Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension

Table 4 Summary of clinical course and safety events in patients positive for anti-AQP4 antibodies

Patient	Treatment	Clinical course and safety events (onset^a)
Continuous fingolimod
1	Fingolimod 0.5 mg	Bradycardia (day 2); chest discomfort (day 2); enlargement of a pre-existing spinal cord lesion, LESCL, pons and midbrain lesions (day 9); myelitis and LESCL (day 145); diplopia, right upper limb paresis, multiple lesions in the cervical and thoracic cord, brainstem, cerebellum and cerebrum (day 235)
2^b	Fingolimod 1.25 mg	Decreased heart rate (day 1); myelitis relapse (day 5); decreased heart rate (day 5; day 1 after drug interruption); abnormal liver function test result (day 85); asymptomatic multiple enhancing lesions in the bilateral cerebral white matter and an asymptomatic enhancing spinal cord lesion at C6 (6 days after fingolimod discontinuation); conduction and amnestic aphasia (3 weeks after fingolimod discontinuation)
Switched from placebo to fingolimod
3	Placebo/fingolimod 0.5 mg	Recurrence of right optic neuritis and myelitis (day 29 of extension phase); dysarthria, right ataxia and weakness, right frontal lobe lesion (3 months); right upper limb weakness (4 months); left parietal lobe lesion, left paresthesia, dizziness and eye movement disturbance (1 month after fingolimod discontinuation)
4	Placebo/fingolimod 1.25 mg	Relapse showing left hemispheric symptoms and exacerbation of cerebral and cerebellar white matter lesions (day 9 in the extension phase)^c

^aDays after initiation of fingolimod in core study or extension phase.
^bThis patient discontinued from the study on day 78 during the core phase.
^cThis case was not diagnosed as progressive multifocal leukoencephalopathy.
Abbreviations: AQP4 aquaporin 4; LESCL longitudinally extensive spinal cord lesion.