For clinicians
IL-1 inhibitors
anakinra, canakinumab, anti-IL-1
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Bottom lineBottom line: EULAR 2024 lists IL-1 inhibitors (anakinra, canakinumab) among non-TNFi biologics usable in pregnancy if needed, and compatible with breastfeeding. Useful in colchicine-resistant autoinflammatory disease. Paternal use compatible.
By reproductive phase
| Phase | Position | Detail | Evidence |
|---|---|---|---|
| Pre-conception | Use if needed | May be continued to maintain control, e.g. in colchicine-resistant FMF.[2] | ●●○○low evidenceconditional |
| 1st trimester | Use if needed | Use if needed to control maternal disease.[2] | ●●○○low evidenceconditional |
| 2nd/3rd trimester | Use if needed | Use if needed; anakinra has a short half-life and minimal placental transfer.[2] | ●●○○low evidenceconditional |
| Breastfeeding | Continue | Compatible with lactation.[2] | ●●●○moderate evidenceconditional |
| Paternal | Continue | Compatible with paternal exposure.[2] | ●●○○low evidenceconditional |
Guideline comparison
| Guideline | Position | Strength |
|---|---|---|
| ACR 2020 | For anakinra (the IL-1 inhibitor ACR addresses): conditionally recommend discontinuing at conception; conditionally recommend AGAINST during pregnancy (other-biologics group). Breastfeeding: conditionally compatible (minimal transfer expected, no data). Paternal: conditionally recommend continuing anakinra. ACR does not separately address canakinumab or rilonacept.[1] | Conditional (discontinue at conception; against during pregnancy); conditional paternal continue (anakinra) |
| EULAR 2024 | Anakinra and canakinumab may be used in pregnancy if needed (both 4/C); compatible with lactation (both 2a/B); continuable in men (both 4/C).[2] | Oxford LoE/GoR as shown |
| BSR 2022/23 | Consider stopping at conception; use in either trimester only for severe maternal disease if no other pregnancy-compatible drugs are suitable. Breastfeeding and paternal exposure compatible (limited evidence). If used in the third trimester, avoid infant live vaccinations until 6 months of age.[3] | Verified against BSR Table 1 |
=Guideline divergence. VERIFIED DIVERGENCE. EULAR 2024 (5b) permits anakinra and canakinumab in pregnancy if needed (both 4/C) and considers both compatible with breastfeeding (2a/B); BSR 2023 advises considering stopping at conception and reserving use for severe maternal disease when no alternative is suitable.
Key points
| Point | Evidence |
|---|---|
| Key option for colchicine-resistant FMF and other autoinflammatory disease in pregnancy.[2] | ●●○○low evidenceconditional |
Monitoring
- EULAR 2024 (footnote b): after non-TNFi bDMARD exposure in the 2nd/3rd trimester, delay infant live-attenuated vaccines for 6 months (4/C-5/D).
References
- Sammaritano LR, et al. 2020 ACR Guideline for the Management of Reproductive Health in RMD. Arthritis Rheumatol. 2020;72(3):529-556. https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.41191
- Ruegg L, et al. EULAR recommendations for antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025;84(6):910-926. https://ard.eular.org/article/S0003-4967(25)00818-0/fulltext
- Russell MD, et al. BSR guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory drugs and corticosteroids. Rheumatology (Oxford). 2023;62(4):e48-e88. https://academic.oup.com/rheumatology/article/62/4/e48/6783012