Contributions
Abstract: EP1648
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Fingolimod (Gilenya®) was approved in 2011 as the first oral disease modifying treatment (DMT) for highly active relapsing remitting multiple sclerosis (RRMS). Since 2011, therapeutic options of baseline MS treatment especially using oral drugs for RRMS have continuously increased. As pivotal studies have been run before the availability of other oral drugs in clinical practice, data on switch from oral vs. injectable baseline treatments to fingolimod are missing.
Objectives: Here we present two year interim results of PANGAEA 2.0 including effectiveness data of patients switching from injectable (interferons and glatiramer acetate; iDMT) and oral (dimethyfumarate and teriflunomide; oDMT) baseline DMT to fingolimod.
Methods: PANGAEA 2.0 is an ongoing non-interventional study conducted in Germany documenting effectiveness, safety and patient reported outcome data of patients that switched to fingolimod between 2015 and 2018. As of January 2018, baseline data for 1802 patients were available. Interim results of approximately 200 patients, who will have completed two years of observation by July 2018, will be presented.
Results: 48.3% patients switched from iDMTs (64.9% interferons, 38.8% glatiramer acetate) and 25% patients from oDMTs (64.9% dimethylfumarate, 35.1% teriflunomide) to fingolimod within PANGAEA 2.0. 12.7% of the patients were treatment naïve. The baseline characteristics of both groups were comparable: Patients switching from iDMTs have been longer on any iDMT (4.2 ±3.9 years) than patients switching from oDMTs (1.4 ±1.1 SD). While only 32.5% of patients in the iDMT subgroup had more than 1 pre-treatment, 71.1% within the oDMT subgroup had more than 1 pretreatment. The annualized relapse rate (± 95%CI) 12 months after switch to fingolimod was reduced by 79.3% from 1.31 ±0.07 to 0.27 ±0.03 (iDMT) and by 72.4% from 1.34 ±0.09 to 0.37 ±0.05 (oDMT). Similar results were obtained for treatment naïve patients and patients switching after different treatment sequences in their disease history. The EDSS (± 95%CI) for the whole population remained stable at 2.3 ±0.37. Similar results were obtained for the subpopulations. An updated analysis focusing on patients who completed two years of observation will be presented.
Conclusion: Real world data from PANGAEA 2.0 indicate that active disease patients switching from iDMT or oDMT to fingolimod can benefit from this switch.
Disclosure: This study is funded by Novartis Pharma GmbH.
T. Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
B.Ettle and C. Cornelissen are employees of the Novartis Pharma GmbH, Nuremberg, Germany.
Abstract: EP1648
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Fingolimod (Gilenya®) was approved in 2011 as the first oral disease modifying treatment (DMT) for highly active relapsing remitting multiple sclerosis (RRMS). Since 2011, therapeutic options of baseline MS treatment especially using oral drugs for RRMS have continuously increased. As pivotal studies have been run before the availability of other oral drugs in clinical practice, data on switch from oral vs. injectable baseline treatments to fingolimod are missing.
Objectives: Here we present two year interim results of PANGAEA 2.0 including effectiveness data of patients switching from injectable (interferons and glatiramer acetate; iDMT) and oral (dimethyfumarate and teriflunomide; oDMT) baseline DMT to fingolimod.
Methods: PANGAEA 2.0 is an ongoing non-interventional study conducted in Germany documenting effectiveness, safety and patient reported outcome data of patients that switched to fingolimod between 2015 and 2018. As of January 2018, baseline data for 1802 patients were available. Interim results of approximately 200 patients, who will have completed two years of observation by July 2018, will be presented.
Results: 48.3% patients switched from iDMTs (64.9% interferons, 38.8% glatiramer acetate) and 25% patients from oDMTs (64.9% dimethylfumarate, 35.1% teriflunomide) to fingolimod within PANGAEA 2.0. 12.7% of the patients were treatment naïve. The baseline characteristics of both groups were comparable: Patients switching from iDMTs have been longer on any iDMT (4.2 ±3.9 years) than patients switching from oDMTs (1.4 ±1.1 SD). While only 32.5% of patients in the iDMT subgroup had more than 1 pre-treatment, 71.1% within the oDMT subgroup had more than 1 pretreatment. The annualized relapse rate (± 95%CI) 12 months after switch to fingolimod was reduced by 79.3% from 1.31 ±0.07 to 0.27 ±0.03 (iDMT) and by 72.4% from 1.34 ±0.09 to 0.37 ±0.05 (oDMT). Similar results were obtained for treatment naïve patients and patients switching after different treatment sequences in their disease history. The EDSS (± 95%CI) for the whole population remained stable at 2.3 ±0.37. Similar results were obtained for the subpopulations. An updated analysis focusing on patients who completed two years of observation will be presented.
Conclusion: Real world data from PANGAEA 2.0 indicate that active disease patients switching from iDMT or oDMT to fingolimod can benefit from this switch.
Disclosure: This study is funded by Novartis Pharma GmbH.
T. Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
B.Ettle and C. Cornelissen are employees of the Novartis Pharma GmbH, Nuremberg, Germany.