For clinicians
IL-6 inhibitors
tocilizumab, sarilumab, anti-IL-6
Looking for the plain-language version? See the patient version of this page.
Bottom lineBottom line: EULAR 2024 lists IL-6 inhibitors (tocilizumab, sarilumab) among non-TNFi biologics that may be used in pregnancy if needed to control maternal disease. Tocilizumab is compatible with breastfeeding; paternal tocilizumab 4/C, sarilumab limited. Individualise.
By reproductive phase
| Phase | Position | Detail | Evidence |
|---|---|---|---|
| Pre-conception | Use if needed | May be continued to maintain control; shared decision.[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; account for IgG transplacental transfer later in pregnancy.[2] | ●●○○low evidenceconditional |
| Breastfeeding | Continue | Tocilizumab compatible with lactation; minimal milk transfer.[2] | ●●○○low evidenceconditional |
| Paternal | Use if needed | Tocilizumab paternal 4/C (compatible); sarilumab limited.[2] | ●○○○very low evidenceconditional |
Guideline comparison
| Guideline | Position | Strength |
|---|---|---|
| ACR 2020 | Conditionally recommend discontinuing at conception; conditionally recommend AGAINST continuing during pregnancy (grouped with the other biologics: limited transfer in early pregnancy but high transfer in the second half). Breastfeeding: conditionally compatible, expecting minimal transfer from the large molecular size, though there are no data. Paternal: unable to make a recommendation (limited data).[1] | Conditional (discontinue at conception; against during pregnancy); no paternal recommendation |
| EULAR 2024 | Tocilizumab and sarilumab may be used in pregnancy if needed (both 4/C); lactation tocilizumab 4/C, sarilumab 4/C; in men tocilizumab 4/C, sarilumab 5/D.[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 tocilizumab and sarilumab in pregnancy if needed to control maternal disease (both 4/C); BSR 2023 advises considering stopping at conception and reserving use for severe maternal disease when no alternative is suitable.
Key points
| Point | Evidence |
|---|---|
| Balance control against limited data; shared decision-making.[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