Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1154-1162 |
| Number of pages | 9 |
| Journal | Annals of Clinical and Translational Neurology |
| Volume | 5 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2018 |
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Predictors of response to opicinumab in acute optic neuritis. / Cadavid, D; Balcer, L; Galetta, S; Aktas, O; Ziemssen, T; Vanopdenbosch, LJ; Leocani, L; Freedman, MS; Plant, GT; Preiningerova, JL; Ziemssen, F; Massacesi, L; Chai, Y; Xu, L; Investigators, on behalf of the RENEW Study.
In: Annals of Clinical and Translational Neurology, Vol. 5, No. 10, 2018, p. 1154-1162.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Predictors of response to opicinumab in acute optic neuritis
AU - Cadavid, D
AU - Balcer, L
AU - Galetta, S
AU - Aktas, O
AU - Ziemssen, T
AU - Vanopdenbosch, LJ
AU - Leocani, L
AU - Freedman, MS
AU - Plant, GT
AU - Preiningerova, JL
AU - Ziemssen, F
AU - Massacesi, L
AU - Chai, Y
AU - Xu, L
AU - Investigators, on behalf of the RENEW Study
PY - 2018
Y1 - 2018
N2 - Objective: The objective of this study was to evaluate prespecified and post hoc analyses in RENEW subgroups to identify participants more likely to benefit from opicinumab. Methods: RENEW assessed the efficacy/safety of opicinumab versus placebo in participants with a first unilateral acute optic neuritis (AON) episode. Difference in visual evoked potential (VEP) latency of the affected eye at 24 weeks versus the fellow eye at baseline was the primary endpoint. Interactions between the primary endpoint and prespecified baseline variables (including age, timing of treatment initiation, and visual impairment) using the median as cut-off were evaluated in the per protocol population using analysis of covariance (ANCOVA); subgroups based on preexisting brain T2 lesion volume were also analyzed. Interactions between the primary endpoint and retinal ganglion cell layer/inner plexiform layer (RGCL/IPL) and retinal nerve fiber layer (RNFL) thickness were assessed post hoc as was weight gain by treatment. Results: Treatment benefit of opicinumab (n = 33) over placebo (n = 36) on the primary endpoint was greatest in participants older than the median age at baseline (≥33 years); the difference versus placebo for baseline age ≥33 years was −14.17 msec [P = 0.01] versus −0.89 msec for baseline age
AB - Objective: The objective of this study was to evaluate prespecified and post hoc analyses in RENEW subgroups to identify participants more likely to benefit from opicinumab. Methods: RENEW assessed the efficacy/safety of opicinumab versus placebo in participants with a first unilateral acute optic neuritis (AON) episode. Difference in visual evoked potential (VEP) latency of the affected eye at 24 weeks versus the fellow eye at baseline was the primary endpoint. Interactions between the primary endpoint and prespecified baseline variables (including age, timing of treatment initiation, and visual impairment) using the median as cut-off were evaluated in the per protocol population using analysis of covariance (ANCOVA); subgroups based on preexisting brain T2 lesion volume were also analyzed. Interactions between the primary endpoint and retinal ganglion cell layer/inner plexiform layer (RGCL/IPL) and retinal nerve fiber layer (RNFL) thickness were assessed post hoc as was weight gain by treatment. Results: Treatment benefit of opicinumab (n = 33) over placebo (n = 36) on the primary endpoint was greatest in participants older than the median age at baseline (≥33 years); the difference versus placebo for baseline age ≥33 years was −14.17 msec [P = 0.01] versus −0.89 msec for baseline age
U2 - 10.1002/acn3.620
DO - 10.1002/acn3.620
M3 - Article
VL - 5
SP - 1154
EP - 1162
JO - Annals of Clinical and Translational Neurology
JF - Annals of Clinical and Translational Neurology
SN - 2328-9503
IS - 10
ER -