A 8-year retrospective cohort study comparing Interferon-β formulations for relapsing‐remitting multiple sclerosis

Moccia, Marcello; Palladino, Raffaele; Carotenuto, Antonio; Saccà, Francesco; Russo, Cinzia Valeria; Lanzillo, Roberta; Morra, Vincenzo Brescia

doi:10.1016/j.msard.2017.11.006

Cited by 8 publications

(6 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Discontinuation of Interferon Beta treatment was observed in 30-45% patients over 20 months, with switch to other DMTs occurring in most cases. As such, persistence rates in our study were relatively higher, when compared with previous studies [38], suggesting overall good patient profiling [10]. Some previous studies failed to find any difference in persistence between Interferon Beta formulations [31], whilst others reported on discording results [23,39].…”

Section: Discussionsupporting

confidence: 47%

“…This hypothesis is further supported by the switching pattern, showing that 15–25% MS patients on Avonex®, Betaferon® and Plegridy®, and 35% on Rebif® switched to DMTs with higher efficacy profile, suggesting the latter was used in more active patients, thus delaying the use of more expensive second-line DMTs [ 36 , 37 ]. This prescription pattern could be due to the evidence suggesting higher efficacy of Rebif®, when compared with other Interferon Beta formulations [ 5 , 10 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, there are limitations to be accounted for when considering RCTs, characterised by a short follow-up (24 months), highly selected populations, and the use of placebo as comparator group. Real-world studies also suggested Interferon Beta formulations can exert long-term beneficial effects on disability outcomes [ 9 , 10 ]. Still, in clinical registries, there are potential risks from patient selection (e.g., inclusion of patients and clinical variables only from participating centres), and follow-up (e.g., variable follow-up duration, with patients doing poorly being most likely to be lost to follow-up) [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Moccia

Loperto

Lanzillo

et al. 2020

BMC Health Serv Res

Self Cite

View full text Add to dashboard Cite

Background: To 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. Methods: In 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. Results: Patients 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®. Discussion: Interferon 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.

show abstract

Section: Discussionsupporting

confidence: 47%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Moccia

Loperto

Lanzillo

et al. 2020

BMC Health Serv Res

Self Cite

View full text Add to dashboard Cite

show abstract

“…This cohort is part of the Italian MS Registry [7] and has already been used for a number of cohort studies [22,23]. Of note, a recent meta-analysis defined this cohort at moderate risk of bias, compared with the serious risk of other similar cohorts [24,25]. The Venn diagram shows the number and the proportions of patients identified from different data sources from the overall population (n = 5362).…”

Section: Clinical Datasetmentioning

confidence: 99%

Multiple Sclerosis in the Campania Region (South Italy): Algorithm Validation and 2015–2017 Prevalence

Moccia

Morra

Lanzillo

et al. 2020

IJERPH

Self Cite

View full text Add to dashboard Cite

We aim to validate a case-finding algorithm to detect individuals with multiple sclerosis (MS) using routinely collected healthcare data, and to assess the prevalence of MS in the Campania Region (South Italy). To identify individuals with MS living in the Campania Region, we employed an algorithm using different routinely collected healthcare administrative databases (hospital discharges, drug prescriptions, outpatient consultations with payment exemptions), from 1 January 2015 to 31 December 2017. The algorithm was validated towards the clinical registry from the largest regional MS centre (n = 1460). We used the direct method to standardise the prevalence rate and the capture-recapture method to estimate the proportion of undetected cases. The case-finding algorithm including individuals with at least one MS record during the study period captured 5362 MS patients (females = 64.4%; age = 44.6 ± 12.9 years), with 99.0% sensitivity (95% CI = 98.3%, 99.4%). Standardised prevalence rate per 100,000 people was 89.8 (95% CI = 87.4, 92.2) (111.8 for females [95% CI = 108.1, 115.6] and 66.2 for males [95% CI = 63.2, 69.2]). The number of expected MS cases was 2.7% higher than cases we detected. We developed a case-finding algorithm for MS using routinely collected healthcare data from the Campania Region, which was validated towards a clinical dataset, with high sensitivity and low proportion of undetected cases. Our prevalence estimates are in line with those reported by international studies conducted using similar methods. In the future, this cohort could be used for studies with high granularity of clinical, environmental, healthcare resource utilisation, and pharmacoeconomic variables.

show abstract

“…However, if we assume Interferon-β1a could have exerted its effects before inclusion in the study, we would have observed smaller Coenzyme Q10-related effects, resulting in subsequently more conservative sample size estimates. Interferon-β1a is an approved treatment for MS, with a well-established long-term efficacy and safety profile [13]. On the contrary, Coenzyme Q10 has proven effect on biomarkers of oxidative stress and inflammation and on MS symptoms [14,15,16], but its disease-modifying effect remains to be established.…”

Section: Discussionmentioning

confidence: 99%

Sample Size for Oxidative Stress and Inflammation When Treating Multiple Sclerosis with Interferon-β1a and Coenzyme Q10

et al. 2019

Self Cite

View full text Add to dashboard Cite

Studying multiple sclerosis (MS) and its treatments requires the use of biomarkers for underlying pathological mechanisms. We aim to estimate the required sample size for detecting variations of biomarkers of inflammation and oxidative stress. This is a post-hoc analysis on 60 relapsing-remitting MS patients treated with Interferon-β1a and Coenzyme Q10 for 3 months in an open-label crossover design over 6 months. At baseline and at the 3 and 6-month visits, we measured markers of scavenging activity, oxidative damage, and inflammation in the peripheral blood (180 measurements). Variations of laboratory measures (treatment effect) were estimated using mixed-effect linear regression models (including age, gender, disease duration, baseline expanded disability status scale (EDSS), and the duration of Interferon-β1a treatment as covariates; creatinine was also included for uric acid analyses), and were used for sample size calculations. Hypothesizing a clinical trial aiming to detect a 70% effect in 3 months (power = 80% alpha-error = 5%), the sample size per treatment arm would be 1 for interleukin (IL)-3 and IL-5, 4 for IL-7 and IL-2R, 6 for IL-13, 14 for IL-6, 22 for IL-8, 23 for IL-4, 25 for activation-normal T cell expressed and secreted (RANTES), 26 for tumor necrosis factor (TNF)-α, 27 for IL-1β, and 29 for uric acid. Peripheral biomarkers of oxidative stress and inflammation could be used in proof-of-concept studies to quickly screen the mechanisms of action of MS treatments.

show abstract

A 8-year retrospective cohort study comparing Interferon-β formulations for relapsing‐remitting multiple sclerosis

Cited by 8 publications

References 24 publications

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

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

Multiple Sclerosis in the Campania Region (South Italy): Algorithm Validation and 2015–2017 Prevalence

Sample Size for Oxidative Stress and Inflammation When Treating Multiple Sclerosis with Interferon-β1a and Coenzyme Q10

Contact Info

Product

Resources

About