Table 3

Efficacy and safety outcomes over the first 2 years of the PRISMS study in patients who did and did not return for PRISMS-15

Outcomes at 2 yearsPatients attending PRISMS-15 (n=290)Patients not attending PRISMS-15 (n=270)p Value for between-group comparison
Mean (SD) number of relapses1.9 (1.7)2.2 (2.0)0.290
Mean (SD) ARR0.98 (0.92)1.15 (1.09)0.104
Mean (SD) change from baseline in EDDS score0.23 (1.08)*0.36 (1.27)†0.516
3-month confirmed EDSS progression, n (%)84 (29.2)‡87 (34.4)§0.193
Mean (SD) % change from baseline in T2 BOD7.36 (45.91)¶21.96 (120.97)**|0.006
Mean (SD) mean number of T2 active lesions per scan2.05 (3.02)‡2.26 (3.64)††0.679
≥1 AE, n (%)290 (100)269 (99.6)0.300
≥1 SAE, n (%)28 (9.7)33 (12.2)0.330
≥1 AE possibly or probably related to treatment, n (%)272 (93.8)258 (95.6)0.355
≥1 AE leading to treatment discontinuation, n (%)8 (2.8)19 (7.0)0.018

  • *n=285.

  • †n=248.

  • ‡n=288.

  • §n=253.

  • ¶n=277.

  • **n=237.

  • ††n=263.

  • p Values for efficacy outcomes were estimated using a non-parametric analysis of variance model on ranked data (except 3-month confirmed EDDS progression where the p value was calculated using a χ2 test); p values for safety outcomes were calculated using a χ2 test.

  • AE, adverse event; ARR, annualised relapse rate; BOD, burden of disease; EDSS, Expanded Disability Status Scale; SAE, serious adverse event.