Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study

Journal of Neurology

Volumn 263, Issue 8, 2016, Pages 1626-1632

  Miclea, A ^a   Leussink, V I ^b   Hartung, H P ^b   Gold, R ^a   Hoepner, R ^a  

^a ST JOSEF HOSPITAL   (Germany)

^b Department of Orthopedic Surgery   (Germany)

Author keywords

Annualized relapse rate; Dimethyl fumarate; EDSS progression; Lymphopenia; Safety

Indexed keywords

FINGOLIMOD; FUMARIC ACID DIMETHYL ESTER; GLATIRAMER; GLUCOCORTICOID; INTERFERON; NATALIZUMAB; RITUXIMAB; IMMUNOSUPPRESSIVE AGENT;

ADULT; ARTICLE; DISABILITY; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXPANDED DISABILITY STATUS SCALE; FEMALE; GASTROINTESTINAL SYMPTOM; HOT FLUSH; HUMAN; IMMUNOTHERAPY; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); MULTIPLE SCLEROSIS; OBSERVATIONAL STUDY; OPPORTUNISTIC INFECTION; PRIORITY JOURNAL; RELAPSE; RETROSPECTIVE STUDY; TREATMENT RESPONSE; CLINICAL TRIAL; FOLLOW UP; MIDDLE AGED; MULTICENTER STUDY; NONPARAMETRIC TEST; TREATMENT OUTCOME;

ADULT; DIMETHYL FUMARATE; DISABILITY EVALUATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LYMPHOCYTE COUNT; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; RETROSPECTIVE STUDIES; STATISTICS, NONPARAMETRIC; TREATMENT OUTCOME;

EID: 84982854800     PISSN: 03405354     EISSN: 14321459     Source Type: Journal    
DOI: 10.1007/s00415-016-8175-3     Document Type: Article

References (17)

1. Noseworthy JH, Lucchinetti C, Rodriguez M et al (2000) Multiple sclerosis. N Engl J Med 343:938–952
2. Gilgun-Sherki Y, Melamed E, Offen D et al (2004) The role of oxidative stress in the pathogenesis of multiple sclerosis: the need for effective antioxidant therapy. J Neurol 251:261–268
3. Scannevin RH, Chollate S, Jung MY et al (2012) Fumarates promote cytoprotection of central nervous system cells against oxidative stress via the nuclear factor (erythroid-derived 2)-like 2 pathway. J Pharmacol Exp Ther 341:274–284
4. Gold R, Kappos L, Arnold DL et al (2012) Placebo-controlled phase 3 study of oral BG- 12 for relapsing multiple sclerosis. N Engl J Med 367:1098–1107
5. Fox RJ, Miller H, Phillips T et al (2012) Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 367:1087–1097
6. Fox EJ, Vasquez A, Grainger W et al (2016) Gastrointestinal tolerability of delayed- release dimethyl fumarate in a multicenter, open-label study of patients with relapsing forms of multiple sclerosis (MANAGE). IJMSC 18:9–18
7. Pozzilli C, Philipps JT, Fox RJ et al (2014) Long-term follow-up of the safety of delayed-release dimethyl fumarate in RRMS: Interim results from the ENDORSE extension study. MSJ 20(S1):67–284
8. Fox RJ, Chan A, Gold R et al (2014) Lymphocyte count reductions in relapsing-remitting multiple sclerosis (RRMS) patients treated with delayed-release dimethyl fumarate: an integrated analysis of the placebo-controlled studies. EJoN 21(S1):343
9. Hoepner R, Faissner S, Klasing A et al (2015) Progressive multifocal leukoencephalopathy during fumarate monotherapy of psoriasis. Neurol Neuroimmunol Neuroinflamm 2:e85
10. Winkelmann A, Loebermann M, Reisinger EC et al (2016) Disease-modifying therapies and infectious risks in multiple sclerosis. Nat Rev Neurol 12:217–233
11. Anonymous. German AWMF MS Guidelines; www.awmf.org. Accessed 20/03/2016
12. Anonymous. Special product information; www.ema.europa.eu/docs/en_GB/document_library/EPAR-Product_Information/human/002601/WC500162069.pdf. Accessed 17/03/2016
13. Anonymous. Cancer, Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS, http://ctep.cancer.gov. Accessed 26/03/2016
14. Cohan S, Calkwood J, LaGanke C et al (2015) Real-World Clinical Outcomes in Relapsing-Remitting Multiple Sclerosis Patients who Switch from Natalizumab to Delayed-Release Dimethyl Fumarate: A Multicenter, Retrospective, Observational Study (STRATEGY). Neurology 84(14 Supplement):P3–P293
15. Spelman T, Mekhael L, Burke T et al (2016) Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis. Eur J Neurol 23:729–736
16. Fox RJ, Chan A, Gold R et al (2015) Characterization of absolute lymphocyte count profiles in MS patients treated with delayed-release dimethyl fumarate: considerations for patient managment. Neurology 85(4):E48
17. Phillips JT, Selmaj K, Gold R et al (2015) Clinical significance of gastrointestinal and flushing events in patients with multiple sclerosis treated with delayed-release dimethyl fumarate. IJMSC 17(5):236–243