Manufacturer's response to case reports of PML

New England Journal of Medicine

Volumn 368, Issue 17, 2013, Pages 1659-1661

  Sweetser, Marianne T ^a   Dawson, Katherine T ^a   Bozic, Carmen ^a  

^a BIOGEN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EFALIZUMAB; FUMADERM; FUMARIC ACID DERIVATIVE; FUMARIC ACID DIMETHYL ESTER; METHOTREXATE; PSORINOVO; STEROID; UNCLASSIFIED DRUG;

DISEASE DURATION; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; HUMAN; LETTER; LONG TERM CARE; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MALIGNANT NEOPLASTIC DISEASE; MULTIPLE SCLEROSIS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PSORIASIS; RISK FACTOR; SARCOIDOSIS; SIDE EFFECT;

EID: 84876563740     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1300283     Document Type: Letter

References (8)

1. Ermis U, Weis J, Schulz JB. PML in a patient treated with fumaric acid. N Engl J Med 2013;368:1657-8.
2. van Oosten BW, Killestein J, Barkhof F, Polman CH, Wattjes MP. PML in a patient treated with dimethyl fumarate from a compounding pharmacy. N Engl J Med 2013;368:1658-9.
3. Outterson K. Regulating compounding pharmacies after NECC. N Engl J Med 2012;367:1969-72.
4. Mrowietz U, Rostami-Yazdi M, Neureither M, Reich K. 15 years Fumaderm: fumaric acid esters for the systemic treatment of moderately severe and severe psoriasis vulgaris. J Dtsch Dermatol Ges 2009;Suppl 2:S3-S16. (In German.)
5. Reich K, Thaci D, Mrowietz U, Kamps A, Neureither M, Luger T. Efficacy and safety of fumaric acid esters in the longterm treatment of psoriasis - a retrospective study (FUTURE). J Dtsch Dermatol Ges 2009;7:603-11.
6. Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: evolving role of biologic therapies. Arthritis Rheum 2012;64:3043-51.
7. 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;367:1098-107. [Erratum, N Engl J Med 2012;367:2362.]
8. 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;367:1087-97. [Erratum, N Engl J Med 2012;367:1673.]