Vedolizumab
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Vedolizumab
- Vedolizumab: From Crohn's Disease and Ulcerative Colitis to Severe Nonproliferative Diabetic Retinopathy
Vedolizumab: From Crohn's Disease and Ulcerative Colitis to Severe Nonproliferative Diabetic Retinopathy
One-Sentence Summary
Vedolizumab is a gut-selective monoclonal antibody originally used to treat inflammatory bowel disease (Crohn's disease and ulcerative colitis). The TxGNN model predicts it may be effective for severe nonproliferative diabetic retinopathy, but this is a computational prediction only, with 0 clinical trials and 0 publications supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Crohn's disease, inflammatory bowel disease, Crohn's colitis, ulcerative colitis (from the knowledge graph; no approved indication text is available in the Singapore licence records) |
| Predicted New Indication | Severe nonproliferative diabetic retinopathy |
| TxGNN Prediction Score | 94.51% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. From known information, vedolizumab is an anti-α4β7 integrin antibody. It blocks T-cell migration into the gut and acts selectively on the gastrointestinal tract.
Retinal microvascular disease is not an established target of this pathway, so no mechanistic link to diabetic retinopathy is supported. The high TxGNN score is a network-based computational prediction, and no trials or literature back it up.
Other predicted indications were also reviewed, and none has supporting evidence for therapeutic use:
| Rank | Predicted Indication | Score | Evidence Level | Assessment |
|---|---|---|---|---|
| 2 | Dermatitis | 93.57% | L4 | The literature mainly describes vedolizumab-induced skin reactions (atopic, psoriasiform, acneiform, granulomatous dermatitis, hidradenitis). This argues against therapeutic use. |
| 3 | Neonatal dermatomyositis | 92.73% | L5 | No mechanistic link or evidence |
| 4 | Acne keloid | 92.33% | L5 | No evidence; vedolizumab-induced acne is reported |
| 5 | Acrodermatitis chronica atrophicans | 92.23% | L5 | Borrelia-related; immunosuppression is not rational |
| 6 | Hydroa vacciniforme, familial | 92.18% | L5 | No mechanistic link or evidence |
| 7 | Secondary childhood interstitial lung disease (connective tissue disease) | 92.06% | L5 | Gut-selective action makes pulmonary benefit unlikely |
| 8 | Amyopathic dermatomyositis | 91.72% | L5 | Disease driven by interferon and T-cell pathways, not gut-homing integrins |
| 9 | Bronchitis | 91.02% | L4 | Appears only as an adverse or infection outcome in safety analyses |
| 10 | Drug-induced osteoporosis | 87.14% | L5 | No direct link |
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
For the top-ranked prediction (severe nonproliferative diabetic retinopathy), currently no related literature is available.
The literature found for the second-ranked prediction (dermatitis) is mostly adverse-event reporting and is shown here for context only:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38740543 | 2024 | Systematic review and meta-analysis | J Gastroenterol Hepatol | Examines the effect of vedolizumab on extraintestinal manifestations in IBD; the direction of effect is not stated in the available text |
| 29668916 | 2018 | Comparative analysis | Inflamm Bowel Dis | Compares incidence of extraintestinal manifestations with vedolizumab vs anti-TNF therapy in IBD |
| 32318735 | 2020 | Case series | J Crohns Colitis | Multicentre series on inflammatory skin lesions in IBD treated with vedolizumab or ustekinumab |
| 39606602 | 2024 | Case series | Postepy Dermatol Alergol | Adult-onset atopic dermatitis induced by vedolizumab |
| 35199379 | 2022 | Case report | J Dermatol | Psoriasiform dermatitis in a girl with ulcerative colitis on vedolizumab |
| 30677821 | 2018 | Case report | Dermatol Online J | Severe acneiform eruption induced by vedolizumab |
| 33208632 | 2021 | Case report | Dermatitis | Hidradenitis suppurativa caused by vedolizumab |
| 35659138 | 2022 | Case report | Cutis | Interstitial granulomatous dermatitis as an adverse reaction to vedolizumab |
| 34759935 | 2021 | Case report | Front Immunol | Vedolizumab used in refractory intestinal Behçet's disease |
| 29788248 | 2018 | Post hoc safety analysis | J Crohns Colitis | Respiratory tract infection rates in vedolizumab clinical trials (relevant to the bronchitis prediction) |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16673P | ENTYVIO Solution for Injection in Pre-filled Pen 108 mg/0.68 mL | Injection, solution | Not available in the records |
| SIN14950P | ENTYVIO Powder for Concentrate for Solution for Infusion 300 mg/vial | Injection, powder, for solution | Not available in the records |
Safety Considerations
Drug Interactions: 69 interactions were identified. Major-level interactions include:
- Adalimumab
- Baricitinib
- Certolizumab pegol
- Cladribine
Moderate-level interactions include:
- Azathioprine
- Alemtuzumab
- Anakinra
- Canakinumab
- Denosumab
- Dimethyl fumarate
- Roflumilast
- Live and inactivated vaccines (e.g., cholera live vaccine, anthrax vaccine, tetanus toxoid)
Minor-level interactions include zinc salts (sulfate, acetate, gluconate, chloride).
Other safety signals from the literature: Case reports describe skin reactions (atopic, psoriasiform and acneiform eruptions, hidradenitis suppurativa, granulomatous dermatitis) and an infusion reaction. Please also refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction is supported only by a model score (94.51%), with no clinical trials, no literature, and no plausible mechanistic link. Vedolizumab acts selectively on the gut, and the other predicted indications show either no evidence or adverse-event signals pointing against benefit.
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA (currently missing, and a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Approved indication text for the two Singapore licences
- Preclinical or mechanistic evidence linking α4β7 integrin biology to retinal microvascular disease
- Review of whether any lower-ranked prediction has a credible rationale; none does at present
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.