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Long‑term real‑world effectiveness and safety of fingolimod over 5 years in GermanyZiemssen, Tjalf, Lang, Michael, Schmidt, Stephan, Albrecht, Holger, Klotz, Luisa, Haas, Judith, Lassek, Christoph, Lang, Stefan, Winkelmann, Veronika E., Ettle, Benjamin, Schulze‑Topphoff, Ulf 19 January 2024 (has links)
Objective:
To evaluate the 5-year real-world benefit–risk profile of fingolimod in patients with relapsing–remitting MS (RRMS) in Germany.
Methods:
Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) is a non-interventional realworld study to prospectively assess the effectiveness and safety of fingolimod in routine clinical practice in Germany. The follow-up period comprised 5 years. Patients were included if they had been diagnosed with RRMS and had been prescribed fingolimod as part of clinical routine. There were no exclusion criteria except the contraindications for fingolimod as defined in the European label. The effectiveness and safety analysis set comprised 4032 and 4067 RRMS patients, respectively.
Results:
At the time of the 5-year follow-up of PANGAEA, 66.57% of patients still continued fingolimod therapy. Annualized relapse rates decreased from baseline 1.5 ± 1.15 to 0.42 ± 0.734 at year 1 and 0.21 ± 0.483 at year 5, and the disability status remained stable, as demonstrated by the Expanded Disability Status Scale mean change from baseline (0.1 ± 2.51), the decrease of the Multiple Sclerosis Severity Score from 5.1 ± 2.59 at baseline to 3.9 ± 2.31 at the 60-months follow-up, and the percentage of patients with ‘no change’ in the Clinical Global Impression scale at the 60-months follow-up (78.11%). Adverse events (AE) occurring in 75.04% of patients were in line with the known safety profile of fingolimod and were mostly non-serious AE (33.62%) and non-serious adverse drug reactions (50.59%; serious AE 4.98%; serious ADR 10.82%).
Conclusions:
PANGAEA demonstrated the sustained beneficial effectiveness and safety of fingolimod in the long-term realworld treatment of patients with RRMS.
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Stochastic models for MRI lesion count sequences from patients with relapsing remitting multiple sclerosisLi, Xiaobai 14 July 2006 (has links)
No description available.
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Statistical Models for Count Data from Multiple Sclerosis Clinical Trials and their ApplicationsRettiganti, Mallikarjuna Rao 17 December 2010 (has links)
No description available.
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