Autoinflammatory & rare systemic diseases

Exposure during pregnancy to Il-1 targeted therapies and pregnancy, foetal and neonatal outcomes: a study from the French Teratology Information Service

Rheumatology (Oxford)Published Descriptive observational study

Authors' conclusion

In this study, the largest series to date, our results do not suggest occurrence of specific negative outcomes in pregnancies exposed to anti-IL-1.

Study context

Population
Pregnancies exposed to anti-IL-1 (anakinra and/or canakinumab) with known outcomes, referred to CRAT 2007–2023; 27 (47.3%) treated for Still's disease
Participants
57 pregnant women
Exposure
Anakinra vs Canakinumab vs Both medications
  • Anakinran = 43
  • Canakinumabn = 5
  • Both medicationsn = 4
Outcome
Pregnancy, foetal and neonatal outcomes
Methodological detailsprospective and retrospective pregnancies, French Teratology Information Service (CRAT) data
  • Prospective and retrospective pregnancies
  • French Teratology Information Service (CRAT) data

Main finding

As reported in the abstract

GroupValueExposed during T1Exposed during all pregnancyEarly miscarriagesMedical abortionElective abortionMajor congenital malformation prevalence among T1-exposedMalformations
Anakinra85.1%40/47 (85.1%)21/47 (44.7%)5/47 (10.6%)113.03% IC 95% [0.1-15.1]
Canakinumab9/9 events9/92/90

Value

Anakinra85.1%
Canakinumab9/9 events

Exposed during T1

Anakinra40/47 (85.1%)
Canakinumab9/9

Exposed during all pregnancy

Anakinra21/47 (44.7%)
Canakinumab2/9

Early miscarriages

Anakinra5/47 (10.6%)
Canakinumab— not stated in the abstract

Medical abortion

Anakinra1
Canakinumab— not stated in the abstract

Elective abortion

Anakinra1
Canakinumab— not stated in the abstract

Major congenital malformation prevalence among T1-exposed

Anakinra3.03% IC 95% [0.1-15.1]
Canakinumab— not stated in the abstract

Malformations

Anakinra— not stated in the abstract
Canakinumab0
Anakinra: one isolated hypospadias (anakinra between 0 and 4 weeks of gestation)
1

Observational data: associations, not effects.

Further findings

Retrospective pregnancies (anakinra)
6/6 · events
Retrospective pregnancies (anakinra) — All resulted in live births; cardiopathy with hypospadias in a child with a rare genetic anomaly
1

Safety

No significant effects reported while breastfeeding (n = 9)

Original publication

Exposure during pregnancy to Il-1 targeted therapies and pregnancy, foetal and neonatal outcomes: a study from the French Teratology Information Service. Rheumatology (Oxford). Published 12 July 2025. doi:10.1093/rheumatology/keaf387

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