scholarly journals Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE)

2019 ◽  
Vol 6 (5) ◽  
pp. e597 ◽  
Author(s):  
William Camu ◽  
Philippe Lehert ◽  
Charles Pierrot-Deseilligny ◽  
Patrick Hautecoeur ◽  
Anne Besserve ◽  
...  
Keyword(s):  
Interferon Beta ◽  
Primary Outcome Measure ◽  
High Dose ◽  
Double Blind ◽  
Serum 25Ohd ◽  
End Point ◽  
Relapsing Remitting ◽  
25Ohd Concentration ◽  
Group 2 ◽  
Low Serum

ObjectiveTo evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).MethodsIn this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS]).ResultsThe primary end point was not met. In patients who completed the 2-year follow-up (45 with cholecalciferol and 45 with placebo), all efficacy parameters favored cholecalciferol with an ARR reduction (p = 0.012), less new hypointense T1-weighted lesions (p = 0.025), a lower volume of hypointense T1-weighted lesions (p = 0.031), and a lower progression of EDSS (p = 0.026). The overall rate of adverse events was well balanced between groups.ConclusionsAlthough the primary end point was not met, these data suggest a potential treatment effect of cholecalciferol in patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration. Together with the good safety profile, these data support the exploration of cholecalciferol treatment in such patients with RRMS.Clinicaltrials.gov identifierNCT01198132.Classification of evidenceThis study provides Class II evidence that for patients with RRMS and low serum 25OHD, cholecalciferol did not significantly affect ARRs.

Hopelessness Ratings in Relapsing-Remitting and Secondary Progressive Multiple Sclerosis

2002 ◽  
Vol 32 (2) ◽  
pp. 155-165 ◽  
Author(s):  
Scott B. Patten ◽  
Luanne M. Metz
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Interferon Beta ◽  
Progressive Multiple Sclerosis ◽  
Double Blind ◽  
Exact Probability ◽  
Secondary Progressive ◽  
Relapsing Remitting ◽  
Trial Participants ◽  
Over Time

Objective: Two recent randomized double-blind placebo controlled clinical trials of interferon beta-1a in multiple sclerosis have obtained hopelessness ratings using the Beck Hopelessness Scale (BHS). One of these studies, the PRISMS trial, evaluated interferon beta-1a in relapsing remitting multiple sclerosis (RRMS). Another, the SPECTRIMS trial, evaluated the same medication in secondary progressive (SP) MS. The objective of this analysis was to compare levels of hopelessness in persons with RRMS and SPMS, and to describe changes over time in the clinical trial participants. Method: Raw data from each clinical trial was obtained from the sponsor of the trials (Serono). Median BHS ratings, and the proportions at or above the BHS cut-point of 10 were calculated over a two (PRISMS) or three (SPECTRIMS) year period. Results: The analysis included n = 532 clinical trial participants. Ratings of hopelessness were higher in SPMS clinical trial participants (SPECTRIMS) than in the RRMS group (PRISMS) at baseline (Fisher's exact test, p = 0.0035). Furthermore, ratings of hopelessness were higher during follow-up than at baseline, in the SPMS group (McNemar's exact probability, p = 0.0015), but not in the RRMS group (McNemar's exact probability, p = 0.65). Depression was strongly associated with hopelessness in both RRMS ( z = 4.13, p < 0.001) and SPMS ( z = 5.24, p < 0.001). Conclusions: Hopelessness is associated with SPMS, and may increase over time in this group. Hopelessness may influence suicide risk in people with MS and may potentially have an impact on coping and quality of life. Additional research is necessary to define the clinical implications of hopelessness in persons with this condition.

Analisi Costo Minimizzazione delle preparazioni di Interferon Beta per il trattamento della Sclerosi Multipla

2004 ◽  
Vol 5 (2) ◽  
pp. 117-122 ◽  
Author(s):  
Francesco Macchia ◽  
Pierluigi Russo ◽  
Luciano Caprino
Keyword(s):  
Biological Activity ◽  
Interferon Beta ◽  
Cost Minimization ◽  
Treatment Protocol ◽  
Health Resources ◽  
Double Blind ◽  
Hospital Perspective ◽  
Sclerosi Multipla ◽  
Relapsing Remitting ◽  
The Central Nervous System

The multiple sclerosis (MS) is a neurologic disease that is characterized by a progressive demielinization of the white matter of the central nervous system. In the lasts decades, several therapies have been introduced after randomized, double-blind, placebo controlled trials. These trials supported the efficacy of Interferon-beta (INF- b) in reducing relapsing frequency and slowing the progressive disability, mainly in cases affected by relapsing- remitting MS course. In Italy four different preparations of INF-b are available for MS treatment having different INF-b types (i.e., INF-b1a e INF-b1b), different administration schemes, different INF-b doses and ways of administration. Recently, the biological activity of these preparations have been compared using the same assay system against the same INF-b standard. The aim of this study was to carry out a cost-minimization analysis, on the MS treatments in Italy comparing of the available preparations in terms of cost per microgram standardized by the level of biological activity. The economic evaluation has been conducted adopting the hospital perspective. Health resources have been valued considering euro currency during 2004. According to registered treatment protocol, the results showed that the micrograms per week of INF-b standardized by the level of biological activity ranged from 30mg of Avonex® to 132mg of Rebif44®. Under the same levels of biological activity, Rebif44® resulted the INF-b preparation with the lower cost per micrograms (1.95 euro), followed by Rebif®22 and Betaferon® that had a similar cost (2.90 e 2.97 respectively). Avonex® resulted the INF-b preparation with the highest cost per micrograms (6,37 euro), about three times higher than that of the preparation with the lowest cost.

scholarly journals Effects of immunomodulatory treatment with subcutaneous interferon beta-1a oncognitive decline in mildly disabled patients with relapsing—remitting multiple sclerosis

2009 ◽  
Vol 16 (1) ◽  
pp. 68-77 ◽  
Author(s):  
F. Patti ◽  
MP Amato ◽  
S. Bastianello ◽  
L. Caniatti ◽  
E. Di Monte ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Impairment ◽  
Treatment Group ◽  
Interferon Beta ◽  
Neuropsychological Testing ◽  
High Dose ◽  
Relapsing Remitting ◽  
Disabled Patients ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

The objective of this study was to assess the effects of subcutaneous (sc) interferon beta-1a (IFNβ-1a) on cognition in mildly disabled patients with relapsing—remitting multiple sclerosis (RRMS). Patients aged 18—50 years with RRMS (McDonald criteria; Expanded Disability Status Scale score ≤4.0) were assigned IFNβ therapy at the physician’s discretion and underwent standardized magnetic resonance imaging, neurological examination and neuropsychological testing at the baseline and regular intervals for up to three years. This analysis included 459 patients who received sc IFNβ-1a (44 mcg: n = 236; 22 mcg: n = 223; three-year follow up was available for 318 patients). The hazard ratio for cognitive impairment over three years (44 mcg versus 22 mcg) was 0.68 (95% confidence interval [CI]: 0.480—0.972), suggesting a 32% lower risk with the higher dose treatment. At year 3, the proportion of patients who were cognitively impaired increased slightly from 23.5% at the baseline to 24.8% in the IFNβ-1a 22 mcg treatment group, but remained stable at 15.2% in the IFNβ-1a 44 mcg treatment group. The proportion of patients with cognitive impairment at year 3 was significantly higher in the 22 mcg group than in the 44 mcg group (P = 0.03), although a trend was also seen at the baseline (P = 0.058). Multivariate logistic regression (corrected for baseline cognitive deficits) indicated that treatment with the higher dose of IFNβ-1a was predictive of lower cognitive impairment at three years (odds ratio: 0.51, 95% CI: 0.26—0.99) compared with the lower dose of IFNβ-1a. These findings suggest that sc IFNβ-1a may have dose-dependent cognitive benefits in mildly disabled patients with RRMS, and may support early initiation of high-dose IFNβ-1a treatment.

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