Contributions
Abstract: P715
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Relapsing MS is approximately 3-fold more common in women than in men, with an average age of onset of 30 years; hence at diagnosis many patients are women of child-bearing age.
Objective: To present updated information on pregnancy outcomes in fingolimod-exposed women from internal data sources and put it in context with the general population.
Methods: We report cumulative data on pregnancy outcomes (prospective and retrospective) from the Multinational Gilenya® Pregnancy Exposure Registry, prospective cases from the PRegnancy outcomes Intensive Monitoring program (PRIM, an enhanced data collection program for pregnancy cases reported to the Novartis safety database [NSD]), and the NSD. Prospective cases are: For the registry, those where the condition of the foetus was not assessed through prenatal testing and pregnancy outcome was not known at the time of enrolment; for the NSD and PRIM, those where the condition of the foetus was not known to be abnormal through prenatal testing and pregnancy outcome was not known at the time of reporting pregnancy, a broader definition (number of cases considered prospective may vary due to different definitions of prospective for the Registry and the NSD).
Results: By end of February 2016, 926 prospective cases related to fingolimod exposure (maternal) were reported in the NSD, including 106 cases from the Registry ("prospective" as per NSD definition; 79 as per the Registry definition, see methods) and 449 cases from PRIM. Among cases with known outcomes in the NSD (n=512), Registry (n=59) and PRIM (n=190), cases of live birth were 324, 43 and 116, respectively. Prevalence (95% CI) of major congenital malformations in live births in the Registry and PRIM was 2.3% (0.1, 12.3) and 0%, respectively. Corresponding prevalence in the NSD (324 live births including 83 Registry and 116 PRIM cases) was 3.08% (1.49, 5.60) and all of the above were comparable with published reports from the general population (2.1% - 4.1%).
Conclusions: Based on limited information at this point, the prevalence of major congenital malformations in live births following fingolimod exposure is similar to that observed in the general population. No unusual syndromes/unexpected multiples of the same defects were reported. The Registry and PRIM will continue to collect information to assess the risk of reproductive toxicity in fingolimod exposed patients.
Disclosure:
Funding source: This study is supported by Novartis Pharma AG, Basel, Switzerland.
Gideon Koren has nothing to disclose.
Hong Wang is an employee of Quintiles, Cambridge, MA, United States.
Helmut Butzkueven has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/research support from Biogen, Novartis, Merck and Genzyme.
Hugh Tilson is widely associated with the multinational pharmaceutical industry, including services rendered on several global pregnancy and disease registries.
T.M. MacDonald has received compensation for serving as a consultant or speaker or he or the institution he works for has received research support from Novartis, Pfizer, Ipsen and Menarini, Kaiser Permanante, Takeda, Recordati, Servier, Menarini, NiCox and AstraZeneca.
Kerstin Hellwig has received compensation for serving as a consultant or speaker or she or the institution she works for has received research support from Bayer, Schering Healthcare, Teva, Sanofi Aventis, Biogen Idec, Merck Serono and Novartis.
Yvonne Geissbühler and Jere Vile are employees of Novartis.
Abstract: P715
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Relapsing MS is approximately 3-fold more common in women than in men, with an average age of onset of 30 years; hence at diagnosis many patients are women of child-bearing age.
Objective: To present updated information on pregnancy outcomes in fingolimod-exposed women from internal data sources and put it in context with the general population.
Methods: We report cumulative data on pregnancy outcomes (prospective and retrospective) from the Multinational Gilenya® Pregnancy Exposure Registry, prospective cases from the PRegnancy outcomes Intensive Monitoring program (PRIM, an enhanced data collection program for pregnancy cases reported to the Novartis safety database [NSD]), and the NSD. Prospective cases are: For the registry, those where the condition of the foetus was not assessed through prenatal testing and pregnancy outcome was not known at the time of enrolment; for the NSD and PRIM, those where the condition of the foetus was not known to be abnormal through prenatal testing and pregnancy outcome was not known at the time of reporting pregnancy, a broader definition (number of cases considered prospective may vary due to different definitions of prospective for the Registry and the NSD).
Results: By end of February 2016, 926 prospective cases related to fingolimod exposure (maternal) were reported in the NSD, including 106 cases from the Registry ("prospective" as per NSD definition; 79 as per the Registry definition, see methods) and 449 cases from PRIM. Among cases with known outcomes in the NSD (n=512), Registry (n=59) and PRIM (n=190), cases of live birth were 324, 43 and 116, respectively. Prevalence (95% CI) of major congenital malformations in live births in the Registry and PRIM was 2.3% (0.1, 12.3) and 0%, respectively. Corresponding prevalence in the NSD (324 live births including 83 Registry and 116 PRIM cases) was 3.08% (1.49, 5.60) and all of the above were comparable with published reports from the general population (2.1% - 4.1%).
Conclusions: Based on limited information at this point, the prevalence of major congenital malformations in live births following fingolimod exposure is similar to that observed in the general population. No unusual syndromes/unexpected multiples of the same defects were reported. The Registry and PRIM will continue to collect information to assess the risk of reproductive toxicity in fingolimod exposed patients.
Disclosure:
Funding source: This study is supported by Novartis Pharma AG, Basel, Switzerland.
Gideon Koren has nothing to disclose.
Hong Wang is an employee of Quintiles, Cambridge, MA, United States.
Helmut Butzkueven has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/research support from Biogen, Novartis, Merck and Genzyme.
Hugh Tilson is widely associated with the multinational pharmaceutical industry, including services rendered on several global pregnancy and disease registries.
T.M. MacDonald has received compensation for serving as a consultant or speaker or he or the institution he works for has received research support from Novartis, Pfizer, Ipsen and Menarini, Kaiser Permanante, Takeda, Recordati, Servier, Menarini, NiCox and AstraZeneca.
Kerstin Hellwig has received compensation for serving as a consultant or speaker or she or the institution she works for has received research support from Bayer, Schering Healthcare, Teva, Sanofi Aventis, Biogen Idec, Merck Serono and Novartis.
Yvonne Geissbühler and Jere Vile are employees of Novartis.