Ectrims 2015

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A lot of ECTRIMS scientific abstracts available:

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Vitamin D and disability in multiple sclerosis patients

Author(s): N. Niedziela , J. Niedziela , K. Pierzchała

(Abstract release date: Sep 23, 2015) ECTRIMS Online Library.

Niedziela N. Oct 9, 2015; 115223


Background: Multiple sclerosis (MS) is associated with increasing disability in young adults. Vitamin D plays protective role in bone health and may influence on physical activity.

Goal: The goal of this paper is to investigate the association between serum vitamin D levels, bone health, quality of life (QoL) and the disability status in MS patients.

Methods: 82 patients with relapsing-remitting MS (with or without immunomodulatory treatment) were included in the study. Baseline characteristics, expanded disability status scale (EDSS) and QoL according to EQ-5D scale were examined. Serum vitamin D (VitD) and parathormon (PTH) levels were assessed. T-Score and Z-score parameters were obtained in the dual-energy X-ray absorptiometry (DXA).

Patients were divided into 3 groups: VitD deficiency (VitDd for serum level < 12ng/ml), VitD insufficiency (VitDi for levels 12-30 ng/ml) and normal VitD levels (VitDn for serum levels >30 ng/ml). PTH, densitometry parameters, EDSS and QoL were compared between the groups.

Results: VitDd, VitDi and VitDn were found in 30, 45 and 7 participants respectively.

There were differences in PTH levels between VitDd, VitDi and VitDn groups: 40,5 pg/ml, 32,9 pg/ml and 26,9 pg/ml (p=0,028), respectively. The differences were also found in complaints about impaired mobility according to EQ-5D scale between VitDd, VitDi and VitDn groups: 73,3%, 42,2% and 28,5% (p=0,013), respectively. There were no differences between VitD groups in EDSS (p=0,84), T-score (p=0,28) and Z-score (p=0,26).

Conclusions: Although lower Vitamin D concentrations were associated with higher PTH levels and more often complaints about impaired mobility, no differences in densitometry parameters or EDSS scale were observed.

Disclosure: Natalia Niedziela: nothing to disclose

Jacek Niedziela: nothing to disclose

Krystyna Pierzchała: nothing to disclose

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Switching from subcutaneous interferon beta-1a to alemtuzumab further decreases new lesion activity and slows brain volume loss in treatment-naive patients with active relapsing-remitting multiple sclerosis: CARE-MS I extension study

Author(s): A. Rovira , F. Barkhof , B. Kieseier , X. Montalban , D.H. Margolin , K. Thangavelu , D.L. Arnold , on behalf of the CARE-MS I Investigators

(Abstract release date: Sep 23, 2015) ECTRIMS Online Library. Rovira A. Oct 9, 2015; 116025

Background: In the CARE-MS I study (NCT00530348) of treatment-naive patients with active relapsing-remitting multiple sclerosis (RRMS), alemtuzumab significantly improved many magnetic resonance imaging (MRI) outcomes, including an increased proportion of patients free of MRI activity compared with subcutaneous interferon beta-1a (SC IFNB-1a), and a slowing of brain volume loss.

Goals: To examine 2-year MRI outcomes in patients who switched to alemtuzumab after receiving SC IFNB-1a.

Methods: In the 2-year, phase 3, head-to-head, rater-blinded CARE-MS I study, SC IFNB-1a-treated patients received 44 µg 3 times/week for 2 years. These patients were eligible for the extension study (NCT00930553); upon enrolment, they received 2 annual courses of alemtuzumab 12 mg (infused on 5 consecutive days at extension study baseline and on 3 consecutive days 12 months later). MRI outcomes were assessed at baseline and yearly thereafter and included: gadolinium (Gd)-enhancing, new/enlarging T2 hyperintense and new T1 hypointense lesion activity/counts; MRI activity-free (absence of new Gd-enhancing and new/enlarging T2 lesions); and brain volume loss measured by brain parenchymal fraction (BPF) change.

Results: Most SC IFNB-1a-treated patients in CARE-MS I (144/173 [83%]) enrolled in the extension. Mean lesion number per patient decreased after switching to alemtuzumab and stayed low through extension Year 2 (new Gd-enhancing: 0.31 [before alemtuzumab] to 0.04 [after]; new/enlarging T2: 1.60 to 0.68; new T1: 0.47 to 0.11). Of those with new Gd-enhancing, T2, and T1 lesion activity after 2 years on SC IFNB-1a (17.9%, 39.3%, and 18.4%), 91.7%, 76.0%, and 95.7% of patients were lesion-free in Year 2 after switching to alemtuzumab. Similarly, of those with MRI activity after 2 years on SC IFNB-1a (40.0%), 76.5% were MRI activity-free in Year 2 of the extension study, following alemtuzumab treatment at Month 0 and Month 12. Median yearly BPF loss declined from -0.50% in Year 2 on SC IFNB-1a to -0.13% in Year 2 after switching to alemtuzumab.

Conclusion: The majority of SC IFNB-1a-treated patients who had MRI activity on SC IFNB-1a in the core study and switched to alemtuzumab was MRI activity-free. Alemtuzumab also markedly reduced the yearly rate of brain volume loss. These findings demonstrate that alemtuzumab further improves outcomes after switching from SC IFNB-1a and support the superior efficacy of alemtuzumab in patients who received prior disease-modifying therapy.

Disclosure: Study supported by Genzyme, a Sanofi company and Bayer Healthcare Pharmaceuticals.

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Novel oral MS treatments: one-year real-life experience with 128 patients treated with dimethyl-fumarate

Author(s): T. Sejbaek , Z. Illes

(Abstract release date: Sep 23, 2015) ECTRIMS Online Library. Sejbaek T. Oct 9, 2015; 115829


Background: Real-life experience with dimethyl-fumarate (Tecfidera), a recently introduced oral MS treatment is limited.

Objective: We examined if treatment of MS patients with dimethyl-fumarate in real-life setting reflects expectations based on the approved label.

Methods: Side effects and laboratory abnormalities were examined in 128 patients treated with dimethyl-fumarate.

Results: Treatment with dimethyl-fumarate was initiated in March 2014 in Denmark: 128 patients were enrolled and followed with a mean duration 258 days±97 days (17-421). The mean age of patients was 40 years±10.5 years (21-67): 43 male and 85 female people with MS were included. Forty-three patients were treatment-naïve, 80 patients received one or more 1st line treatment and 5 were treated with a 2nd line treatment before dimethyl-fumarate. We observed adverse events (AEs) in 74% of cases. Most frequent was transient flushing and gastrointestinal side effects. In 7 cases (5 %), the AEs were associated with discontinuation of treatment (flushing, gastrointestinal, pruritus, urticaria). Six patients (4.6 %) were concomitantly treated with low-dose aspirin (max 75mg a day). Twenty-five patients (19.5%) developed lymphocytopenia grade I or grade II. We observed grade III lymphocytopenia in 3 cases, no grade IV occurred. Both transient and persisting lymphocytopenia were present. Mild liver enzyme elevation was seen in 6 cases.

Conclusion: Adverse events with dimethyl-fumarate were frequent but usually mild and well tolerated. Less than 5% were treated with concomitant low-dose aspirin. Only 5% of patients discontinued treatment due to side effects during the first year. Surprisingly, more than 20% of patients developed lymphocytopenia, however only grade I or II. Adherence seems stronger with dimethyl-fumarate than 1st line injectables.