Contributions
Abstract: P640
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Gilenya® (fingolimod) was approved in Canada in March 2011 for RRMS. While well documented in the phase III trials, having information about the frequency of adverse events (AEs) or reasons for treatment discontinuation in routine clinical practice may be helpful for neurologists to better optimize patient care.
Objective: To analyse retention to fingolimod therapy, reasons for treatment discontinuation and incidence of AEs during treatment.
Methods: The Gilenya® Go ProgramTM was launched in March 2011 and offers education and support services, including coordination of first dose observation (FDO) and follow-up contact to reinforce monitoring recommendations and compliance. Data were collected and analysed for patients enrolled in the Canadian Gilenya® Go ProgramTM from launch to January 2016.
Results: At data cut-off, 3956 patients had completed FDO, with 3201 patients being actively treated. Mean age at enrolment was 41.0 years; 74.9% were female. Overall fingolimod exposure was 7869 patient-years. Most recent previous therapies (n=3746) were glatiramer acetate (29.6%), subcutaneous IFN β-1a (21.7%), natalizumab (16.2%), intramuscular IFN β-1a (13.6%), subcutaneous IFN β-1b (8.0%), dimethyl fumarate (5.2%), teriflunomide (2.1%), none (1.9%), fingolimod (1.3%) and others (0.5%). Most common reasons for switching to fingolimod (n=3674) included lack of efficacy (31.8%), AEs (29.9%) and dissatisfaction/intolerance with injections (19.8%). Overall retention to therapy at data cut off (month 58) was 81.3%. There were 739 treatment discontinuations; the most common reasons were AEs (45.2%), physician request (11.4%), lack of efficacy (8.9%) and patient request (4.5%). AEs causing discontinuation and relative proportions included: (n=334) low lymphocyte count/abnormal haematology values (13.8%), gastrointestinal disturbance (6.9%), elevated liver enzymes (7.8%) and headache (5.4%). Seven cases of 2nd degree atrioventricular blocks (AVBs) and two cases of complete AVBs were reported. All AVBs occurred at first dose. Adherence to recommended 3-4 month ophthalmic examination was 92.4%.
Conclusions: In real-world clinical practice in Canada, adherence to fingolimod treatment was high. Over the observation period (58 months), retention to therapy was >80%; adherence to monitoring was also high. The Gilenya® Go Program helps to meet the safety monitoring recommendations for RRMS patients treated with fingolimod.
®Gilenya is a registered trademark
Disclosure: FUNDING: This Program is funded by Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada.
V. Bhan has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, Roche and Teva Neuroscience. He has acted as site principal investigator for clinical trials for Biogen Idec, EMD Serono, Novartis, Sanofi-Aventis and Teva Neuroscience.
Y. Lapierre has participated in Ad-boards for Biogen-Idec, Novartis and Genzyme. He also has given presentations at conferences sponsored by Teva, EMD-Serono, Novartis and Genzyme in the past and taken part in clinical trials sponsored by Novartis, Biogen-Idec, EMD-Serono and Opexa.
V. Devonshire has received honoraria for advisory meetings and speaker honorarium from EMD Serono, Biogen Idec, Teva Neurosciences, Novartis, Allergan and Genzyme. UBC has received payments for clinical trials in which Dr. Devonshire was the Principal Investigator from Novartis, Serono, and Genzyme.
F. Emond has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience. He has acted or is currently acting as site principal investigator for clinical trials for EMD Serono and Roche.
S. A. Morrow has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience. She has acted as site principal investigator for clinical trials for Biogen Idec. She has received investigator initiated study funds from Biogen Idec, Genzyme and Novartis and funding from the National MS Society and the Multiple Sclerosis Society of Canada.
J.M. Burton: In past two years, participation on ad boards, CME speaking engagements and unrestricted educational support from Novartis, Biogen, Genzyme, EMD Serono.
J. Oh: I have received personal compensation for consulting or speaking from EMD-Serono, Genzyme, Biogen-Idec, Novartis, Teva, and Roche. I recieve Research funding from the MS Society of Canada, Biogen-Idec and Genzyme.
P. Haddad and R. Schecter are employees of Novartis Pharmaceuticals Canada Inc.
Abstract: P640
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Gilenya® (fingolimod) was approved in Canada in March 2011 for RRMS. While well documented in the phase III trials, having information about the frequency of adverse events (AEs) or reasons for treatment discontinuation in routine clinical practice may be helpful for neurologists to better optimize patient care.
Objective: To analyse retention to fingolimod therapy, reasons for treatment discontinuation and incidence of AEs during treatment.
Methods: The Gilenya® Go ProgramTM was launched in March 2011 and offers education and support services, including coordination of first dose observation (FDO) and follow-up contact to reinforce monitoring recommendations and compliance. Data were collected and analysed for patients enrolled in the Canadian Gilenya® Go ProgramTM from launch to January 2016.
Results: At data cut-off, 3956 patients had completed FDO, with 3201 patients being actively treated. Mean age at enrolment was 41.0 years; 74.9% were female. Overall fingolimod exposure was 7869 patient-years. Most recent previous therapies (n=3746) were glatiramer acetate (29.6%), subcutaneous IFN β-1a (21.7%), natalizumab (16.2%), intramuscular IFN β-1a (13.6%), subcutaneous IFN β-1b (8.0%), dimethyl fumarate (5.2%), teriflunomide (2.1%), none (1.9%), fingolimod (1.3%) and others (0.5%). Most common reasons for switching to fingolimod (n=3674) included lack of efficacy (31.8%), AEs (29.9%) and dissatisfaction/intolerance with injections (19.8%). Overall retention to therapy at data cut off (month 58) was 81.3%. There were 739 treatment discontinuations; the most common reasons were AEs (45.2%), physician request (11.4%), lack of efficacy (8.9%) and patient request (4.5%). AEs causing discontinuation and relative proportions included: (n=334) low lymphocyte count/abnormal haematology values (13.8%), gastrointestinal disturbance (6.9%), elevated liver enzymes (7.8%) and headache (5.4%). Seven cases of 2nd degree atrioventricular blocks (AVBs) and two cases of complete AVBs were reported. All AVBs occurred at first dose. Adherence to recommended 3-4 month ophthalmic examination was 92.4%.
Conclusions: In real-world clinical practice in Canada, adherence to fingolimod treatment was high. Over the observation period (58 months), retention to therapy was >80%; adherence to monitoring was also high. The Gilenya® Go Program helps to meet the safety monitoring recommendations for RRMS patients treated with fingolimod.
®Gilenya is a registered trademark
Disclosure: FUNDING: This Program is funded by Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada.
V. Bhan has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, Roche and Teva Neuroscience. He has acted as site principal investigator for clinical trials for Biogen Idec, EMD Serono, Novartis, Sanofi-Aventis and Teva Neuroscience.
Y. Lapierre has participated in Ad-boards for Biogen-Idec, Novartis and Genzyme. He also has given presentations at conferences sponsored by Teva, EMD-Serono, Novartis and Genzyme in the past and taken part in clinical trials sponsored by Novartis, Biogen-Idec, EMD-Serono and Opexa.
V. Devonshire has received honoraria for advisory meetings and speaker honorarium from EMD Serono, Biogen Idec, Teva Neurosciences, Novartis, Allergan and Genzyme. UBC has received payments for clinical trials in which Dr. Devonshire was the Principal Investigator from Novartis, Serono, and Genzyme.
F. Emond has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience. He has acted or is currently acting as site principal investigator for clinical trials for EMD Serono and Roche.
S. A. Morrow has received honoraria for speaking, consulting, and advisory board participation from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience. She has acted as site principal investigator for clinical trials for Biogen Idec. She has received investigator initiated study funds from Biogen Idec, Genzyme and Novartis and funding from the National MS Society and the Multiple Sclerosis Society of Canada.
J.M. Burton: In past two years, participation on ad boards, CME speaking engagements and unrestricted educational support from Novartis, Biogen, Genzyme, EMD Serono.
J. Oh: I have received personal compensation for consulting or speaking from EMD-Serono, Genzyme, Biogen-Idec, Novartis, Teva, and Roche. I recieve Research funding from the MS Society of Canada, Biogen-Idec and Genzyme.
P. Haddad and R. Schecter are employees of Novartis Pharmaceuticals Canada Inc.