Comparative effectiveness of dimethyl fumarate versus non-specific immunosuppressants: Real-world evidence from MSBase
Status PubMed-not-MEDLINE Jazyk angličtina Země Spojené státy americké Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
38800132
PubMed Central
PMC11128181
DOI
10.1177/20552173241247182
PII: 10.1177_20552173241247182
Knihovny.cz E-zdroje
- Klíčová slova
- Dimethyl fumarate, effectiveness, non-specific immunosuppressants, real-world, relapsing-remitting multiple sclerosis,
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The use of non-specific immunosuppressants (NSIS) to treat multiple sclerosis (MS) remains prevalent in certain geographies despite safety concerns, likely due to resource limitations. OBJECTIVE: To use MSBase registry data to compare real-world outcomes in adults with relapsing-remitting MS (RRMS) treated with dimethyl fumarate (DMF) or NSIS (azathioprine, cyclosporine, cyclophosphamide, methotrexate, mitoxantrone or mycophenolate mofetil) between January 1, 2014 and April 1, 2022. METHODS: Treatment outcomes were compared using inverse probability of treatment weighting (IPTW) Cox regression. Outcomes were annualized relapse rates (ARRs), time to discontinuation, time to first relapse (TTFR) and time to 24-week confirmed disability progression (CDP) or 24-week confirmed disability improvement (CDI; in patients with baseline Expanded Disability Status Scale [EDSS] score ≥2). RESULTS: After IPTW, ARR was similar for DMF (0.13) and NSIS (0.16; p = 0.29). There was no difference in TTFR between cohorts (hazard ratio [HR]: 0.98; p = 0.84). The DMF cohort experienced longer times to discontinuation (HR: 0.75; p = 0.001) and CDP (HR: 0.53; p = 0.001), and shorter time to CDI (HR: 1.99; p < 0.008), versus the NSIS cohort. CONCLUSION: This analysis supports the use of DMF to treat patients with relapsing forms of MS, and may have implications for MS practices in countries where NSIS are commonly used to treat RRMS.
American University of Beirut Medical Center Beirut Lebanon
CISSS Chaudière Appalache Lévis QC Canada
Department of Clinical Neuroscience Karolinska Institute Stockholm Sweden
Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia Catania Italy
Department of Neurology University Hospital and University of Basel Basel Switzerland
Dokuz Eylul University Konak Izmir Turkey
Hospital Universitario Virgen Macarena Sevilla Spain
Isfahan University of Medical Sciences Isfahan Iran
KTU Medical Faculty Farabi Hospital Trabzon Turkey
Mayis University Samsun Turkey
Monash University Melbourne Australia
MSBase Foundation Melbourne Australia
South Eastern HSC Trust Belfast UK
The Alfred Hospital Melbourne Australia
University Hospital Ghent Ghent Belgium
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Confavreux C, Vukusic S. Non-specific immunosuppressants in the treatment of multiple sclerosis. Clin Neurol Neurosurg 2004; 106: 263–269. PubMed
Pfizer. Novantrone® (Mitoxantrone) prescribing information. https://www.pfizermedicalinformation.com/en-us/mitoxantrone/dosage-admin (accessed July 23, 2023).
Pfizer. Novantrone® (Mitoxantrone) summary of product characteristics. https://www.ema.europa.eu/en/documents/referral/novantrone-article-30-referral-annex-iii_en.pdf (2016, accessed July 21, 2023).
Neuhaus O, Kieseier BC, Hartung HP. Immunosuppressive agents in multiple sclerosis. Neurotherapeutics 2007; 4: 654–660. PubMed PMC
Bierhansl L, Hartung HP, Aktas O, et al. Thinking outside the box: non-canonical targets in multiple sclerosis. Nat Rev Drug Discov 2022; 21: 578–600. PubMed PMC
Lebrun C, Rocher F. Cancer risk in patients with multiple sclerosis: potential impact of disease-modifying drugs. CNS Drugs 2018; 32: 939–949. PubMed
Confavreux C, Saddier P, Grimaud J, et al. Risk of cancer from azathioprine therapy in multiple sclerosis: a case-control study. Neurology 1996; 46: 1607–1612. PubMed
Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology 2018; 90: 777–788. PubMed
Filippini G, Del Giovane C, Vacchi L, et al. Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis. Cochrane Database Syst Rev 2013; 6: CD008933. PubMed PMC
McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and treatment of multiple sclerosis: a review. JAMA 2021; 325: 765–779. PubMed
Biogen. TECFIDERA® (dimethyl fumarate) delayed-release capsules, for oral use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s029lbl.pdf (2023, accessed July 4, 2023).
Biogen Netherlands BV. TECFIDERA® summary of product characteristics. https://www.ema.europa.eu/en/documents/product-information/tecfidera-epar-product-information_en.pdf (2022, accessed July 4, 2023).
Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012; 367: 1087–1097. PubMed
Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012; 367: 1098–1107. PubMed
Gold R, Arnold DL, Bar-Or A, et al. Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: final ENDORSE study results. Mult Scler 2022; 28: 801–816. PubMed PMC
Biogen. Data on file. 2024.
Jia D, Zhang Y, Yang C. The incidence and prevalence, diagnosis, and treatment of multiple sclerosis in China: a narrative review. Neurol Sci 2022; 43: 4695–4700. PubMed PMC
Spelman T, Ozakbas S, Alroughani R, et al. Comparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis: results from MSBase registry. Mult Scler 2023; 29: 221–235. PubMed PMC
MSBase Neuro-Immunology Registry. https://www.msbase.org/ (accessed February 2023).
Butzkueven H, Chapman J, Cristiano E, et al. MSBase: an international, online registry and platform for collaborative outcomes research in multiple sclerosis. Mult Scler 2006; 12: 769–774. PubMed
Genentech. OCREVUS® (ocrelizumab) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761053s031lbl.pdf (2023, accessed November 24, 2023).
Genzyme. LEMTRADA® (alemtuzumab) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5187lbl.pdf (2023, accessed November 24, 2023).
Prosperini L, Mancinelli CR, Solaro CM, et al. Induction versus escalation in multiple sclerosis: a 10-year real world study. Neurotherapeutics 2020; 17: 994–1004. PubMed PMC
Le Page E, Leray E, Taurin G, et al. Mitoxantrone as induction treatment in aggressive relapsing remitting multiple sclerosis: treatment response factors in a 5 year follow-up observational study of 100 consecutive patients. J Neurol Neurosurg Psychiatry 2008; 79: 52–56. PubMed
Fenu G, Lorefice L, Frau F, et al. Induction and escalation therapies in multiple sclerosis. Antiinflamm Antiallergy Agents Med Chem 2015; 14: 26–34. PubMed
Vollmer B, Nair KV, Sillau SH, et al. Comparison of fingolimod and dimethyl fumarate in the treatment of multiple sclerosis: two-year experience. Mult Scler J Exp Transl Clin 2017; 3: 2055217317725102. PubMed PMC
Bosco-Levy P, Debouverie M, Brochet B, et al. Comparative effectiveness of dimethyl fumarate in multiple sclerosis. Br J Clin Pharmacol 2022; 88: 1268–1278. PubMed
Fox EJ, Vasquez A, Grainger W, et al. Gastrointestinal tolerability of delayed-release dimethyl fumarate in a multicenter, open-label study of patients with relapsing forms of multiple sclerosis (MANAGE). Int J MS Care 2016; 18: 9–18. PubMed PMC
Min J, Cohan S, Alvarez E, et al. Real-world characterization of dimethyl fumarate-related gastrointestinal events in multiple sclerosis: management strategies to improve persistence on treatment and patient outcomes. Neurol Ther 2019; 8: 109–119. PubMed PMC
Tramacere I, Del Giovane C, Salanti G, et al. Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. Cochrane Database Syst Rev 2015; 9: CD011381. PubMed PMC
Kieseier BC, Jeffery DR. Chemotherapeutics in the treatment of multiple sclerosis. Ther Adv Neurol Disord 2010; 3: 277–291. PubMed PMC
Massacesi L, Tramacere I, Amoroso S, et al. Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: a multicentre randomized non-inferiority trial. PLoS One 2014; 9: e113371. PubMed PMC
Viglietta V, Miller D, Bar-Or A, et al. Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials. Ann Clin Transl Neurol 2015; 2: 103–118. PubMed PMC
Gold R, Giovannoni G, Phillips JT, et al. Sustained effect of delayed-release dimethyl fumarate in newly diagnosed patients with relapsing-remitting multiple sclerosis: 6-year interim results from an extension of the DEFINE and CONFIRM studies. Neurol Ther 2016; 5: 45–57. PubMed PMC
Chinea A, Amezcua L, Vargas W, et al. Real-world safety and effectiveness of dimethyl fumarate in Hispanic or Latino patients with multiple sclerosis: 3-year results from ESTEEM. Neurol Ther 2020; 9: 495–504. PubMed PMC
Williams MJ, Amezcua L, Okai A, et al. Real-world safety and effectiveness of dimethyl fumarate in Black or African American patients with multiple sclerosis: 3-year results from ESTEEM. Neurol Ther 2020; 9: 483–493. PubMed PMC
Alroughani R, Ahmed SF, Behbehani R, et al. Effectiveness and safety of dimethyl fumarate treatment in relapsing multiple sclerosis patients: real-world evidence. Neurol Ther 2017; 6: 189–196. PubMed PMC
Pasternak B, Svanstrom H, Schmiegelow K, et al. Use of azathioprine and the risk of cancer in inflammatory bowel disease. Am J Epidemiol 2013; 177: 1296–1305. PubMed
Ingenus Pharmaceuticals. Cyclophosphamide prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212501s000lbl.pdf (2020, accessed July 21, 2023).