Abstract Details

Title Evaluation of the NEDA (No Evidence of Disease Activity) measure for predicting long-term outcomes from the pivotal trial of interferon beta-1b in multiple sclerosis

Topic Multiple Sclerosis

Presentation(s) (-)

Poster/Presentation
Number 011

Background Lack of disease activity is thought to be an important endpoint in clinical trials. Follow-up from the randomized trial of interferon beta-1b (IFNB-1b) in RRMS can be used to assess the importance of NEDA in predicting long-term outcomes.

Objective

Design/Methods NEDA was defined in two ways; 1) no relapses and no new T2-active lesions since Baseline during the first 2 years of treatment, and no confirmed 1-point EDSS progression by Year 2 (standard); and 2) no relapses and no EDSS worsening from Baseline to Year 2 (clinical). NDOs were death, need for a wheelchair, progression to unremitting EDSS ≥6, or secondary progressive MS after Year 2.

Results Following the randomized trial, 245 and 371/376 total patients were evaluated at 16 and 21 years, respectively. At 16 years, standard NEDA did not predict NDO. By contrast, clinical NEDA did predict NDO (p=0.0029), as did baseline EDSS (p=0.0033) with a trend for change in 3^rd ventricular size from Baseline to Year 2 (p=0.0854). Neither definition of NEDA was significantly associated with cognitive performance at Year 16. Standard NEDA did not predict survival after 21 years. By contrast, there was a trend for clinical NEDA to predict time to death (p=0.0865), as did IFNB-1b treatment (p=0.0251), relapse rate in the 2 years prior to study start (p=0.0260), T2-BOD at Baseline (p=0.0014), and change in T2-BOD from Baseline to Year 2 (p=0.0129).

Conclusions Although clinical NEDA did predict long-term outcomes, this effect was not seen for standard NEDA, which included measures of T2-activity. Thus, the MRI measures of T2-BOD and 3^rd ventricular size (atrophy) may be more useful than T2-activity as predictors of outcomes.

Authors/Disclosures
Douglas S. Goodin, MD (Univ of Calif at San Francisco)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

��ɫ��

��ɫ��