Guidelines on the clinical use for the detection of neutralizing antibodies (NAbs) to IFN beta in multiple sclerosis therapy: report from the Italian Multiple Sclerosis Study group

Bertolotto, Antonio; Capobianco, Marco; Amato, Maria Pia; Capello, Elisabetta; Capra, Ruggero; Centonze, Diego; Ioia, Maria di; Gallo, Antonio; Grimaldi, Luigi M. E.; Mancinelli, Chiara; Marrosu, Maria Giovanna; Moiola, Lucia; Montanari, E.; Romano, Silvia; Musu, Luigina; Paolicelli, Damiano; Patti, Francesco; Pozzilli, Carlo; Rossi, Silvia; Salvetti, Marco; Tedeschi, G; Tola, Maria Rosaria; Troiano, Maria; Zaffaroni, Mauro; Malucchi, Simona

doi:10.1007/s10072-013-1616-1

Cited by 33 publications

(25 citation statements)

References 61 publications

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“…Secondo le più recenti pubblicazioni, in Italia il costo medio per paziente-anno con SM, nella prospettiva della società, si aggira intorno a € 38.000, e varia da circa € 23.000 nei pazienti con lieve disabilità (Expanded Disability Status Scale, EDSS = 0-3), a circa € 44.000 nei pazienti con disabilità moderata (EDSS = 4-6.5), fino a oltre € 63.000 nei pazienti con disabilità grave (EDSS ≥ 7) [7]. La correlazione fra incremento della gravità della malattia e aumento dei costi è stata riportata da diversi studi italiani [1,2,4,[7][8][9][10][11] suggerendo l'opportunità di un investimento in trattamenti che siano in grado di rallentare la progressione di gravità della malattia migliorando anche la qualità di vita dei pazienti. I trattamenti per la SM hanno l'obiettivo di modificare il decorso clinico della malattia (Disease Modifying Therapies, DMT), e di ridurre o eliminare i sintomi o i segni delle ricadute.…”

Section: Farmeconomia Health Economics and Therapeutic Pathways 2016unclassified

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

Iannazzo¹,

Santoni²,

Saleri³

et al. 2016

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cronicità e la progressione della malattia con ricadute e disabilità crescente incidono sulla qualità di vita del paziente e sui costi per la società. L'esordio della malattia nella fase giovaneadulta coincide con il pieno della vita affetIntroduzIone L'organizzazione mondiale della sanità (OMS) ha definito la sclerosi multipla (SM) una delle malattie sociali maggiormente costose. L'esordio nella fase giovane-adulta, la AbstrActBACKGROUND: Peginterferon beta-1a is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (RRMS). The efficacy and safety of peginterferon beta-1a was demonstrated in the placebo-controlled ADVANCE trial. OBJECTIVE: The objective of this study was to assess the cost-effectiveness of peginterferon beta-1a as compared with injectable first-line treatments for RRMS in Italy. METHODS: The cost-effectiveness analysis was developed through a Markov model with lifetime simulation in the perspective of the Italian National Healthcare Service (NHS). It was added an alternative scenario to take into account the Italian societal perspective. Outcomes were measured in terms of life years (LYs), quality adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness ratio (ICER). The natural progression of the disease was informed by the published literature and previously published modelling exercises. The efficacy of treatments was simulated as reduction of disability progression (EDSS) and relapse rate. Efficacy data were derived from a published network meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. A 3.5% discount rate was applied to costs and outcomes. One-way and probabilistic sensitivity analyses were developed and cost-effectiveness acceptability curves generated. RESULTS: Peginterferon beta-1a was more effective than the comparators in terms of survival (19.94 vs.19.68-19.81 discounted LYs, respectively), and QALYs (9.07 vs. 8.06 and 8.55 discounted QALY, respectively). In the perspective of the Italian NHS, the ICER was € 11,111/QALY vs. interferon beta-1a 30 µg, € 12,604/QALY vs. interferon beta-1a 22 µg, € 10,580/QALY and € 16,702/QALY vs. interferon beta-1b 250 µg and € 22,023/QALY vs. glatiramer acetate 20 mg. Peginterferon beta-1a dominated interferon beta-1a 44 µg. In the societal perspective, peginterferon beta-1a was dominant due to being more effective and with a lower social cost compared to first-line injectable treatments (interferon beta -1a, interferon beta-1b, glatiramer acetate) for RRMS. The outcomes of the sensitivity analyses confirmed the trend of the base case results. CONCLUSIONS: Peginterferon beta-1a shows a favourable pharmaco-economic profile for the treatment of RRMS. Even if an official threshold for the cost-effectiveness does not exist in Italy, the ICER values obtained were far below the commonly accepted thresholds (30,000-50,000 €/per QALY gained). Keywords Cost-effectiveness; Peginterferon beta-1a; Multiple SclerosisAnalisi di costo-efficacia dell'utilizzo ...

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Section: Farmeconomia Health Economics and Therapeutic Pathways 2016unclassified

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

Iannazzo¹,

Santoni²,

Saleri³

et al. 2016

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“…Because of its biological nature, recombinant IFN-β also carries a risk for patients of developing NABs, 145 and this is thought to reduce the treatment efficacy. 146 The occurrence of NABs depends on patient-specific factors but also treatment-specific factors such as formulation, route of administration, dosage and frequency of administration.…”

Section: Beta-interferonsmentioning

confidence: 99%

“…147 Some guidelines recommend testing patients treated with IFN-β for the presence of NABs after 12 and 24 months of treatment. 145,148 In the UK, the monitoring of NABs is not performed in routine practice.…”

Section: Beta-interferonsmentioning

confidence: 99%

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Melendez‐Torres

Auguste

Armoiry

et al. 2017

Health Technol Assess

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Background At the time of publication of the most recent National Institute for Health and Care Excellence (NICE) guidance [technology appraisal (TA) 32] in 2002 on beta-interferon (IFN-β) and glatiramer acetate (GA) for multiple sclerosis, there was insufficient evidence of their clinical effectiveness and cost-effectiveness. Objectives To undertake (1) systematic reviews of the clinical effectiveness and cost-effectiveness of IFN-β and GA in relapsing–remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) and clinically isolated syndrome (CIS) compared with best supportive care (BSC) and each other, investigating annualised relapse rate (ARR) and time to disability progression confirmed at 3 months and 6 months and (2) cost-effectiveness assessments of disease-modifying therapies (DMTs) for CIS and RRMS compared with BSC and each other. Review methods Searches were undertaken in January and February 2016 in databases including The Cochrane Library, MEDLINE and the Science Citation Index. We limited some database searches to specific start dates based on previous, relevant systematic reviews. Two reviewers screened titles and abstracts with recourse to a third when needed. The Cochrane tool and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and Philips checklists were used for appraisal. Narrative synthesis and, when possible, random-effects meta-analysis and network meta-analysis (NMA) were performed. Cost-effectiveness analysis used published literature, findings from the Department of Health’s risk-sharing scheme (RSS) and expert opinion. A de novo economic model was built for CIS. The base case used updated RSS data, a NHS and Personal Social Services perspective, a 50-year time horizon, 2014/15 prices and a discount rate of 3.5%. Outcomes are reported as incremental cost-effectiveness ratios (ICERs). We undertook probabilistic sensitivity analysis. Results In total, 6420 publications were identified, of which 63 relating to 35 randomised controlled trials (RCTs) were included. In total, 86% had a high risk of bias. There was very little difference between drugs in reducing moderate or severe relapse rates in RRMS. All were beneficial compared with BSC, giving a pooled rate ratio of 0.65 [95% confidence interval (CI) 0.56 to 0.76] for ARR and a hazard ratio of 0.70 (95% CI, 0.55 to 0.87) for time to disability progression confirmed at 3 months. NMA suggested that 20 mg of GA given subcutaneously had the highest probability of being the best at reducing ARR. Three separate cost-effectiveness searches identified > 2500 publications, with 26 included studies informing the narrative synthesis and model inputs. In the base case using a modified RSS the mean incremental cost was £31,900 for pooled DMTs compared with BSC and the mean incremental quality-adjusted life-years (QALYs) were 0.943, giving an ICER of £33,800 per QALY gained for people with RRMS. In probabilistic sensitivity analysis the ICER was £34,000 per QALY gained. In sensitivity analysis, using the assessment group inputs gave an ICER of £12,800 per QALY gained for pooled DMTs compared with BSC. Pegylated IFN-β-1 (125 µg) was the most cost-effective option of the individual DMTs compared with BSC (ICER £7000 per QALY gained); GA (20 mg) was the most cost-effective treatment for CIS (ICER £16,500 per QALY gained). Limitations Although we built a de novo model for CIS that incorporated evidence from our systematic review of clinical effectiveness, our findings relied on a population diagnosed with CIS before implementation of the revised 2010 McDonald criteria. Conclusions DMTs were clinically effective for RRMS and CIS but cost-effective only for CIS. Both RCT evidence and RSS data are at high risk of bias. Research priorities include comparative studies with longer follow-up and systematic review and meta-synthesis of qualitative studies. Study registration This study is registered as PROSPERO CRD42016043278. Funding The National Institute for Health Research Health Technology Assessment programme.

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“…L'IFN può indurre la produzione di anticorpi (Ab) neutralizzanti [18]. Il test per tali Ab anti-IFN non è attualmente universalmente raccomandato, ma è consigliato nel caso di attività clinica o neuroradiologica di malattia e nel caso di positività va considerata l'interruzione della tp [19].…”

Section: Terapie Sottocutanee (Sc)unclassified

Il monitoraggio della terapia nel paziente con sclerosi multipla

Moiola

2015

abtpn

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La scelta della terapia nella sclerosi multipla (SM) è guidata da un attento bilancio tra l'efficacia del trattamento nel prevenire le ricadute, la disabilità, l'attività neuroradiologica e l'atrofia, e il peso della terapia stessa in termini di sicurezza, tollerabilità e monitoraggio. Negli ultimi venti anni, grazie ai progressi della ricerca clinica e di base, si è assistito all'introduzione di numerosi nuovi farmaci, ciascuno con uno specifico profilo rischio-beneficio. Mentre per il glatiramer acetato (GA) e gli interferoni beta (IFNβ), utilizzati nella SM da quasi venti anni, possiamo parlare di sicurezza a lungo termine, per i farmaci di più recente approvazione non tutti i rischi potenziali sono ancora noti. La finalità di questo capitolo è proprio quella di riassumere per ogni farmaco approvato i potenziali eventi avversi (EA), il monitoraggio per individuarli, la loro gestione e quando sia necessario interrompere la terapia (tp) in atto. Iniziamo ad analizzare i farmaci in ordine di immissione in commercio (Tabella 1). Come osservazione generale va ricordato che, prima di iniziare qualsiasi trattamento, è opportuno eseguire esami ematochimici (EE) di base: emocromo, funzionalità renale, epatica e tiroidea in modo tale che nei controlli successivi eventuali alterazioni degli stessi siano più facilmente correlabili al farmaco intrapreso. Terapie sottocutanee (sc)Sono rappresentate da IFN e GA, farmaci immunomodulanti [1] che condividono la via di somministrazione sc. In relazione a tale modalità di somministrazione vi possono essere reazioni a livello del sito di iniezione che variano da eritema localizzato a rara necrosi cutanea [2][3][4]. Una corretta tecnica di iniezione e la rotazione del sito di iniezione sono fondamentali per ridurre questi effetti. Inoltre, la terapia con GA a lungo termine può causare lipoatrofia a livello dei siti di iniezione [4].

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Guidelines on the clinical use for the detection of neutralizing antibodies (NAbs) to IFN beta in multiple sclerosis therapy: report from the Italian Multiple Sclerosis Study group

Cited by 33 publications

References 61 publications

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

[Cost-effectiveness analysis of peginterferon beta-1a in Italian relapsing remitting multiple sclerosis management]

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Il monitoraggio della terapia nel paziente con sclerosi multipla

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