8394
Patient-Reported Outcomes from NOVA: A Randomized Controlled Study of the Efficacy of Natalizumab 6-Week Dosing Vs Continued 4-Week Dosing for MS

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Lana Zhovtis Ryerson, MD , Department of Neurology, NYU Langone Health, New York University, New York, NY
Gilles Defer, MD , Department of Neurology, Centre Hospitalier Universitaire de Caen, Caen, France
Jeffrey A Cohen, MD , Mellen MS Center, Cleveland Clinic, Cleveland, OH
Douglas L Arnold, MD , Montreal Neurological Institute, McGill University, and NeuroRx Research, Montreal, QC, Canada
Helmut Butzkueven, MBBS, PhD , Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia
Gary Cutter, PhD , University of Alabama School of Public Health, Birmingham, AL
Gavin Giovannoni, MD, PhD , Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
Joep Killestein, MD, PhD , Department of Neurology, MS Centre Amsterdam, VU University Medical Centre, Amsterdam, Netherlands
Heinz Wiendl, MD, MPH , University of Muenster, Muenster, Germany
John Foley, MD , Rocky Mountain MS Clinic, Salt Lake City, UT
George Kong, PhD , Biogen, Cambridge, MA
Susie Sinks, PhD , Biogen, Cambridge, MA
Robert Kuhelj, PhD , Biogen, Baar, Sweden
Tyler Lasky, PharmD , Biogen, Cambridge, MA
Karthik Bodhinathan, PhD , Biogen, Cambridge, MA



Background:

Natalizumab 300 mg every-4-weeks (Q4W) is approved for treatment of relapsing-remitting multiple sclerosis. Extended dosing frequencies (approximately every-6-weeks [Q6W]) are associated with lower progressive multifocal leukoencephalopathy risk in retrospective analyses. NOVA (NCT03689972) is the first randomized, controlled trial to assess efficacy of Q6W vs Q4W dosing. Patient-reported outcomes (PROs) may provide important information on Q6W vs Q4W dosing given reports of a natalizumab “wearing-off” effect.

Objectives:

To evaluate PROs in patients treated with natalizumab Q6W over 72 weeks who were previously treated with Q4W dosing for ≥12 months compared with continuation of Q4W dosing

Methods:

PROs (Treatment Satisfaction Questionnaire for Medication [TSQM], Neurology Quality of Life [NQoL] fatigue questionnaire, Multiple Sclerosis Impact Scale [MSIS-29], EuroQol 5 Dimensions [EQ-5D-5L] index score), and in Clinical Global Impression (CGI)-improvement and CGI-severity rating scales were assessed in NOVA as exploratory clinical efficacy outcomes. Data were analyzed using a mixed model of repeated measures (PROs) or ordinal logistic regression (CGI Scale), adjusted for geographic region, baseline (BL) body weight, duration of natalizumab exposure at BL (PROs and CGI Scale), and respective BL PRO score (PROs only). Higher scores in TQSM, EQ-5D-5L, and CGI-improvement, and lower scores in NQoL fatigue, MSIS-29 and CGI-severity indicate better outcomes.

Results:

Changes in PROs and CGI scores from BL to week 72 were assessed in 247 Q6W and 242 Q4W patients who received ≥1 dose of study treatment and had ≥1 post-baseline efficacy assessment. Difference in least-squares mean change from BL to week 72 for Q6W vs Q4W patients was not significant for PROs (TSQM −1.00, P=0.410; NQoL fatigue 0.52, P=0.292; MSIS-29 Physical 0.74, P=0.429; MSIS-29 Psychological 0.67, P=0.572; EQ-5D-5L 0.00, P=0.978). Odds ratio (ORs) of improvement in CGI scores from BL to week 72 for Q6W vs Q4W did not show meaningful differences between groups (CGI-improvement [patient]: OR [95% confidence interval] 1.2 [0.80–1.73]; CGI-improvement [physician]: 0.8 [0.47–1.36]; CGI-severity [physician]: 1.0 [0.71–1.54]). None of the changes in PROs or CGI scores were clinically meaningful based on published estimates.

Conclusions:

Overall, there were no significant or clinically meaningful differences in PRO or CGI rating scores between natalizumab Q6W and Q4W groups in NOVA.

See more of: Late-breaking Abstracts
See more of: Late-Breaking
<< Previous Abstract | Next Abstract >>