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4th April 2024
Cladribine tablets (brand name Mavenclad) have been granted a label extension by the Medicines and Healthcare products Regulatory Agency (MHRA) to expand access for additional patient populations with multiple sclerosis (MS), its manufacturer Merck has announced.
It is now indicated for the treatment of adult patients in Great Britain with relapsing forms of MS with active disease as defined by clinical or imaging features.
The expanded label means more newly diagnosed patients will be eligible for treatment with cladribine earlier in their disease course. Since 2017 it has been approved for use in patients with highly active relapsing MS as defined by clinical or imaging features.
Its latest approval makes cladribine the only short-course oral treatment for active relapsing MS available in Europe.
Cladribine tablets, which can be taken at home, are taken for a maximum of 20 treatment days in each of years 1 and 2 with no further treatment required in years 3 and 4.
This low administrative burden can offer advantages to a patient’s quality of life over other types of MS treatment, which can require drugs to be administered via regular self-injections, as an infusion in hospital, or as daily tablets, Merck said.
Speaking about the approval, Dr Wallace Brownlee, consultant neurologist and multiple sclerosis specialist, said: ‘The expansion of the label for cladribine tablets could improve patient outcomes and quality of life for many MS patients with active relapsing MS in Great Britain by allowing us to use cladribine tablets earlier in the treatment pathway.
‘This will be the first high-efficacy oral short-course treatment to be available for this patient group in Europe and could provide clinicians with an additional treatment option which also provides patients with treatment which has a low monitoring and administration burden.’
This approval by the MHRA follows a robust review of the current evidence around the benefit-risk profile of cladribine tablets for this patient group. The pre- and post-approval studies considered in the review included:
The review concluded that there is a favourable benefit-risk profile to warrant use in this wider population.
Dr Doina Ionescu, managing director of Merck Healthcare UK and Ireland, said: ‘We know from our long history of working in the field of MS that there is still an unmet need for many patients to have access to a high-efficacy oral treatment which can be used early in the course of the disease.
‘Since the NICE approval in 2017, cladribine tablets have treated globally over 80,000 patients which has been supported by data from both our pivotal studies and real-world evidence we have shared. More patients could benefit from cladribine tablets than before, so we look forward to applying for NHS reimbursement with urgency.’
3rd May 2023
Multiple sclerosis (MS) affects more than two million people worldwide and is currently incurable. Some evidence shows that high levels of vitamin D reduce the risk of MS. In fact, among MS patients using interferon beta-1b, adding vitamin D reduces disease activity. Despite this, randomised trials of vitamin D in relapsing-remitting MS fail to show an improvement. Nevertheless, these trials only involve interferon beta. Glatiramer acetate reduces the relapse rate in MS and therefore affects disability. Whether addition of vitamin D to glatiramer could reduce the relapse rate in MS is uncertain.
The present study tested if adding vitamin D to glatiramer could reduce disease activity in those with active MS. In a phase 3 RCT, participants had either a high (5000 IU/day) or low (600 IU/day) dose of vitamin D in conjunction with glatiramer. Participants with relapsing-remitting (RR) MS aged 18–50 years and with recent disease activity were eligible to enrol. Participated had an Expanded Disability Status Scale score ≤4.0 and a minimum serum vitamin D level of 15 ng/ml. The primary outcome was the proportion experiencing a confirmed relapse.
Glatiramer acetate and vitamin D and relapses
A total of 172 individuals, 89 receiving high dose vitamin D were enrolled. Participants were followed for 96 weeks.
Confirmed relapse rates did not differ at week 96 (hazard ratio, HR = 1.17, 95% CI 0.67 – 2.05, p = 0.57).
The authors suggested that vitamin D and glatiramer does not reduce the risk of clinical relapse in people with RRMS.
6th April 2023
In a case-controlled study, Iranian researchers have determined that drinking black or green tea, coffee and non-alcoholic beverages are associated with a lower risk of developing multiple sclerosis (MS), whereas in contrast, for instance, a higher intake of carbonated beverages, increases the risk.
Multiple sclerosis (MS) is the most common cause of neurological disability in young adults worldwide and a 2020 study estimated that, globally, some 2.8 million people are living with the condition. Although the underlying cause remains uncertain, there is evidence that certain dietary factors may have an effect. For example, the consumption of alcoholic beverages, coffee and fish have been shown to be inversely associated with progression of disability in relapsing onset MS, but not in progressive onset MS. In fact, it has been suggested that a high coffee consumption may decrease the risk of developing MS. While it is known that polyphenolic compounds such as resveratrol exhibit several other biological/biochemical protective effects on the heart, circulation, brain and age-related diseases, the Iranian researchers wondered if black or green tea (which also contains several polyphenols) may exert a protective effect in MS.
The researchers performed case-control study on 150 patients with MS and 300 healthy individuals who served as a control group. Data on demographic and beverage consumption was collected by a questionnaire and analysed by univariate and multiple logistic regression models.
Black or green tea and multiple sclerosis
The mean age of the MS patients was 38.6 years (80.1% female) which was similar for the control group, (37.2 years) although there were less women (58.5%).
The results showed that drinking black tea was significantly associated with a reduced risk of developing MS (Odds ratio, OR = 0.20, 95% CI 0.10 – 0.37, p < 0.001), as was drinking green tea (OR = 0.29, 95% CI 0.13 – 0.63, p = 0.002), coffee (OR = 0.07) and non-alcoholic beer (OR = 0.48)
In contrast, consumption of natural juice or (OR = 2.49), milk (OR = 5.46) and carbonated beverages (OR = 16.17) were all associated with an increased odds of developing MS.
The researchers acknowledged that a limitation of the study design was the possibility of memory bias and consequently suggested that their findings could be used to design interventional research and to change people’s lifestyles to prevent MS.
Citation
Dastoorpoor M et al. A case-control study of drinking beverages and the risk of multiple sclerosis in Iran. J Health Popul Nutr 2023
29th November 2022
Patients aged 45 years and older prescribed anti-diabetic medication have an increased risk of developing multiple sclerosis compared to younger patients, but in the younger age group, the risk is actually significantly reduced according to the findings of a study by US researchers based at the university of Arizona.
Globally, an estimated 2.8 million people live with multiple sclerosis (MS) and the prevalence has increased in every world region since 2013, with a pooled incidence across 75 countries of 2.1 per 100,000 persons/year. Moreover, there is a good deal of data to suggest that axonal degeneration is the major determinant of irreversible neurological disability in patients with MS.
Although the precise underlying cause for MS remains to be determined, observational research suggests both genetic and environment influences and which are widely believed to be autoimmune in nature. Nevertheless, one prospective study following people for 9 years, demonstrated a moderate but significant association of type 2 diabetes with MS incidence. In addition, it has also been found that patients with type 1 diabetes have a more than 3-fold increased risk of developing MS.
Given the association with diabetes, the US researchers wondered if the use of anti-diabetic medication might positively impact on the risk of developing MS. The team turned to a US insurance claims database and identified those with type 2 diabetes and set the index data as the first recorded entry of their type 2 diabetes (T2D) diagnosis and the start date of the study, as 12 months after this index date.
For their analysis, researchers categorised participants with T2D as either under or over 45 years of age and propensity matched both cohorts, based on several factors including age, gender and co-morbidities.
Multiple sclerosis risk and use of anti-diabetic medication
A total of 143,613 individuals prescribed anti-diabetic medication (mean age of 30.16 years) and 638,625 (mean age of 61.85) were identified and both groups propensity matched.
Among the younger diabetic cohort, there was a significantly reduced risk of developing multiple sclerosis (relative risk, RR = 0.22, 95% CI 0.17 – 0.29, p < 0.001). In contrast, among the older cohort, the risk of developing MS was actually significantly higher (RR = 1.36, 95% CI 1.25 – 1.47, p < 0.001). The increased or decreased risk was also apparent for both sexes although among older men the risk was only slightly elevated (RR = 1.17, 95% CI 1.01 – 1.37, p = 0.04).
Interestingly, when researchers considered the individual anti-diabetic medicines, the risk was higher (or lower for younger patients) for all classes e.g., insulin, metformin, sulfonylureas, glitazones, DPP4 inhibitors and the combination of metformin and sulfonylureas.
The authors concluded that exposure to anti-diabetic medication in those with type 2 diabetes either increased or decreased the subsequent risk of developing multiple sclerosis and that this elevated or reduced risk was age-dependent.
Citation
Branigan GL et al. Age and sex differences on anti-hyperglycemic medication exposure and risk of newly diagnosed multiple sclerosis in propensity score matched type 2 diabetics. Heliyon 2022.
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