A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif®) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis

2005 ◽  
Vol 11 (5) ◽  
pp. 585-591 ◽  
Author(s):  
D Mikol ◽  
M Lopez-Bresnahan ◽  
S Taraskiewicz ◽  
P Chang ◽  
J Rangnow ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Study Endpoint ◽  
Primary Study ◽  
Open Label ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Injection site reactions (ISRs) are a common side effect of subcutaneous interferon beta therapy, particularly during initiation of therapy. Retrospective analysis of two clinical trials showed that patients using an autoinjector experienced fewer ISRs than patients administering interferon beta manually. This randomized, open-label trial compared the occurrence of ISRs in relapsing-remitting multiple sclerosis patients subcutaneously injecting interferon beta-1a manually or with autoinjector. In total, 1825 patients (autoinjector, 932; manual injection, 893) were included in the intention-to-treat analysis. Significantly fewer patients using the autoinjector experienced ISRs, based on physician assessment, compared with manual injection (78.7% versus 85.4%; p<0.001). There was no statistical difference on primary study endpoint: number of patients experiencing moderate to severe ISRs after 12 weeks’ therapy (25.3% versus 23.2%, P=0.449). The patient-reported proportion of any ISR during the treatment period was significantly greater for the manual injection group (71.8% versus 66.1%; p<0.001). The decreased incidence of ISRs with the autoinjector compared to manual injection seen in this short-term study, coupled with ease of use of the autoinjector, suggest that it could improve compliance, and therefore therapeutic outcomes in some patients.

Both paracetamol and ibuprofen are equally effective in managing flu-like symptoms in relapsing-remitting multiple sclerosis patients during interferon beta-1a (AVONEX®) therapy

2002 ◽  
Vol 8 (1) ◽  
pp. 15-18 ◽  
Author(s):  
J Reeß ◽  
J Haas ◽  
K Gabriel ◽  
A Fuhlrott ◽  
M Fiola
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Open Label ◽  
Treatment Groups ◽  
Significant Difference ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Mild Impairment ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Interferon beta-1a is an established therapy for patients with relapsing-remitting multiple sclerosis (MS). Adverse effects in the first weeks of treatment are common. This open-label, multicenter, randomized, prospective study compared treatment of flu-like symptoms (FLS) with paracetamol versus ibuprofen administered 48 h within interferon injection. The percentage of patients with FLS was comparable between both treatment groups and improved during the course of the study (baseline: paracetamol 92%, ibuprofen 90%; week 12: paracetamol 60%, ibuprofen 57%). More than 75% of patients receiving either paracetamol or ibuprofen reported no or only mild impairment of daily activities. There was no significant difference in general satisfaction or incidence of additional symptoms (weakness, nausea, headache; paracetamol 84.6% patients, ibuprofen 86.0% patients) between the two groups. A significant overall improvement from baseline to week 12 was observed for all parameters studied (paracetamol and ibuprofen groups were pooled). These results indicate that neither the paracetamol nor the ibuprofen treatment regimen is better.

Both paracetamol and ibuprofen are equally effective in managing flu-like symptoms in relapsing-remitting multiple sclerosis patients during interferon beta-la (AVONEX®) therapy

2002 ◽  
Vol 8 (1_suppl) ◽  
pp. 15-18
Author(s):  
J. Reeß ◽  
J. Haas ◽  
K. Gabriel ◽  
A. Fuhlrott ◽  
M. Fiola
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Open Label ◽  
Treatment Groups ◽  
Significant Difference ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Mild Impairment ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Interferon beta-la is an established therapy for patients with relapsing-remitting multiple sclerosis (MS). Adverse effects in the first weeks of treatment are common. This open-label, multicenter, randomized, prospective study compared treatment of flu-like symptoms (FLS) with paracetamol versus ibuprofen administered 48 h within interferon injection. The percentage of patients with FLS was comparable between both treatment groups and improved during the course of the study (baseline: paracetamol 92%, ibuprofen 90%; week 12: paracetamol 60%, ibuprofen 57%). More than 75% of patients receiving either paracetamol or ibuprofen reported no or only mild impairment of daily activities. There was no significant difference in general satisfaction or incidence of additional symptoms (weakness, nausea, headache; paracetamol 84.6% patients, ibuprofen 86.0% patients) between the two groups. A significant overall improvement from baseline to week 12 was observed for all parameters studied (paracetamol and ibuprofen groups were pooled). These results indicate that neither the paracetamol nor the ibuprofen treatment regimen is better. Multiple Sclerosis (2002) 8, 15-18

scholarly journals Thrombotic Thrombocytopenic Purpura in Interferon Beta-1a-Treated Patient Diagnosed with Relapsing-Remitting Multiple Sclerosis: A Case Report

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 80
Author(s):  
Cristina-Florentina Plesa ◽  
Diana Maria Chitimus ◽  
Carmen Adella Sirbu ◽  
Monica Marilena Țânțu ◽  
Minerva Claudia Ghinescu ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Thrombotic Thrombocytopenic Purpura ◽  
Thrombotic Microangiopathy ◽  
Interferon Beta ◽  
Thrombocytopenic Purpura ◽  
Beta Interferon ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Background: Secondary thrombotic thrombocytopenic purpura (TTP) due to interferon beta-1a intramuscular (im) treatment is an uncommon adverse effect with only a few cases in multiple sclerosis patients reported worldwide. TTP together with haemolytic uremic syndrome (HUS) are classic forms of thrombotic microangiopathy, characterized by small-vessel platelet micro-thrombi that manifest clinically in a similar manner. Most common signs and symptoms include bruises and ecchymosis, neurologic symptoms and renal impairment. Interferon beta-1a represents one of the first-line therapies for relapsing-remitting multiple sclerosis due to its accessibility and efficacy. Case presentation: A 36-year-old woman who was previously diagnosed with relapsing-remitting multiple sclerosis had received weekly intramuscular injections with beta-interferon-1a (Avonex 30 mcg). After 9 months of treatment, she presented bruises and ecchymosis on her limbs and torso, epistaxis, gingival bleeding aggravated within 48 h and a persistent headache that was non-responsive to common analgesics. Haematology tests revealed typical results for thrombotic microangiopathy, including severe thrombocytopenia (4000/mm3) and microangiopathic haemolytic anaemia with frequent schistocytes on the peripheral blood smear. Once the beta-interferon administration was ceased and upon the initiation of methylprednisolone, the symptoms remitted. Conclusions: In this case study, we portrayed the particular association between the remission phase of multiple sclerosis and the violent onset of interferon-induced thrombotic thrombocytopenic purpura.

Polymorphisms of innate pattern recognition receptors, response to interferon-beta and development of neutralizing antibodies in multiple sclerosis patients

2010 ◽  
Vol 16 (8) ◽  
pp. 942-949 ◽  
Author(s):  
Christian Enevold ◽  
Annette B Oturai ◽  
Per Soelberg Sørensen ◽  
Lars P Ryder ◽  
Nils Koch-Henriksen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Pattern Recognition ◽  
Neutralizing Antibodies ◽  
Interferon Beta ◽  
Pattern Recognition Receptors ◽  
Single Nucleotide ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Background: Interferon-beta therapy of patients with relapsing—remitting multiple sclerosis involves repeated ‘immunizations’ with exogenous protein solutions. Innate pattern recognition receptors play an important role in immune responses towards foreign substances and may thus be related to treatment outcome. Objective: To determine the genotypes at 42 single nucleotide polymorphism loci in selected pattern recognition receptors for 567 prospectively followed relapsing—remitting multiple sclerosis patients treated with recombinant interferon-beta, and test for relationships to several outcome parameters, including formation of interferon-beta neutralizing antibodies. Results: The results suggest an association between the rs5743810 polymorphism (Ser249Pro) of TLR6 and development of neutralizing antibodies after 24 months of therapy in males ( p = 0.00002), but not in females ( p = 0.2). This association survived crude Bonferroni correction ( pcorrected = 0.02). Additional associations were observed in carriers of the TLR2-rs5743708 and NOD2-rs3135499 SNPs (time to relapse), the TLR7-rs179008 and NOD1-rs2075820 SNPs (time to disease progression) and the TLR4-rs7873784, TLR9-rs5743836, and NOD2-rs2066842 SNPs (frequency of neutralizing antibodies development). All of these, however, failed to survive correction for multiple testing. There were no significant differences between interferon-beta responders and non-responders for any of the investigated single nucleotide polymorphisms. Conclusions: The rs5743810 polymorphism of TLR6 may be involved in development of anti-interferon-beta antibodies in males, although further studies are required to firmly establish this.

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