1Carrie M. Hersh, 2Carl De Moor, 3Deborah M. Miller, 2Robin Avila, 2James R. Williams, 4Kathryn C. Fitzgerald, 2Menglan Pang, 3Marisa P. Mcginley, 5Megan Hyland, 6Tjalf Ziemssen, 7Irene Koulinska
1Mellen Program for MS, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, United States; 2Biogen, Cambridge, United States; 3Mellen Center, Cleveland Clinic, Cleveland, United States; 4Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, United States; 5Department of Neurology, University of Rochester Medical Center, Rochester, United States; 6University Clinic Carl-Gustav Carus, Dresden, Dresden, Germany; 7Biogen, at the time of this study, Cambridge, United States
Understanding patient-reported changes in physical, mental, and social health after initiation of multiple sclerosis (MS) disease-modifying therapy (DMT) is important to optimize treatment.
To compare time to improvement in each Quality of Life in Neurological Disorders (Neuro-QoL [NQ]) domain in patients treated with natalizumab (NAT) vs ocrelizumab (OCR).
Material(s) and Method(s):
T-scores of 12 NQ domains were obtained at routine visits in the MS Partners Advancing Technology and Health Solutions (MS PATHS) network. Baseline (BL) was defined as the last NQ measurement ≤1 year prior to initiating NAT or OCR, and eligible patients had >1 follow-up NQ assessment after initiation of NAT or OCR. Patients with primary progressive MS, prior NAT or OCR therapy, and/or a BL NQ score <5 points below the maximum (for positively worded domains) or <5 points above the minimum (for negatively worded domains) were excluded. T-score improvements of ≥5 points from BL were considered clinically meaningful. Time to first ≥5-point NQ improvement in propensity score (PS)–matched NAT and OCR patients was compared using a semiparametric accelerated failure time model for interval-censored data. BL variables for PS matching included age, sex, race, years of education, MS duration, prior DMT, self-reported disability and relapses in prior year, processing speed and manual dexterity test scores, co-medications, and corresponding NQ domain scores.
There were 146 NAT and 632 OCR patients eligible for this analysis. Mean (standard deviation) follow-up times were 1.1 (0.7) and 1.2 (0.7) years for NAT- and OCR-treated patients, respectively. After exclusion based on BL NQ scores, 88–139 NAT and OCR patients were PS matched, depending on NQ domain. For matched patients, time to improvement was significantly shorter with NAT than with OCR for cognitive function (event time ratio: 0.45; P=0.002) and satisfaction with social roles and activities (event time ratio: 0.47; P=0.04). There were no significant differences between groups in the remaining 10 NQ domains.
NAT treatment can shorten the time to clinically meaningful improvement in the NQ domains of cognition and satisfaction with social roles and activities compared with OCR. These results complement previous findings from MS PATHS indicating that NAT treatment can produce meaningful improvements in mental and social health, with overall annualized improvement rates higher than those observed with OCR.
*Additional authors: Irene Koulinska (Biogen, Cambridge, MA, USA, at the time of this study)