The Change of Fingolimod Patient Profiles over Time: A Descriptive Analysis of Two Non-Interventional Studies PANGAEA and PANGAEA 2.0

被引:4
作者
Ziemssen, Tjalf [1 ]
Schulze-Topphoff, Ulf [2 ]
机构
[1] Univ Klinikum Carl Gustav Carus, Zentrum Klin Neurowissensch, D-01307 Dresden, Germany
[2] Novartis Pharma GmbH, D-90429 Nurnberg, Germany
来源
JOURNAL OF PERSONALIZED MEDICINE | 2021年 / 11卷 / 06期
关键词
fingolimod; real-world evidence; patient profiles; MULTIPLE-SCLEROSIS; LONG-TERM; THERAPY; DESIGN;
D O I
10.3390/jpm11060561
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
(1) Background: Fingolimod (Gilenya(R)) was the first oral treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Since its approval, the treatment landscape has changed enormously. (2) Methods: Data of PANGAEA and PANGAEA 2.0, two German real-world studies, were descriptively analysed for possible evolution of patient profiles and treatment behavior. Both are prospective, multi-center, non-interventional, long-term studies on fingolimod use in RRMS in real life. Data of 4229 PANGAEA patients (recruited 2011-2013) and 2441 PANGAEA 2.0 patients (recruited 2015-2018) were available. Baseline data included demographics, RRMS characteristics and disease severity. (3) Results: The mean age of PANGAEA and PANGAEA 2.0 patients was similar (38.8 vs. 39.2 years). Patients in PANGAEA 2.0 had shorter disease duration (7.1 vs. 8.2 years) and fewer relapses in the year before baseline (1.2 vs. 1.6). Disease severity at baseline estimated by EDSS and SDMT was lower in PANGAEA 2.0 patients compared to PANGAEA (EDSS difference 1.0 points; SDMT difference 3.3 points). (4) Conclusions: The results hint at an influence of changes in the treatment guidelines and the label on fingolimod patients profiles over time. Patients tended to have lower disease activity at fingolimod initiation, suggesting an earlier intervention. This indicates increased experience in using fingolimod for sub-optimally treated RRMS patients and a change in mindset towards an early treatment optimization.
引用
收藏
页数:10
相关论文
共 17 条
  • [1] [Anonymous], Guideline on Clinical Investigation of Medicinal Products for the Treatment of Sepsis.
  • [2] Patient satisfaction and healthcare services in specialized multiple sclerosis centres in Germany
    Becker, Veit
    Heeschen, Volker
    Schuh, Katrin
    Schieb, Heinke
    Ziemssen, Tjalf
    [J]. THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS, 2018, 11
  • [3] Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis
    Benedict, Ralph H. B.
    DeLuca, John
    Phillips, Glenn
    LaRocca, Nicholas
    Hudson, Lynn D.
    Rudick, Richard
    [J]. MULTIPLE SCLEROSIS JOURNAL, 2017, 23 (05) : 721 - 733
  • [4] Association of Initial Disease-Modifying Therapy With Later Conversion to Secondary Progressive Multiple Sclerosis
    Brown, J. William L.
    Coles, Alasdair
    Horakova, Dana
    Havrdova, Eva
    Izquierdo, Guillermo
    Prat, Alexandre
    Girard, Marc
    Duquette, Pierre
    Trojano, Maria
    Lugaresi, Alessandra
    Bergamaschi, Roberto
    Grammond, Pierre
    Alroughani, Raed
    Hupperts, Raymond
    McCombe, Pamela
    Van Pesch, Vincent
    Sola, Patrizia
    Ferraro, Diana
    Grand'Maison, Francois
    Terzi, Murat
    Lechner-Scott, Jeannette
    Flechter, Schlomo
    Slee, Mark
    Shaygannejad, Vahid
    Pucci, Eugenio
    Granella, Franco
    Jokubaitis, Vilija
    Willis, Mark
    Rice, Claire
    Scolding, Neil
    Wilkins, Alastair
    Pearson, Owen R.
    Ziemssen, Tjalf
    Hutchinson, Michael
    Harding, Katharine
    Jones, Joanne
    McGuigan, Christopher
    Butzkueven, Helmut
    Kalincik, Tomas
    Robertson, Neil
    Onofrj, Marco
    De Luca, Giovanna
    Di Tommaso, Valeria
    Travaglini, Daniela
    Pietrolongo, Erika
    di Ioia, Maria
    Farina, Deborah
    Mancinelli, Luca
    Hodgkinson, Suzanne
    Oreja-Guevara, Celia
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2019, 321 (02): : 175 - 187
  • [5] Deutsche Gesellschaft fur Neurologie, DIAGN THER MULT SKER
  • [6] Long-Term Effect of Immediate Versus Delayed Fingolimod Treatment in Young Adult Patients with Relapsing-Remitting Multiple Sclerosis: Pooled Analysis from the FREEDOMS/FREEDOMS II Trials
    Ghezzi, Angelo
    Chitnis, Tanuja
    K-Laflamme, Annik
    Meinert, Rolf
    Haering, Dieter A.
    Pohl, Daniela
    [J]. NEUROLOGY AND THERAPY, 2019, 8 (02) : 461 - 475
  • [7] Brain health: time matters in multiple sclerosis
    Giovannoni, Gavin
    Butzkueven, Helmut
    Dhib-Jalbut, Suhayl
    Hobart, Jeremy
    Kobelt, Gisela
    Pepper, George
    Sormani, Maria Pia
    Thalheim, Christoph
    Traboulsee, Anthony
    Vollmer, Timothy
    [J]. MULTIPLE SCLEROSIS AND RELATED DISORDERS, 2016, 9 : S5 - S48
  • [8] Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study
    He, Anna
    Merkel, Bernd
    Brown, James William L.
    Ryerson, Lana Zhovits
    Kister, Ilya
    Malpas, Charles B.
    Sharmin, Sifat
    Horakova, Dana
    Havrdova, Eva Kubala
    Spelman, Tim
    Izquierdo, Guillermo
    Eichau, Sara
    Trojano, Maria
    Lugaresi, Alessandra
    Hupperts, Raymond
    Sola, Patrizia
    Ferraro, Diana
    Lycke, Jan
    Grand'Maison, Francois
    Prat, Alexandre
    Girard, Marc
    Duquette, Pierre
    Larochelle, Catherine
    Svenningsson, Anders
    Petersen, Thor
    Grammond, Pierre
    Granella, Franco
    Van Pesch, Vincent
    Bergamaschi, Roberto
    McGuigan, Christopher
    Coles, Alasdair
    Hillert, Jan
    Piehl, Fredrik
    Butzkueven, Helmut
    Kalincik, Tomas
    [J]. LANCET NEUROLOGY, 2020, 19 (04) : 307 - 316
  • [9] Clinical outcome measures in multiple sclerosis: A review
    Inojosa, Hernan
    Schriefer, Dirk
    Ziemssen, Tjalf
    [J]. AUTOIMMUNITY REVIEWS, 2020, 19 (05)
  • [10] KURTZKE JF, 1983, NEUROLOGY, V33, P1444, DOI 10.1212/WNL.33.11.1444