Subcutaneous Interferon Beta-1b Research Articles

Persistence, adherence, healthcare resource utilisation and costs for interferon Beta in multiple sclerosis: a population-based study in the Campania region (southern Italy)

BackgroundTo differentiate five formulations of Interferon Beta for the treatment of multiple sclerosis (MS) in clinical practice, by analysing persistence, adherence, healthcare resource utilisation and costs at population level.MethodsIn this population-based study, we included individuals with MS living in the Campania Region of Italy from 2015 to 2017, on treatment with intramuscular Interferon Beta-1a (Avonex® = 618), subcutaneous pegylated Interferon Beta-1a (Plegridy® = 259), subcutaneous Interferon Beta-1a (Rebif® = 1220), and subcutaneous Interferon Beta-1b (Betaferon® = 348; and Extavia® = 69). We recorded healthcare resource utilisation from administrative databases (hospital discharges, drug prescriptions, MS-related outpatients), and derived costs from the Regional formulary. We classified hospital admissions into MS-related and non-MS-related. Persistence (time to switch to other disease modifying treatments (DMTs)), and adherence (medication possession ratio (MPR) = medication supply obtained/medication supply expected during follow-up period) were calculated.ResultsPatients treated with Rebif® were younger, when compared with other Interferon Beta formulations (p < 0.01). The probability of switching to other DMTs was 60% higher for Betaferon®, 90% higher for Extavia®, and 110% higher for Plegridy®, when compared with Rebif® (p < 0.01). Plegridy® presented with 7% higher adherence (p < 0.01), and Betaferon® with 3% lower adherence (p = 0.03), when compared with Rebif®. The probability of MS-related hospital admissions was 40% higher in Avonex® (p = 0.03), 400% higher in Betaferon® (p < 0.01), and 60% higher in Plegridy® (p = 0.04), resulting into higher non-DMT-related costs, when compared with Rebif®.DiscussionInterferon Beta formulations presented with different prescription patterns, persistence, adherence, healthcare resource utilisation and costs, with Rebif® being used in younger patients and with less MS-related hospital admissions.

Cost-Effectiveness of Peginterferon Beta-1a and Alemtuzumab in Relapsing-Remitting Multiple Sclerosis.

Multiple sclerosis (MS) is a chronic inflammatory disorder of the central nervous system, affecting 2.5 million people globally and 400,000 people in the United States. While no cure exists for MS, the goal is to manage the disease using disease-modifying therapies (DMTs), which have been shown to slow disease progression and prevent relapses. Relapsing-remitting MS (RRMS) is the most common form of MS at the time of diagnosis. Peginterferon beta-1a (PEG) and alemtuzumab (ALT) were recently approved and have demonstrated good clinical outcomes, including reduced relapse rates in clinical trials. High costs associated with these DMTs necessitates cost-effectiveness analyses to understand their overall value in RRMS management. To assess the cost-effectiveness of (a) Model 1: PEG relative to intramuscular interferon beta-1a (IM IFN), subcutaneous interferon beta-1b (SC IFN), glatiramer acetate 20 mg per mL (GA), fingolimod (FIN), natalizumab (NAT), and dimethyl fumarate (DMF), and (b) Model 2: ALT relative to subcutaneous interferon beta-1a 44 μg (IFN beta-1a 44 μg). Both analyses were conducted from a U.S. third-party payer perspective. Two static decision models were used to compare the cost-effectiveness of PEG and ALT over a 1-year and a 2-year time horizon, respectively. Model inputs were drug acquisition costs (wholesale acquisition cost from RED BOOK); drug administration and monitoring costs (package inserts and Centers for Medicare & Medicaid Services 2015 Physician Fee Schedule); relapse rates and relapse rate reduction (clinical trials); and cost of managing relapses (published literature). All costs were adjusted to 2015 U.S. dollars using the medical care component of the Consumer Price Index. Outcomes measured were total cost of therapy per patient, cost per relapse avoided, and incremental cost-effectiveness ratios (ICERs) calculated as cost per relapse avoided. Sensitivity analysis was conducted to test model robustness given the uncertainty of model inputs and study assumptions. Model 1 results showed that PEG dominated IM IFN and GA, compared with SC IFN; PEG had an ICER of $1,978,000 per relapse avoided. Compared with FIN, NAT, and DMF, PEG was less expensive and less effective. Model 2 showed that ALT had an ICER of $25,276 per relapse avoided relative to IFN beta-1a 44 μg. In patients with RRMS, PEG is a viable alternative when compared with the DMTs in our model. Deciding whether to choose PEG over other DMTs would depend on multiple factors. On the other hand, ALT had an ICER of $25,276 cost per relapse avoided relative to IFN beta-1a 44 μg. The study results will assist payers in evaluating different medication choices for effective therapy. No outside funding supported this study. Kamal has received research funding from Novartis Pharmaceuticals and the College of Psychiatric and Neurologic Pharmacists and also serves as a consultant for the Lynx Group. Dashputre and Pawar report no conflicts of interest. Study concept and design were primarily contributed by Dashputre, along with Kamal and Pawar. Dashputre took the lead in data collection, along with Kamal, and data analysis was performed by Dashputre, Kamal, and Pawar. The manuscript was written and revised primarily by Dashputre, along with Kamal and Pawar.

Adherence to Multiple Sclerosis Disease-Modifying Therapies in Ontario is Low

Differences in patient adherence to various disease-modifying drugs (DMDs) in the treatment of multiple sclerosis (MS) are not well understood. The goal of this study was to evaluate adherence of adult MS patients in Ontario with public drug plan coverage to various DMDs: intramuscular interferon beta-1a (i.m. IFNβ-1a, Avonex), subcutaneous interferon beta-1a (s.c. IFNβ-1a, Rebif), subcutaneous interferon beta-1b (IFNβ-1b, Betaseron) or glatiramer acetate (Copaxone). In this retrospective cohort study, Ontario Public Drug Plan beneficiaries aged 15 or older who were newly treated with i.m. IFNβ-1a, s.c. IFNβ-1a, IFNβ-1b or glatiramer acetate between April 2006 and March 2008 were followed forward until treatment discontinuation, switch to another DMD or a maximum two year follow-up period. Cumulative persistence rates were analyzed by the Kaplan-Meier method. The proportion of patients reaching the study endpoints after the two year follow-up period was also calculated. Cumulative persistence rates for all four DMDs were similar over time (p=0.80), ranging from 73.6-79.1% at six months, 59.1-63.1% at one year and 41.5-47.4% at two years. After two years, the proportion of patients who had discontinued treatment, switched to another DMD or died was similar among DMDs (p=0.79, Fisher's exact test). Switching between DMD types was low and occurred in 3.4-6.5% of new DMD users. Adherence to DMDs in adult MS patients in Ontario is poor, which is consistent with previously reported adherence rates to MS DMDs in other regions. No significant differences in adherence exist between the DMDs evaluated in this study.

Actualités thérapeutiques de la sclérose en plaques

Since commercialisation of the first immunomodulatory drug (IMD) for multiple sclerosis (subcutaneous interferon beta-1b) in 1995, three new IMD have been on the market: two interferons (intramuscular interferon beta-1a and subcutaneous interferon beta-1a) and glatiramer acetate. These four immunomodulatory drugs have a similar efficiency: they reduce by about 30% the relapse rate of treated patients compared to untreated patients. Their effect on disability is moderate mainly due to the reduced relapse rate. Lately, in 2002, mitoxantrone was approved for aggressive relapsing-remitting MS and in 2007 the first monoclonal antibody (natalizumab) was approved for active relapsing-remitting MS.

SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS) - rationale, design and methodology

BackgroundStatins have anti-inflammatory and immunomodulatory properties in addition to their lipid-lowering effects. Currently, the effects of statins on multiple sclerosis are still controversial. Therefore, randomized clinical trials are needed to provide better evidence on the therapeutic potential of statins in multiple sclerosis. The SWiss Atorvastatin and Interferon Beta-1b trial in Multiple Sclerosis (SWABIMS) evaluates the efficacy, safety and tolerability of atorvastatin 40 mg per os daily and subcutaneous interferon beta-1b every other day compared to monotherapy with subcutaneous interferon beta-1b every other day in patients with relapsing-remitting multiple sclerosis.Methods/DesignSWABIMS is a multi-centre, randomized, parallel-group, rater-blinded, Phase IIb-study conducted in eight hospitals in Switzerland. 80 treatment naïve patients with relapsing-remitting forms of multiple sclerosis will receive subcutaneous interferon beta-1b for three months. Afterwards, they are randomized into two equal-sized parallel arms, receiving atorvastatin 40 mg/d or not in addition to interferon beta-1b for another 12 months. Disease activity measured by the proportion of patients with new T2 lesions is the primary endpoint.DiscussionSWABIMS is designed to give further information about the therapeutic effect of atorvastatin 40 mg per os daily as add-on therapy to interferon beta-1b in patients with relapsing-remitting multiple sclerosis. Furthermore important safety and tolerability data will be generated.Trial Registrationhttp://www.clinicaltrials.gov. Identifier: NCT00942591; Swissmedic reference number: 2005DR2119

Utilization, cost trends, and member cost-share for self-injectable multiple sclerosis drugs--pharmacy and medical benefit spending from 2004 through 2007.

In 1993, interferon beta-1b became the first of 4 self-injectable multiple sclerosis (MS) drugs to be approved by the U.S. Food and Drug Administration. Initially covered as a medical expense, self-injectable MS drugs are increasingly considered specialty pharmaceuticals and are often covered under the pharmacy benefit. Self-injectable MS drugs are expensive, costing approximately $2,000 per month per patient in 2007. To (1) determine the trends for price and utilization of self-injectable MS drugs, (2) meld medical and pharmacy claims data to capture total health care spending on self-injectable MS drugs, and (3) calculate the out-of-pocket cost-share for members with pharmacy benefits. A pharmacy benefits manager with integrated medical claims for approximately 1.8 million commercial members, about 20% of its total of 9 million commercial members, analyzed self-injectable MS pharmacy claims for a 45-month period beginning in January 2004 and ending in September 2007 and integrated medical and pharmacy claims for a 42-month period beginning in January 2004 and ending in June 2007. The 9 million members are beneficiaries of 10 Blue Cross Blue Shield (BCBS) health plans distributed throughout the United States, and the subset of 1.8 million members are enrolled in 1 BCBS health plan in the Northern Plains states. Self-injectable MS drugs were identified using Generic Product Identifier (GPI) codes for the National Drug Code (NDC) numbers on pharmacy claims. Mail order pharmacy claims with up to a 90-day supply were counted as 3 claims, and community pharmacy claims dispensed with up to a 34-day supply were counted as 1 claim. Self-injectable MS drugs were identified from medical claims using Healthcare Common Procedure Coding System (HCPCS) codes: J1595 for glatiramer, J1830 for subcutaneous interferon beta-1b, Q3026 for subcutaneous interferon beta-1a, and Q3025 and J1825 for intramuscular interferon beta-1a. For the approximately 9 million members with data from pharmacy claims only, these 4 self-injectable MS drugs accounted for approximately 1.8% of total pharmacy benefit spending in 2004, 1.9% in 2005, 2.3% in 2006, and 2.4% in 2007. The mean average wholesale price (AWP) per member per month (PMPM) increased by 56.8%, from $1.11 PMPM in the first quarter of 2004 to $1.74 PMPM in the third quarter of 2007. Utilization was flat at about 82-83 claims per 100,000 members per month during the 45-month measurement period. The average annual price increase per unit ranged from 8.9% for interferon beta-1a to 13.3% per year for interferon beta-1b. Members paid a median out-of-pocket cost per pharmacy claim of $15 in 2004, $20 in 2005 and 2006, and $25 in the first 9 months of 2007. For the 1.8 million members with both pharmacy and medical benefit claims, the medical benefit accounted for 2.5% of total spending on MS self-injectables in 2004, 2.0% in 2005 and 2006, and 1.2% in 2007. The percentage of all pharmacy expenditures that was attributable to self-injectable MS drugs increased from 1.8% in 2004 to 2.5% in 2007. Nearly all of the increase in spending on self-injectable MS drugs over the nearly 4-year period was attributable to drug price increases because PMPM utilization was essentially unchanged. The median member cost-share was approximately 1% of the total cost of self-injectable MS drugs.

Factors Leading Patients to Discontinue Multiple Sclerosis Therapies

To determine the percentages of patients who discontinued treatment with the multiple sclerosis medications intramuscular interferon beta-1a (IFN-beta-1a; Avonex-Biogen), interferon beta-1b (IFN-beta-1b; Betaseron-Berlex), and glatiramer acetate (Copaxone-Teva) and to determine the factors that led to discontinuation of the medications. Cross-sectional study. University-based neurology clinic. 108 patients with multiple sclerosis who were prescribed intramuscular interferon beta-1a, subcutaneous interferon beta-1b, or subcutaneous glatiramer acetate. Telephone survey. Discontinuation percentages and the factors that contributed to discontinuation. There was no significant difference between the percentages of patients who discontinued and did not restart treatment with the products (interferon beta-1b, 41%; intramuscular interferon beta-1a, 34%; and glatiramer acetate, 28%). Four main reasons for medication discontinuation emerged: adverse effects (52%), physician-documented disease progression (40%), patient perception of drug ineffectiveness (20%), and cost (4%). No statistical differences were identified among the three agents for any of the reasons for discontinuation. Patient education on adverse effects and realistic patient expectations may be potential areas of study to improve discontinuation percentages with these agents.

Effects of Dose Titration on Tolerability and Efficacy of Interferon Beta-1b in People with Multiple Sclerosis

Multiple sclerosis (MS) treatment with interferon beta is associated with well-known, easily managed adverse events, including influenza-like symptoms and injection-site reactions that decline over time. Initial dose titration has been shown to be one way of limiting these adverse events. Hence, a placebo-controlled, multicentre study of 98 patients was set up to explore whether a slower, four-stage, 4-week titration to a final dose of 250 microg subcutaneous interferon beta-1b might improve tolerability over a more rapid two-stage, 2-week titration in patients with relapsing-remitting MS. Frequency of adverse events was found to be similar between the two regimens: notably, no difference in the incidence of injection-site reactions, with a trend towards fewer influenza-like symptoms in the slow-titration group. Relative to placebo, significantly fewer patients receiving interferon beta-1b relapsed. This was more pronounced in the rapid-titration group than in the slow-titration group, showing that rapid and significant improvements in relapse rates were achieved within 90 days of starting interferon beta-1b. Although a rapid-titration regimen results in a quicker onset of clinical benefit, slow titration showed a non-significant trend towards reduced influenza-like symptoms.

Retinopatía secundaria a tratamiento con interferón beta 1a en paciente con esclerosis múltiple

Although visual symptoms of multiple sclerosis (MS) are very frequent, they are rarely related with treatment with interferon. This is the first case reported in the literature of retinopathy associated with subcutaneous interferon beta-1a, and the second related to interferons in MS.A 30-year-old female diagnosed with relapsing-remitting MS who, at 3 months after starting treatment with subcutaneous interferon beta-1a (44 microg/3 times a week), displayed visual disorders. Retinal lesions in the form of cotton wool spots were found as symptoms of microinfarctions in the retina. The lesions got better after stopping treatment and the patient was found to be asymptomatic.The existence of retinopathy secondary to interferon has been known in the treatment of hepatitis C and neoplasias with interferon alfa since 1990. Despite being a frequently occurring complication, it is usually a mild condition and disappears on withdrawing treatment, or even if it is continued. It is attributed to deposits of immunocomplexes and complement activation in the blood vessels of the retina. Only one other case associated to treatment of MS with interferon beta has been reported in the literature, more specifically related to subcutaneous interferon beta-1b. The clinical characteristics of both cases are identical to those associated to interferon alfa. Despite the fact that the frequency of appearance seems to be lower than in the case of interferon alfa, the physician must bear in mind the possibility encountering this complication.

The phosphodiesterase inhibitor pentoxifylline reduces early side effects of interferon-beta 1b treatment in patients with multiple sclerosis.

Treatment of MS with subcutaneous interferon-beta 1b (IFN-beta 1b) significantly reduces relapse rate and disease activity as demonstrated on serial MRI of the brain. [1-3] Although treatment is effective in many patients, initial side effects, like myalgia, chills, fever, and injection site reactions, which occur in more than one-third of patients, are still a major concern and may affect patient compliance. Recently, Bykosh and …

Interferon beta-1b in Multiple Sclerosis

Interferon beta-1b (interferon-γser-17) is a recombinant human fibroblast interferon which improves suppressor T cell function, reduces the production of interferon-γ, tumour necrosis factor-α and lymphotoxin, and enhances transforming growth factor-β production. These properties indicate interferon beta-1b may have a role in the treatment of multiple sclerosis. Subcutaneous interferon beta-1b 8 MIU (n = 124) every second day for 3 years significantly reduced the rate and severity of disease exacerbations, and reduced total disease burden (assessed by magnetic resonance imaging) compared with placebo (n = 123) in patients with relapsing/remitting multiple sclerosis. Interferon beta-1b 1.6 MIU (n = 125) in a comparable treatment regimen produced a lesser therapeutic effect. Adverse events were also dose-related, although both dosages were well tolerated. Injection site reactions and ‘flu-like’ symptoms were the most common adverse events but declined in incidence after 3 months’ therapy. Thus, prophylactic interferon beta-1b appears to slow the development of multiple sclerosis in patients with relapsing/remitting disease, although the long term effects on disease course remain unknown. Evaluation of its use in patients with a progressive disease component is awaited with interest.