[P06.137] CHAMPIONS Extension Study: 10 Year Follow-Up after a Clinically Isolated Syndrome (CIS) in High Risk Patients

Revere Kinkel, Boston, MA, Jean Paul Tanner, Tampa, FL, Jack Simon, Wilsonville, OR, Paul O'Connor, Toronto, ON, Canada, Craig Kollman, Tampa, FL

OBJECTIVE: 1) Determine long term clinical outcomes in a high risk CIS population; 2) Determine predictors of disease activity and progression; 3) Determine if Immediate initiation of IFNb-1a 30 mcg IM once weekly after a CIS affects long term outcomes. BACKGROUND: CHAMPIONS was an open label study involving 203 patients from 32 of 50 Phase III CHAMP study sites. CHAMPIONS reported that immediate initiation of IFNb-1a 30 mcg IM once weekly after a CIS decreased the development of CDMS over 5 years compared to delaying initiation of therapy. 43 % of patients developed CDMS, 13 % reached an EDSS > 3.0 and 2% developed progressive disease by 5 years. Following completion of CHAMPIONS, patients were offered enrollment in this 10 year study. DESIGN/METHODS: Patients followed yearly until their 10-year evaluation. Patients who originally received placebo in CHAMPS were considered the Delayed Treatment (DT) group and patients who originally received IFNb-1a in CHAMPS were considered the Immediate Treatment (IT) group. Outcomes included the development of CDMS as determined by an independent outcomes committee, relapses, disease course classification,EDSS, MSFC, SF-36, MSQLI and MRI at 10 years. RESULTS: Eighty-five percent (155 /183) of patients from 24 participating sites enrolled in the 10 year extension (n=81, IT group; n=74, DT group). There were no meaningful differences in CHAMPS baseline characteristics between the IT and DT group. Study Database lock will occur on 12/19/08. Preliminary results indicate 21 percent of patients developed an EDSS > 3.0 and 10 percent of patients developed progressive disease by last study visit. CONCLUSIONS/RELEVANCE: This is the longest follow-up of well-characterized high risk CIS patients initiating disease modifying therapy before or shortly after the development of CDMS. Results from this study will help clarify the long term impact of early disease modifying therapy and may identify early risk factors responsible for long term disease activity and progression. Supported by: Biogen Idec
Category - MS and Related Diseases - Clinical Science

Wednesday, April 29, 2009 4:00 PM

Poster Session VI: Multiple Sclerosis: Therapeutics I (4:00 PM-7:00 PM)