Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study

Bucello, Sebastiano; Annovazzi, Pietro; Ragonese, Paolo; Altieri, Marta; Barcella, Valeria; Bergamaschi, Roberto; Bianchi, Alessia; Borriello, Giovanna; Buscarinu, Maria Chiara; Callari, Graziella; Capobianco, Marco; Capone, Fioravante; Cavalla, Paola; Cavarretta, Rosella; Cortese, Antonio; Luca, Giovanna De; Dattola, Vincenzo; Fantozzi, Roberta; Ferraro, Elisabetta; Filippi, M; Gasperini, Claudio; Grimaldi, Luigi Maria Edoardo; Landi, Doriana; Re, Marianna Lo; Mallucci, Giulia; Manganotti, Paolo; Marfia, Girolama Alessandra; Mirabella, Massimiliano; Perini, Paola; Pisa, Marco; Realmuto, Sabrina; Russo, Margherita; Tomassini, Valentina; Clerici, Valentina Torri; Zaffaroni, Mauro; Zuliani, Cristina; Zywicki, Sofia; Filippi, Massimo; Prosperini, Luca

doi:10.1007/s00415-021-10455-3

Cited by 21 publications

(21 citation statements)

References 32 publications

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“…We have also put this data in context, in relation to other large cohorts of patients treated with teriflunomide, specifically with the Danish registry (4), the German registry TAURUS-MS (5), and the Italian registry (6). The patients have a mean age of 46 years and multiple sclerosis of an average of 11.5 years of evolution.…”

Section: Discussionmentioning

confidence: 95%

Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain

et al. 2021

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Introduction: We have different treatment alternatives for relapsing-remitting multiple sclerosis–RRMS–within the so-called platform drugs. It would be desirable to know the ideal drug for each patient. Real clinical practice studies provide us with data on drug efficacy in the medium and long term, safety beyond clinical trials, and can help us to know the patient profile appropriate for each therapy.Material and Methods: An observational multicenter study of real clinical practice in patients with RRMS who were treated with teriflunomide in the Valencian Community, since teriflunomide was authorized in Spain. The database created for this study collects retrospectively patients followed prospectively in the MS clinics.Objectives: To analyze the efficacy and safety of teriflunomide treatment in patients with RRMS under the conditions of real clinical practice, and to identify a patient profile responding to the treatment.Results: We obtained data from 340 patients who received at least one dose of 14 mg teriflunomide. The patients were 69.4% female to 30.6% male, had a mean age of 46.4 years, and a mean time of progression of MS of 11.5 years. The mean pre-teriflunomide relapse rate was 0.4 years, the mean EDSS scorewas 1.98, IgG Oligoclonal bands were present in the CSF of 66.2% of the patients, IgM Oligoclonal bands were present in 46.9%, and the mean number of gadolinium-enhancing lesions was 1.07 lesions per patient at the beginning of treatment. The average number of treatments previously received was 1.04, and 28.53% were naïve. After a follow-up of up to 4 years, a reduction in the annualized and cumulative annualized relapse rate was observed in the first year, in the second year, and in the third year, compared to the pre-treatment year. The EDSS scores were stabilized throughout the follow-up. Likewise, there was a reduction in gadolinium-enhancing lesions in the 1st and 2nd years compared to the pre-treatment period. Applying different generalized multiple linear regression models, we identified a profile of a responding patient to teriflunomide as a male without IgM oligoclonal bands in the CSF, a previous EDSS score of <3, and more than 5 years duration of MS.

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Section: Discussionmentioning

confidence: 95%

Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain

et al. 2021

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“…The small number of cases in this observational study was due to the limited number of centers and study participants willing to participate. However, we think that our results can add relevant knowledge to the current understanding of teriflunomide effectiveness and safety in a real-world setting for several reasons: In contrast to an Italian survey, the TAURUS MS study was designed in a prospective way [ 20 ]. Furthermore, different recent studies did not include patient-related outcomes as an outcome parameter [ 20 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, outside clinical trials, the available data on the effectiveness of teriflunomide are limited, especially in real-life settings within larger and more diverse populations [ [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] ]. Therefore, we conducted a prospective, multicenter, open-label, noninterventional study of patients with RRMS who were assigned to treatment with teriflunomide: the TAURUS MS study.…”

Section: Introductionmentioning

confidence: 99%

Favorable benefit–risk ratio with teriflunomide treatment in relapsing-remitting multiple sclerosis: Results of the 2-year, multicenter, prospective, noninterventional TAURUS MS study in Austria

Guger

Ackerl²,

Heine³

et al. 2022

eNeurologicalSci

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“…Batista et al showed that fingolimod could significantly reduce the ARR of MS patients, and that the EDSS score remained stable during the use of fingolimod ( 12 ). Teliflunomide has a good effect on patients with mild disabilities (EDSS ≤ 2) initial treatment ( 13 ). Rituximab can reduce the ARR of RRMS and PPMS, as well as help maintain a stable or slightly improved EDSS score ( 14 ).…”

Section: Discussionmentioning

confidence: 99%

Factors Influencing the Degree of Disability in Patients With Multiple Sclerosis

et al. 2021

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Objective: To explore the factors influencing the degree of disability in patients with multiple sclerosis (MS), and to provide evidence for its early diagnosis, prognostic evaluation and clinical intervention.Methods: This retrospective observational study included 72 patients with relapsing-remitting multiple sclerosis (RRMS) at the First Hospital of Shanxi Medical University. All patients completed craniocerebral and spinal cord MRI (with or without Gd enhancement) and were evaluated for Expanded Disability Status Score (EDSS) scores before receiving treatment.Results: Among 72 patients with RRMS, 45 (62.5%) had an EDSS score ≤3; A total of 27 patients (37.5%) had an EDSS score >3 points. Univariate analysis showed that age, annual recurrence rate (ARR), drug use, albumin (ALB), triglycerides (TG), and total number of lesions in groups with EDSS score ≤3 were significantly different from those with an EDSS score > 3 points (P < 0.05). Multivariate logistic regression analysis showed that ALB, total number of lesions, and drug use were independent influencing factors of the degree of disability in patients with MS, and the difference was statistically significant (P < 0.05). An ROC curve was constructed using ALB and the total number of lesions. The AUC of ALB was 0.681, P < 0.05, and the best cut-off value was 44.2 g/L. Its sensitivity to predict the degree of disability in patients with multiple sclerosis was 85.2%, while its specificity was 51.1%. The AUC of the total number of lesions was 0.665 (P < 0.05) and the best cut-off value was 5.5. Its sensitivity to predict the degree of disability in patients with multiple sclerosis was 70.4%, while its specificity was 64.4%. The AUC of the combined ALB, total number of lesions, and drug use was 0.795 (P < 0.05), sensitivity was 77.8, and specificity was 73.3%. The optimal diagnostic cut-off value of the regression equation for the EDSS score of patients with multiple sclerosis was 0.420.Conclusion: Serum ALB, total number of lesions, and drug use in patients with multiple sclerosis were independent factors influencing the degree of disability. These findings provide clinical evidence for the prognostic evaluation and early intervention of patients with multiple sclerosis.

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Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study

Cited by 21 publications

References 32 publications

Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain

Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain

Favorable benefit–risk ratio with teriflunomide treatment in relapsing-remitting multiple sclerosis: Results of the 2-year, multicenter, prospective, noninterventional TAURUS MS study in Austria

Factors Influencing the Degree of Disability in Patients With Multiple Sclerosis

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