Contributions
Abstract: P1219
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Fingolimod has been approved in Switzerland since January 2011 as the first oral treatment for relapsing-remitting multiple scleroses (RRMS) to reduce frequency of relapses and delay disability progression. As opposite to the label granted by the European Medicines Agency, fingolimod has a first-line indication in Switzerland. With this study we wanted to assess the effectiveness of fingolimod in a real-world population that has been treated for up to 60 months with fingolimod.
Methods: For this cross-sectional, retrospective study conducted in 19 centers in Switzerland, consecutive RRMS patients receiving fingolimod for a minimum of 7 and up to 58 months were included of whom demographic as well as clinical data were collected. The primary endpoint was number of patients being relapse-free. Key secondary endpoints included freedom of disability progression (EDSS score increase by ≥1 points) and treatment retention. All analyses have been performed using descriptive statistical methods including Wilcoxon- and paired t-tests as well (SAS® package, version 9.2 or higher).
Results: 275 RRMS patients were included. Seventy-nine (28.7%) patients were treatment-naïve and the remaining 196 (71.3%) patients were switched from another therapy. Fingolimod treatment duration was < 2 years in 75 (27.3%) patients, 2 to < 3 years in 91 (33.1%) patients and ≥ 3 years in 109 (39.6%) patients. After a mean treatment duration of 32 months (range: 7 - 57.9 months) 214/275 (77.8%) [95% CI: 72.4%, 82.6%] patients were free from relapses. In addition, 244/270 (90.4%) [95% CI: 86.2%, 93.6%] patients were free from disability progression, and 195/270 (72.2%) [95% CI: 66.5%, 77.5%] patients were free from both relapses and disability progression. Treatment retention with fingolimod was 89.5%. Fingolimod was discontinued in 29 (10.5%) patients, of whom ten (3.6%) because of adverse events.
Conclusion: In this Swiss cohort of naïve and pre-treated RRMS subjects fingolimod treatment prevented the occurrence of relapses and disability progression in the majority of patients over 3 years. These findings support that fingolimod used in a real-life setting maintains the effectiveness shown over 2 years in the pivotal phase III trials.
Disclosure:
Serge Roth has received compensation as a consultant from Biogen, Merck, Novartis, Sanofi-Aventis, Teva Pharma.
Oliver Findling has received compensation as a consultant from Novartis, Biogen, Bayer, Teva, Merck, Genzyme and Allmiral.
Guillaume Perriard is an employee of Novartis Pharma Switzerland AG, Rotkreuz, Switzerland.
Valerie Bachmann is an employee of Novartis Pharma Switzerland AG, Rotkreuz, Switzerland.
Misha Luis Pless received compensation from Bayer, Biogen, Merck, Novartis, Sanofi Genzyme, TEVA.
Andreas Baumann has received personal compensation for activities with Abbvie AG, Bayer Pharmaceuticals Corporation, Biogen Idec, Merck & Co. Inc., Novartis, Genzyme Corporation, UCB Pharma, Teva Neuroscience, CSL-Behring, Pangas, Eli Lilly & Company, Boehringer Ingelheim Pharmaceuticals Inc., and Merz Pharma.
Christian Philipp Kamm has received honoraria for lectures as well as research support from Biogen-idec, Novartis, Almirall, Bayer Schweiz AG, Teva, Merck-Serono, Genzyme and the Swiss MS Society (SMSG).
Patrice H. Lalive received honoraria for speaking from Biogen-Idec, CSL Bering, Merck Serono, Novartis, Sanofi-Aventis, Teva; consulting fees from Biogen-Idec, Geneuro, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Teva; research grants from Biogen-Idec, Merck Serono, Novartis.
Adam Czaplinski received compensations from Allergan, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, TEVA
Abstract: P1219
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Fingolimod has been approved in Switzerland since January 2011 as the first oral treatment for relapsing-remitting multiple scleroses (RRMS) to reduce frequency of relapses and delay disability progression. As opposite to the label granted by the European Medicines Agency, fingolimod has a first-line indication in Switzerland. With this study we wanted to assess the effectiveness of fingolimod in a real-world population that has been treated for up to 60 months with fingolimod.
Methods: For this cross-sectional, retrospective study conducted in 19 centers in Switzerland, consecutive RRMS patients receiving fingolimod for a minimum of 7 and up to 58 months were included of whom demographic as well as clinical data were collected. The primary endpoint was number of patients being relapse-free. Key secondary endpoints included freedom of disability progression (EDSS score increase by ≥1 points) and treatment retention. All analyses have been performed using descriptive statistical methods including Wilcoxon- and paired t-tests as well (SAS® package, version 9.2 or higher).
Results: 275 RRMS patients were included. Seventy-nine (28.7%) patients were treatment-naïve and the remaining 196 (71.3%) patients were switched from another therapy. Fingolimod treatment duration was < 2 years in 75 (27.3%) patients, 2 to < 3 years in 91 (33.1%) patients and ≥ 3 years in 109 (39.6%) patients. After a mean treatment duration of 32 months (range: 7 - 57.9 months) 214/275 (77.8%) [95% CI: 72.4%, 82.6%] patients were free from relapses. In addition, 244/270 (90.4%) [95% CI: 86.2%, 93.6%] patients were free from disability progression, and 195/270 (72.2%) [95% CI: 66.5%, 77.5%] patients were free from both relapses and disability progression. Treatment retention with fingolimod was 89.5%. Fingolimod was discontinued in 29 (10.5%) patients, of whom ten (3.6%) because of adverse events.
Conclusion: In this Swiss cohort of naïve and pre-treated RRMS subjects fingolimod treatment prevented the occurrence of relapses and disability progression in the majority of patients over 3 years. These findings support that fingolimod used in a real-life setting maintains the effectiveness shown over 2 years in the pivotal phase III trials.
Disclosure:
Serge Roth has received compensation as a consultant from Biogen, Merck, Novartis, Sanofi-Aventis, Teva Pharma.
Oliver Findling has received compensation as a consultant from Novartis, Biogen, Bayer, Teva, Merck, Genzyme and Allmiral.
Guillaume Perriard is an employee of Novartis Pharma Switzerland AG, Rotkreuz, Switzerland.
Valerie Bachmann is an employee of Novartis Pharma Switzerland AG, Rotkreuz, Switzerland.
Misha Luis Pless received compensation from Bayer, Biogen, Merck, Novartis, Sanofi Genzyme, TEVA.
Andreas Baumann has received personal compensation for activities with Abbvie AG, Bayer Pharmaceuticals Corporation, Biogen Idec, Merck & Co. Inc., Novartis, Genzyme Corporation, UCB Pharma, Teva Neuroscience, CSL-Behring, Pangas, Eli Lilly & Company, Boehringer Ingelheim Pharmaceuticals Inc., and Merz Pharma.
Christian Philipp Kamm has received honoraria for lectures as well as research support from Biogen-idec, Novartis, Almirall, Bayer Schweiz AG, Teva, Merck-Serono, Genzyme and the Swiss MS Society (SMSG).
Patrice H. Lalive received honoraria for speaking from Biogen-Idec, CSL Bering, Merck Serono, Novartis, Sanofi-Aventis, Teva; consulting fees from Biogen-Idec, Geneuro, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Teva; research grants from Biogen-Idec, Merck Serono, Novartis.
Adam Czaplinski received compensations from Allergan, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, TEVA