2025 American Academy of Neurology Abstract Website

Orhan Aktas¹, Friedemann Paul², Douglas Sato³, Jodie M. Burton⁴, Michael A. Smith⁵, William Rees⁵, Kristina Patterson⁵, Bruce A. C. Cree⁶
¹Department of Neurology, Heinrich Heine University Düsseldorf, ²Experimental and Clinical Research Center, Charite Universitatsmedizin in Berlin, ³School of Medicine, Pontifical Catholic University of Rio Grande do Sul, ⁴Departments of Clinical Neurosciences and Community Health Sciences, University of Calgary Cumming School of Medicine, ⁵Amgen, Inc., ⁶Department of Neurology, UCSF Weill Institute for Neurosciences,University of California San Francisco

Objective:

Here we further evaluated Pain and QoL improvement in attack-free, inebilizumab-treated participants over 3-years to determine improvements in non-attack related Pain and QoL.

Background:

Chronic pain and disability are enduring effects of NMOSD and contribute to decreased quality of life (QoL). Previous analyses showed year-over-year improvements in pain and QoL with inebilizumab.

Design/Methods:

N-MOmentum (NCT02200770) was a phase 2/3 trial in 230 participants (randomized 3:1, inebilizumab 300mg:placebo), with an open-label extension of ≥2 years. This analysis was conducted in 95 participants who were attack-free with ≥3-years of inebilizumab. Year-over-year changes in pain (SF-36-Bodily-Pain-Score[BPS]), QoL (SF-36-physical-component-summary[PCS]), and disability (Expanded-Disability-Status-Scale [EDSS]) were assessed for significance using mixed linear models. Sensitivity analysis was conducted in 72/95 participants who were attack-free for ≥6 months prior to inebilizumab treatment to control for acute attack-related recovery.

Results:

At Baseline, 38%(36/95) participants reported an abnormal QoL score (SF36-PCS<40), 89%(32/36) of these participants reported increased pain (SF36-BPS<40) and 50%(18/36) reported significant disability (EDSS≥5). After 3-years of inebilizumab, QoL scores improved in 89%(32/36) of attack-free participants with an abnormal baseline QoL score.

39%(37/95) of participants had abnormal pain scores (SF36-BPS<40) at baseline and improvements were reported in 78%(29/37) p<0.001 after 3-years of inebilizumab. SF36-PCS and BPS scores also improved in participants with normal (≥40) baseline scores after 3-years of inebilizumab.

Improvements in EDSS from baseline to 3-years of inebilizumab were observed in 44%(40/91) of participants including 36%(25/69) with less disability (<5 EDSS) and 68%(15/22) with greater disability (≥5 EDSS) at baseline.

Functional System Scores (FSS) improvements coincide with improvements in EDSS for ambulation (ie. walking ability) score in 68%(15/22) participants and pyramidal (ie. paraparesis or hemiparesis) score in 36%(8/22) participants.

These results were consistent with the sensitivity analysis.

Conclusions:

Year-over-year Improvements in Pain, QoL, EDSS and FSS were observed in attack-free participants on inebilizumab. Interestingly, these improvements were independent of acute attack-related recovery.