Contributions
Abstract: P779
Type: Poster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background and aims: Magnetic resonance imaging (MRI) plays an indispensable role in monitoring treatment in multiple sclerosis (MS). As new lesions on cerebral MRI scans represent a validated biomarker for disease activity and prognosis, clinicians are increasingly using MRIs to assess subclinical activity that might prompt earlier change of disease-modifying therapies (DMTs) in the absence of clinical relapses. ≥3 new cerebral lesions in patients treated with interferon-beta for ≥ 1 year have been linked to worse prognosis. The practical use of MRIs for treatment failure determination is unknown. Using real world data, we assessed the relationship between MRI lesion count and DMT change, taking into account different treatment types.
Methods: MRI lesions counts were extracted from MSBase in December 2016, and analyzed using univariable logistic regression. We included all relapsing-remitting multiple sclerosis (RRMS) patients on DMT, aged < 55 years, with at least one clinical assessment, followed by DMT change within 12 months of the index scan. Those with DMT alterations due to clinical relapses, EDSS change, documented side effects or pregnancy were excluded. DMTs at time of index MRI were subdivided into 'orals', 'injectables' or 'infusions'.
Results: A total of 8311 MRI brain scans of 4232 patients were identified. 26% of MRIs with ≥1 new T2 lesion resulted in starting a new DMT, whilst 50% of MRIs with ≥6 new T2 lesions resulted in a change of DMT. The mean time for DMT change after the index MRI was 4.65 months irrespective of lesion count. For every additional new T2 lesion, the odds of changing DMT were 1.25 (p< 0.001). DMT changes were more frequently observed with initial 'orals' and 'injectables', than with 'infusions'. The odds ratio for additional T2 lesions was 1.39 (p< 0.001) in the 'oral' group compared to 1.24 (p< 0.001) in the 'injectables' group. New Gadolinium-enhancing (Gd+) T1 lesions were 2.43 times more likely to result in a DMT change, irrespective of country. Patients who were on injectables were most likely to change DMTs (OR 2.86; p< 0.001) with a new Gd+ T1 lesion.
Conclusions: Clinicians have low thresholds in making decisions on DMT change with new T2 or Gd+ T1 lesions despite clinical stability. The probability of changing DMTs is highest in patients treated with 'injectable' DMTs. This study suggests that no evidence of disease activity (NEDA) 3 has become a target for MS treatment in various countries.
Disclosure:
Dr. Min has received travel compensation from Novartis, Biogen, Merck, Teva and Sanofi Genzyme.
Dr. Lechner-Scott has accepted travel compensation from Novartis, Biogen and Merck. Her institution receives the honoraria for talks and advisory board commitment from Bayer Health Care, Biogen, Genzyme Sanofi, Merck, Novartis, Teva and Roche, has been involved in clinical trials with Biogen, Novartis and Teva.
Dr. Spelman received honoraria for consultancy, funding for travel and compensation for serving on scientific advisory boards from Biogen Idec Inc; speaker honoraria from Novartis.
Dr. Sola reports no disclosures.
Dr. Granella has received research grants from Biogen; has served on advisory boards for Biogen, Novartis, Sanofi Genzyme and Merck Serono.
Dr Butzkueven has accepted research support from Biogen, Novartis, Merck. Advisory Board and Speaker fees from Roche, Biogen, Novartis, Merck, Teva, Medscape, Oxford Pharamgenesis.
Dr. Alroughani has accepted research support from Biogen, Novartis, Sanofi, and received Advisory Board and Speaker fees from Roche, Bayer, Biogen, Novartis, Merck, Sanofi, GSK.
Dr. Grammond is a Novartis, Teva-neuroscience, Biogen Idec and Genzyme advisory board member, consultant for Merck Serono, received payments for lectures by Merck Serono, Teva-Neuroscience and Canadian Multiple sclerosis society, and received grants for travel from Teva-Neuroscience and Novartis.
Dr. Lugaresi has received personal compensations or Research grants to the institution from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme and Teva.
Dr Trojano received speaking honoraria from Biogen-Idec, Bayer-Schering, Sanofi Aventis, Merck-Serono, Teva and Novartis; has received research grants from Biogen-Idec, Merck-Serono, and Novartis.
Dr. Grand´Maison received honoraria or research funding from Biogen Idec, Genzyme, Novartis, Teva Neurosciences, Mitsubishi and ONO Pharmaceuticals.
Dr. José Luis Sánchez Menoyo has accepted travel compensation from Novartis, Merck Serono, and Biogen; speaking honoraria from Biogen, Novartis, Sanofi, Merck Serono, Almirall, Bayer, and Teva; and has participated in a clinical trial by Biogen.
Dr. Duquette has served on editorial boards and has been supported to attend meetings by EMDSerono, Biogen-Idec, Novartis, Genzyme, and TEVA Neuroscience. He holds grants from the CIHR and the MS Society of Canada and has received funding for investigator-initiated trials from Biogen-Idec, Novartis, and Genzyme.
Dr. Girard has received speaker honoraria and has been on advisory board for Novartis, Biogen Idec, Teva Neuroscience, EMD Serono and Genzyme. He has received research grant from CIHR and the MS Society of Canada.
Dr. Izquierdo received speaking honoraria from Biogen-Idec, Novartis, Sanofi, Merck Serono and Teva.
Dr. Rio report no disclosures.
Dr. Boz received conference travel support from Biogen, Novartis, Bayer-Schering, Merck and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis.
Dr. Hupperts received honoraria as consultant on scientific advisory boards from Merck-Serono, Biogen-Idec, Genzyme-Sanofi and Teva, research funding from Merck-Serono and Biogen-Idec, and speaker honoraria from Sanofi-Genzyme and Novartis.
Dr. Vucic reports no disclosures.
Dr. Van Pesch received travel grants and his institution honoraria for consultancy, lectures and research grants from Biogen, Bayer Schering, Genzyme, Merck, Teva, Sanofi and Roche.
Dr. Barnett received Institutional payments for speaking and consulting from Genzyme, Biogen, Novartis, Merck and Teva; and institutional grant/research support from Novartis, Biogen and Genzyme. He is a research consultant for Medical Safety Systems.
Dr. Pucci served on scientific advisory boards for Genzyme, Merck-Serono and Biogen-Idec; he received conference travel support and/or speaker honoraria from Sanofi Aventis, Novartis, Biogen-Idec, Merck-Serono, Genzyme, Teva and Associazione Marchigiana Sclerosi Multipla e altre malattie neurologiche. Dr. Spitaleri reports no disclosures.
Dr. Kalincik served on scientific advisory boards for Roche, Genzyme-Sanofi, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Genzyme-Sanofi, Teva, BioCSL and Merck and received research support from Biogen.
Abstract: P779
Type: Poster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background and aims: Magnetic resonance imaging (MRI) plays an indispensable role in monitoring treatment in multiple sclerosis (MS). As new lesions on cerebral MRI scans represent a validated biomarker for disease activity and prognosis, clinicians are increasingly using MRIs to assess subclinical activity that might prompt earlier change of disease-modifying therapies (DMTs) in the absence of clinical relapses. ≥3 new cerebral lesions in patients treated with interferon-beta for ≥ 1 year have been linked to worse prognosis. The practical use of MRIs for treatment failure determination is unknown. Using real world data, we assessed the relationship between MRI lesion count and DMT change, taking into account different treatment types.
Methods: MRI lesions counts were extracted from MSBase in December 2016, and analyzed using univariable logistic regression. We included all relapsing-remitting multiple sclerosis (RRMS) patients on DMT, aged < 55 years, with at least one clinical assessment, followed by DMT change within 12 months of the index scan. Those with DMT alterations due to clinical relapses, EDSS change, documented side effects or pregnancy were excluded. DMTs at time of index MRI were subdivided into 'orals', 'injectables' or 'infusions'.
Results: A total of 8311 MRI brain scans of 4232 patients were identified. 26% of MRIs with ≥1 new T2 lesion resulted in starting a new DMT, whilst 50% of MRIs with ≥6 new T2 lesions resulted in a change of DMT. The mean time for DMT change after the index MRI was 4.65 months irrespective of lesion count. For every additional new T2 lesion, the odds of changing DMT were 1.25 (p< 0.001). DMT changes were more frequently observed with initial 'orals' and 'injectables', than with 'infusions'. The odds ratio for additional T2 lesions was 1.39 (p< 0.001) in the 'oral' group compared to 1.24 (p< 0.001) in the 'injectables' group. New Gadolinium-enhancing (Gd+) T1 lesions were 2.43 times more likely to result in a DMT change, irrespective of country. Patients who were on injectables were most likely to change DMTs (OR 2.86; p< 0.001) with a new Gd+ T1 lesion.
Conclusions: Clinicians have low thresholds in making decisions on DMT change with new T2 or Gd+ T1 lesions despite clinical stability. The probability of changing DMTs is highest in patients treated with 'injectable' DMTs. This study suggests that no evidence of disease activity (NEDA) 3 has become a target for MS treatment in various countries.
Disclosure:
Dr. Min has received travel compensation from Novartis, Biogen, Merck, Teva and Sanofi Genzyme.
Dr. Lechner-Scott has accepted travel compensation from Novartis, Biogen and Merck. Her institution receives the honoraria for talks and advisory board commitment from Bayer Health Care, Biogen, Genzyme Sanofi, Merck, Novartis, Teva and Roche, has been involved in clinical trials with Biogen, Novartis and Teva.
Dr. Spelman received honoraria for consultancy, funding for travel and compensation for serving on scientific advisory boards from Biogen Idec Inc; speaker honoraria from Novartis.
Dr. Sola reports no disclosures.
Dr. Granella has received research grants from Biogen; has served on advisory boards for Biogen, Novartis, Sanofi Genzyme and Merck Serono.
Dr Butzkueven has accepted research support from Biogen, Novartis, Merck. Advisory Board and Speaker fees from Roche, Biogen, Novartis, Merck, Teva, Medscape, Oxford Pharamgenesis.
Dr. Alroughani has accepted research support from Biogen, Novartis, Sanofi, and received Advisory Board and Speaker fees from Roche, Bayer, Biogen, Novartis, Merck, Sanofi, GSK.
Dr. Grammond is a Novartis, Teva-neuroscience, Biogen Idec and Genzyme advisory board member, consultant for Merck Serono, received payments for lectures by Merck Serono, Teva-Neuroscience and Canadian Multiple sclerosis society, and received grants for travel from Teva-Neuroscience and Novartis.
Dr. Lugaresi has received personal compensations or Research grants to the institution from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme and Teva.
Dr Trojano received speaking honoraria from Biogen-Idec, Bayer-Schering, Sanofi Aventis, Merck-Serono, Teva and Novartis; has received research grants from Biogen-Idec, Merck-Serono, and Novartis.
Dr. Grand´Maison received honoraria or research funding from Biogen Idec, Genzyme, Novartis, Teva Neurosciences, Mitsubishi and ONO Pharmaceuticals.
Dr. José Luis Sánchez Menoyo has accepted travel compensation from Novartis, Merck Serono, and Biogen; speaking honoraria from Biogen, Novartis, Sanofi, Merck Serono, Almirall, Bayer, and Teva; and has participated in a clinical trial by Biogen.
Dr. Duquette has served on editorial boards and has been supported to attend meetings by EMDSerono, Biogen-Idec, Novartis, Genzyme, and TEVA Neuroscience. He holds grants from the CIHR and the MS Society of Canada and has received funding for investigator-initiated trials from Biogen-Idec, Novartis, and Genzyme.
Dr. Girard has received speaker honoraria and has been on advisory board for Novartis, Biogen Idec, Teva Neuroscience, EMD Serono and Genzyme. He has received research grant from CIHR and the MS Society of Canada.
Dr. Izquierdo received speaking honoraria from Biogen-Idec, Novartis, Sanofi, Merck Serono and Teva.
Dr. Rio report no disclosures.
Dr. Boz received conference travel support from Biogen, Novartis, Bayer-Schering, Merck and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis.
Dr. Hupperts received honoraria as consultant on scientific advisory boards from Merck-Serono, Biogen-Idec, Genzyme-Sanofi and Teva, research funding from Merck-Serono and Biogen-Idec, and speaker honoraria from Sanofi-Genzyme and Novartis.
Dr. Vucic reports no disclosures.
Dr. Van Pesch received travel grants and his institution honoraria for consultancy, lectures and research grants from Biogen, Bayer Schering, Genzyme, Merck, Teva, Sanofi and Roche.
Dr. Barnett received Institutional payments for speaking and consulting from Genzyme, Biogen, Novartis, Merck and Teva; and institutional grant/research support from Novartis, Biogen and Genzyme. He is a research consultant for Medical Safety Systems.
Dr. Pucci served on scientific advisory boards for Genzyme, Merck-Serono and Biogen-Idec; he received conference travel support and/or speaker honoraria from Sanofi Aventis, Novartis, Biogen-Idec, Merck-Serono, Genzyme, Teva and Associazione Marchigiana Sclerosi Multipla e altre malattie neurologiche. Dr. Spitaleri reports no disclosures.
Dr. Kalincik served on scientific advisory boards for Roche, Genzyme-Sanofi, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Genzyme-Sanofi, Teva, BioCSL and Merck and received research support from Biogen.