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Offline agate

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Presented at the recent annual AAN conference in Washington, DC:

[S20.003] Pregnancy does not prevent disease re-activation after natalizumab suspension in patients with multiple sclerosis

Maria Amato,1Bahia Hakiki,2Luisa Pastò,2Marta Giannini,2Lorenzo Razzolini,2Carla Tortorella,3Mariangela D'Onghia,4Maria Trojano,4Eleonora Cocco,5Marta Melis,5Maria Marrosu,6Valeria Di Tommaso,7Deborah Farina,7Alessandra Lugaresi,8Pietro Annovazzi,8Angelo Ghezzi,9Claudio Gasperini,10Alfonso Iudice,9Roberta Fantozzi,9Paolo Bellantonio,11Silvia Messina,12Francesco Patti,12Silvia Masera,13Paola Cavalla,9Alessandra Protti,6Maria Rossi,14Rocco Totaro,14Laura De Giglio,9Carlo Pozzilli,10Emilio Portaccio,2MS Study Group of the Italian Neurological Society

1Firenze, Italy, 2Florence, Italy, 3Nampoli, Italy, 4Bari, Italy, 5Cagliari, Italy, 6Milano, Italy, 7Chieti, Italy, 8Milan, Italy, 9Italy, 10Rome, Italy, 11Pozzilli, Italy, 12Catania, Italy, 13Torino, Italy, 14L'Aquila, Italy.


To assess multiple sclerosis (MS) disease activity during pregnancy after natalizumab exposure (NE) and the impact of natalizumab exposure (NE) on pregnancy outcomes.


While the risk of disease re-activation after natalizumab suspension is widely acknowledged, little is known on disease activity during pregnancy occurring after suspension of natalizumab in MS patients. In hypothesis, since gestational period is related to a reduction [in the] relapse-rate, a “protection” from disease re-activation could be expected.


We recruited NE pregnancies in MS patients prospectively followed-up in 13 Italian MS Centres, in the period 2010-2013. Exposure to natalizumab was defined as suspension of the drug < ten weeks prior to conception. Clinical relapses and pregnancy outcomes during pregnancy were compared with data from the Italian dataset on interferon-beta exposed (IFNBE) pregnancies (Amato et al., 2010). All the patients were administered a structured interview which gathered detailed information on pregnancy course and outcomes, as well as on possible confounders. Group comparisons were assessed through the χ2 test, the analysis of variance and a mixed factorial design, when appropriate.


So far 32 pregnancies were recruited. Pregnancies resulted in 25 live births, six spontaneous abortions and two voluntary abortions (one due to Down Syndrome). The occurrence of relapses during pregnancy in 9/25 (36%) patients was higher that observed in IFNBE patients (10/75, 13.3%; mixed factorial design F=2.668,p=0.003). Proportion of spontaneous abortion in NE pregnancies (18.8%) was not significantly different from that previously observed in IFNBE pregnancies (8%;p=0.106).

Proportions of pre-term deliveries (20%), mean birth-weight (2907gr) and birth-length (49.3cm) were also comparable to those of IFNBE pregnancies (p>0.3).


In our study pregnancy did not protect from disease re-activation after natalizumab suspension in MS patients. The risk of relapses during pregnancy should be taken into account in the counselling of natalizumab-treated MS patients contemplating pregnancy.

Category - MS and CNS Inflammatory Disease: Clinical Science

Session: S20: Platform Session: Treatment Mechanisms in Multiple Sclerosis (2:00 PM-3:45 PM)
Date/Time: Wednesday, April 22, 2015 - 2:30 pm
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.