Abstract Details

Title Safety and Tolerability of Conversion to Siponimod in Patients with Advancing Relapsing Multiple Sclerosis: A Subgroup Analysis by Race and Ethnicity of EXCHANGE Interim Data

Topic Multiple Sclerosis

Presentation(s) P8 - Poster Session 8 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-006

Objective

Report on a subgroup analysis by race/ethnicity of EXCHANGE interim data.

Background

Minority groups are persistently underrepresented in clinical trials, resulting in limited data to inform clinical decision-making for these patients. EXCHANGE (NCT03623243) enrolled a diverse patient population and presents opportunity to assess real-world MS treatment patterns and safety/tolerability in conversion to siponimod.

Design/Methods

EXCHANGE included patients aged 18–65 years with advancing RMS, EDSS 2.0–6.5, and on continuous oral/injectable/infusion DMTs for ≥3 months at time of consent; primary endpoint was drug-related AE incidence. Subgroups were assessed according to patient-reported race/ethnicity.

Results

Of 163 patients in the overall EXCHANGE interim population, 126 (77.3%) identified as White non-Hispanic/Latino, 23 (14.1%) Black/African American, and 36 (22.1%) Hispanic/Latino. Mean (SD) age was 46.6 (10.3) overall, 43.8 (8.6) Black/African American, and 40.3 (11.3) years Hispanic/Latino. Mean (SD) time since MS diagnosis was 12.2 (8.7), 10.5 (7.1), 10.2 (7.7) years; median EDSS scores were 3.5, 3.5, 3.0, respectively. Proportion of patients with no relapses in the year prior to screening were 54.0%, 34.8%, 41.7%. 47.8% of the Black/African American subgroup were on injectable DMTs before switching to siponimod, vs 27.6% overall and 16.7% Hispanic/Latino. 77.8% of the Hispanic/Latino subgroup were on oral DMTs, vs 68.7% overall and 47.8% Black/African American. Patients reporting ≥1 AE possibly related to siponimod treatment were 31.3% (95%CI: 24.4–39.1) overall, 17.4% (5.7–39.5) Black/African American, and 44.4% (28.3–61.7) Hispanic/Latino. Most common AE by preferred term was headache in the overall population (n=13; 8.0%), 11 of whom were Hispanic/Latino. AEs experienced in Black/African American subgroup were different from the other two groups.

Conclusions

EXCHANGE enrolled a higher proportion of minority groups vs other recent MS clinical trials. Findings of this analysis may suggest differences in MS treatment patterns and presents limited evidence that a differed safety/tolerability profile may be experienced in minority groups.

Authors/Disclosures
Gina Mavrikis Cox, PhD (Novartis Pharmaceuticals) PRESENTER	Dr. Mavrikis Cox has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Dr. Mavrikis Cox has stock in Novartis Pharmaceuticals.
Amit Bar-Or, MD, FRCPC (University of Pennsylvania)	Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Bianca Weinstock-Guttman, MD (Department of Neurology, University At Buffalo)	Dr. Weinstock-Guttman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Weinstock-Guttman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Weinstock-Guttman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme &Sanofi. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen . Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Weinstock-Guttman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Weinstock-Guttman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Weinstock-Guttman has received personal compensation in the range of $0-$499 for serving as a Reviewer with NIH.
Yang Mao-Draayer, MD (University of Michigan, Department of Neurology)	Dr. Mao-Draayer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen Idec. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme-Sanofi. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme-Sanofi. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizone. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen Idec. The institution of Dr. Mao-Draayer has received research support from NIH .
Angel R. Chinea, MD	Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for novartis. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for biogen. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for emd serono. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for genentech. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for sanofi. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for biogen. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for emd serono. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for allergan.
	No disclosure on file
Xiangyi Meng, PhD (Novartis)	Dr. Meng has nothing to disclose.
Stanley L. Cohan, MD, PhD, FAAN	Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb (Celgene). Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Icometrix. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi genzyme. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Icometrix.

��ɫ��

��ɫ��