Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study

Saccà, Francesco; Lanzillo, Roberta; Signori, Alessio; Maniscalco, Giorgia Teresa; Signoriello, Elisabetta; Fermo, Salvatore Lo; Repice, Annamaria; Annovazzi, Pietro; Baroncini, Damiano; Clerico, Marinella; Binello, E; Cerqua, Raffaella; Mataluni, Giorgia; Bonavita, Simona; Zarbo, Ignazio Roberto; Laroni, Alice; Rossi, Silvia; Gutierrez, Lorena Pareja; Gioia, Sara La; Frigeni, Barbara; Barcella, Valeria; Frau, Jessica; Cocco, Eleonora; Fenu, Giuseppe; Clerici, Valentina Torri; Sartori, Arianna; Rasia, Sarah; Cordioli, Cinzia; Sapio, Alessia Di; Pontecorvo, Simona; Grasso, Roberta; Barrilà, Caterina; Russo, Cinzia Valeria; Esposito, Sabrina; Ippolito, Domenico; Bovis, Francesca; Gallo, Fabio; Sormani, Maria Pia

doi:10.1177/1352458518790390

Cited by 44 publications

(47 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Our casefinding algorithm has 99.0% sensitivity, and is applied on 10% of the Italian population [15]. Of note, our demographics and Interferon Beta prescription rates are in line with international studies conducted within the same time frame, on equally sized populations [26,[31][32][33][34], thus suggesting overall generalisability of current findings.…”

Section: Discussionsupporting

confidence: 75%

“…Reasons for Interferon Beta discontinuation are unfortunately not traceable in routinely-collected healthcare data, though possibly resulting from a combination of poor tolerance/side effects (accounting for up to 60% of discontinuation reasons), and lack of efficacy [23,24], and could be only derived from the switching pattern indirectly. For instance, in our cohort, lower persistence to Plegridy® could be attributed to poor tolerance and/or higher number of side effects, since most patients switched towards medications with similar efficacy profile (horizonal switch) [33], as also suggested in clinical studies [24,40].…”

Section: Discussionsupporting

confidence: 61%

“…Among limitations, we have to acknowledge the present study was conducted from 2015 to 2017, and, thus, our findings do not necessarily apply to the future treatment scenario of MS, which has become more complex with the introduction of new DMTs [ 3 , 31 – 33 ]. Unfortunately, there are a number of clinical variables that can affect treatment persistence and adherence (e.g., disease duration, disability, MRI measures) [ 33 , 41 , 42 ], that cannot be retrieved from routinely-collected healthcare data; in the future, data linkage to clinical registries and validation of clinical outcomes should be considered. Also, results obtained in the Campania Region of Italy might not easily refer to other geographical areas, with different prescription patterns and healthcare organisation.…”

Section: Discussionmentioning

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: 75%

Section: Discussionsupporting

confidence: 61%

Section: Discussionmentioning

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

“…Given the increasing availability of oral drugs for MS, namely once daily terilunomide (TFN) and twice daily dimethyl fumarate (DMF), a potential strategy to enhance adherence in the long term might be switching from an injective to an orally administered treatment [18][19][20]. Another potential strategy encompasses the reduction of IFNB administration frequency by switching to pegylated interferon (PEG) that is given every 2 weeks.…”

Section: Introductionmentioning

confidence: 99%

Exit strategies for “needle fatigue” in multiple sclerosis: a propensity score-matched comparison study

et al. 2019

Self Cite

View full text Add to dashboard Cite

Check the metadata sheet to make sure that the header information, especially author names and the corresponding affiliations are correctly shown. • Check the questions that may have arisen during copy editing and insert your answers/ corrections. • Check that the text is complete and that all figures, tables and their legends are included. Also check the accuracy of special characters, equations, and electronic supplementary material if applicable. If necessary refer to the Edited manuscript. • The publication of inaccurate data such as dosages and units can have serious consequences. Please take particular care that all such details are correct. • Please do not make changes that involve only matters of style. We have generally introduced forms that follow the journal's style. Substantial changes in content, e.g., new results, corrected values, title and authorship are not allowed without the approval of the responsible editor. In such a case, please contact the Editorial Office and return his/her consent together with the proof. • If we do not receive your corrections within 48 hours, we will send you a reminder. • Your article will be published Online First approximately one week after receipt of your corrected proofs. This is the official first publication citable with the DOI. Further changes are, therefore, not possible. • The printed version will follow in a forthcoming issue.

show abstract

“…Details on the study design of the CLARITY data set can be found in the article reporting the clinical trial results, 3 and details about the i-MuST database collection can be found in previous publications. 5 This study takes advantage of the availability of the placebo arm of the CLARITY study, thus providing a reference to which each treatment can be compared.…”

Section: Methodsmentioning

confidence: 99%

Cladribine vs other drugs in MS

Signori

Saccà

Lanzillo³

et al. 2020

Neurol Neuroimmunol Neuroinflamm

Self Cite

View full text Add to dashboard Cite

ObjectiveCladribine tablets were tested against placebo in randomized controlled trials (RCTs). In this study, the effectiveness of cladribine vs other approved drugs in patients with relapsing-remitting MS (RRMS) was compared by matching RCT to observational data.MethodsData from the pivotal trial assessing cladribine tablets vs placebo (CLARITY) were propensity score matched to data from the Italian multicenter database i-MuST. This database included 3,150 patients diagnosed between 2010 and 2018 at 24 Italian MS centers who started a disease-modifying drug. The annualized relapse rate (ARR) over 2 years from treatment start and the 24-week confirmed disability progression were compared between patients treated with cladribine and other approved drugs (interferon, glatiramer acetate, fingolimod, natalizumab, and dimethyl fumarate), with comparisons with placebo as a reference. Treatment effects were estimated by the inverse probability weighting negative binomial regression model for ARR and Cox model for disability progression. The treatment effect has also been evaluated according to baseline disease activity.ResultsAll weighted baseline characteristics were well balanced between groups. All drugs tested had an effect vs placebo close to that detected in the RCT. Patients treated with cladribine had a significantly lower ARR compared with interferon (relapse ratio [RR] = 0.48; p < 0.001), glatiramer acetate (RR = 0.49; p < 0.001), and dimethyl fumarate (RR = 0.6; p = 0.001); a similar ARR to that with fingolimod (RR = 0.74; p = 0.24); and a significantly higher ARR than natalizumab (RR = 2.13; p = 0.014), confirming results obtained by indirect treatment comparisons from RCTs (network meta-analyses). The relative effect of cladribine tablets 10 mg (cumulative dose 3.5 mg/kg over 2 years) was higher in patients with high disease activity vs all treatments except fingolimod and natalizumab. Effects on disability progression were largely nonsignificant, probably due to lack of power for such analysis.ConclusionIn patients with RRMS, cladribine tablets showed lower ARR compared with matched patients who started interferon, glatiramer acetate, or dimethyl fumarate; was similar to fingolimod; and was higher than natalizumab. The beneficial effect of cladribine tablets was generally amplified in the subgroup of patients with high disease activity.Classification of evidenceThis study provides Class III evidence that for patients with RRMS, cladribine-treated patients had lower ARR compared with interferon, glatiramer acetate, or dimethyl fumarate; similar ARR compared with fingolimod; and higher ARR compared with natalizumab.

show abstract

Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study

Abstract: Several factors are associated with higher switch risk in patients starting a first-line therapy and could be integrated in the decision-making process of first treatment choice.

Cited by 44 publications

References 28 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)

Exit strategies for “needle fatigue” in multiple sclerosis: a propensity score-matched comparison study

Cladribine vs other drugs in MS

Contact Info

Product

Resources

About