Effect of early interferon beta-1a therapy on conversion to multiple sclerosis in Iranian patients with a first demyelinating event

Pakdaman, Hossein; Sahraian, Mohammad Ali; Fallah, A.; Pakdaman, R.; Ghareghozli, K.; Majid, Ghafarpour; Rahimian, Elham; Shirani, Afsaneh

doi:10.1111/j.1600-0404.2007.00813.x

Cited by 10 publications

(13 citation statements)

References 13 publications

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“…The CHAMPS (Controlled High Risk Avonex Multiple Sclerosis Study) trial, 172 which followed up 393 patients for up to 3 years, found a reduction in hazard of more than half (HR 0.49, 95% CI 0.33 to 0.73). The study by Pakdaman et al, 173 which followed up 202 patients for up to 3 years, found a reduction in conversion to CDMS in the IFN-β-1a group (incidence 36.6% vs. 58.2%). We converted this to a HR of 0.54 (95% CI 0.36 to 0.81).…”

Section: Results Of the Assessment Of Clinical Effectivenessmentioning

confidence: 97%

“…[171][172][173][174][175] It should be noted that triallists generally examined time to CDMS, defined using the Poser criteria 64 and involving a second relapse or neurological deterioration, although some also presented analyses examining time to 'McDonald MS', in which MRI findings could be used with clinical findings to arrive at a diagnosis.…”

Section: Results Of the Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…172,173 Time to diagnosis of multiple sclerosis Both studies reported significant differences in favour of IFN-β-1a with regard to delaying time to confirmation of CDMS, diagnosed generally by a second relapse but in some cases by progressive neurological deterioration. The CHAMPS (Controlled High Risk Avonex Multiple Sclerosis Study) trial, 172 which followed up 393 patients for up to 3 years, found a reduction in hazard of more than half (HR 0.49, 95% CI 0.33 to 0.73).…”

Section: Results Of the Assessment Of Clinical Effectivenessmentioning

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%

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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: Results Of the Assessment Of Clinical Effectivenessmentioning

confidence: 97%

Section: Results Of the Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: Results Of the Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: Risk In Randomisation or Allocation Methodsmentioning

confidence: 99%

See 2 more Smart Citations

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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“…2. The current standard of care of starting treatment early, which makes nowadays treatment-naïve subjects available for clinical trials only when they are at a very early stage of the disease [6][7][8][9][10][11][12][13][14][15][16][17].…”

Section: The Adoption Of Mcdonald Criteria That Allowsmentioning

confidence: 99%

Evolving landscapes in multiple sclerosis research: adaptive designs and novel endpoints

Beelke¹,

Antonini²,

Murphy

2016

Mult Scler Demyelinating Disord

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The increasing amount of highly effective treatment options in relapsing forms of multiple sclerosis (MS) requires innovative clinical trial design strategies. These strategies may encompass the application of adaptive designs as well as the adoption of innovative primary outcome measurements. The offered advantages would include, among others, shorter study follow-up periods and reduction in the number of patients either on placebo or on non-suitable dosages of the small molecules or biological products under examination. Changing the primary endpoint during the study conduct additionally represents an option, when the primary endpoint originally is either a composite endpoint of Magnetic Resonance Imaging (MRI) and clinical variables or a unitary endpoint of clinical variables. The new outcome measurement of no-evidence-of-disease activity (NEDA) -the former disease activity free (DAF) status, might represent an attractive approach and NEDA may become a new standard for clinical trials in relapsing MS (RMS), particularly for pivotal Phase III trials, though also earlier phase trials and exploratory clinical research might benefit from this endpoint. Future studies in RMS could incorporate NEDA as a primary endpoint and utilize the adaptive design methodology in order to reduce the sample size and the duration of new therapeutic agents' clinical development.

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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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Effect of early interferon beta-1a therapy on conversion to multiple sclerosis in Iranian patients with a first demyelinating event

Abstract: The results of our study, which are consistent with those from western studies, show that treatment at an early stage of MS delays conversion to definite MS and has positive effects on MRI outcomes.

Cited by 10 publications

References 13 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

Evolving landscapes in multiple sclerosis research: adaptive designs and novel endpoints

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

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