Interleukin-10
Also known as: CSIF (Cytokine Synthesis Inhibitory Factor), IL-10, Ilodecakin, Interleukin 10, Pegilodecakin, Tenovil
Summary
Interleukin-10 (IL-10) is a pleiotropic anti-inflammatory cytokine produced by multiple immune cells including macrophages, T cells, and B cells. Recombinant human IL-10 (Tenovil/ilodecakin) was investigated for Crohn's disease, psoriasis, and rheumatoid arthritis but failed to demonstrate sufficient clinical efficacy in pivotal trials. Current research focuses on engineered IL-10 fusion proteins and pegylated forms (pegilodecakin) with improved pharmacokinetics, particularly for oncology indications.
Mechanism of Action
Binds to the IL-10 receptor (IL-10R1/IL-10R2 heterodimer), activating JAK1/TYK2 and STAT3 signaling pathways, leading to suppression of pro-inflammatory cytokine production (TNF-α, IL-1, IL-6, IL-12), inhibition of antigen presentation, and promotion of regulatory T cell function.
Routes of Administration
Goals & Uses
- PsoriasisDermatology / InflammatoryModerate
- Inflammatory bowel disease / Crohn's diseaseAutoimmune / InflammatoryModerate
- Rheumatoid arthritisAutoimmune DiseaseLow
- Sepsis / systemic inflammationCritical CareLow
- Cancer immunotherapyOncologyModerate
Contraindications
- Severe immunodeficiencyImmunologyHigh
- Hypersensitivity to IL-10 or recombinant human proteinsAllergy / ImmunologyHigh
- Active severe infectionsInfectious DiseaseHigh
Adverse Effects
- Injection site reactionsLocalCommon
- Anemia / thrombocytopeniaHematologicCommon
- Flu-like symptoms (fever, chills, myalgia)SystemicCommon
- Autoantibody inductionImmunologicUncommon
- Opportunistic infectionsInfectiousUncommon
Drug Interactions
- Live vaccinesHigh
- Biologics / TNF inhibitorsModerate
- Immunosuppressants (e.g., cyclosporine, methotrexate)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Patients with active malignancyOncologyRelative
- Pediatric populationsAgeRelative
- Elderly patientsAgeRelative
Regulatory Status
- European UnionInvestigationalInvestigated for Crohn's disease and psoriasis; not approved by EMA.
- United StatesInvestigationalPegilodecakin received FDA Fast Track designation; no approved indications. rHuIL-10 trials conducted but not approved.
- United KingdomUnknownNo approved indication; research use only.
Recombinant human IL-10 (ilodecakin) was investigated by Schering-Plough but not approved by FDA or EMA for any indication. Pegilodecakin (AM0010) received FDA Fast Track designation for certain cancers but failed Phase III trials. No approved therapeutic formulation exists as of 2024.
Evidence & Sources
No sources recorded yet.