دورية أكاديمية
Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study.
| العنوان: | Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study. |
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| المؤلفون: | Bowen JD; Swedish Neuroscience Institute, Seattle, WA, USA., Stulc J; Minneapolis Clinic of Neurology, Golden Valley, MN, USA., Hunter SF; Advanced Neurosciences Institute, Franklin, TN, USA., Chen H; Biogen, Cambridge, MA, USA., Lewin JB; Biogen, Cambridge, MA, USA., Scaramozza M; Biogen, Cambridge, MA, USA., Bozin I; Biogen, Neuhofstrasse 30, 6340, Baar, Switzerland. ivan.bozin@biogen.com., Then Bergh F; Department of Neurology, University of Leipzig, Leipzig, Germany. |
| المصدر: | Advances in therapy [Adv Ther] 2024 Aug; Vol. 41 (8), pp. 3396-3406. Date of Electronic Publication: 2024 Jun 15. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Health Communications Inc Country of Publication: United States NLM ID: 8611864 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1865-8652 (Electronic) Linking ISSN: 0741238X NLM ISO Abbreviation: Adv Ther Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York : Springer Healthcare Communications, 2008- : Health Communications Inc. Original Publication: Metuchen, N.J. : Health Communications Inc., c1984- |
| مواضيع طبية MeSH: | Multiple Sclerosis, Relapsing-Remitting*/drug therapy , Dimethyl Fumarate*/therapeutic use , Magnetic Resonance Imaging* , Fumarates*/therapeutic use , Fumarates*/pharmacology, Humans ; Adult ; Female ; Male ; Immunosuppressive Agents/therapeutic use ; Middle Aged ; Treatment Outcome ; Disease Progression ; Double-Blind Method |
| مستخلص: | Introduction: Diroximel fumarate (DRF) and dimethyl fumarate (DMF) are orally administered fumarate disease-modifying therapies (DMTs) for multiple sclerosis (MS). The safety, tolerability, and exploratory efficacy of DRF were evaluated in the phase 3 EVOLVE-MS-1 study. No Evidence of Disease Activity (NEDA-3) is a composite efficacy endpoint used in clinical trials for MS defined as no relapse, no 24-week confirmed disability progression (CDP), no new/newly enlarging T2 lesions, and no new gadolinium-enhancing lesions. As NEDA outcomes in studies may be confounded by initial disease activity, the objective of this analysis was to evaluate NEDA-3 in EVOLVE-MS-1 for newly enrolled patients and patients who were re-baselined after approximately 7 weeks. Methods: Patients entered EVOLVE-MS-1 as either newly enrolled or having completed the 5-week phase 3 EVOLVE-MS-2 study of DRF and DMF. Magnetic Resonance Imaging (MRI) was performed at baseline before each study (approx. 7 weeks apart) and at weeks 48 and 96 in EVOLVE-MS-1. Therefore, patients entering from EVOLVE-MS-2 were re-baselined after approximately 7 weeks. NEDA-3 outcomes on DRF are reported for prior DRF, prior DMF, and de novo patient groups. Results: Of 1057 patients in EVOLVE-MS-1, 239 (22.6%) had rolled over from receiving DRF in EVOLVE-MS-2 ("prior DRF"), 225 (21.3%) had rolled over from receiving DMF in EVOLVE-MS-2 ("prior DMF"), and 593 (56.1%) were newly enrolled ("de novo"). At week 48, Kaplan-Meier estimates of NEDA-3 were 72.3% (prior DRF), 72.1% (prior DMF), and 62.1% (de novo); at week 96, estimates were 50.2% (prior DRF), 48.2% (prior DMF), and 36.5% (de novo). Conclusions: In EVOLVE-MS-1, after re-baselining at approximately 7 weeks, approximately half of DRF-treated patients achieved NEDA-3 at week 96, compared with 36.5% of patients who were not re-baselined. Re-baselining may be useful for assessing efficacy of DMTs by mitigating the influence of disease activity prior to the onset of efficacy. Clinical Trial Registrations: NCT03093324 (EVOLVE-MS-2); NCT02634307 (EVOLVE-MS-1). (© 2024. The Author(s).) |
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| فهرسة مساهمة: | Keywords: Dimethyl fumarate; Diroximel fumarate; Disease-modifying therapies; Efficacy; Multiple sclerosis; No Evidence of Disease Activity (NEDA); Re-baselining |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03093324; NCT02634307 |
| المشرفين على المادة: | FO2303MNI2 (Dimethyl Fumarate) 0 (Fumarates) 0 (Immunosuppressive Agents) |
| تواريخ الأحداث: | Date Created: 20240615 Date Completed: 20240722 Latest Revision: 20240725 |
| رمز التحديث: | 20240726 |
| مُعرف محوري في PubMed: | PMC11263382 |
| DOI: | 10.1007/s12325-024-02901-1 |
| PMID: | 38878121 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1865-8652 |
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| DOI: | 10.1007/s12325-024-02901-1 |