Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial

Mokhber, Naghmeh; Azarpazhooh, Amir; Orouji, Elias; Rao, Stephen M.; Khorram, Bita; Sahraian, Mohammad Ali; Foroghipoor, Mohsen; Gharavi, Morteza Modares; Kakhi, Sorayya; Nikkhah, Karim; Azarpazhooh, Mahmoud Reza

doi:10.1016/j.jns.2014.01.038

Cited by 30 publications

(23 citation statements)

References 47 publications

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“…[174][175][186][187][188][189][190][191][192][195][196][197][198][199][200]213,216,[219][220][222][223][224] Studies that reported methods of allocation concealment (the concealment of study allocation before the beginning of assigned treatment) were also judged to be at low risk of bias (n = 22/35), 171,[174][175]181,[188][189][190][191][195][196][198][199]207,213,[216][217][219][220][221][222][223][224] with the exception of one study that used open allocation. 170 All studies citing central allocation were judged as having a low risk of bias.…”

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

“…[170][171][172][174][175][181][182][183][184][185][186]188,190,192,[195][196][197][198][199]209,211,213,[216][217][219][220][221][222][223][224] Fourteen studies, most of which were comparisons between different active drugs, specifically did not blind participants or practitioners; 170,[182][183][184][185][186]188,190,192,[195][196][197]199,216 in another 15 studies, participants were initially blinded but were at high risk of unblinding from increased rates of side effects. [171][172][174][175]…”

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

“…170,174,184,209,211,213,[216][217]219 Additionally, studies in which participants were unblinded were designated as being at high risk of bias for outcome assessment if they did not report that participants were given specific instructions against sharing treatment information with assessors. 170,[182][183][184][185][186]188,190,192,[195][196][197][198][199]216 All studies that reported MRI outcomes and detailed methods for blinding of MRI assessment were found to be at low risk of bias (n = 13/15). [171][172]184,188,196,[199][200]209,213,216,[219][220][221] Risk in data analysis and reporting…”

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

“…173,181,183,186,191,200,209,213,216,223 In 17% (n = 6/35) of studies, outcomes were not reported as stated, and these were designated to be at high risk of bias from selective reporting. 173,181,188,[198][199]207 Finally, all studies funded by drug manufacturers were designated as being at high risk of bias under the 'other' category, [171][172][173]175,[183][184]186,[189][190]192,195,[197][198][199][200]207,209,213,216,[219][220][221][222][223][224] as this was not covered by other questions in the Cochrane risk of bias tool. …”

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

“…Of the 24 trials reporting clinical outcomes, four trials had three relevant treatment arms: An additional six trials compared 30 µg of IM IFN-β-1a once a week against other drugs: three multiarm trials [185][186][187][188] and three two-arm trials. 191,[193][194][195][196] Relapse outcomes…”

Section: Summary: Clinically Isolated Syndromementioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Melendez‐Torres

Auguste

Armoiry

et al. 2017

Health Technol Assess

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Background At the time of publication of the most recent National Institute for Health and Care Excellence (NICE) guidance [technology appraisal (TA) 32] in 2002 on beta-interferon (IFN-β) and glatiramer acetate (GA) for multiple sclerosis, there was insufficient evidence of their clinical effectiveness and cost-effectiveness. Objectives To undertake (1) systematic reviews of the clinical effectiveness and cost-effectiveness of IFN-β and GA in relapsing–remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) and clinically isolated syndrome (CIS) compared with best supportive care (BSC) and each other, investigating annualised relapse rate (ARR) and time to disability progression confirmed at 3 months and 6 months and (2) cost-effectiveness assessments of disease-modifying therapies (DMTs) for CIS and RRMS compared with BSC and each other. Review methods Searches were undertaken in January and February 2016 in databases including The Cochrane Library, MEDLINE and the Science Citation Index. We limited some database searches to specific start dates based on previous, relevant systematic reviews. Two reviewers screened titles and abstracts with recourse to a third when needed. The Cochrane tool and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and Philips checklists were used for appraisal. Narrative synthesis and, when possible, random-effects meta-analysis and network meta-analysis (NMA) were performed. Cost-effectiveness analysis used published literature, findings from the Department of Health’s risk-sharing scheme (RSS) and expert opinion. A de novo economic model was built for CIS. The base case used updated RSS data, a NHS and Personal Social Services perspective, a 50-year time horizon, 2014/15 prices and a discount rate of 3.5%. Outcomes are reported as incremental cost-effectiveness ratios (ICERs). We undertook probabilistic sensitivity analysis. Results In total, 6420 publications were identified, of which 63 relating to 35 randomised controlled trials (RCTs) were included. In total, 86% had a high risk of bias. There was very little difference between drugs in reducing moderate or severe relapse rates in RRMS. All were beneficial compared with BSC, giving a pooled rate ratio of 0.65 [95% confidence interval (CI) 0.56 to 0.76] for ARR and a hazard ratio of 0.70 (95% CI, 0.55 to 0.87) for time to disability progression confirmed at 3 months. NMA suggested that 20 mg of GA given subcutaneously had the highest probability of being the best at reducing ARR. Three separate cost-effectiveness searches identified > 2500 publications, with 26 included studies informing the narrative synthesis and model inputs. In the base case using a modified RSS the mean incremental cost was £31,900 for pooled DMTs compared with BSC and the mean incremental quality-adjusted life-years (QALYs) were 0.943, giving an ICER of £33,800 per QALY gained for people with RRMS. In probabilistic sensitivity analysis the ICER was £34,000 per QALY gained. In sensitivity analysis, using the assessment group inputs gave an ICER of £12,800 per QALY gained for pooled DMTs compared with BSC. Pegylated IFN-β-1 (125 µg) was the most cost-effective option of the individual DMTs compared with BSC (ICER £7000 per QALY gained); GA (20 mg) was the most cost-effective treatment for CIS (ICER £16,500 per QALY gained). Limitations Although we built a de novo model for CIS that incorporated evidence from our systematic review of clinical effectiveness, our findings relied on a population diagnosed with CIS before implementation of the revised 2010 McDonald criteria. Conclusions DMTs were clinically effective for RRMS and CIS but cost-effective only for CIS. Both RCT evidence and RSS data are at high risk of bias. Research priorities include comparative studies with longer follow-up and systematic review and meta-synthesis of qualitative studies. Study registration This study is registered as PROSPERO CRD42016043278. Funding The National Institute for Health Research Health Technology Assessment programme.

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Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

Section: Summary: Clinically Isolated Syndromementioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Melendez‐Torres

Auguste

Armoiry

et al. 2017

Health Technol Assess

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Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis

Gonzalez-Lorenzo,

Ridley,

Minozzi

et al. 2024

Cochrane Database of Systematic Reviews

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Background Different therapeutic strategies are available for the treatment of people with relapsing‐remitting multiple sclerosis (RRMS), including immunomodulators, immunosuppressants and biological agents. Although each one of these therapies reduces relapse frequency and slows disability accumulation compared to no treatment, their relative benefit remains unclear. This is an update of a Cochrane review published in 2015. Objectives To compare the efficacy and safety, through network meta‐analysis, of interferon beta‐1b, interferon beta‐1a, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, pegylated interferon beta‐1a, daclizumab, laquinimod, azathioprine, immunoglobulins, cladribine, cyclophosphamide, diroximel fumarate, fludarabine, interferon beta 1‐a and beta 1‐b, leflunomide, methotrexate, minocycline, mycophenolate mofetil, ofatumumab, ozanimod, ponesimod, rituximab, siponimod and steroids for the treatment of people with RRMS. Search methods CENTRAL, MEDLINE, Embase, and two trials registers were searched on 21 September 2021 together with reference checking, citation searching and contact with study authors to identify additional studies. A top‐up search was conducted on 8 August 2022. Selection criteria Randomised controlled trials (RCTs) that studied one or more of the available immunomodulators and immunosuppressants as monotherapy in comparison to placebo or to another active agent, in adults with RRMS. Data collection and analysis Two authors independently selected studies and extracted data. We considered both direct and indirect evidence and performed data synthesis by pairwise and network meta‐analysis. Certainty of the evidence was assessed by the GRADE approach. Main results We included 50 studies involving 36,541 participants (68.6% female and 31.4% male). Median treatment duration was 24 months, and 25 (50%) studies were placebo‐controlled. Considering the risk of bias, the most frequent concern was related to the role of the sponsor in the authorship of the study report or in data management and analysis, for which we judged 68% of the studies were at high risk of other bias. The other frequent concerns were performance bias (34% judged as having high risk) and attrition bias (32% judged as having high risk). Placebo was used as the common comparator for network analysis. Relapses over 12 months: data were provided in 18 studies (9310 participants). Natalizumab results in a large reduction of people with relapses at 12 months (RR 0.52, 95% CI 0.43 to 0.63; high‐certainty evidence). Fingolimod (RR 0.48, 95% CI 0.39 to 0.57; moderate‐certainty evidence), daclizumab (RR 0.55, 95% CI 0.42 to 0.73; moderate‐certainty evidence), and immunoglobulins (RR 0.60, 95% CI 0.47 to 0.79; moderate‐certainty...

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Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis

Tramacere,

Virgili,

Perduca

et al. 2023

Cochrane Database of Systematic Reviews

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Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial

Cited by 30 publications

References 47 publications

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis

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