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Abstract Details

The impact of relapses on quality of life in patients with neuromyelitis optica spectrum disorder: data from the phase 3 PREVENT study
Autoimmune Neurology
P14 - Poster Session 14 (8:00 AM-9:00 AM)
15-009

To evaluate the effect of relapse on quality of life in patients with neuromyelitis optica spectrum disorder (NMOSD) using phase 3 data from PREVENT.

Data are lacking on the impact of relapses on patients with NMOSD. PREVENT was a randomized, double-blind study of eculizumab in patients with aquaporin-4 immunoglobulin-G positive NMOSD, which showed a 94% reduction in the risk of adjudicated relapse versus placebo and also included survey measurements of quality of life.

Patients’ quality of life was assessed using the 5-dimension EuroQol questionnaire (EQ-5D) and the 36-item Short-Form Health Survey (SF-36), with higher values in both indicating better health status. In the current post hoc analysis, data from the eculizumab and placebo groups were pooled and the last recorded EQ-5D and SF-36 scores before an adjudicated relapse were compared (at relapse level) with post-relapse scores (recorded ≥30 days after relapse) using paired t-test.

In the absence of relapse, EQ-5D and SF-36 scores were stable over time as expected. Mean scores at pre-relapse (n = 24) and post-relapse (n = 22) were: EQ-5D index (possible range, 0–1): 0.656 and 0.595, respectively [pre–post difference, –0.067, p = 0.012]; EQ-5D visual analog score (possible range, 0–100): 60.458 and 56.500, respectively [pre–post difference, –4.227, p = 0.226]; SF-36 physical component summary score (possible range, 0–100): 38.487 and 36.431, respectively [pre–post difference, –2.602, p = 0.049]; and SF-36 mental component summary score (possible range, 0–100): 45.300 and 41.774, respectively [pre–post difference, –3.164, p = 0.041]. There were significant differences between pre- and post-relapse scores in the SF-36 domains bodily pain, physical functioning, role emotional and vitality.

 

This analysis suggests that relapses in patients with NMOSD are associated with a significant reduction in certain aspects of quality of life beyond the immediate relapse period.

Authors/Disclosures
Achim Berthele, MD
PRESENTER
No disclosure on file
Michael Levy, MD, PhD, FÂé¶¹´«Ã½Ó³»­ (Massachusetts General Hospital/Harvard Medical School) Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Pharma. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Levy has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Various law firms. The institution of Dr. Levy has received research support from National Institutes Health.
Karissa Johnston Karissa Johnston has nothing to disclose.
No disclosure on file
Adrian Kielhorn Adrian Kielhorn has received personal compensation for serving as an employee of Alexion. Adrian Kielhorn has stock in Alexion.
No disclosure on file
Guido Sabatella (Alexion) Guido Sabatella has received personal compensation for serving as an employee of Alexion.
Jacqueline Palace (John Radcliff Hospital Oxford Univeristy Hospitals Trust) Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono, Medimmune, Argenx, Janssen, AMgen, UCB, Roche, Novartis, Amplo, Alexion, . Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx, Sanofi. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche, UCB, Alexion, Amgen. Dr. Palace has or had stock in Astra Zenica. The institution of Dr. Palace has received research support from Roche, AMPLO, Alexion, UCB,. argenx, amgen. Dr. Palace has received intellectual property interests from a discovery or technology relating to health care.