Table 3.
Unadjusted and adjusted discontinuation and efficacy outcomes at 24-month follow-up.
| Discontinuation outcomes at 24 months | ||
|---|---|---|
| Causal effect of treatment | Unadjusted | ATT weighting |
| Discontinuation | 1.27 | 1.42 |
| OR (95% CI) | (0.92–1.75) | (0.94–2.14) |
| Intolerability | 1.96 a | 1.98 a |
| OR (95% CI) | (1.30–2.94) | (1.18–3.23) |
| Breakthrough disease | 0.82 | 0.98 |
| OR (95% CI) | (0.50–1.34) | (0.54–1.79) |
| Time to discontinuation | 1.29b | 1.40 a |
| Relative hazard ratio (95% CI) |
(1.00–1.66) |
(1.11–1.77) |
| Efficacy outcomes at 24 months: clinical measures of disease activity | ||
| Causal effect of treatment |
Unadjusted |
ATT weighting |
| Annualized relapse rate (ARR) | 1.08 | 1.45 |
| ARR ratio (95% CI) | (0.74–1.58) | (0.53–3.99) |
| Proportion with relapses | 0.98 | 1.27 |
| OR (95% CI) | (0.65–1.49) | (0.72–2.23) |
| Time to first relapse | 1.02 | 1.26 |
| Relative hazard ratio (95% CI) | (0.70–1.49) | (0.87–1.81) |
| T25FW 20% worsening | 1.55b | 1.23 |
| OR (95% CI) | (1.00–2.40) | (0.72–2.13) |
| 9-Hole peg test 20% worsening | 0.80 | 0.79 |
| OR (95% CI) |
(0.41–1.56) |
(0.34–1.80) |
| Efficacy outcomes at 24 months: MRI measures of disease activity | ||
| Causal effect of treatment |
Unadjusted |
ATT weighting |
| Brain MRI activity on DMT by 24 months c | 1.19 | 1.38 |
| OR (95% CI) | (0.80–1.79) | (0.83–2.32) |
| Brain MRI Gad-enhancing lesions | 1.36 | 2.07b |
| OR (95% CI) | (0.77–2.39) | (1.04–4.12) |
| Brain MRI new T2 lesions | 1.43 | 1.38 |
| OR (95% CI) | (0.91–2.24) | (0.78–2.43) |
| Brain MRI activity on DMT at 24 months | 1.58 | 1.50 |
| OR (95% CI) | (0.82–3.04) | (0.90–4.37) |
| Brain MRI Gad-enhancing lesions | 1.68 | 1.64 |
| OR (95% CI) | (0.73–3.86) | (0.82–5.63) |
| Brain MRI new T2 lesions | 1.67 | 1.60 |
| OR (95% CI) |
(0.78–3.57) |
(0.80–5.12) |
| Efficacy outcomes at 24 months: patient reported outcome | ||
| Causal effect of treatment |
Unadjusted |
ATT weighting |
| Depressed (PHQ9 ≥ 10) | 1.83b | 2.18b |
| OR (95% CI) | (1.09–3.08) | (1.14–4.15) |
ATT: average treatment effect on the treated; CI: confidence interval; DMT: disease-modifying therapy; Gad: gadolinium; MRI: magnetic resonance imaging; OR: odds ratio; PHQ9: Patient Health Questionnaire-9; T25FW: timed 25-foot walk.
Significance level at alpha = 0.05.
a
p < 0.01; bp < 0.05; ccumulative MRI data that include 12-month and 24-month MRI time points.