Wondering if this is true

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Wondering if this is true

Postby scoobyjude » Sat Mar 11, 2006 1:27 pm

I was just on another site and a poster claimed that Rebif was implicated in a death from PML in 2005. Anyone know anything about this? Seems strange that this could have been kept quiet so I'm a little suspicious. No one on the other site has responded so I don't think it could have been reported in any widely read media. I checked around and couldn't find anything. Definitely got my attention since I'll be beginning Rebif any day now but seems unlikely to be just hearing about it.
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Postby Brownsfan » Sat Mar 11, 2006 2:57 pm

I've never heard of any of the CRABs being implicated in PML. This very question is addressed on the Rebif website which also flatly denies any link.

http://www.rebif.com/assets/pdfs/FinalS ... bif%20pml'
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Re: Wondering if this is true

Postby HarryZ » Sat Mar 11, 2006 7:02 pm

The poster of that message actually quoted the case number report so perhaps there is some merit to it.

A PML death from Avonex was stated as well. But in each case it was one situation out of hundreds of thousands of patient months with these drugs. That risk is incredibly small and likely doesn't mean all that much.

Harry
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Postby Bucks » Sat Mar 11, 2006 8:03 pm

Scooby, you likely read the same post as I or a post I made passing this info on a couple of days ago. After reading the information I confirmed myself that there is a Rebif PML case in the just released FDA Adverse Event Reporting Database for Q3 2005. I also confirmed the existence of the earlier Avonex monotherapy PML case in the database. I found the reports by downloading data direct from the FDA Adverse Event Reporting Database here: http://www.fda.gov/cder/aers/extract.htm

Everyone can do the same by downloading each quarterly zip file and then extracting the zip and you will see several large files. Using Wordpad I searched each file for 4747129 to see all records for the reported Rebif PML case. Below is what I found. After that is data I found for the March 1 2005 Avonex monotherapy PML case.

I agree with Harry, there is so many patient years of experience any risk should be very low. The significant interest to me and I'm sure others is all about better assessment of Tysabri monotherapy PML risk. If you are about to start Rebif I wouldn't let these reports dissuade you.

DEMO05Q3.TXT (Patient Demographic and Administrative Info)
4747129$5865713$I$$4747129-6$$20050802$20050815$EXP$2005109935$PFIZER INC$41$YR$F$N$$$20050812$MD$20050224$$$UNITED STATES$

DRUG05Q3.TXT (Drug/Bilogic Info)
4747129$1006329862$PS$METHYLPREDNISOLONE SODIUM SUCCINATE$1$INTRAVENOUS$1000 MG (500 MG, 2 IN 1 D), INTRAVENOUS$D$D$$$11856$
4747129$1006348446$SS$INTERFERON BETA-1A (INTERFERON BETA)$2$INTRAMUSCULAR$(30 MCG, 1 IN 1 WK), INTRAMUSCULAR$D$D$$$$
4747129$1006348448$SS$ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)$2$INTRAVENOUS$(300 MG, 1 4 WK), INTRAVENOUS$D$D$$$$
4747129$1006348449$C$DONEPEZIL HCL$1$$$$$$$$
4747129$1006348450$C$TIZANIDINE HCL$1$$$$$$$$
4747129$1006348453$C$GALANTAMINE (GALANTAMINE)$2$$$$$$$$
4747129$1006348454$C$CITALOPRAM (CITALOPRAM)$2$$$$$$$$
4747129$1006348455$C$ROFECOXIB$1$$$$$$$$
4747129$1006348457$C$TRAMADOL HCL$1$$$$$$$$

REAC05Q3.TXT (ALL MedDRA terms coded for the adverse event)
4747129$CACHEXIA$
4747129$CONDITION AGGRAVATED$
4747129$MULTIPLE SCLEROSIS$
4747129$PNEUMONIA ASPIRATION$
4747129$PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY$
4747129$ROSAI-DORFMAN SYNDROME$

OUTC05Q3.TXT (Patient Outcome for the adverse event)
4747129$DE$
4747129$HO$
4747129$OT$

RPSR05Q3.TXT (reporting source for event)
4747129$HP$

THER05Q3.TXT (start dates and end dates for each drug therapy)
4747129$1006329862$20010316$20050109$$$
4747129$1006348446$20000201$20050101$$$
4747129$1006348448$20020412$20050118$$$

INDI05Q3.TXT (MedDRA terms coded for the indications for reported drugs)
4747129$1006329862$RELAPSING-REMITTING MULTIPLE SCLEROSIS
4747129$1006348446$RELAPSING-REMITTING MULTIPLE SCLEROSIS
4747129$1006348448$RELAPSING-REMITTING MULTIPLE SCLEROSIS

==================
4599260
DEMO05Q1.TXT (Patient Demographic and Administrative Info)
4599260$5756178$I$$4599260-6$20040119$$20050302$DIR$$$$$F$N$100$LBS$20050301$CN$20040430$Y$N$

DRUG05Q1.TXT (Drug/Bilogic Info)
4599260$1005752402$PS$AVONEX$1$$INJECTION WEEKLY$$$$$$

REAC05Q1.TXT (ALL MedDRA terms coded for the adverse event)
4599260$GENERAL PHYSICAL HEALTH DETERIORATION$
4599260$HALLUCINATION$
4599260$JC VIRUS INFECTION$
4599260$PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY$
4599260$PYREXIA$
4599260$THERAPY NON-RESPONDER$
4599260$UNEVALUABLE EVENT$
4599260$URINARY TRACT INFECTION$

OUTC05Q1.TXT (Patient Outcome for the adverse event)
4599260$DE$
4599260$HO$

RPSR05Q1.TXT (reporting source for event)

THER05Q1.TXT (start dates and end dates for each drug therapy)

INDI05Q1.TXT (MedDRA terms coded for the indications for reported drugs)
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Postby scoobyjude » Sat Mar 11, 2006 8:50 pm

I don't think it will dissuade me from taking Rebif but I have to admit I'm a little taken aback. I know that the risk is very small and many thousands of people have taken it without developing PML but I guess I just didn't think I would have to worry about this. I'm surprised I haven't read more about it considering all that they have put Tysabri through. Oh well, guess nothing is ever simple.
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