Abstract Details

Title Disability Progression and Improvement Among Active and Nonactive Secondary Progressive Multiple Sclerosis Patients in Placebo Arms of Clinical Trials

Topic Multiple Sclerosis

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 305

Objective Evaluate the percentage of active and nonactive secondary progressive multiple sclerosis (SPMS) patients with a 6-month confirmed disability progression and improvement in the MSOAC Placebo Database.

Background Natural history of patients can be evaluated using MSOAC Placebo Database, which includes pooled placebo arm data from 9 clinical trials.

Design/Methods SPMS patients between 18 and <61 years of age with baseline EDSS score between 3 and 6.5 in the MSOAC Placebo Database were identified. Confirmed disability progression or improvement was defined as an increase or decrease of ≥1.0 point from an EDSS baseline score ≤5.0 or ≥0.5 point from an EDSS baseline score ≥5.5 confirmed at the following 6-months timepoint. Patients with no relapses within 1 year prior to enrollment into clinical trial were classified as nonactive and the rest were classified as active.

Results A total of 449 SPMS patients (124 nonactive and 325 active patients) were included. Mean age was 48.5 years with 64.1% female and median EDSS at baseline was 6.0 (range 3.5-6.5). Percentage of nonactive and active SPMS patients with disability improvement at 6 months confirmed at 12 months was 4.0% and 7.4%, p=0.20; this difference between nonactive and active SPMS patients was statistically significant at 1 year confirmed at 18 months (4.0% and 11.1%; p=0.02). No difference was seen for disability progression at 1 year confirmed at 18-months between active and nonactive SPMS (19.4% and 18.5%; p=0.83).

Conclusions When looking at placebo arms of clinical trials, a significantly lower percentage of nonactive SPMS patients showed improvement in disability at 1 year (4%) than active SPMS (11%). Both active and nonactive SPMS patients have similar and substantial disability progression within the first year. With this high disease burden, more transformational treatments are needed to improve disability in SPMS, especially in the nonactive patients where there are no approved treatments.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
Kiren Kresa-Reahl, MD (Atara Biotherapeutics)	Dr. Kresa-Reahl has received personal compensation for serving as an employee of Atara Biotherapeutics Inc.. Dr. Kresa-Reahl has received stock or an ownership interest from Atara Biotherapeutics Inc.
Sasha Bogdanovich, MD, PhD (AtaraBio)	Dr. Bogdanovich has received personal compensation for serving as an employee of Atara Bio. Dr. Bogdanovich has received stock or an ownership interest from Atara Bio.
	No disclosure on file
Crystal Watson (Atara Biotherapeutics)	Ms. Watson has received personal compensation for serving as an employee of Atara Biotherapeutics. Ms. Watson has received stock or an ownership interest from Atara Biotherapeutics.

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