For clinicians
Anifrolumab
Saphnelo, anti-IFNAR1, type I interferon receptor antagonist
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Bottom lineType I interferon receptor (IFNAR1) antagonist for active, autoantibody-positive SLE, added to standard therapy. Not recommended in severe active lupus nephritis or severe active CNS lupus, or with other biologics. Limited pregnancy data; the product monograph does not recommend use during pregnancy (increased embryo-fetal loss in a primate study; IgG crosses the placenta). Individualise and plan pre-conception.
By reproductive phase
| Phase | Position | Detail | Evidence |
|---|---|---|---|
| Pre-conception | Individualise | Not recommended during pregnancy; plan a switch to a pregnancy-compatible agent before conception.[1] | ●○○○very low evidenceconditional |
| 1st trimester | Avoid | Not recommended during pregnancy (limited human data).[1] | ●○○○very low evidenceconditional |
| 2nd/3rd trimester | Avoid | Not recommended during pregnancy; IgG crosses the placenta, especially in the second half.[1] | ●○○○very low evidenceconditional |
| Breastfeeding | Individualise | No lactation data; minimal milk transfer expected for a large antibody, but unstudied. Individualise.[1] | ●○○○very low evidenceconditional |
| Paternal | Individualise | Limited paternal data; individualise.[1] | ●○○○very low evidenceconditional |
Guideline comparison
| Guideline | Position | Strength |
|---|---|---|
| Health Canada product monograph (2026) | Not recommended during pregnancy; limited human data, with increased embryo-fetal loss in a cynomolgus monkey study and transplacental transfer of IgG. Not recommended in severe active lupus nephritis or severe active CNS lupus, or in combination with other biologic therapies.[1] | Product monograph |
Key points
| Point | Evidence |
|---|---|
| Balance disease control against limited pregnancy data; it is not recommended during pregnancy, so plan pre-conception.[1] | ●○○○very low evidenceconditional |
Monitoring
- Monitor for infections including herpes zoster; do not initiate with a clinically significant active infection until it resolves.
- Watch for hypersensitivity and infusion-related reactions during and after intravenous dosing.
References
- SAPHNELO (anifrolumab) Product Monograph. AstraZeneca Canada Inc. Health Canada; 2026-03-05. https://pdf.hres.ca/dpd_pm/00083796.PDF