Table 2

Treatment exposure and safety outcomes

CharacteristicNatalizumab (n=54)Fingolimod (n=54)
Study drug exposure, days
 Mean (SD)183.0 (90.9)182.6 (101.8)
 Median (range)197 (1–364)172 (1–362)
Patients receiving treatment at each time point, n (%)
 Baseline54 (100)54 (100)
 Week 452 (96.3)50 (92.6)
 Week 850 (92.6)47 (87.0)
 Week 1245 (83.3)45 (83.3)
 Week 1642 (77.8)40 (74.1)
 Week 2036 (66.7)35 (64.8)
 Week 2432 (59.3)31 (57.4)
 Week 3225 (46.3)23 (42.6)
 Week 4011 (20.4)13 (24.1)
 Week 522 (3.7)1 (1.9)
Treatment-emergent AEs, n (%) of patients23 (42.6)32 (59.3)
Most commonly reported events, n (%) of patients*
 Headache6 (11.1)4 (7.4)
 MS relapse1 (1.9)8 (14.8)
 Hypoesthesia03 (5.6)
 Migraine03 (5.6)
 Upper respiratory tract infection1 (1.9)5 (9.3)
 Urinary tract infection2 (3.7)3 (5.6)
 Lymphocyte count decreased05 (9.3)
 Alanine aminotransferase increased03 (5.6)
 Anxiety1 (1.9)3 (5.6)
 Fatigue3 (5.6)0
 Oropharyngeal pain3 (5.6)1 (1.9)
Serious AEs, n (%) of patients02 (3.7)
 Second-degree atrioventricular block01 (1.9)
 Migraine with aura01 (1.9)
Events leading to study discontinuation, n (%) of patients†1 (1.9)3 (5.6)
 Second-degree atrioventricular block01 (1.9)
 Infusion site rash1 (1.9)0
 Alanine aminotransferase increased01 (1.9)
 Aspartate aminotransferase increased01 (1.9)
 Headache01 (1.9)
Patients who discontinued, n (%)53 (98.1)‡51 (94.4)§
  • *Treatment-emergent AEs reported by ≥5% patients in either group, listed by MedDRA preferred term.

  • †With the exception of atrioventricular block, AEs leading to study discontinuation were classified as non-serious events.

  • ‡Forty-nine patients discontinued due to sponsor study termination, two were lost to follow-up, one discontinued due to an AE and one discontinued due to withdrawal of consent.

  • §Forty-three patients discontinued due to sponsor study termination, three discontinued due to AEs, three discontinued due to physician decision, one was lost to follow-up and one discontinued for another reason.

  • AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; MS, multiple sclerosis.