Therapy Switches in Fingolimod-Treated Patients with Multiple Sclerosis: Long-Term Experience from the German MS Registry

Abstract

Introductions: Therapy switches in patients with multiple sclerosis (MS) receiving treatment with fingolimod occur frequently in clinical practice but are not well represented in realworld data. The aim of this study was to identify and characterize treatment switches and reveal sociodemographic/clinical changes over time in fingolimod-treated people with MS (PwMS). Methods: Data on 2536 fingolimod-treated PwMS extracted from the German MS Registry during different time periods were analyzed (2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018)(2019). Results: Overall, 28.3% of PwMS were treatment-naı ¨ve before fingolimod initiation. Interferon beta (30.7%) was the most common prefingolimod treatment. Ocrelizumab (19.8%) was the most frequent subsequent treatment in the 944 patients on fingolimod who switched.

Real‐world evaluation of ocrelizumab in multiple sclerosis: A systematic review

“…In addition to demonstrating favorable real-world effectiveness that appear to be consistent with clinical trial data, this SLR highlights other important aspects of realworld ocrelizumab use in RRMS and PPMS patients; three studies report stable or improving HRQoL following up to 1 year of ocrelizumab treatment, 9,20,44 five studies reported on the clinical effectiveness of switching to ocrelizumab from natalizumab, 8,25,36,39,58 and three further studies described the effective and safe transition to ocrelizumab from other DMTs, 16,18,27 highlighting ocrelizumab as a suitable option for previously treated patients that can mitigate the risk of disease reactivation.…”

“…In the studies by Frahm et al 18 and Bigaut et al, 8 a low ARR at baseline relative to the trial and other real‐world studies was observed, which may be driven partly by the absence of treatment‐naïve patients in these studies. Notably, in the studies by Frahm et al and Bigaut et al, which capture patient groups that differ to those in the pivotal trials, ARR values following ocrelizumab were numerically lower than at baseline and of a similar magnitude to those in the other real‐world studies and the trials.…”

“…Six studies assessed time to first relapse in patients treated with ocrelizumab, with patient numbers ranging from 33 to 1104 8,18,28,34,39,51,58 (Table S5). Median time to first relapse following treatment initiation with ocrelizumab ranged from 52.5 days (411 RRMS patients switching to ocrelizumab following fingolimod treatment) 51 to 8.7 months (66 RRMS and PPMS patients switching to ocrelizumab following natalizumab treatment) 58 .…”

“…Full text articles were available for 23 (44%) of the studies, while only conference abstracts were available for the remainder. Studies varied widely by geographical region; 33 reported real‐world outcomes in Europe, 7–39 seven in the United States, 40–46 two in the Middle East, 47,48 three in various geographical regions, 49–51 one in South America, 52 and six did not report the country in which the study was conducted 53–58 . The most frequently reported study populations included combined populations of RRMS, PPMS, and SPMS patients for which data were not stratified by type of MS ( n = 20).…”

“…59 Two studies performed statistical analysis of relapse data between RRMS patients receiving different disease-modifying therapies (DMTs) and both reported significantly fewer relapses in ocrelizumabtreated patients. 8,39 Time to relapse Six studies assessed time to first relapse in patients treated with ocrelizumab, with patient numbers ranging from 33 to 1104 8,18,28,34,39,51,58 (Table S5). Median time to first relapse following treatment initiation with ocrelizumab ranged from 52.5 days (411 RRMS patients switching to ocrelizumab following fingolimod treatment) 51 to 8.7 months (66 RRMS and PPMS patients switching to ocrelizumab following natalizumab treatment).…”