Oral disease-modifying therapies for multiple sclerosis in the Middle Eastern and North African (MENA) region: an overview

Deleu, Dirk; Mesraoua, Boulenouar; Canibaño, Beatriz; Melikyan, Gayane; Hail, Hassan Al; Elsheikh, Lubna; Ali, Musab; Ibrahim, Faiza; Hanssens, Yolande

doi:10.1080/03007995.2018.1476334

Cited by 10 publications

(8 citation statements)

References 73 publications

(108 reference statements)

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“…Therefore, oral DMTs are believed to have better adherence rates among MS patients [ 19 ]. However, oral DMTs can cause serious adverse events, such as fetal abnormalities with fingolimod, hepatotoxicity with teriflunomide, and lymphopenia with cladribine [ 21 ]. Furthermore, oral DMTs, such as teriflunomide, were found to be less effective in managing MS in comparison to injectable DMTs, such as natalizumab, based on the findings of a single-centered retrospective cohort study that was conducted at the University of Washington in St. Louis, United States [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Real-World Comparative Cost-Effectiveness Analysis of Different Classes of Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in Saudi Arabia

AlRuthia

Balkhi

Alkhalifah

et al. 2021

IJERPH

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The very fact that multiple sclerosis (MS) is incurable and necessitates life-long care makes it one of the most burdensome illnesses. The aim of this study was to compare the cost-effectiveness of orally administered medications (e.g., fingolimod, dimethyl fumarate, and teriflunomide), interferon (IFN)-based therapy, and monoclonal antibodies (MABs) (e.g., natalizumab and rituximab) in the management of relapsing-remitting multiple sclerosis (RRMS) in Saudi Arabia using real-world data. This was a retrospective cohort study in which patients with RRMS aged ≥18 years without any other chronic health conditions with non-missing data for at least 12 months were recruited from the electronic health records of a university-affiliated tertiary care center. Multiple logistic regressions controlling for age, sex, and duration of therapy were conducted to examine the odds of disability progression, clinical relapse, MRI lesions, and composite outcome (e.g., relapse, lesion development on MRI, disability progression). The number of patients who met the inclusion criteria and were included in the analysis was 146. Most of the patients were female (70.51%) and young (e.g., ≤35 years of age). There were 40 patients on the orally administered agents (e.g., dimethyl fumarate, teriflunomide, fingolimod), 66 patients were on IFN-based therapy (e.g., Rebif®), and 40 patients were on monoclonal antibodies (e.g., rituximab and natalizumab). Patients on MABs had lower odds of the composite outcome (OR = 0.17 (95% CI: 0.068–0.428)). The use of orally administered agents was dominant (e.g., more effective and less costly), with average annual cost savings of USD −4336.65 (95% CI: −5207.89–−3903.32) and 8.11% higher rate of effectiveness (95% CI: −14.81–18.07) when compared with Rebif®. With regard to the use of MABs in comparison to Rebif®, MABs were associated with higher cost but a better rate of effectiveness, with an average additional annual cost of USD 1381.54 (95% CI: 421.31–3621.06) and 43.11% higher rate of effectiveness (95% CI: 30.38–61.15) when compared with Rebif®. In addition, the use of MABs was associated with higher cost but a better rate of effectiveness, with an average additional annual cost of USD 5717.88 (95% CI: 4970.75–8272.66) and 35% higher rate of effectiveness (95% CI: 10.0–42.50) when compared with orally administered agents. The use of MABs in the management of RRMS among the young patient population has shown to be the most effective therapy in comparison to both IFN-based therapy (e.g., Rebif®) and orally administered agents, but with higher cost. Orally administered agents resulted in better outcomes and lower costs in comparison to IFN-based therapy. Future studies should further examine the cost-effectiveness of different disease-modifying therapies for the management of RRMS using more robust study designs.

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Section: Introductionmentioning

confidence: 99%

Real-World Comparative Cost-Effectiveness Analysis of Different Classes of Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in Saudi Arabia

AlRuthia

Balkhi

Alkhalifah

et al. 2021

IJERPH

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“…No head-to-head clinical trials have compared the efficacy of DMF versus TRF, although a recent number needed to treat (NNT) analysis comparing outcomes from pivotal studies of DMF, TRF, and fingolimod showed that the NNT for key clinical outcomes was similar in the three agents. 9 – 11 …”

Section: Introductionmentioning

confidence: 99%

“…In recent years, there has been growing interest in performing high-quality observational cohort studies to collect longitudinal information that is representative of real MS clinical practice, revealing data highly concordant with the evidence obtained from clinical trials. 9 – 11 …”

Section: Introductionmentioning

confidence: 99%

Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

D’Amico

Zanghì

Callari

et al. 2018

Ther Adv Neurol Disord

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Background:The aim of the study was to evaluate the achievement of ‘no evidence of disease activity’ (NEDA) over a 12-month period in a large multicenter population with relapsing remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) and teriflunomide (TRF) using a propensity-score adjustment.Methods:A time-to-event method was used to determine the percentages of patients with RRMS (pwRRMS) in both groups achieving NEDA 3 (no relapses, no 12-week confirmed disability progression, and no new T2/gadolinium-enhancing brain lesions). We described the safety profile of the investigated drugs.Results:Of the 587 pwRRMS treated with DMF and the 316 pwRRMS treated with TRF, 468 pwRRMS were successfully paired by propensity score: 234 on DMF and 234 on TRF. The percentages of pwRRMS who achieved NEDA 3 were 80.3% in the DMF group and 77.2% in the TRF group. Serious adverse events occurred in four (1.9%) pwRRMS on DMF and in three (1.3%) pwRRMS on TRF.Conclusions:DMF and TRF significantly impacted RRMS disease activity in our study. Serious safety concerns were recorded in less than 2% of the studied population.

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“…The mechanism of action and adverse effect profile of the different DMTs have been the subject of previous publications 98,99 . In this section, the DMTs have been classified as injectable, oral and infusion DMDs.…”

Section: The Use Of Dmts Before During and After Pregnancymentioning

confidence: 99%

Pregnancy-related issues in women with multiple sclerosis: an evidence-based review with practical recommendations

Canibaño

Deleu

Mesraoua

et al. 2020

Journal of Drug Assessment

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Objective: To review the current evidence regarding pregnancy-related issues in multiple sclerosis (MS) and to provide recommendations specific for each of them. Research design and methods: A systematic review was performed based on a comprehensive literature search. Results: MS has no effect on fertility, pregnancy or fetal outcomes, and pregnancies do not affect the long-term disease course and accumulation of disability. There is a potential risk for relapse after use of gonadotropin-releasing hormone agonists during assisted reproduction techniques. At short-term, pregnancy leads to a reduction of relapses during the third trimester, followed by an increased risk of relapses during the first three months postpartum. Pregnancies in MS are not per se high risk pregnancies, and MS does not influence the mode of delivery or anesthesia unless in the presence of significant disability. MRI is not contraindicated during pregnancy; however, gadolinium contrast media should be avoided whenever possible. It is safe to use pulse dose methylprednisolone infusions to manage acute disabling relapses during pregnancy and breastfeeding. However, its use during the first trimester of pregnancy is still controversial. Women with MS should be encouraged to breastfeed with a possible favorable effect of exclusive breastfeeding. Disease-modifying drugs can be classified according to their potential for pregnancy-associated risk and impact on fetal outcome. Interferon beta (IFNb) and glatiramer acetate (GA) may be continued until pregnancy is confirmed and, after consideration of the individual risk-benefit if continued, during pregnancy. The benefit of continuing natalizumab during the entire pregnancy may outweigh the risk of recurring disease activity, particularly in women with highly active MS. GA and IFNb are considered safe during breastfeeding. The use of natalizumab during pregnancy or lactation requires monitoring of the newborn. Conclusions: This review provides current evidence and recommendations for counseling and management of women with MS preconception, during pregnancy and postpartum.

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Oral disease-modifying therapies for multiple sclerosis in the Middle Eastern and North African (MENA) region: an overview

Cited by 10 publications

References 73 publications

Real-World Comparative Cost-Effectiveness Analysis of Different Classes of Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in Saudi Arabia

Real-World Comparative Cost-Effectiveness Analysis of Different Classes of Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in Saudi Arabia

Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

Pregnancy-related issues in women with multiple sclerosis: an evidence-based review with practical recommendations

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