Contributions
Abstract: P696
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Fingolimod is a relatively new, efficient and safe drug for treating relapsing-remitting multiple sclerosis (RRMS). In vivo, fingolimod is phosphorylated and resembles naturally occurring sphingosine 1-phosphate (S1P). S1P binds to receptors that are expressed in a wide range of cells involved in many biological processes relevant to RRMS. S1P plays a key role in the immune system, regulating lymphocyte egress from lymphoid tissues into the circulation. Taking into consideration that lymphocyte sequestration into lymph nodes is the main mechanism of action of this drug, the present study analyzed, in a real-world setting, whether decreasing the lymphocyte count in peripheral blood could positively influence patients" response to treatment.
Method: Data were obtained from the MSBase Registry. Patients were divided into groups: those who reached less than 750 lymphocytes/mm3 in peripheral blood at any given time on fingolimod (< 750-ever group); and a propensity matched group who never had recorded less than 1000 lymphocytes/mm3 in peripheral blood (< 1000-never group) on fingolimod. Annualised Relapse Rate (ARR) was compared between groups using a paired signed-ranks test. Time to first relapse and time to six-month confirmed disability progression were compared using a marginal Cox model.
Results: A total of 202 patients in the < 750-ever group were successfully propensity matched on a 2:1 basis to 101 patients in the < 1000-never group. Mean (SD) follow-up time for the < 750 and < 1000-never groups were 2.31 (1.28) and 1.91 (1.18) years respectively. There was no difference between groups in ARR (p=0.2967) with the < 750 ever group recording a mean (SD) ARR of 0.34 (0.84) compared with 0.52 (0.98) in the < 1000 never group. Similarly there was no difference between groups in either time to first relapse (HR 0.79; 95% CI 0.54, 1.15; reference = < 1000 never) or time to six-month confirmed disability progression (HR 0.96; 95% CI 0.47, 1.95; reference = < 1000 never).
Conclusion: Decreasing the peripheral lymphocyte count below 750 cells/mm3 in RRMS patients on fingolimod was not associated with a difference in ARR, time to first relapse and disability progression rate relative to patients who maintained their lymphocyte count above 1000 cells/mm3 on fingolimod.
Disclosure:
Yara Dadalti Fragoso has nothing to disclose in relation to this study and the participation in MSBase
Raed Alroughani Received speaker´s honoraria from Biogen, Bayer, Merck-Sorono, Novartis, GSK, and Genzyme. Served on scientific advisory board of Bayer, Genzyme, Biogen, Merck-Sorono and Novartis
Michael Barnett has served on scientific advisory boards for Biogen-Idec, Novartis and Genzyme and has received conference travel support from Biogen-Idec and Novartis. His institution has received research support from Biogen-Idec, Merck-Serono and Novartis.
Joseph Bruno B. Books has nothing to disclose in relation to this study and the participation in MSBase
Helmut Butzkueven has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/research support from Biogen, Novartis, Merck and Genzyme
Cavit Boz has nothing to disclose
Franco Granella has served on scientific advisory boards for Biogen Idec, Novartis and Sanofi Aventis and has received funding for travel and speaker honoraria from Biogen Idec, Merck Serono, and Almirall
Jodi Haartsen has received honoraria for talks and advisory boards, and support for scientific meetings, from Novartis, Biogen Idec, Merck-Serono and Genzyme.,
Eva Havrdova eceived speaker honoraria and consultant fees from Biogen Idec, Merck Serono, Novartis, Genzyme and Teva, as well as support for research activities from Biogen Idec and Merck Serono
Alessandra Lugaresi has served as a Bayer, Biogen, Merck Serono, Novartis and Genzyme Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck Serono, Novartis, Sanofi, Teva and Fondazione Italiana Sclerosi Multipla and research grants for her Institution from Bayer, Biogen, Merck Serono, Novartis, Sanofi, Teva and Fondazione Italiana Sclerosi Multipla.
Javier Olascoaga has nothing to disclose
José Luis Sánchez Menoyo has accepted travel compensation from Novartis, Merch Serono and Biogen, speaking honoraria from Biogen, Novartis, Sanofi, Merck Serono, Almirall, Bayer and Teva and has participated in a clinical trial by Biogen.
Eugenio Pucci has nothing to disclose in relation to this study and the participation in MSBase
Tim Spelman received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen Inc; speaker honoraria from Novartis.
Murat Terzi received travel grants from Merck Serono, Novartis, Bayer-Schering, Merck-Serono and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis.
Steve Vucic has nothing to disclose in relation to this study and the participation in MSBase
Veronika Ticha has nothing to disclose in relation to this study and the participation in MSBase
Abstract: P696
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Fingolimod is a relatively new, efficient and safe drug for treating relapsing-remitting multiple sclerosis (RRMS). In vivo, fingolimod is phosphorylated and resembles naturally occurring sphingosine 1-phosphate (S1P). S1P binds to receptors that are expressed in a wide range of cells involved in many biological processes relevant to RRMS. S1P plays a key role in the immune system, regulating lymphocyte egress from lymphoid tissues into the circulation. Taking into consideration that lymphocyte sequestration into lymph nodes is the main mechanism of action of this drug, the present study analyzed, in a real-world setting, whether decreasing the lymphocyte count in peripheral blood could positively influence patients" response to treatment.
Method: Data were obtained from the MSBase Registry. Patients were divided into groups: those who reached less than 750 lymphocytes/mm3 in peripheral blood at any given time on fingolimod (< 750-ever group); and a propensity matched group who never had recorded less than 1000 lymphocytes/mm3 in peripheral blood (< 1000-never group) on fingolimod. Annualised Relapse Rate (ARR) was compared between groups using a paired signed-ranks test. Time to first relapse and time to six-month confirmed disability progression were compared using a marginal Cox model.
Results: A total of 202 patients in the < 750-ever group were successfully propensity matched on a 2:1 basis to 101 patients in the < 1000-never group. Mean (SD) follow-up time for the < 750 and < 1000-never groups were 2.31 (1.28) and 1.91 (1.18) years respectively. There was no difference between groups in ARR (p=0.2967) with the < 750 ever group recording a mean (SD) ARR of 0.34 (0.84) compared with 0.52 (0.98) in the < 1000 never group. Similarly there was no difference between groups in either time to first relapse (HR 0.79; 95% CI 0.54, 1.15; reference = < 1000 never) or time to six-month confirmed disability progression (HR 0.96; 95% CI 0.47, 1.95; reference = < 1000 never).
Conclusion: Decreasing the peripheral lymphocyte count below 750 cells/mm3 in RRMS patients on fingolimod was not associated with a difference in ARR, time to first relapse and disability progression rate relative to patients who maintained their lymphocyte count above 1000 cells/mm3 on fingolimod.
Disclosure:
Yara Dadalti Fragoso has nothing to disclose in relation to this study and the participation in MSBase
Raed Alroughani Received speaker´s honoraria from Biogen, Bayer, Merck-Sorono, Novartis, GSK, and Genzyme. Served on scientific advisory board of Bayer, Genzyme, Biogen, Merck-Sorono and Novartis
Michael Barnett has served on scientific advisory boards for Biogen-Idec, Novartis and Genzyme and has received conference travel support from Biogen-Idec and Novartis. His institution has received research support from Biogen-Idec, Merck-Serono and Novartis.
Joseph Bruno B. Books has nothing to disclose in relation to this study and the participation in MSBase
Helmut Butzkueven has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/research support from Biogen, Novartis, Merck and Genzyme
Cavit Boz has nothing to disclose
Franco Granella has served on scientific advisory boards for Biogen Idec, Novartis and Sanofi Aventis and has received funding for travel and speaker honoraria from Biogen Idec, Merck Serono, and Almirall
Jodi Haartsen has received honoraria for talks and advisory boards, and support for scientific meetings, from Novartis, Biogen Idec, Merck-Serono and Genzyme.,
Eva Havrdova eceived speaker honoraria and consultant fees from Biogen Idec, Merck Serono, Novartis, Genzyme and Teva, as well as support for research activities from Biogen Idec and Merck Serono
Alessandra Lugaresi has served as a Bayer, Biogen, Merck Serono, Novartis and Genzyme Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck Serono, Novartis, Sanofi, Teva and Fondazione Italiana Sclerosi Multipla and research grants for her Institution from Bayer, Biogen, Merck Serono, Novartis, Sanofi, Teva and Fondazione Italiana Sclerosi Multipla.
Javier Olascoaga has nothing to disclose
José Luis Sánchez Menoyo has accepted travel compensation from Novartis, Merch Serono and Biogen, speaking honoraria from Biogen, Novartis, Sanofi, Merck Serono, Almirall, Bayer and Teva and has participated in a clinical trial by Biogen.
Eugenio Pucci has nothing to disclose in relation to this study and the participation in MSBase
Tim Spelman received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen Inc; speaker honoraria from Novartis.
Murat Terzi received travel grants from Merck Serono, Novartis, Bayer-Schering, Merck-Serono and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis.
Steve Vucic has nothing to disclose in relation to this study and the participation in MSBase
Veronika Ticha has nothing to disclose in relation to this study and the participation in MSBase