Khan's five year imaging data

Background--
Rudick showed brain parenchymal fraction declines in MS
Summers showed cognitive impairment is proportional to atrophy (MS 2008)
Khan looked at 5 years of patients treated continuously with one drug (n=608) picked (how?) 275 including 121 GA 101 high dose IFN 57 low dose IFN used SIENA technique updated in 2004 to include voxel based analysis reliable to 5 mm gaps. He threw out the first year due to known problems with "pseudoatrophy" which is due to loss of extracellular fluid. Was interested in changed in atrophy from year 2-5.
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Note that in BEYOND beta 500 , beta 250, and GA had the following amount of atrophy at year one and two: -.9(second year). I Khan study at 2 years IFN -.64, GA was -.46. In interval to year five, betaseron had -2.2, Avonex had -1.83, and GA had -1.4, controls -3.8.

Predictors of disability in MS

Robust--
Incomplete recovery after first attack
short interval to a second attack
sphincter affected at onset
motor function affected at onset

Others-
increased age
male gender
multifocal onset with cerebellar involvement

PRECISE Comi et al. for CIS using copaxone

481 patients 81 centers 1:1 randomization 3 years then openlabel extension. For entry patients had to have a unifooal attack and more than 2 large MRI lesions and enroll within 90 days . There was a robust effect on MRI and black holes, data on EDSS is pending. There was a 45 % reduction in relapse rate.

Current clinical trials/ recent trials quick hits August 2008

PRECISE Comit et al CIS and copaxone 481 patients 81 centers 1:1 randomization 3 years then open label robust effect on conversion to CDMS, black holes, EDSS data is pending.

 

FORTE study-- dosage study of copaxone 20 v. 40 mg 1155 patients 12 months negative  result

 

CHAMPS   (older study ) best prediictor of relapse is Gd++ lesions

 

BEYOND-- Betaseron 25v. Betaseron50 v. copaxone-- year two brain atrophy data was -.63, -.64 and -.59 respectively, favoring copaxone

 

REGARD  year two atrophy -.6% for rebif,-.5 % for copaxone favors copaxone but beware of pseudoatrophy effect in year one

 

CAREMS1 phase 3 Campath trial for naive early active patients

 

CAREMS2 phase 3 Campath trial for treatment failures on IFN who relapse with rrms 1200 patients

 

Freedoms  fingolimid, 2 doses .5 and 1.25 v placebo

 

Tranforms fingolimid v avonex

 

DEFINE BG12 fumarate dose finding 240 bid v tid

 

CONFIRM  fumarate v. comparator (which one?)

 

CLARITY  cladribine phase 3 pivotal fast track

 

ORACLE  cladribine trial for CIS

 

BRAVO  laquinomodv. placebo for rrms

 

OlympusRituxan v.placebo for PPMS failed trial in press

 

HERMES    Rituxan v. placebo for rrms reported in NEJM 2008

 

CAMMS223 Campath for RRMS phase 2 trial in press NEJM

 

 

 

 

 

 

 

 

 

 

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