Contributions
Abstract: P1253
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Teriflunomide (Aubagio®) is one of the most recent specific treatments for Multiple Sclerosis (MS), available in France from November 2014. As embryotoxic and teratogenic effects have been shown, this drug is contraindicated in pregnant women and its prescription must be accompanied by an effective contraception. The French national pharmacovigilance system has received some spontaneous reports of exposed pregnancies (~20), but under-notification is strongly suspected.
Objectives: To count and describe pregnancies that have been exposed to Aubagio® in France, using the national health insurance database.
Methods: This retrospective cohort study included all 15 to 49 year-old French women, identified as having MS, not sterile, and benefiting from health insurance between August 1st, 2014 and December 31st, 2016. Three groups were compared: Aubagio®/ interferons or glatiramer acetate (IFN-GA) / no treatment (NOTT). Pregnancies were identified through their outcomes, and then linked to newborns hospital birth stays. A pregnancy was considered as exposed to Aubagio® if the woman had taken it during pregnancy or did not follow the appropriate recommendations (accelerated disposal procedure) after treatment stop.
Results: Among the 44,008 women, 5 628 had received Aubagio® at least once. A total of 2 639 pregnancies was identified over the study period, of which 47 were considered as exposed to Aubagio®. The corresponding incidence rate of pregnancies was 1.4 per 100 patient-years (PY), i.e. 3 to 4 times smaller than in the IFN-GA and NOTT groups (5.6 and 4.7 per 100 PY, respectively). The median exposure duration to Aubagio® during pregnancy was 45 days. The 47 outcomes were as follows: 23 live births (47.9%), 22 voluntary or medical abortions (46.8% versus 10.3% in IFN-GA and 15.3% in NOTT) and 2 miscarriages (4.2% versus 4.6% in IFN-GA and 5.1% in NOTT). No effect of exposure on newborns health was reported at birth.
Conclusion: Despite strong recommendations, this study showed that a significant number of pregnancies in MS women were exposed to Aubagio®. The high rate of abortions was consistent with a probable high rate of unplanned pregnancies and/or with the consequences of a known exposure to a teratogenic drug. Accelerated disposal procedures incorrectly carried out were often the cause of exposed pregnancy. A reminder of recommendations regarding Aubagio® use and desire of pregnancy seems necessary to both prescribers and patients.
Disclosure: The study was funded by the French National Agency for Medicines and Health Products Safety (ANSM)
E. Leray reports consulting, lecture fees or travel grants from Biogen, Genzyme, MedDay Pharmaceuticals, Merck, Novartis and Roche.
A. Reilhac has nothing to disclose.
S. Kerbrat has nothing to disclose.
J. Roux has nothing to disclose.
E. Polard has nothing to disclose.
Abstract: P1253
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Teriflunomide (Aubagio®) is one of the most recent specific treatments for Multiple Sclerosis (MS), available in France from November 2014. As embryotoxic and teratogenic effects have been shown, this drug is contraindicated in pregnant women and its prescription must be accompanied by an effective contraception. The French national pharmacovigilance system has received some spontaneous reports of exposed pregnancies (~20), but under-notification is strongly suspected.
Objectives: To count and describe pregnancies that have been exposed to Aubagio® in France, using the national health insurance database.
Methods: This retrospective cohort study included all 15 to 49 year-old French women, identified as having MS, not sterile, and benefiting from health insurance between August 1st, 2014 and December 31st, 2016. Three groups were compared: Aubagio®/ interferons or glatiramer acetate (IFN-GA) / no treatment (NOTT). Pregnancies were identified through their outcomes, and then linked to newborns hospital birth stays. A pregnancy was considered as exposed to Aubagio® if the woman had taken it during pregnancy or did not follow the appropriate recommendations (accelerated disposal procedure) after treatment stop.
Results: Among the 44,008 women, 5 628 had received Aubagio® at least once. A total of 2 639 pregnancies was identified over the study period, of which 47 were considered as exposed to Aubagio®. The corresponding incidence rate of pregnancies was 1.4 per 100 patient-years (PY), i.e. 3 to 4 times smaller than in the IFN-GA and NOTT groups (5.6 and 4.7 per 100 PY, respectively). The median exposure duration to Aubagio® during pregnancy was 45 days. The 47 outcomes were as follows: 23 live births (47.9%), 22 voluntary or medical abortions (46.8% versus 10.3% in IFN-GA and 15.3% in NOTT) and 2 miscarriages (4.2% versus 4.6% in IFN-GA and 5.1% in NOTT). No effect of exposure on newborns health was reported at birth.
Conclusion: Despite strong recommendations, this study showed that a significant number of pregnancies in MS women were exposed to Aubagio®. The high rate of abortions was consistent with a probable high rate of unplanned pregnancies and/or with the consequences of a known exposure to a teratogenic drug. Accelerated disposal procedures incorrectly carried out were often the cause of exposed pregnancy. A reminder of recommendations regarding Aubagio® use and desire of pregnancy seems necessary to both prescribers and patients.
Disclosure: The study was funded by the French National Agency for Medicines and Health Products Safety (ANSM)
E. Leray reports consulting, lecture fees or travel grants from Biogen, Genzyme, MedDay Pharmaceuticals, Merck, Novartis and Roche.
A. Reilhac has nothing to disclose.
S. Kerbrat has nothing to disclose.
J. Roux has nothing to disclose.
E. Polard has nothing to disclose.