Table 4.
Change from baseline in pRNFL and mGCIPL thickness and comparison between groups at Month 36.
|
ON history Visit group |
n |
LS mean of change from baseline (95% CI) |
Group difference (95% CI) in change from baseline (Patients with MS – Reference participants, adjusted for baseline) | p‐value |
|---|---|---|---|---|
| pRNFL thickness (µm) 1 | ||||
| All | ||||
| Patients with MS (N = 333) | 284 | −1.74 (−2.04, −1.45) | −1.86 (−2.54, −1.17) | <0.0001 |
| Reference participants (N = 64) | 56 | 0.12 (−0.51, 0.74) | ||
| Non‐MS‐ON | ||||
| Patients with MS (N = 235) | 200 | −1.79 (−2.12, −1.45) | −1.88 (−2.59, −1.16) | <0.0001 |
| Reference participants (N = 64) | 56 | 0.09 (−0.55, 0.72) | ||
| MS‐ON | ||||
| Patients with MS (N = 98) | 84 | −1.61 (−2.25, −0.96) | −1.80 (−2.71, −0.88) | 0.0001 |
| Reference participants (N = 64) | 56 | 0.19 (−0.41, 0.79) | ||
| mGCIPL thickness (µm) 2 | ||||
| All | ||||
| Patients with MS (N = 333) | 285 | −0.54 (−0.85, −0.24) | −2.03 (−2.78, −1.28) | <0.0001 |
| Reference participants (N = 64) | 55 | 1.49 (0.80, 2.18) | ||
| Non‐MS‐ON | ||||
| Patients with MS (N = 235) | 201 | −0.47 (−0.83, −0.12) | −1.77 (−2.51, −1.03) | <0.0001 |
| Reference participants (N = 64) | 55 | 1.30 (0.63, 1.97) | ||
| MS‐ON | ||||
| Patients with MS (N = 98) | 84 | −1.58 (−2.32, −0.85) | −3.89 (−5.17, −2.61) | <0.0001 |
| Reference participants (N = 64) | 55 | 2.31 (1.37, 3.25) | ||
N is the total number of participants in the analysis population, n is the number of participants with data available.
The average pRNFL thickness was the mean of the circular scan subfields 1 to 8.
Eye was nested within subject, and both were included as random effects. For participants with a history of ON, the unaffected eye was excluded. The reference participants were included as the reference group in all models. Participants who experienced an adverse event of ON during the study were re‐categorized and included in the ON history subgroup.
CI, confidence interval; mGCIPL, combined macular ganglion cell and inner plexiform layers; LS, least squares; MS, multiple sclerosis; MS‐ON, MS‐ associated optic neuritis; pRNFL, peripapillary retinal nerve fiber layer.
Mixed model for repeated measures (MMRM) included terms for group, visit, age, gender, and the interaction of group and visit with baseline average pRNFL thickness as a covariate.
Mixed model includes terms for group, age, gender, and baseline mGCIPL thickness as a covariate.