What are the needs
An effective start on therapy
Rebif® (interferon beta-1a) delivered proven efficacy across all 3 key disease measures in the 2-year PRISMSa study
Significant relapse reductions and MRI improvement seen at 2 years1-3,b
| Placebo | Rebif 44 mcg | Significance | |||
 | Mean number of relapses | 2.56 | 1.73 | P<0 .0001=".0001" td="td"> |  |
| Percentage of patients relapse-free | 15% | 32% | P<0 .0001=".0001" td="td"> |  | |
 | Median number of T2 active lesions per patient per scan1,b | 2.25 | 0.5 | P<0 .0001=".0001" td="td"> |  |
The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
aPrevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis (PRISMS) was a randomized, double-blind, placebo-controlled, 2-year study. Patients received subcutaneous injections of Rebif 22 mcg tiw (n=189),Rebif 44 mcg tiw (n=184), or placebo (n=187).
bBased on comparisons from a rank-based ANOVA.
Early reductions in relapses and MRI activity in the 2-year PRISMS study
- In a post-hoc analysis of a subset of patients in the PRISMS study, significantly fewer combined active MRI scansd per patient were seen at 2 months with Rebif 44 mcg tiw than with placebo (32% vs 55% mean combined active scans per patient; P=0.0008)2,e
- Over 9 months in a subset of patients in the PRISMS study, significantly fewer combined active MRI scansd per patient were seen with Rebif 44 mcg tiw than with placebo (19% vs 50% mean combined active scans per patient; P<0 .0001=".0001" style="bottom: 0.4em; font-size: 11px; position: relative; vertical-align: baseline;" sup="sup">2,e
The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
dProportion of scans per patient per treatment group with new activity including new, enlarging, recurrent PD/T2 lesions, or enhancing T1 lesions.
eAnalysis of the subgroup of patients undergoing PD/T2 and T1-Gd MRI scans at pre-study screening, study day 1, and monthly for the first 9 months of treatment based on ANOVA on the ranks taking center and number of active lesions at baseline into account.
Demonstrated efficacy in a range of relapsing MS patients (Expanded Disability Status Scale [EDSS] 0 to 5.0)
Rebif® (interferon beta-1a) delivered significant relapse reductions in a range of relapsing MS patients in the 2-year PRISMS study
Total patient cohort (EDSS 0 to 5.0): Significant reductions in mean number of relapses with 44 mcg at 2 years1,2
High-EDSS cohort (EDSS >3.5 to 5.0): Significant reductions in mean number of relapses with 44 mcg at 2 years2
Rebif® (interferon beta-1a) delivered a significant delay in disability progression in a range of relapsing MS patients in the 2-year PRISMS study
Total patient cohort (EDSS 0 to 5.0): Significantly longer time to disability progression with Rebif 44 mcg at 2 years versus placebo1,2
High-EDSS cohort (EDSS >3.5 to 5.0): Significantly longer time to disability progression with Rebif 44 mcg at 2 years versus placebo1
- In time to confirmed progression, a statistically significant difference was seen between Rebif®(interferon beta-1a) 22 mcg and placebo in the total patient cohort (0 to 5.0) but was not seen in the high-EDSS group (>3.5 to 5.0)1
The rate of serious events (regardless of causality) was 20% versus 11.3% for the total patient cohort (EDSS 0 to 5.0).
Rebif® (interferon beta-1a) allows you to adjust the dose to meet individual patient needs without changing therapy.
• Like Rebif 44 mcg, Rebif 22 mcg is proven in all 3 keydisease measures
Superior efficacy versus Avonex® (interferon beta-1a)
Rebif® (interferon beta-1a) is the only self-injected treatment with superior relapse reductions versus Avonex in a class I clinical trial
Rebif 44 mcg tiw delivered superior relapse outcomes versus Avonex 30 mcg qw in the EVIDENCEf study3,4
fEVidence of Interferon Dose-response: European North American Comparative Efficacy (EVIDENCE)—a head-to-head, randomized, class I, evaluator-blinded comparison of Rebif 44 mcg tiw (n=339) with intramuscular injections of Avonex30 mcg qw (n=338) over an average of 64 weeks.
Patients who transitioned from Rebif to Avonex experienced significant relapse reduction
Relapse rates were reduced over an average of 8 months in patients taking Rebif 44 mcg compared with the last 6 months on Avonex (P<0 .001=".001" style="bottom: 0.4em; font-size: 11px; position: relative; vertical-align: baseline;" sup="sup">5
Change in relapse rate during EVIDENCE extension phase
Of the 605 patients receiving therapy at the end of the comparative phase of EVIDENCE, 495 patients enrolled in the extension phase of the study. In the comparative arm of the study, 73% (n=223) had been in the Avonex arm and 91% (n=272) had been in the Rebif arm. Clinical assessments were not blinded, but MRI evaluations were blinded. All assessments were within-treatment-group comparisons. Patients were followed for an average of 8 months posttransition. Annualized relapse rate is based on a time-adjusted analysis.
Important Safety Information
Compared with Avonex, adverse events were similar, despite higher, more frequent dosing with Rebif. Exceptions included injection-site disorders (85% vs 33%), hepatic function disorders (18% vs 10%), and white blood cell disorders (14% vs 5%), which were more frequent with Rebif. Flu-like symptoms were more frequent with Avonex (53% vs 45%).
Adverse events reported more frequently posttransition by patients who transitioned from Avonex to Rebif were (Rebif vs Avonex): injection-site disorders (51% vs 33%), hepatic function disorders (14% vs 10%), and white blood cell disorders (10% vs 5%).
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INDICATION
Rebif is indicated for the treatment of patients with relapsing forms of MS to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability. The efficacy of Rebif in chronic progressive MS has not been established. Available in22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack.
IMPORTANT SAFETY INFORMATION
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon, human albumin, or any other component of the formulation.
Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.
Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury.
Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif.
Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been associated with the use of beta interferons including Rebif. Leukopenia and new or worsening thyroid abnormalities have developed in some patients treated with Rebif. Regular monitoring for these conditions is recommended.
Female patients should be warned about the potential risk of miscarriage; discontinuation should be considered if pregnancy occurs.
Potential serious side effects with Rebif include hepatic dysfunction, depression, suicidal ideation, suicide attempts, risk to pregnancy, allergic reactions, and injection-site reactions, which include redness, pain, and swelling. A few patients developed necrosis at the injection site, which resolved with conservative management.
The most common side effects with Rebif are injection-site reactions, flu-like symptoms, depression, abdominal pain, elevated liver enzymes, and blood abnormalities.
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ResponderEliminarThanks Lina , this article is only a guide ,and I think that any terapeutical trial must be do it with your doctor .
ResponderEliminarBut is very important that the patients know all their treatments options before to take it any drugs.
Thanks for your coments.