Contributions
Abstract: P591
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Once-daily fingolimod (Gilenya®, Novartis Pharma AG) is a sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing remitting multiple sclerosis (RRMS). As of February 2018 more than 231.000 patients have been treated with fingolimod; total patient exposure exceeds 536.000 patient-years. PANGAEA is a non-interventional study (NIS), conducted in Germany, to investigate long-term safety, effectiveness and patient reported outcomes in daily clinical practice.
Objective: Here we present interim results on the effectiveness of fingolimod in RRMS patients treated for 5 years in daily clinical practice.
Methods: Recruitment into the study finished in December 2013. 4229 patients from 374 centers were enrolled. By Jan 2018, 726 patients finished the 5 years documentation period of fingolimod treatment, of which 433 (59.6%) were treated for the first time with fingolimod.
Results: Within the analyzed subgroup of 5 years completers, the mean age at baseline was 40.6 (±9.0 SD) years and the proportion of female patients was 69.0%. With an annual relapse rate of 1.2 (±0.08 95%CI) at baseline, the annualized relapse rate over the entire 5 years observational period improved by approximately 84.2% to 0.19 (±0.02 95%CI). The mean baseline EDSS was 3.1 (±1.7 SD) and remained stable over 5 years. In the fifth year of treatment, 82.0% of the patients showed a stable EDSS or experienced a 6 months confirmed improvement. The documentation period of 5 years allows calculating a 6 months confirmed disability progression up to year 4 of treatment. The proportion of patients free of relapses and 6 months confirmed disability progression increased from 60.4% in year 1 to 70.3% in year 4 of treatment. 46.9% of the patients neither had a relapse nor a 6 months confirmed disability progression over the observational period. After 5 years, 94.8% of physicians and 95.7% of patients rated treatment effectiveness under fingolimod as “good” or “very good”. After 5 years, total score of the symbol digital modalities test (SDMT; baseline 45.7 (±3.49 95%CI)) as a measure of cognitive processing speed improved by 10.0 points (±3.48).
Conclusion: The results of the 5 year interim analysis of PANGAEA support the positive efficacy profile of fingolimod demonstrated in phase III clinical trials with long-term real world evidence data.
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.H. Albrecht has nothing to discloseL. Klotz received compensation for serving on scientific advisory boards for Genzyme and Novartis. She received speaker honoraria and travel support from Novartis, Merck Serono and CSL Behring. She receives research support from Novartis and Biogen.M. Lang has received research support from NovartisC. Lassek has received travel grants, speaker's honoraria, financial research support, consultancy fees from Teva, Merck Serono, Genzyme -Sanofi, Novartis, Bayer, Biogen.S. Schmidt has received speaking honoraria, travel compensations and has served on advisory boards for BayerVital, Biogen, MerckSerono, Novartis and Teva.B. Tackenberg has received travel reimbursements, speaker and consulting honoraria from Bayer Healthcare, Biogen, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva as well as research support from Bayer Healthcare, Biogen and Novartis.C. Cornelissen and B. Ettle are employees of the Novartis Pharma GmbH, Nuremberg, Germany
Abstract: P591
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Once-daily fingolimod (Gilenya®, Novartis Pharma AG) is a sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing remitting multiple sclerosis (RRMS). As of February 2018 more than 231.000 patients have been treated with fingolimod; total patient exposure exceeds 536.000 patient-years. PANGAEA is a non-interventional study (NIS), conducted in Germany, to investigate long-term safety, effectiveness and patient reported outcomes in daily clinical practice.
Objective: Here we present interim results on the effectiveness of fingolimod in RRMS patients treated for 5 years in daily clinical practice.
Methods: Recruitment into the study finished in December 2013. 4229 patients from 374 centers were enrolled. By Jan 2018, 726 patients finished the 5 years documentation period of fingolimod treatment, of which 433 (59.6%) were treated for the first time with fingolimod.
Results: Within the analyzed subgroup of 5 years completers, the mean age at baseline was 40.6 (±9.0 SD) years and the proportion of female patients was 69.0%. With an annual relapse rate of 1.2 (±0.08 95%CI) at baseline, the annualized relapse rate over the entire 5 years observational period improved by approximately 84.2% to 0.19 (±0.02 95%CI). The mean baseline EDSS was 3.1 (±1.7 SD) and remained stable over 5 years. In the fifth year of treatment, 82.0% of the patients showed a stable EDSS or experienced a 6 months confirmed improvement. The documentation period of 5 years allows calculating a 6 months confirmed disability progression up to year 4 of treatment. The proportion of patients free of relapses and 6 months confirmed disability progression increased from 60.4% in year 1 to 70.3% in year 4 of treatment. 46.9% of the patients neither had a relapse nor a 6 months confirmed disability progression over the observational period. After 5 years, 94.8% of physicians and 95.7% of patients rated treatment effectiveness under fingolimod as “good” or “very good”. After 5 years, total score of the symbol digital modalities test (SDMT; baseline 45.7 (±3.49 95%CI)) as a measure of cognitive processing speed improved by 10.0 points (±3.48).
Conclusion: The results of the 5 year interim analysis of PANGAEA support the positive efficacy profile of fingolimod demonstrated in phase III clinical trials with long-term real world evidence data.
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.H. Albrecht has nothing to discloseL. Klotz received compensation for serving on scientific advisory boards for Genzyme and Novartis. She received speaker honoraria and travel support from Novartis, Merck Serono and CSL Behring. She receives research support from Novartis and Biogen.M. Lang has received research support from NovartisC. Lassek has received travel grants, speaker's honoraria, financial research support, consultancy fees from Teva, Merck Serono, Genzyme -Sanofi, Novartis, Bayer, Biogen.S. Schmidt has received speaking honoraria, travel compensations and has served on advisory boards for BayerVital, Biogen, MerckSerono, Novartis and Teva.B. Tackenberg has received travel reimbursements, speaker and consulting honoraria from Bayer Healthcare, Biogen, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva as well as research support from Bayer Healthcare, Biogen and Novartis.C. Cornelissen and B. Ettle are employees of the Novartis Pharma GmbH, Nuremberg, Germany