Research news
Open Door - February 2011 pages 4-5
- Drug licensing news
- Aquatic exercise is beneficial
- Does fampridine improve walking speed?
- Massage to alleviate constipation
- Mindfulness training improves well-being
- Lower dose of Botox to treat overactive bladder
- Oral laquinimod reduces MRI lesions
Drug licensing news
There has been mixed news for new MS following the January meeting of the committee that advises the European Medicines Agency (EMA), the regulatory body for drugs in the EU.
Fingolimod
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the EMA license fingolimod (Gilenya) as a second line treatment for people with relapsing remitting MS. They suggest that the drug, which is taken as a tablet, should be available for people who are continuing to experience frequent relapses despite treatment with beta interferon or glatiramer acetate or for people with rapidly evolving severe relapsing remitting MS.
This means that most people will continue to start treatment with one of the beta interferon drugs (Avonex, Betaferon, Extavia, or Rebif) or glatiramer acetate (Copaxone). Fingolimod will join natalizumab (Tysabri) as a treatment option for people whose MS is not controlled by these first line drugs.
The CHMP recommendation will be considered by the EMA in the next three months. Once a licence is granted, fingolimod will be appraised by NICE before funding by the NHS can be guaranteed. NICE has already started its appraisal of fingolimod and the first appraisal committee meeting is scheduled for July.
Cladribine
At the same meeting, CHMP upheld their decision to reject cladribine (Movectro), another oral disease modifying drug. This was originally rejected in September 2010 but the manufacturer, Merck, appealed this decision. CHMP has stood by its earlier decision that the benefits of cladribine do not outweigh its risks. Merck now plan further trials but don't expect to re-submit cladribine until 2012 at the earliest.
Fampridine
Fampridine (Fampyra), a drug that can improve walking ability in multiple sclerosis, has also not been recommended for a licence. Fampridine was licensed in the USA - where it is known as Ampyra - in January 2010. The manufacturer, Biogen Idec, intends to appeal against this decision.
Aquatic exercise is beneficial
A small study of 11 people with MS who took part in a group aquatic exercise programme reported that the training improved their mobility and that the participants enjoyed the experience.
The hour long sessions were held twice weekly for five weeks and included a variety of exercises encompassing aerobic activity, strength and flexibility exercises, walking and balance activities. Improvements were found in grip strength, walking speed and balance. The authors suggest that an aquatic training programme is suitable and beneficial for people with MS and could be used within community-based wellness programmes.
Salem Y, et al.
Community-based group aquatic programme for individuals with multiple sclerosis: a pilot study.
Disability & Rehabilitation 2010 Aug 20. [Epub ahead of print].
abstract
Does fampridine improve walking speed?
Initial clinical trials of a sustained-release formulation of fampridine (fampridine-SR or dalfampridine) have shown the drug improves walking in some people with MS. This study was designed to confirm the results of previous studies and to establish how long the effect of the sustained release formulation persisted.
In a multicentre double blind study, participants with any type of MS received either fampridine tablets (120 people) or a placebo (119 people) twice daily for nine weeks. The time taken to walk 25 feet was measured. More people in the fampridine group showed a consistent improvement in walking speed (42.9%) compared with placebo (9.3%). For those responding to fampridine, walking speed increased on average by 24.7%. The mean improvement in walking 8-12 hours after the last dose was 25.7%, indicating continued effectiveness of the drug during the period between doses.
Fampridine (Ampyra) has been licensed in the USA. More on the situation in Europe above.
Goodman AD, et al.
A phase 3 trial of extended release oral dalfampridine in multiple sclerosis.
Annals of Neurology 2010;68(4):494-502.
abstract
Massage to alleviate constipation
Constipation can have a big impact on quality of life. Abdominal massage has previously been found to help people with other conditions; this research, which was supported by the MS Trust, aimed to establish whether abdominal massage might be helpful for people with MS.
30 people with MS were allocated to two groups, both of which were given bowel management advice. In addition, people in the massage group or their carers were taught how to do abdominal massage on a daily basis. An improvement in constipation symptoms was found in both groups at the end of the four week study, however, the massage group improved significantly more.
McClurg D, et al.
Abdominal massage for the alleviation of constipation symptoms in people with multiple sclerosis: a randomized controlled feasibility study.
Multiple Sclerosis 2011;17(2):223-233.
abstract
Mindfulness training improves well-being
Mindfulness, using concepts borrowed from Buddhist practices, combines meditation, stretching exercises and breathing techniques to focus on the present moment. It is increasingly being used in combination with talking therapies to reduce anxiety and stress.
A study has evaluated mindfulness training in people with MS. 150 people with relapsing remitting or secondary progressive MS took part in an eight week study, receiving either standard care or a mindfulness training course involving group and daily home sessions. Learning these techniques helped people in the mindfulness group cope better with depression, fatigue and anxiety at the end of the course and also at a six-month follow-up.
Grossman P, et al.
MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial.
Neurology 2010;75(13):1141-1149.
abstract
Lower dose of Botox to treat overactive bladder
Botulinum toxin A (Botox), injected directly into the bladder wall, has been found to be very effective at treating the symptoms of urgency and frequency due to overactive bladder. However, at the dose normally used, Botox also affects normal bladder emptying so people need to carry out self-catheterisation. A small study (12 people) has found that a lower dose of Botox was effective at managing bladder problems. There was an initial increase in urine retention but this had decreased by 12 weeks after treatment. The authors conclude that the lower dose of Botox is effective and that for most people, normal bladder emptying will be retained, avoiding the need for self-catherisation. Larger studies will be needed to confirm these initial results.
Mehnert U, et al.
The effect of botulinum toxin type A on overactive bladder symptoms in patients with multiple sclerosis: a pilot study.
Journal of Urology 2010;184(3):1011-1016.
abstract
Oral laquinimod reduces MRI lesions
The results of a 36-week extension study of oral laquinimod in people with relapsing remitting MS has shown significant reductions in disease activity seen on MRI.
Two earlier studies compared the safety and effectiveness of 0.3mg and 0.6mg daily doses against placebo in people with relapsing remitting MS. Upon completion of these 36-week studies, participants were enrolled into a 36-week extension study during which they all took a daily dose of 0.3mg or 0.6mg laquinimod.
An average 52% reduction in the number of active lesions on MRI was seen in the group who were switched from placebo to laquinimod, while the reduction in the average number of active lesions seen in the groups receiving laquinimod in both studies, was sustained at around 40%.
Comi G, et al.
Oral laquinimod in patients with relapsing-remitting multiple sclerosis: 36-week double-blind active extension of the multi-centre, randomized, double-blind, parallel-group placebo-controlled study.
Multiple Sclerosis 2010;16(11):1360-1366.
abstract
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