Safety and immunogenicity of a new formulation of interferon β-1a (Rebif® New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results

Giovannoni, Gavin; Barbarash, O. L.; Casset‐Semanaz, Florence; King, John; Metz, Luanne M.; Pardo, Gabriel; Simsarian, J; Sørensen, P. Soelberg; Stubinski, Bettina

doi:10.1177/1352458508097299

Cited by 68 publications

(47 citation statements)

References 32 publications

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“…In addition, since the time that this survey was conducted, the formulation for SC IFNβ-1a has changed, and the new formulation seems to produce fewer ISRs than the previous formulation, although this difference may depend on the delivery device used. 39,40 The present findings reaffirm the importance of patient education on injectable DMT use and ISRs, and also suggest strategies for anticipating which patients may experience more severe ISRs. All patients should receive instruction on strategies for reducing ISR incidence and severity, including education regarding ways to manage side effects, such as site rotation and site massage.…”

Section: Factors Associated With Injection-site Reactions In Mssupporting

confidence: 52%

Injectable Multiple Sclerosis Medications

Stewart¹,

Tran²

2012

International Journal of MS Care

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Although injection-site reactions (ISRs) occur with US Food and Drug Administration-approved injectable disease-modifying therapies (DMTs) for multiple sclerosis, there are currently few reports of real-world data on ISR management strategies or possible correlations between ISRs and patient demographics, disease characteristics, and missed injections. Patient-reported data on the use of DMTs, patient demographic and disease characteristics, missed injections, and ISR reduction strategies were collected via e-mail, a patient registry (www.ms-cam.org), and a Web-based survey. Of the 1380 respondents, 1201 (87%) indicated that they had used injectable DMTs, of whom 377 (31%) had used intramuscular (IM) interferon beta-1a (IFNβ-1a), 172 (14%) had used subcutaneous (SC) IFNβ-1a, 183 (15%) had used SC IFNβ-1b, and 469 (39%) had used glatiramer acetate (GA). The majority of respondents were older (73% were ≥40 years), female (79%), married or living with a partner (72%), white (94%), and nonsmoking (82%). Injection-site reaction incidence, grouped according to severity, varied among DMTs, with IM IFNβ-1a causing significantly (P < .001) fewer mild, moderate, or severe ISRs than the other therapies. Female sex and younger age were significantly (P < .05) associated with more moderate ISRs among users of IM IFNβ-1a, SC IFNβ-1b, and GA. Nonwhites reported severe ISRs more often than whites. For all DMTs injection-site massage and avoidance of sensitive sites were the most frequently used strategies to minimize ISRs. These data may help identify patients with characteristics associated with a higher risk for ISRs, allowing health-care professionals to provide anticipatory guidance to patients at risk for decreased adherence or discontinuation. Int J MS Care. 2012;14:46-53.

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Section: Factors Associated With Injection-site Reactions In Mssupporting

confidence: 52%

Injectable Multiple Sclerosis Medications

Stewart¹,

Tran²

2012

International Journal of MS Care

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“…40,41 Educating the patient on appropriate injection techniques, the availability of new injection devices, the use of escalating dosages, and concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) can minimize these adverse events and thus increase adherence. 32,[42][43][44][45][46][47] Physician-documented disease progression was another factor in nonadherence in our study, with 17.7% of nonadherent patients discontinuing their DMTs upon being told that the disease had entered a progressive phase and the likelihood of ongoing beneficial effects was low. This rate is lower than other published data, but the number of SPMS patients included in our analysis was small.…”

Section: Figure 2 Reasons For Discontinuation Of Various Disease-modmentioning

confidence: 91%

Adherence to First-Line Disease-Modifying Therapy for Multiple Sclerosis in Kuwait

Alroughani

Thussu

2012

International Journal of MS Care

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The aim of this retrospective study was to determine the rate of nonadherence to disease-modifying therapies (DMTs) among multiple sclerosis (MS) patients in Kuwait and to identify reasons for patient discontinuation of long-term therapy. Using a newly established MS registry at our institution, we collected data on MS patients' demographics, clinical characteristics, disability measures, and continuation or discontinuation of first-line DMTs. Reasons for nonadherence were divided into four categories: adverse events, inconvenience, perceived lack of efficacy, and physician-documented disease progression. Of 212 eligible patients, 40.1% were found to be nonadherent to first-line DMTs. In the nonadherent group, the female-to-male ratio was 1.75:1 and the mean age at disease onset was 26.8 years. Of this group, 69.4% of patients had a relapsing-remitting course, 18.8% had a secondary progressive course, and 11.8% had clinically isolated syndrome. Compared with the adherent group, the nonadherent group had a shorter mean disease duration (P = .014) and a greater likelihood of having Expanded Disability Status Scale (EDSS) scores of 3 or lower (67.1% vs. 48.0%; P = .007). Inconvenience was the most common reason for nonadherence (32.9%), followed by perceived lack of efficacy (25.9%), adverse events (23.5%), and physician-documented disease progression (17.7%). In summary, the rate of nonadherence to first-line DMTs in MS patients at our institution is considered high. Most nonadherent patients had a short disease duration and low EDSS scores. Inconvenience and perceived lack of efficacy were the most common reasons for nonadherence. The results demonstrate a need to improve treatment adherence among MS patients in Kuwait through providing better patient education, improving communication between patients and health-care providers, defining therapy expectations, and instituting new therapeutic techniques. Int J MS Care. 2012;14:17-24.

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“…10 Methylprednisolone as an add-on therapy to interferon beta-1b has been shown to reduce the production of neutralising antibodies to interferon beta.11 Because methylprednisolone might enhance the therapeutic effect of interferon beta and reduce the concentrations of neutralising antibodies, we tested the efficacy and safety of oral methylprednisolone given every 4 weeks as an add-on therapy to subcutaneous interferon beta-1a in patients with relapsing-remitting multiple sclerosis who had had at least one relapse during the previous 12 months while taking interferon beta.…”

Section: Introductionmentioning

confidence: 99%

NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting Multiple Sclerosis (NORMIMS study): a randomised, placebo-controlled trial

Sørensen

Mellgren

Svenningsson

et al. 2009

The Lancet Neurology

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Safety and immunogenicity of a new formulation of interferon β-1a (Rebif® New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results

Abstract: RNF has improved overall immunogenicity and safety profiles compared with the original formulation.

Cited by 68 publications

References 32 publications

Injectable Multiple Sclerosis Medications

Injectable Multiple Sclerosis Medications

Adherence to First-Line Disease-Modifying Therapy for Multiple Sclerosis in Kuwait

NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting Multiple Sclerosis (NORMIMS study): a randomised, placebo-controlled trial

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