Table 1.
Reported post hoc sub-group analysis from pivotal phase 3 trials of different DMTs based on age.
| Treatment | Trial | Age-based effect on disease activity markers | Age-based effect on the risk of confirmed disability progression |
|---|---|---|---|
| Teriflunomide | TEMSO (118) | Significant reduction of the ARR in patients <38 and ≥38 years vs. placebo | Reduction of the risk of disability progression only in patients <38 years vs. placebo |
| Dimethyl fumarate | DEFINE (119) CONFIRM (120) |
Significant reduction in the ARR in patients <40 and ≥ 40 years vs. placebo No significant reduction in the ARR in patients ≥40 years vs. glatiramer acetate |
Reduction of the risk of disability progression only in patients <40 years vs. placebo No reduction in the risk of disability progression in both age groups (<40 and >40 years) vs. glatiramer acetate |
| Fingolimod | FREEDOMS (121) | No significant reduction in the ARR in patients ≥40 years vs. placebo | No reduction in the risk of disability progression in both age groups vs. placebo |
| Siponimod | EXPAND (122) | – | Significant reduction in the risk of disability progression in patients <50 and years ≥50 years vs. placebo |
| Ozanimod | SUNBEAM (123) and RADIANCE (124) | No significant reduction in the ARR in patients ≥40 years vs. IFN-b1a | No reduction in the risk of disability progression in both age groups vs. placebo vs. IFN-b1a |
| Cladribine | CLARITY (125) | Significant reduction in the odds of remaining free of disease activity in patients <40 and ≥40 years vs. placebo | Significant reduction in the risk of disability progression in patients <40 and years ≥40 years vs. placebo |
| Ocrelizumab | OPERA I and II (126) OROTARIO (127) |
No significant reduction in the ARR in patients ≥40 years, but significant reduction in NEDA rates in both sub-groups vs. IFN-b1a Significant reduction in the ARR in patients <45 and ≥45 years vs. placebo |
Significant reduction in the risk of disability progression in patients <40 and years ≥40 years vs. IFN-b1a Significant reduction in the risk of disability progression in patients <45 and ≥45 years vs. placebo with a notable trend to benefit younger subjects |
| Ofatumumab | ASCLEPIOS (128) | Significant reduction in the ARR in patients <40 and years ≥40 years vs. teriflunomide | Significant reduction in the risk of disability progression in patients <40 and years ≥40 years vs. teriflunomide |
| Natalizumab | AFFIRM and SENTINEL (129) | Significant reduction in the ARR in patients <40 and ≥40 years vs. placebo in AFFIRM and in combination with iINF-b1a vs. INF- b1a alone in SENTINEL | Reduction of the risk of disability progression only in patients <40 years vs. placebo in AFFIRM and in combination with INF-b1a vs. INF-b1a alone in SENTINEL |
ARR, annualized relapse rate; INF, interferon; NEDA, no evidence of disease activity.