Abstract: P673
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Introduction: Continued disease activity during first line disease modifying therapy (DMT) in relapsing-remitting multiple sclerosis (RRMS) indicate suboptimal treatment response and should therefore prompt treatment escalation to a second line DMT. In Sweden rituximab (RTX) is used off label as a second line DMT by one third of all treated multiple sclerosis (MS) patients. A retrospective study suggested that RTX had favourable adverse event (AE) profile, efficacy and drug survival compared to fingolimod (FGL) in patients switching from natalizumab (NTZ) due to JC virus positivity (JCV+). There are currently no comparative studies between RTX and other highly effective (HE) DMTs after breakthrough disease on first line therapy.
Objective: To compare the safety and efficacy of RTX, FGL, NTZ and alemtuzumab (ALZ) in RRMS cases who, despite treatment with first line DMTs, experienced clinical relapses and/or had contrast enhancing lesions (CELs) on magnetic resonance imaging (MRI).
Method: At three Swedish MS Centres, the Swedish MS registry was searched for patients with RRMS who had switched from first line DMTs (interferons or glatiramer acetate) to either RTX, FGL, NTZ or ALZ between 2011-01-01 and 2015-12-31 due to breakthrough disease. Patients with a follow-up period of at least 12 months were included. Data in this retrospective observational study were collected from the MS registry and medical charts.
Result: Preliminary data shows an approximate number of 220 RRMS patients meeting the inclusion criteria. The majority of patients (78%) had switched from interferons, and the most common reason to switch was CELs (65%). The most common HE drug was FGL (44%), followed by NTZ (40%), RTX (15%) and ALZ (< 1%). The annualised relapse rate (ARR) after switch was 0,016 (NTZ), 0,032 (RTX) and 0,058 (FGL). 15% of patients treated with NTZ discontinued treatment due to JCV+. The efficacy will further be estimated by comparing the proportion of patients with continued inflammatory disease activity, measured as new CEL(s) or clinical relapses on treatment. Drug survival will be measured as time to discontinuation of treatment with Kaplan-Meier plots. The safety measure will be a comparison of the number and severity of AEs during the observed time period.
Conclusion: This study has the potential to show how the studied drugs perform in a real life setting and data may be used to guide future treatment decisions.
Disclosure: M.B. has no disclosures. A.J. reports no conflicts of interest. L.N. has no disclosures. M.A. has received compensation for lectures and/or advisory boards from Biogen, Genzyme, and Novartis. T.F. has nothing to disclose. J.L. has received travel support and/or lecture honoraria from Biogen, Novartis, Teva and Genzyme/SanofiAventis; has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Genzyme/SanofiAventis; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva. F.P. has received unrestricted academic research grants from Biogen, Genzyme and Novartis, and travel support and/or compensation for lectures and/or participation in advisory boards from Biogen, Merckserono, Novartis, Genzyme and Teva, which have been exclusively used for the support of research activities. J.S. has received research support from Synapsys.
Abstract: P673
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Introduction: Continued disease activity during first line disease modifying therapy (DMT) in relapsing-remitting multiple sclerosis (RRMS) indicate suboptimal treatment response and should therefore prompt treatment escalation to a second line DMT. In Sweden rituximab (RTX) is used off label as a second line DMT by one third of all treated multiple sclerosis (MS) patients. A retrospective study suggested that RTX had favourable adverse event (AE) profile, efficacy and drug survival compared to fingolimod (FGL) in patients switching from natalizumab (NTZ) due to JC virus positivity (JCV+). There are currently no comparative studies between RTX and other highly effective (HE) DMTs after breakthrough disease on first line therapy.
Objective: To compare the safety and efficacy of RTX, FGL, NTZ and alemtuzumab (ALZ) in RRMS cases who, despite treatment with first line DMTs, experienced clinical relapses and/or had contrast enhancing lesions (CELs) on magnetic resonance imaging (MRI).
Method: At three Swedish MS Centres, the Swedish MS registry was searched for patients with RRMS who had switched from first line DMTs (interferons or glatiramer acetate) to either RTX, FGL, NTZ or ALZ between 2011-01-01 and 2015-12-31 due to breakthrough disease. Patients with a follow-up period of at least 12 months were included. Data in this retrospective observational study were collected from the MS registry and medical charts.
Result: Preliminary data shows an approximate number of 220 RRMS patients meeting the inclusion criteria. The majority of patients (78%) had switched from interferons, and the most common reason to switch was CELs (65%). The most common HE drug was FGL (44%), followed by NTZ (40%), RTX (15%) and ALZ (< 1%). The annualised relapse rate (ARR) after switch was 0,016 (NTZ), 0,032 (RTX) and 0,058 (FGL). 15% of patients treated with NTZ discontinued treatment due to JCV+. The efficacy will further be estimated by comparing the proportion of patients with continued inflammatory disease activity, measured as new CEL(s) or clinical relapses on treatment. Drug survival will be measured as time to discontinuation of treatment with Kaplan-Meier plots. The safety measure will be a comparison of the number and severity of AEs during the observed time period.
Conclusion: This study has the potential to show how the studied drugs perform in a real life setting and data may be used to guide future treatment decisions.
Disclosure: M.B. has no disclosures. A.J. reports no conflicts of interest. L.N. has no disclosures. M.A. has received compensation for lectures and/or advisory boards from Biogen, Genzyme, and Novartis. T.F. has nothing to disclose. J.L. has received travel support and/or lecture honoraria from Biogen, Novartis, Teva and Genzyme/SanofiAventis; has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Genzyme/SanofiAventis; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva. F.P. has received unrestricted academic research grants from Biogen, Genzyme and Novartis, and travel support and/or compensation for lectures and/or participation in advisory boards from Biogen, Merckserono, Novartis, Genzyme and Teva, which have been exclusively used for the support of research activities. J.S. has received research support from Synapsys.