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

Frahm, Niklas; Fneish, Firas; Ellenberger, David; Flachenecker, Peter; Paul, Friedemann; Warnke, Clemens; Kleinschnitz, Christoph; Parciak, Tina; Krefting, Dagmar; Hellwig, Kerstin; Haas, Judith; Stahmann, Alexander; Zettl, Uwe K.

doi:10.1007/s40120-021-00320-w

Cited by 8 publications

(5 citation statements)

References 40 publications

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“…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.…”

Section: Discussionsupporting

confidence: 55%

“…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.…”

Section: Discussionmentioning

confidence: 78%

“…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 .…”

Section: Resultsmentioning

confidence: 99%

“…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).…”

Section: Resultsmentioning

confidence: 99%

“…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).…”

Section: Clinical Relapsementioning

confidence: 99%

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

Montalbán¹,

Matthews

Simpson

et al. 2023

Ann Clin Transl Neurol

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Across its clinical development program, ocrelizumab demonstrated efficacy in improving clinical outcomes in multiple sclerosis, including annualized relapse rates and confirmed disability progression. However, as with any new treatment, it was unclear how this efficacy would translate into real‐world clinical practice. The objective of this study was to systematically collate the published real‐world clinical effectiveness data for ocrelizumab in relapsing remitting multiple sclerosis and primary progressive multiple sclerosis. A search strategy was developed in MEDLINE and Embase to identify articles reporting real‐world evidence in people with relapsing remitting multiple sclerosis or primary progressive multiple sclerosis receiving treatment with ocrelizumab. The search focused on English language articles only but was not limited by the country in which the study was conducted or the time frame of the study. Additional manual searches of relevant websites were also performed. Fifty‐two studies were identified reporting relevant evidence. Real‐world effectiveness data for ocrelizumab were consistently favorable, with reductions in relapse rate and disease progression rates similar to those reported in the OPERA I/OPERA II and ORATORIO clinical trials, including in studies with more diverse patient populations not well represented in the pivotal trials. Although direct comparisons are confounded by lack of randomization of treatments, outcomes reported suggest that ocrelizumab has a similar or greater efficacy than other therapy options. Initial real‐world effectiveness data for ocrelizumab appear favorable and consistent with results reported in clinical trials, providing clinicians with an efficacious option to treat patients with multiple sclerosis.

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