and contact dermatitis, which are indirect or tangential.
Note that the prediction list also includes “dermatitis, atopic” (a synonymous entry, score 0.9981) and several other conditions, including bronchitis (0.9981, evidence level L2) and various polyp-type conditions (mostly L4-L5, no meaningful evidence). The bronchitis entry has the strongest clinical trial support of the predictions, but it is not the top-ranked prediction.
Clinical Trial Evidence
Currently no related clinical trials registered for atopic eczema.
For context, the second-ranked prediction (bronchitis) has budesonide-relevant trials, for example NCT00624754 and NCT01560689 (both Phase 2, completed, n=32, budesonide/formoterol in bronchiolitis obliterans after stem cell transplantation). These do not support the atopic eczema indication.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38275852 | 2024 | Preclinical formulation study | Gels | Budesonide-loaded pH-sensitive nanoparticles in hydrogels developed for local therapy of paediatric atopic dermatitis |
| 31705907 | 2020 | Review | J Allergy Clin Immunol | Emerging therapies for eosinophilic oesophagitis, including topical steroid formulations (indirect) |
| 14616123 | 2003 | Review | Allergy | Corticosteroid allergy in asthma patients; delayed contact allergy is frequent (safety caution) |
| 19571596 | 2009 | Review | Neuroimmunomodulation | Intranasal corticosteroids and adrenal suppression (safety signal) |
| 16428071 | 2006 | Laboratory study | Int Immunopharmacol | Budesonide, but not tacrolimus, affected immune functions of normal human keratinocytes |
| 9496795 | 1998 | Open longitudinal study | Pediatr Dermatol | Knemometry used to assess short-term growth effects of topical budesonide in 14 children with atopic dermatitis |
| 33931866 | 2021 | Patch test study | Contact Dermatitis | Budesonide is a marker for corticosteroid hypersensitivity; budesonide allergy has trended downward over two decades |
| 37927648 | 2023 | Case report | Cureus | Steroid-induced angioedema and urticaria in a patient with atopic dermatitis |
No randomised controlled trial of budesonide in human atopic eczema was identified.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 10034D | Budenofalk | Rectal foam 2 mg per application, 14 applications, aerosol 16.8 g | Not available in the data compiled for this report |
The only listed Australian product is a rectal foam, which is not a dermatological or topical skin formulation. A suitable route of administration for atopic eczema would therefore need separate consideration.
Safety Considerations
- Contraindications flagged by the knowledge graph (not label text): hypertension, epilepsy, liver disease, gallbladder disease, hyperglycaemia, measles, congestive heart failure, herpes simplex virus keratitis, and a range of pituitary and growth hormone deficiency conditions (e.g. hypopituitarism, Kallmann syndrome, Sheehan syndrome), as well as urea cycle disorders (e.g. citrullinemia, hyperargininemia).
- Drug Interactions: 100 interactions were identified. Notable ones include major interactions with adalimumab and fosamprenavir. Moderate interactions include zidovudine, isotretinoin, ketorolac, nifedipine, ibuprofen, ethinylestradiol, fluvoxamine, aldesleukin, alemtuzumab, fosaprepitant, fosinopril and fostamatinib. Minor interactions include formoterol and salbutamol.
- Literature-derived cautions in atopic dermatitis: corticosteroid contact allergy and hypersensitivity, adrenal suppression with corticosteroid use, and potential growth effects in children.
Warnings and contraindications from the TGA-approved Product Information (PI) were not available. Please refer to the PI for authoritative safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, and the anti-inflammatory rationale is plausible, but there are no clinical trials in atopic eczema, and the only budesonide-specific therapeutic work is preclinical. The only Australian product is a rectal foam, and the safety data from the PI are missing.
To proceed, the following is needed:
- Mechanism of action data for budesonide
- TGA Product Information (warnings, contraindications) for the Australian product
- Budesonide-specific clinical studies in atopic eczema, ideally randomised and controlled, with an appropriate topical formulation
- A route and formulation assessment, since the registered product is a rectal foam
- Safety assessment for dermal use, covering systemic absorption, adrenal suppression, growth in children and contact sensitisation
- Review of bronchitis (L2) as a possible alternative lead, once the indication is clearly defined (bronchiolitis obliterans, post-viral bronchiolitis, or COPD-related)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.