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Pregnancy outcomes in female patients and partners of male patients in the teriflunomide clinical development program
Sleep quality among patients with multiple sclerosis in West Azerbaijan http://dx.doi.org/10.1016/j.msard.2014.09.190
P042
Effect of natalizumab on clinical/radiological disease activity and EDSS of relapsing remitting multiple sclerosis patients
M. Agiela Libya Introduction: Natalizumab is a humanized monoclonal antibody that blocks T-cell transmigration through the blood–brain barrier into CNS. Objective: AFFIRM showed monotherapy with Natalizumab for 2 year reduced the annualized relapse rate ARR by 68% and the disability progression rate by 42%. This is our first experince in use of Natalizumab in Benghazi-Libya. So we want to evalute its efficacy. Methods: Four patients of relapsing remitting multiple scerosis on Natalizumab (JC virus negative and MRI prior to use drug done) followed in our clinical practice regarding frequency of relapse, EDSS and new T2-hyperintense lesion on MRI for 24 months for 3 patients and 1 ptient for 12 months. Results: All the patients have no relapse (frequency of relapse zero) during 24 months in 3 patients and 12 months in 1 patient, no new T2 hyperintense MRI lesion in 3 patients. there are decrease in EDSS in 3 patients. Table and graphs will show more details later on. Conclusion: The efficency of Natalizumab on disease activity i.e. relapse free is higher in my study which 100% in comparsion with AFFIRM which was 68% (our study is small size) so our recommondation to have bigger size for right comparsion and more evalution of efficacy. No reaction to the drug (side effect) recorded during this follow up. http://dx.doi.org/10.1016/j.msard.2014.09.191
755
program. Animal data suggest that teriflunomide may be associated with a risk of teratogenicity. Teriflunomide plasma concentrations o0.02 mg/L in the mother confer minimal risk of teratogenicity, and can be achieved with an accelerated elimination procedure in humans. Design and methods: Despite the requirement for reliable contraception, pregnancies were reported across the teriflunomide clinical trial program. Upon discovery of pregnancy, patients were instructed to discontinue treatment and undergo an accelerated elimination procedure. Pregnancy outcomes were collected across phase 2 and 3 clinical studies in the teriflunomide clinical development program and available data through October 2013 are reported. Results: Eighty-three pregnancies were reported in female patients and 22 in partners of male patients; 26 live births occurred in female patients and 16 in partners of male patients receiving teriflunomide. Twenty-nine pregnancies in female patients and two in partners of male patients were terminated electively. Newborns whose parents were exposed to teriflunomide were healthy and had no structural defects or functional deficits at birth. Spontaneous abortion rate (18.6%) was within the range for general population. Median birth weight for 18 newborns was 3.3 kg, and mean gestational age at birth among 23 cases was 39 weeks, all within typical ranges for general population. Conclusions: Data from the clinical program have shown no teratogenic signals for teriflunomide in humans, consistent with findings of the Organization of Teratology Information Specialists registry and over 2.5 million patient-years of postmarketing data for leflunomide. Further prospective data in the postmarketing setting are being collected in global teriflunomide pregnancy registries. http://dx.doi.org/10.1016/j.msard.2014.09.192
P044
Long-term clinical and magnetic resonance imaging outcomes from patients treated with teriflunomide: Results from a phase 2 extension study
M.A. Jumah, D.B. Li, B. Yamout, Philippe Truffinet, D. Dukovic, P.W. O’Connor P043
Pregnancy outcomes in female patients and partners of male patients in the teriflunomide clinical development program
R. Alroughani, B. Kieseier, R. Gouider, M. Benamor, P. Truffinet, L. Henson Kuwait Background/objectives: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting multiple sclerosis. Consistent efficacy and safety of teriflunomide were demonstrated in a large clinical trial
Saudi Arabia Background/objectives: Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsingremitting multiple sclerosis. The clinical development program for teriflunomide demonstrated consistent efficacy and a well-characterized, manageable safety and tolerability profile. Here we report efficacy outcomes from patients treated long-term with teriflunomide in a phase 2 study (nct01487096) and its extension (nct00228163). Design and methods: Patients with relapsing multiple sclerosis were randomized 1:1:1 to teriflunomide 14 mg or 7 mg, or placebo. Of 160 patients completing the 36-week core study, 147 entered the long-term extension.
P042
Effect of natalizumab on clinical/radiological disease activity and EDSS of relapsing remitting multiple sclerosis patients
M. Agiela Libya Introduction: Natalizumab is a humanized monoclonal antibody that blocks T-cell transmigration through the blood–brain barrier into CNS. Objective: AFFIRM showed monotherapy with Natalizumab for 2 year reduced the annualized relapse rate ARR by 68% and the disability progression rate by 42%. This is our first experince in use of Natalizumab in Benghazi-Libya. So we want to evalute its efficacy. Methods: Four patients of relapsing remitting multiple scerosis on Natalizumab (JC virus negative and MRI prior to use drug done) followed in our clinical practice regarding frequency of relapse, EDSS and new T2-hyperintense lesion on MRI for 24 months for 3 patients and 1 ptient for 12 months. Results: All the patients have no relapse (frequency of relapse zero) during 24 months in 3 patients and 12 months in 1 patient, no new T2 hyperintense MRI lesion in 3 patients. there are decrease in EDSS in 3 patients. Table and graphs will show more details later on. Conclusion: The efficency of Natalizumab on disease activity i.e. relapse free is higher in my study which 100% in comparsion with AFFIRM which was 68% (our study is small size) so our recommondation to have bigger size for right comparsion and more evalution of efficacy. No reaction to the drug (side effect) recorded during this follow up. http://dx.doi.org/10.1016/j.msard.2014.09.191
755
program. Animal data suggest that teriflunomide may be associated with a risk of teratogenicity. Teriflunomide plasma concentrations o0.02 mg/L in the mother confer minimal risk of teratogenicity, and can be achieved with an accelerated elimination procedure in humans. Design and methods: Despite the requirement for reliable contraception, pregnancies were reported across the teriflunomide clinical trial program. Upon discovery of pregnancy, patients were instructed to discontinue treatment and undergo an accelerated elimination procedure. Pregnancy outcomes were collected across phase 2 and 3 clinical studies in the teriflunomide clinical development program and available data through October 2013 are reported. Results: Eighty-three pregnancies were reported in female patients and 22 in partners of male patients; 26 live births occurred in female patients and 16 in partners of male patients receiving teriflunomide. Twenty-nine pregnancies in female patients and two in partners of male patients were terminated electively. Newborns whose parents were exposed to teriflunomide were healthy and had no structural defects or functional deficits at birth. Spontaneous abortion rate (18.6%) was within the range for general population. Median birth weight for 18 newborns was 3.3 kg, and mean gestational age at birth among 23 cases was 39 weeks, all within typical ranges for general population. Conclusions: Data from the clinical program have shown no teratogenic signals for teriflunomide in humans, consistent with findings of the Organization of Teratology Information Specialists registry and over 2.5 million patient-years of postmarketing data for leflunomide. Further prospective data in the postmarketing setting are being collected in global teriflunomide pregnancy registries. http://dx.doi.org/10.1016/j.msard.2014.09.192
P044
Long-term clinical and magnetic resonance imaging outcomes from patients treated with teriflunomide: Results from a phase 2 extension study
M.A. Jumah, D.B. Li, B. Yamout, Philippe Truffinet, D. Dukovic, P.W. O’Connor P043
Pregnancy outcomes in female patients and partners of male patients in the teriflunomide clinical development program
R. Alroughani, B. Kieseier, R. Gouider, M. Benamor, P. Truffinet, L. Henson Kuwait Background/objectives: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting multiple sclerosis. Consistent efficacy and safety of teriflunomide were demonstrated in a large clinical trial
Saudi Arabia Background/objectives: Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsingremitting multiple sclerosis. The clinical development program for teriflunomide demonstrated consistent efficacy and a well-characterized, manageable safety and tolerability profile. Here we report efficacy outcomes from patients treated long-term with teriflunomide in a phase 2 study (nct01487096) and its extension (nct00228163). Design and methods: Patients with relapsing multiple sclerosis were randomized 1:1:1 to teriflunomide 14 mg or 7 mg, or placebo. Of 160 patients completing the 36-week core study, 147 entered the long-term extension.