Systematic review of immunomodulatory drugs for the treatment of people with multiple sclerosis: Is there good quality evidence on effectiveness and cost?

Bryant, Jackie; Clegg, Andrew; Milne, Ruairidh

doi:10.1136/jnnp.70.5.574

Cited by 26 publications

(14 citation statements)

References 22 publications

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“…Neurologic disability was stable, and the relapse rate decreased consistently with the new brain lesion rate. The study was not powered to evaluate clinical outcomes; however, these results confirm the previously reported azathioprine efficacy on the relapse rate [5][6][7] and suggest that the clinical activity of this medication is mediated by the suppression of new brain lesions. In this study, the median number of Gdϩ lesions per patient was stable across the baseline period, confirming that this trial design can minimize the regression of extreme values to the mean, as previously reported.…”

Section: Commentsupporting

confidence: 65%

Efficacy of Azathioprine on Multiple Sclerosis New Brain Lesions Evaluated Using Magnetic Resonance Imaging

Massacesi¹,

Parigi²,

Barilaro³

et al. 2005

Arch Neurol

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Background: Azathioprine is an immunosuppressive agent that reduces relapse rates in patients with multiple sclerosis (MS), but its efficacy in suppressing new brain lesions has never been evaluated. Objective: To evaluate the efficacy of azathioprine therapy on new brain lesion suppression in MS. Design: Open-label treatment vs baseline study. Setting: Outpatient MS clinical center at a university hospital. Patients: Fourteen patients with relapsing-remitting MS ofshortdurationandatleast3gadolinium-enhancing(Gdϩ) brain lesions observed within 6 months before treatment. Intervention: Azathioprine, up to 3 mg/kg daily, individually adjusted according to blood lymphocyte number and the occurrence of adverse events. Main Outcome Measures: Brain Gdϩ lesions evaluated by monthly magnetic resonance imaging for 6 months before and 6 months during treatment and new T2 lesions evaluated during the same periods and after an additional 6 months. Results: The treatment reduced to 0 the median Gdϩ lesion number and volume per magnetic resonance image (PϽ.001 for both), resulting in a Gdϩ lesion number reduction of 50% or more in 12 of 14 patients (PϽ.01). An equivalent reduction in the new T2 lesion number was observed (PϽ.02); this activity also persisted during the additional treatment period evaluated using this outcome measure (PϽ.01). The median azathioprine dose administered (2.6-2.8 mg/kg daily) reduced the mean blood lymphocyte count to 57% of the baseline value. Adverse events were transient or reversible with dose adjustment. Conclusions: This study indicates for the first time that azathioprine, administered at lymphocyte-suppressing doses, is effective in reducing MS new brain inflammatory lesions and is well tolerated.

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Section: Commentsupporting

confidence: 65%

Efficacy of Azathioprine on Multiple Sclerosis New Brain Lesions Evaluated Using Magnetic Resonance Imaging

Massacesi¹,

Parigi²,

Barilaro³

et al. 2005

Arch Neurol

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“…First line immune-modulating drugs such as beta interferon and glatiramer acetate reduce relapse rates by around 30%, show MRI evidence of reducing disease activity, and can help preserve cognition; however there remain concerns regarding the short- and long-term side effects of such drugs and whether they make a real difference to the progression of the illness [6–8]. Nonetheless, observational studies have suggested that the disease-modifying treatments may have increased the survival, with somewhat slower accumulation of disability, raising the possibility of a new natural history of the illness [9].…”

Section: Introductionmentioning

confidence: 99%

Health-related quality of life outcomes at 1 and 5 years after a residential retreat promoting lifestyle modification for people with multiple sclerosis

et al. 2012

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There is a strong body of evidence that supports the use of non-drug therapies in the management of people with multiple sclerosis (MS). A 5-day residential retreat for people with MS in Victoria, Australia, promotes lifestyle modification within a patient-centred model of care. Analysis of the health-related quality of life (HRQOL) of the retreat participants was undertaken using the MSQOL-54, prior to attendance, 1 and 5 years after the retreat. 274 retreat participants (71%) completed baseline questionnaires. Despite the usually progressive nature of MS, the cohort demonstrated clinically and statistically significant improvements in HRQOL. One year after attending the retreat, median improvements of 11.3% were observed in the overall quality of life domain (p < 0.001); 18.6% in the physical health composite (p < 0.001); and 11.8% in the mental health composite (p < 0.001). In the subset of 165 who had reached the 5-year time-point, there was a 19.5% median improvement in overall quality of life (p < 0.001); 17.8% in the physical health composite (p < 0.001) and 22.8% in the mental health composite (p < 0.001), compared to baseline. Attendance at a retreat promoting lifestyle modification for the integrated management of MS appears to have positive effects on short and medium-term HRQOL. Non-drug therapies should be considered as part of any comprehensive treatment plan for people with MS.

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“…However, doubts have continued to be expressed about the validity of such evidence and the extent to which interferons are effective3,13 and the extent of their benefits relative to side effects and costs 74. In addition to the clinical trials of interferons in MS, a number of reviews have aimed to assess the effectiveness of these therapeutic interventions,3,13,58,75–83 but arriving at a consensus has been problematic due to the methodological quality of trials undertaken 3,79,84,85. It has been argued that “well conducted trials using outcome measures with clinical significance for groups of patients with different types of multiple sclerosis and long term follow up are needed if the evidence base of treatment for the disease is to be improved.”85…”

Section: The Clinical Effectiveness Of Treatments In Msmentioning

confidence: 99%

Assessing cost-effectiveness in the management of multiple sclerosis

Phillips

Humphreys²

2009

CEOR

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Multiple sclerosis (MS) is one of the most common causes of neurological disability in young and middle-aged adults, with current prevalence rates estimated to be 30 per 100,000 populations. Women are approximately twice as susceptible as males, but males are more likely to have progressive disease. The onset of the disease normally occurs between 20 and 40 years of age, with a peak incidence during the late twenties and early thirties, resulting in many years of disability for a large proportion of patients, many of whom require wheelchairs and some nursing home or hospital care. The aim of this study is to update a previous review which considered the cost-effectiveness of disease-modifying drugs (DMDs), such as interferons and glatiramer acetate, with more up to date therapies, such as mitaxantrone hydrochloride and natalizumab in the treatment of MS. The development and availability of new agents has been accompanied by an increased optimism that treatment regimens for MS would be more effective; that the number, severity and duration of relapses would diminish; that disease progression would be delayed; and that disability accumulation would be reduced. However, doubts have been expressed about the effectiveness of these treatments, which has only served to compound the problems associated with endeavors to estimate the relative cost-effectiveness of such interventions.

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Systematic review of immunomodulatory drugs for the treatment of people with multiple sclerosis: Is there good quality evidence on effectiveness and cost?

Cited by 26 publications

References 22 publications

Efficacy of Azathioprine on Multiple Sclerosis New Brain Lesions Evaluated Using Magnetic Resonance Imaging

Efficacy of Azathioprine on Multiple Sclerosis New Brain Lesions Evaluated Using Magnetic Resonance Imaging

Health-related quality of life outcomes at 1 and 5 years after a residential retreat promoting lifestyle modification for people with multiple sclerosis

Assessing cost-effectiveness in the management of multiple sclerosis

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