Safety of Exposure to Natalizumab During Pregnancy
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Questionnaire
- Registration Number
- NCT05209815
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
Multiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes. Nevertheless, disease-modifying therapies can have a teratogenic effect. Discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus.
Natalizumab (NTZ) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting MS (RRMS). When it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. At present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: Pregnancy and postpartum under NTZ (group1), Pregnancy partially under NTZ (with or without immunomodulator (IM) supplementation, group 2), or NTZ stopped before pregnancy (with or without IM supplementation, group3).
The first part of the BABYZUMAB study, a retrospective study of Natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of NTZ treatment The investigators analyzed the annual relapse rate (ARR) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the OFSEP database. The investigators showed that the risk of relapses was four times higher in Group 2 versus Group 1 (p=0,014) and six times higher in Group 3 versus Group 1 (p=0,001).
In the literature, there are few studies of newborns from NTZ-exposed pregnancies. No specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to NTZ-exposed mothers in the third trimester of pregnancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
- Age greater than 18 years at the index date (date of pregnancy onset) of data collection,
- RRMS according to McDonald's 2017 criteria (Thompson et al., 2018)
- Affiliated person or beneficiary of a social security scheme.
- followed up at one of the participating centers (OFSEP centers)
- NTZ exposure during pregnancy according to 3 pre-defined sub-groups: continuation of NTZ throughout pregnancy and postpartum (Group 1), exposure during the first trimester (Group 2) exposure during the first and the second trimester (Group 3).
- Participants capable of expressing non objection
- French-speaking, without comprehension disorders
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Questionnaire continuation of NTZ throughout pregnancy and postpartum Group 2 Questionnaire exposure during the first trimester Group 3 Questionnaire exposure during the first and the second trimester
- Primary Outcome Measures
Name Time Method Proportion of patients who presented serious adverse events (SAE) during their pregnancy At baseline (Day 0)
- Secondary Outcome Measures
Name Time Method Proportion of patients who presented postpartum AEs of interest At baseline (day 0) Proportion of patients who presented pregnancy complications At baseline (day 0) Proportion of viable children at birth At baseline (day 0) Proportion of patients who presented delivery complications At baseline (day 0) Average weight at birth At baseline (day 0) apgar score at birth At baseline (day 0) Number of child AEs of interest (haematological, infectious, malformations) at birth At baseline (day 0) Number of child AEs of interest (haematological, infectious, malformations) two years after birth At baseline (day 0)
Trial Locations
- Locations (27)
Fondation Rothschild - service de neurologie
🇫🇷Paris, France
CHU de Limoges - service de neurologie
🇫🇷Limoges, France
CHU de Poitiers - service de neurologie
🇫🇷Poitiers, France
CHU de Tours - service de neurologie
🇫🇷Tours, France
CHRU de Nancy - service de neurologie
🇫🇷Nancy, France
CHU de Nice - service de neurologie
🇫🇷Nice, France
CHU d'Amiens - service de neurologie
🇫🇷Salouël, France
AP-HP - Hôpital Saint-Antoine - service de neurologie
🇫🇷Paris, France
AP-HP - Hôpital de Créteil - service de neurologie
🇫🇷Créteil, France
CHU de Rennes - service de neurologie
🇫🇷Rennes, France
AP-HM - service de neurologie
🇫🇷Marseille, France
CHU de Rouen - service de neurologie
🇫🇷Rouen, France
HCL - service de neurologie
🇫🇷Bron, France
CH Sud Francilien - service de neurologie
🇫🇷Corbeil-Essonnes, France
CHRU de Strasbourg - service de neurologie
🇫🇷Strasbourg, France
CHU de Nîmes - service de neurologie
🇫🇷Nîmes, France
CH de Saint-Denis - service de neurologie
🇫🇷Saint-Denis, France
CHU de Fort de France - service de neurologie
🇲🇶Fort-de-France, Martinique
CHRU de Besançon - service de neurologie
🇫🇷Besançon, France
CHU de Bordeaux - service de neurologie
🇫🇷Bordeaux, France
CHU de Dijon-Bourgogne
🇫🇷Dijon, France
CHU de Grenoble-Alpes
🇫🇷La Tronche, France
CHRU de Lille - service de neurologie
🇫🇷Lille, France
CHU de Montpellier - service de neurologie
🇫🇷Montpellier, France
CHU de Nantes - service de neurologie
🇫🇷Nantes, France
AP-HP - Hôpital La Pitié Salpétrière - service de neurologie
🇫🇷Paris, France
CHU de Toulouse - service de neurologie
🇫🇷Toulouse, France