Background

Additional data on alemtuzumab use including clinical, imaging and safety outcomes in a real-world setting can improve patient care.

Objectives

To examine clinical, imaging and safety outcomes in relapsing multiple sclerosis (MS) patients who received at least 2 courses of alemtuzumab.

Methods

This retrospective, single-center study included patients treated with at least 2 courses of alemtuzumab and at least 12 months of follow-up. Demographic, clinical (annualized relapse rate; disability progression); imaging characteristics (brain and spine MRI); previous treatment; co-morbidities and adverse events were analyzed. Patient data for 2 years prior to course 1 (index date) and for up to 4 years after initiation of alemtuzumab was available for all patients.

Results

74 patients were included. Mean age (SD) at baseline was 41.8 (9.9), diagnosis duration 11.5 (7.8) years. 33 patients needed help with ambulation; of which 11 were wheelchair-bound. 45% of patients switched from natalizumab and 23% from fingolimod primarily due to MS worsening. After Alemtuzumab treatment, ARR was significantly decreased from 1.231 (1-year pre-) to 0.392 (1-year post-) index date (P < 0.0001) and to 0.313, 0.240 and 0.291 during each of following 3 years respectively. Comparing one year prior to and 2-years post- treatment: more patients had stable spinal cord MRI (94.3% vs 62.5%) and fewer showed worsening (37.5% vs 5.7%) (p = 0.0017). On brain MRI, more patients were stable (87.7% vs. 52.1%) and fewer patients showed worsening (48.0% vs. 9.6%) (p<0.0001). On disability, 69% of patients remained stable; 3 of 11 wheelchair-bound patients became ambulatory. Safety outcomes will be available for presentation.

Conclusions

This real-world data suggests alemtuzumab is clinically and radiographically safe and effective in a wide spectrum of MS patients including those with severe disability, longer disease duration and multiple comorbidities. Long term follow-up of this cohort will help assess the clinical efficacy of alemtuzumab in a real-world setting.

Background

Teriflunomide is a once-daily oral immunomodulator approved for treating relapsing multiple sclerosis (RMS) and relapsing-remitting MS, depending on the local label. Efficacy and safety of teriflunomide were established in the phase 2 (NCT01487096) and phase 3 trials of patients with RMS (TEMSO [NCT00134563], TOWER [NCT00751881], TENERE [NCT00883337]) and clinically isolated syndrome (TOPIC [NCT00622700]). In post hoc analysis of TEMSO patients stratified by age, structural image evaluation using normalization of atrophy (SIENA) revealed teriflunomide 14 mg significantly reduced the percentage of brain volume change in patients aged >25 to ≤35 years (48%; P=0.0217) and >45 to ≤55 years (35%; P=0.0092) versus placebo over 2 years.

Objectives

To analyze the effect of teriflunomide treatment on MRI lesion activity in TEMSO study patients with RMS stratified by age.

Methods

In TEMSO, patients were randomized 1:1:1 to receive either placebo or teriflunomide 7 mg or 14 mg for ≤108 weeks (Year 2). Through Year 2, MRI lesion activity (unique combined active lesions [UCAL], contrast-enhancing T1 weighted lesions [CEL], and T2 weighted [T2w] lesions) and safety were assessed in the SIENA analysis subgroup; patients were stratified by age at baseline: ≥18 to ≤25 years (n=97 [10%]); >25 to ≤35 years (n=283 [29%]); >35 to ≤45 years (n=388 [40%]); and >45 to ≤55 years (n=201 [21%]). P values between treatment groups were determined for MRI lesions using a Poisson model.

Results

Of 1086 patients in the TEMSO core study, 969 (89%) had scans appropriate for SIENA analysis. Compared with placebo, teriflunomide 14 mg significantly reduced the number of UCAL (0.31–1.44 vs 0.92–6.11 lesions; P≤0.0013) and CEL (0.10–0.46 vs 0.54–3.42 lesions; P≤0.0001) per scan across all age groups. In all age groups except the >45 to ≤55 years group, teriflunomide 14 mg significantly reduced the number of T2w lesions (0.50–0.93 vs 1.07–2.80 lesions; P≤0.001) per scan versus placebo. Similar effects on MRI lesion activity were seen with teriflunomide 7 mg versus placebo. Incidence of adverse events (AEs) generally increased with age, with no deaths reported through Year 2.

Conclusions

Over 2 years in TEMSO RMS patients, teriflunomide reduced the number of new MRI lesions versus placebo across age groups. Significant treatment effects were seen with teriflunomide 14 mg across all age groups for UCAL and CEL. Age-related increases in AEs were observed through Year 2.

STUDY SUPPORT: Sanofi.

Background

Additional data on alemtuzumab use including clinical, imaging and safety outcomes in a real-world setting can improve patient care.

Objectives

To examine clinical, imaging and safety outcomes in relapsing multiple sclerosis (MS) patients who received at least 2 courses of alemtuzumab.

Methods

This retrospective, single-center study included patients treated with at least 2 courses of alemtuzumab and at least 12 months of follow-up. Demographic, clinical (annualized relapse rate; disability progression); imaging characteristics (brain and spine MRI); previous treatment; co-morbidities and adverse events were analyzed. Patient data for 2 years prior to course 1 (index date) and for up to 4 years after initiation of alemtuzumab was available for all patients.

Results

74 patients were included. Mean age (SD) at baseline was 41.8 (9.9), diagnosis duration 11.5 (7.8) years. 33 patients needed help with ambulation; of which 11 were wheelchair-bound. 45% of patients switched from natalizumab and 23% from fingolimod primarily due to MS worsening. After Alemtuzumab treatment, ARR was significantly decreased from 1.231 (1-year pre-) to 0.392 (1-year post-) index date (P < 0.0001) and to 0.313, 0.240 and 0.291 during each of following 3 years respectively. Comparing one year prior to and 2-years post- treatment: more patients had stable spinal cord MRI (94.3% vs 62.5%) and fewer showed worsening (37.5% vs 5.7%) (p = 0.0017). On brain MRI, more patients were stable (87.7% vs. 52.1%) and fewer patients showed worsening (48.0% vs. 9.6%) (p<0.0001). On disability, 69% of patients remained stable; 3 of 11 wheelchair-bound patients became ambulatory. Safety outcomes will be available for presentation.

Conclusions

This real-world data suggests alemtuzumab is clinically and radiographically safe and effective in a wide spectrum of MS patients including those with severe disability, longer disease duration and multiple comorbidities. Long term follow-up of this cohort will help assess the clinical efficacy of alemtuzumab in a real-world setting.