DX09
Efficacy of Teriflunomide in MS Patients with a Primary Presentation of Optic Neuritis: A Subgroup Analysis of the Phase 3 TOPIC Study
TOPIC (NCT00622700) evaluated the efficacy and safety of teriflunomide, a once-daily oral immunomodulator for treatment of relapsing forms of MS, in patients with a first clinical episode suggestive of MS. Teriflunomide 14 mg significantly reduced the risk of relapse determining conversion to clinically definite MS (CDMS; primary endpoint) by 42.6% (P=0.0087) and the occurrence of relapse or new magnetic resonance imaging (MRI) lesion by 34.9% (P=0.0003) vs placebo.
Objectives:
To report clinical and MRI outcomes from an analysis of a subgroup of patients with optic neuritis (ON) in TOPIC.
Methods:
Patients with a primary presentation of ON, based on clinical assessment and with an MRI scan demonstrating ≥2 T2 lesions of ≥3 mm in diameter (ie, at least 1 lesion periventricular in location or ovoid in shape) were identified post hoc based on the description of symptoms by the investigators.
Results:
Of the 614 patients randomized and treated in TOPIC, 200 (32.6%) had a primary presentation of ON. A greater proportion of these patients had monofocal (n=147) vs multifocal (n=53) presentations. In the overall ON group of patients, teriflunomide 14 mg decreased the risk of relapse determining conversion to CDMS (58.4% risk reduction vs placebo, P=0.0458). At baseline, a similar proportion of patients had gadolinium (Gd)-enhancing lesions in the placebo (27.7%) and teriflunomide 14-mg (26.2%) groups. Following treatment with teriflunomide 14 mg, a smaller proportion of patients with ON had Gd-enhancing lesions (odds ratio [OR] 0.32; 95% CI 0.15, 0.68; P=0.0028 vs placebo; risk reduction of 68%). Similarly, a smaller proportion of patients in the teriflunomide 14-mg group had unique active lesions (OR 0.44; 95% CI 0.19, 0.98; P=0.0427 vs placebo; risk reduction of 56%). Patients treated with teriflunomide 14 mg with a monofocal presentation of ON had a significant reduction in the risk of further relapse (75.7%; P=0.0325).
Conclusions:
Treatment with teriflunomide 14 mg significantly reduced the risk of relapse determining conversion to CDMS in patients with a primary presentation of ON. Teriflunomide 14 mg also had a significant impact on MRI lesion activity. Taken together with data from studies in patients with relapsing MS, these observations demonstrate the consistent efficacy of teriflunomide on clinical and MRI outcomes across a range of MS patient subtypes.