Towards a validated definition of the clinical transition to secondary progressive multiple sclerosis: A study from the Italian MS Register

Iaffaldano, Pietro; Lucisano, Giuseppe; Guerra, Tommaso; Patti, Francesco; Onofrj, Marco; Morra, Vincenzo Brescia; Zaffaroni, Mauro; Pozzilli, Carlo; Cocco, Eleonora; Sola, Patrizia; Salemi, Giuseppe; Inglese, Matilde; Bergamaschi, Roberto; Gasperini, Claudio; Conte, Antonella; Salvetti, Marco; Lus, Giacomo; Maniscalco, Giorgia Teresa; Totaro, Rocco; Vianello, Marika; Granella, Franco; Ferraro, Elisabetta; Aguglia, Umberto; Gatto, Maurizia; Sangalli, Francesca; Chisari, Clara Grazia; Luca, Giovanna De; Carotenuto, Antonio; Baroncini, Damiano; Colombo, Delia; Nica, Mihaela; Paolicelli, Damiano; Comı, Gıancarlo; Filippi, Massimo; Amato, Maria Pia; Trojano, María

doi:10.1177/13524585221114007

Cited by 7 publications

(6 citation statements)

References 27 publications

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“…A recent study from the I-MS&RD Register investigated the contribution of relapse-associated worsening and PIRA to confirmed disability accumulation in patients with clinically isolated syndrome and Relapsing Remitting MS [27]. The use of the Register data also allows to analyze and trace the path of the evolution of disability over time [38].…”

Section: Discussionmentioning

confidence: 99%

Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

et al. 2023

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Introduction Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked. This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register. Methods The Register collects, through a standardized Web-based Application, unique patients. Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated. Results The Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients. The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000–2015) to 60% (enrolment period 2016–2022). In the cohort of patients registered after 2016, there were ≥ 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2). Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months. Conclusions Data from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.

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Section: Discussionmentioning

confidence: 99%

Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

et al. 2023

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“…The results of this study suggest that prescribing high efficacy drugs early in the history of the disease represents a prominent strategy with the most favorable cost–benefit ratio. This is even more clear if we consider that clinical relapses are only the tip of the iceberg in terms of MS disease activity ( 16 ).…”

Section: Discussionmentioning

confidence: 99%

“…This result agrees with the current literature. Recent observational studies showed that early initiation of second-line treatment in RR-MS may provide more benefit that an escalation approach in both decreasing the risk of developing secondary progression and disability accrual, at least in terms of a 5-6 years of follow-up (14)(15)(16). This is even more evident when one considers that patients who receive second-line drugs from the beginning are generally those with worst prognostic factors (2,17).…”

Section: Discussionmentioning

confidence: 99%

Assessing ‘no evidence of disease activity’ status in patients with relapsing–remitting multiple sclerosis: a long-term follow-up

Zilli,

Scribani Rossi,

Di Stadio

et al. 2023

Front. Neurol.

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IntroductionMultiple Sclerosis (MS) is a chronic inflammatory demyelinating disease of the CNS with an autoimmune pathogenesis. Over the years, numerous disease-modifying therapies (DMTs) have proven effective in disease control; to date, there is a need to identify a personalized treatment effective in ensuring disease-free status or no evidence of disease activity (NEDA).Objectiveidentify clinical, demographic and treatment approach characteristics that affect the maintenance of NEDA-3 and the occurrence of clinical relapses during a 6-years follow-up.Materials and methoda retrospective study was conducted on a cohort of MS patients followed up with six-year period. All participants were treated with first- or second-line MS drugs.Clinical relapse, NEDA-3 at 6 years and sustained EDSS were assessed as disease activity outcomes. Patients with follow-up of less than 6 years and insufficient clinical and radiological data were excluded from the study.ResultsTwo-hundred-eighty naive patients (mean age was 49.8 years, SD ± 11.35 years, 23–76, F/M 182/98), with MS were followed up for 6 years.The mean age at diagnosis was 34.3 years (SD ±11.5, 14–62 years), the mean EDSS score at the onset was 1.9 (±1.3), 76.8% of patients had an EDSS below or equal to 2.5 at diagnosis.In the cohort 37 (13.2%) directly received second-line treatment, 243 (86.8%) received first-line drugs.The analysis showed that second-line treatment from beginning had a protective effect for the achievement of NEDA-3 (p = 0.029), on the prevention of clinical relapse (p = 0.018) and on number of relapses (p = 0.010); this finding was confirmed by logistic regression analysis (p = 0.04) and Kaplan–Meier analysis (p = 0.034).ConclusionThe results of this study demonstrate the efficacy of targeted and early intervention so as to act in the right time window, ensuring a favorable outcome in both clinical and radiological terms; this could be decisive in reducing clinical relapse, disease progression and related disability. Therefore, prescribing highly effective drug in the early stages of the disease represents a leading strategy with the most favorable cost–benefit ratio.

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“…Application of each of the three objective classifiers increased the proportion in all registries as shown in Figure 2(a) for the different methods in each country and in total. Overall, the proportion of SPMS increased using objective classifiers: from 17.7% clinical assignment, 20.1% by EXPAND criteria, 21.8% by the MSBase algorithm, to 28.1% (17,402) according to the decision tree method.…”

Section: Proportion Of Spmsmentioning

confidence: 99%

“…14 It has also previously been applied in a study regarding risk factors in SPMS, 15 in a study to identify RRMS patients at risk for SPMS, 16 and in a comparison with the performance of the neurologist's definition of SPMS. 17 However, since this algorithm requires three visits to establish a conversion, many patient files in registries lack enough documentation to allow classification. The need for a simpler yet accurate approach recently resulted in the development of a decision tree-based classifier that only relies on age and one EDSS score.…”

Section: Introductionmentioning

confidence: 99%

Proportion and characteristics of secondary progressive multiple sclerosis in five European registries using objective classifiers

Forsberg

Spelman

Klyve

et al. 2023

Multiple Sclerosis Journal - Experimental, Translational and Cl

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Background To assign a course of secondary progressive multiple sclerosis (MS) (SPMS) may be difficult and the proportion of persons with SPMS varies between reports. An objective method for disease course classification may give a better estimation of the relative proportions of relapsing–remitting MS (RRMS) and SPMS and may identify situations where SPMS is under reported. Materials and methods Data were obtained for 61,900 MS patients from MS registries in the Czech Republic, Denmark, Germany, Sweden, and the United Kingdom (UK), including date of birth, sex, SP conversion year, visits with an Expanded Disability Status Scale (EDSS) score, MS onset and diagnosis date, relapses, and disease-modifying treatment (DMT) use. We included RRMS or SPMS patients with at least one visit between January 2017 and December 2019 if ≥ 18 years of age. We applied three objective methods: A set of SPMS clinical trial inclusion criteria (“EXPAND criteria”) modified for a real-world evidence setting, a modified version of the MSBase algorithm, and a decision tree-based algorithm recently published. Results The clinically assigned proportion of SPMS varied from 8.7% (Czechia) to 34.3% (UK). Objective classifiers estimated the proportion of SPMS from 15.1% (Germany by the EXPAND criteria) to 58.0% (UK by the decision tree method). Due to different requirements of number of EDSS scores, classifiers varied in the proportion they were able to classify; from 18% (UK by the MSBase algorithm) to 100% (the decision tree algorithm for all registries). Objectively classified SPMS patients were older, converted to SPMS later, had higher EDSS at index date and higher EDSS at conversion. More objectively classified SPMS were on DMTs compared to the clinically assigned. Conclusion SPMS appears to be systematically underdiagnosed in MS registries. Reclassified patients were more commonly on DMTs.

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Towards a validated definition of the clinical transition to secondary progressive multiple sclerosis: A study from the Italian MS Register

Cited by 7 publications

References 27 publications

Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

Assessing ‘no evidence of disease activity’ status in patients with relapsing–remitting multiple sclerosis: a long-term follow-up

Proportion and characteristics of secondary progressive multiple sclerosis in five European registries using objective classifiers

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