Contributions
Abstract: 261
Type: Scientific Session
Abstract Category: N/A
One of the most vexing issues in treating patients with MS is determining whether and when to switch therapies. The importance of this therapeutic decision has been highlighted in the recent AAN guidelines. The difficulty arises from a paucity of data to elucidate if an agent is working for any given individual, absent a predictable clinical course of MS or a reliable marker of therapeutic response. While head-to-head studies provide some comparative efficacy for groups of patients, they do not have sufficient granular data to guide individual decisions and do not address switching. Experience based studies provide practice data but have significant limitations as to their generalizability. Most switch studies suffer from serious design shortcomings that limit their interpretation. Some potential study design strategies will be discussed. Also, the potential role of adding agents instead of switching will be explored. Available markers of disease activity, such as relapses and MRI activity continue to be important determinants of treatment response. Newer biomarkers of treatment response may assist in decision making. The role of safety, side effect profile and adherence factor into medication switching decisions. Also to be considered is the potential adverse effects of stopping some therapies, such as potential rebound activity. New, more rigorous scientific approaches will better inform this therapeutic area.
Disclosure: Sources of Funding for Research: Novartis Pharmaceuticals Corp; Teva Neuroscience; Actelion; Transparency Life Sciences; NMSS, Sanofi
Consulting Agreements/Advisory Boards/DSMB: Bayer HealthCare Biogen; EMD Serono; Novartis; Teva; Actelion; Sanofi/Genzyme; Acorda; Roche/Genentech; MedImmune; Receptos/Celgene; Forward Pharma; TG Therapeutics; Abbvie; Regeneron; Medday; Atara Biotherapeutics; Polpharma; Mapi Pharma; Innate Immunotherapeutics; Apitope; Orion Biotechnology.
Abstract: 261
Type: Scientific Session
Abstract Category: N/A
One of the most vexing issues in treating patients with MS is determining whether and when to switch therapies. The importance of this therapeutic decision has been highlighted in the recent AAN guidelines. The difficulty arises from a paucity of data to elucidate if an agent is working for any given individual, absent a predictable clinical course of MS or a reliable marker of therapeutic response. While head-to-head studies provide some comparative efficacy for groups of patients, they do not have sufficient granular data to guide individual decisions and do not address switching. Experience based studies provide practice data but have significant limitations as to their generalizability. Most switch studies suffer from serious design shortcomings that limit their interpretation. Some potential study design strategies will be discussed. Also, the potential role of adding agents instead of switching will be explored. Available markers of disease activity, such as relapses and MRI activity continue to be important determinants of treatment response. Newer biomarkers of treatment response may assist in decision making. The role of safety, side effect profile and adherence factor into medication switching decisions. Also to be considered is the potential adverse effects of stopping some therapies, such as potential rebound activity. New, more rigorous scientific approaches will better inform this therapeutic area.
Disclosure: Sources of Funding for Research: Novartis Pharmaceuticals Corp; Teva Neuroscience; Actelion; Transparency Life Sciences; NMSS, Sanofi
Consulting Agreements/Advisory Boards/DSMB: Bayer HealthCare Biogen; EMD Serono; Novartis; Teva; Actelion; Sanofi/Genzyme; Acorda; Roche/Genentech; MedImmune; Receptos/Celgene; Forward Pharma; TG Therapeutics; Abbvie; Regeneron; Medday; Atara Biotherapeutics; Polpharma; Mapi Pharma; Innate Immunotherapeutics; Apitope; Orion Biotechnology.