Safety liver profile of teriflunomide versus interferon β in multiple sclerosis: Systematic review and indirect comparison meta-analysis

Salas, Paola Andrea Ortiz; Parra, Camila Olarte; Flórez, Carlos Eduardo Pinzón; Goez, Lina Maria; Vélez-van-Meerbeke, Alberto; Rodríguez, Jesús Hernán

doi:10.1016/j.msard.2018.09.014

Cited by 5 publications

(6 citation statements)

References 29 publications

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“…In 19 of the MTCs [ 19 , 20 , 23 – 29 , 31 , 33 , 35 – 43 ] relapse was analysed on the basis of the ARR. Appropriate data on MS subtype were more commonly reported in the more recent studies and were often unavailable for older treatments.…”

Section: Resultsmentioning

confidence: 99%

“…In ten out of 16 MTCs the analysis was based on using Bayesian methods to fit generalised linear models [ 18 , 19 , 25 , 27 – 29 , 33 , 38 , 39 , 41 , 43 ]. Hutchinson [ 26 ] also used linear models but applied frequentist methods in SAS software to fit the model.…”

Section: Resultsmentioning

confidence: 99%

“…The results available from nine MTCs [ 19 , 21 , 22 , 24 , 26 , 29 , 30 , 36 , 40 ] were limited in applicability to decision-making as they reported the relative effects of one drug compared with other treatments in line with the objectives of the studies, and therefore did not present results for all treatments compared with placebo. Three studies [ 17 , 26 , 34 ] combined all of the IFNβ1a treatments into a single treatment class, while two [ 18 , 44 ] merged treatments in studies comparing the same agent at different doses but summing the number of events and the sample size.…”

Section: Resultsmentioning

confidence: 99%

“…Many of the MTCs did not report full details of their methodologies. In 12 of the studies [17,19,21,24,[28][29][30][31][32][33][34][35] omissions were identified in reporting of inclusion screening, data extraction, quality assessment or discrepancy resolution. Table 1 details the inclusion criteria and methods used in the systematic review underlying the MTCs.…”

Section: Comparison Of Inclusion Criteria and Methodologymentioning

confidence: 99%

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Overview of Differences and Similarities of Published Mixed Treatment Comparisons on Pharmaceutical Interventions for Multiple Sclerosis

et al. 2020

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Introduction: Mixed treatment comparisons (MTCs) are increasingly important in the assessment of the benefit-risk profile of pharmaceutical treatments for relapsing-remitting multiple sclerosis (RRMS). Interpretation of MTCs requires a clear understanding of the methods of analysis and population studied. The objectives of this work were to compare MTCs of pharmaceutical treatments for RRMS, including a detailed description of differences in populations, treatments assessed, methods used and findings; and to discuss key considerations when conducting an MTC. Methods: Fourteen databases were searched until July 2019 to identify MTCs (published during or after 2010) in adults (at least 18 years of age) with RRMS or rapidly evolving severe RRMS treated with any form of pharmaceutical treatment. No language restriction was imposed. Results: Twenty-seven MTCs assessing 21 treatments were identified. Comparison highlighted many differences in conduct and reporting between MTCs relating to the patient populations or treatments included, duration of follow-up and outcomes of interest measured. The lack of similarity between the MTCs leads to questions about variability in the robustness of analyses and makes comparisons between studies challenging. Conclusion: Given the importance of MTCs for healthcare decision-making, it is imperative that reporting of methods, results and assumptions is clear and transparent to allow accurate interpretation of findings. For MTCs to be relevant, the choice of outcome measures should reflect clinical practice. Combination of treatments or of outcomes measured at different points of time should be avoided, as should imputation without justification. Furthermore, all approved treatment options should be Digital Features To view digital features for this article go to

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Comparison Of Inclusion Criteria and Methodologymentioning

confidence: 99%

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Overview of Differences and Similarities of Published Mixed Treatment Comparisons on Pharmaceutical Interventions for Multiple Sclerosis

et al. 2020

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“…In particular, sporadic cases of autoimmune hepatitis (AIH) have been described in untreated MS patients or following treatment with interferon-beta or other immunomodulatory therapeutic agents, including steroids and glatiramer acetate [9]. Despite the slightly increased prevalence of AIH, compared to that of the general population, routine screening for AILD of patients with established MS has been discouraged and is only recommended in those with abnormal liver enzymes or patients with a clinical suspicion of liver disease of unknown origin and drug-induced liver injury [5,10].…”

Section: Introductionmentioning

confidence: 99%

A comprehensive analysis of antigen-specific autoimmune liver disease related autoantibodies in patients with multiple sclerosis

Tsouris

Liaskos

Dardiotis

et al. 2020

Autoimmun Highlights

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Introduction: Abnormal liver function tests are frequently seen in patients with multiple sclerosis (MS) and their origin at times is attributed to the possible co-occurrence or the de novo induction of autoimmune liver diseases (AILD), namely autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC), but comprehensive analysis of AILD-related autoantibody has not been carried out. Aim: To assess the presence of AILD-related autoantibodies in a well-defined cohort of MS patients, and to assess their clinical significance. Materials and methods: 133 MS (93 female) patients (102 RRMS, 27 SPMS, and 5 PPMS), mean age 42.7 ± 11.9 SD years, mean duration of disease 11.2 ± 7.2 years were studied. 150 age and sex-matched healthy individuals were tested as normal controls (NCs).Autoantibody testing was performed by indirect immunofluorescence (IF) using triple tissue and HEp-2, a multiparametric line immunoassay detecting anti-LKM1(anti-CYP2D6), anti-LC1(anti-FTCD), soluble liver antigen/liver-pancreas(anti-SLA/LP), AMA-M2, and AMA-MIT3 (BPO), PBC-specific ANA (anti-gp210, anti-sp100 and anti-PML), and ELISA for anti-F-actin SMA and anti-dsDNA antibodies. Results: Reactivity to at least one autoantibody was more frequent in MS patients compared to NCs (30/133, 22.6% vs 12/150, 8%) NCs (p = 0.00058). SMAs by IIF were more frequent in MS patients (18/133, 13.53%) compared to NCs (6/150, 4%, p = 0.002%). The AIH-1 related anti-F-actin SMA by ELISA were present in 21 (15.8%), at relatively low titres (all but three of the SMA-VG pattern by IF); anti-dsDNA in 3 (2.3%), and anti-SLA/LP in none; AIH-2 anti-LKM1 autoantibodies in 1 (0.8%, negative by IF), and anti-LC1 in none; PBC-specific AMA-M2 in 2 (1.5%, both negative for AMA-MIT3 and AMA by IF) and PBC-specific ANA anti-PML in 6 (4.5%), anti-sp100 in 1 (0.8%) and anti-gp210 in 1 (0.8%). Amongst the 30 MS patients with at least one autoantibody positivity, only 4 (3%) had overt AILD (2 AIH-1 and 2 PBC). Autoantibody positivity did not differ between naïve MS patients and patients under treatment.

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Drugs that act on the immune system: Immunosuppressive and immunostimulatory drugs

Walker

Ray

2019

Side Effects of Drugs Annual

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Safety liver profile of teriflunomide versus interferon β in multiple sclerosis: Systematic review and indirect comparison meta-analysis

Cited by 5 publications

References 29 publications

Overview of Differences and Similarities of Published Mixed Treatment Comparisons on Pharmaceutical Interventions for Multiple Sclerosis

Overview of Differences and Similarities of Published Mixed Treatment Comparisons on Pharmaceutical Interventions for Multiple Sclerosis

A comprehensive analysis of antigen-specific autoimmune liver disease related autoantibodies in patients with multiple sclerosis

Drugs that act on the immune system: Immunosuppressive and immunostimulatory drugs

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