Contributions
Abstract: EP1527
Type: ePoster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Objective: To characterize safety and efficacy of Extended Interval Dosing (EID) for Natalizumab (NTZ) by adding European experience to the previously reported USA EID cohort.
Background: NTZ, highly effective treatment for RRMS, carries well recognized risk of PML. In attempt to mitigate risk, we are continuing to explore the effect of extended interval dosing (EID) for NTZ with previously reported US experience with 1099 NTZ treated standard interval dose (SID) and 905 EID patients. We are looking to expand our description of EID NTZ cohort by reporting on data from Italian MS Center Spedali Civili, BS, IT.
Method: Retrospective chart review of NTZ-treated patients from MS Center Spedali Civili was conducted and compared to results previously reported from 9 U.S. centers. ARR, frequency of steroid usage, new T2 lesions, T1 enhancing lesions, and No Evidence of Disease Activity (NEDA) is calculated.
Results: The Italian cohort adds: EID 138; SID 49 (age mean 42.6yrs (range 11-71); 71% Female; MS dz duration 13.4yrs (range 0-34) with average NTZ infusion 33; mean duration on EID 14.7 (range 3-42)). ARR for EID is 0.4 and SID 0.1 (p = 0.14; CI -0.99 - 3.5) with 56% of EID pts having no evidence of radiological activity, compared to 64% in SID cohort (p =0.2; CI -1.26 - 3.06). Previously reported US cohort"s ARR was 0.1 for both EID and SID with 82% of EID patients having no evidence of radiological activity, compared to 85% in SID cohort. No cases of PML in the EID group. 8 PML cases were seen in SID groups.
Conclusion: The Italian cohort showed EID group to have comparable efficacy across both clinical and radiological measures compared to SID group, a trend which is consistent with the data from the US sites. EID of NTZ up to q8.5wks appears to maintain excellent efficacy profile of drug, with promising risk reduction of PML.
Disclosure: Lana Zhovtis Ryerson has received research support from Biogen Idec. She has received compensation for advisory board and speaker activities from Biogen Idec and Teva. Ruggero Capra has nothing to disclose. Sarah Rasia has nothing to disclose. Kister I served on scientific advisory board for Biogen Idec and received research support from Guthy-Jackson Charitable Foundation, National Multiple Sclerosis Society, Biogen-Idec, Serono, and Novartis. Foley J has served as a consultants for and receives honoraria from Biogen, Genzyme, Teva, Novartis, and Avanir. Weinstock-Guttman B has participated in speaker´s bureaus and served as a consultant for Biogen Idec, Teva Neuroscience, EMD Serono, Novartis, Genzyme & Sanofi, Acorda Therapeutics, Inc. and Genentech. Dr. Weinstock-Guttman also has received grant/research support from the agencies listed in the previous sentence as well as Questcor Pharmaceuticals, Inc., and Shire. She serves in the editorial board for BMJ Neurology, Journal of International MS and CNS DrugsTornatore C has received speaker and consulting fees from Biogen Idec.Pandey K has received speaker and consulting fees from Acorda , TEVA, and Biogen Pawate S has no financial disclosures. Bomprezzi R has no financial disclosuresSmith D has received speaker and consulting fees from Biogen Idec.Kolb C has served as speaker and received consulting fees from Biogen, Teva, EMD Serono, and Acorda,Frohman TC has served as speaker and received consultant fees from Novartis, Genzyme, and Acorda.Okuda D received lecture fees from Acorda Therapeutics, Genzyme, and TEVA Neuroscience, consulting and advisory board fees from Genzyme, Novartis, and TEVA Neuroscience, and research support from Biogen.Hoyt T has no financial disclosures. Guadalupe Estrada- Zuniga has no finacial disclosures. April Jacob has no financial disclosures. Frohman EM Speaker and consultant fees from Novartis, Genzyme, TEVA, and Acorda.
Abstract: EP1527
Type: ePoster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Objective: To characterize safety and efficacy of Extended Interval Dosing (EID) for Natalizumab (NTZ) by adding European experience to the previously reported USA EID cohort.
Background: NTZ, highly effective treatment for RRMS, carries well recognized risk of PML. In attempt to mitigate risk, we are continuing to explore the effect of extended interval dosing (EID) for NTZ with previously reported US experience with 1099 NTZ treated standard interval dose (SID) and 905 EID patients. We are looking to expand our description of EID NTZ cohort by reporting on data from Italian MS Center Spedali Civili, BS, IT.
Method: Retrospective chart review of NTZ-treated patients from MS Center Spedali Civili was conducted and compared to results previously reported from 9 U.S. centers. ARR, frequency of steroid usage, new T2 lesions, T1 enhancing lesions, and No Evidence of Disease Activity (NEDA) is calculated.
Results: The Italian cohort adds: EID 138; SID 49 (age mean 42.6yrs (range 11-71); 71% Female; MS dz duration 13.4yrs (range 0-34) with average NTZ infusion 33; mean duration on EID 14.7 (range 3-42)). ARR for EID is 0.4 and SID 0.1 (p = 0.14; CI -0.99 - 3.5) with 56% of EID pts having no evidence of radiological activity, compared to 64% in SID cohort (p =0.2; CI -1.26 - 3.06). Previously reported US cohort"s ARR was 0.1 for both EID and SID with 82% of EID patients having no evidence of radiological activity, compared to 85% in SID cohort. No cases of PML in the EID group. 8 PML cases were seen in SID groups.
Conclusion: The Italian cohort showed EID group to have comparable efficacy across both clinical and radiological measures compared to SID group, a trend which is consistent with the data from the US sites. EID of NTZ up to q8.5wks appears to maintain excellent efficacy profile of drug, with promising risk reduction of PML.
Disclosure: Lana Zhovtis Ryerson has received research support from Biogen Idec. She has received compensation for advisory board and speaker activities from Biogen Idec and Teva. Ruggero Capra has nothing to disclose. Sarah Rasia has nothing to disclose. Kister I served on scientific advisory board for Biogen Idec and received research support from Guthy-Jackson Charitable Foundation, National Multiple Sclerosis Society, Biogen-Idec, Serono, and Novartis. Foley J has served as a consultants for and receives honoraria from Biogen, Genzyme, Teva, Novartis, and Avanir. Weinstock-Guttman B has participated in speaker´s bureaus and served as a consultant for Biogen Idec, Teva Neuroscience, EMD Serono, Novartis, Genzyme & Sanofi, Acorda Therapeutics, Inc. and Genentech. Dr. Weinstock-Guttman also has received grant/research support from the agencies listed in the previous sentence as well as Questcor Pharmaceuticals, Inc., and Shire. She serves in the editorial board for BMJ Neurology, Journal of International MS and CNS DrugsTornatore C has received speaker and consulting fees from Biogen Idec.Pandey K has received speaker and consulting fees from Acorda , TEVA, and Biogen Pawate S has no financial disclosures. Bomprezzi R has no financial disclosuresSmith D has received speaker and consulting fees from Biogen Idec.Kolb C has served as speaker and received consulting fees from Biogen, Teva, EMD Serono, and Acorda,Frohman TC has served as speaker and received consultant fees from Novartis, Genzyme, and Acorda.Okuda D received lecture fees from Acorda Therapeutics, Genzyme, and TEVA Neuroscience, consulting and advisory board fees from Genzyme, Novartis, and TEVA Neuroscience, and research support from Biogen.Hoyt T has no financial disclosures. Guadalupe Estrada- Zuniga has no finacial disclosures. April Jacob has no financial disclosures. Frohman EM Speaker and consultant fees from Novartis, Genzyme, TEVA, and Acorda.