Studies from various parts of India indicate an increase in the number of multiple sclerosis (MS) and related demyelinating disorders. In view of these facts, remarkable advances in the diagnostic and therapeutic management of MS have been made. One such advancement is the first pen form version of the most popular injection— interferon beta-1a (Avonex) which has recently received approval from the Drug Controller General of India’s (DCGI). This is expected to reduce pain, anxiety and suffering in the lives of thousands of MS patients who have been desperately seeking new innovative ways in treatment procedures. Experts say that this novel way of administering injection will increase compliance in MS patients who otherwise may skip treatment due to fear of the needle. Raelene Kambli catches up with Dr BS Singhal, Neurologist, Bombay Hospital to understand the latest techniques available with Indian neurologists in the management of MS. Excerpts from the interview
Can you give us a brief scenario of multiple sclerosis (MS) and related demyelinating disorders in India?
MS is well recognised by all the neurologists in India. McDonald’s revised criteria are used for the diagnosis. Recurrent Neuromyelitis Optica (more severe and distinct disease) is equally well recognised. Neurologists are careful to exclude other conditions which may mimic MS. Like in the West, we see patients with relapses and remissions (majority) and later some develop what is called secondary progressive (SP) course resulting in disability. A small minority may have
a steady deterioration of MS designated as primary progressive MS.
What are the causes of MS?
We do not know the precise cause of MS. Genetic susceptibility and as yet unidentified environmental factors result in altered immunity. The activated T-cells enter the nervous system by crossing the blood-brain barrier and result in demyelination and axonal damage.
A study conducted by the Department of Neurosciences, University of Medicine and Dentistry of New Jersey states that on comparison between MS in India and the US, the Indian patient had no family history of MS. This suggests an environmental disease-triggering agent. How far is this true? Please throw some light on this aspect.
We do see familial cases as well but these are not common. We may not be probing enough and so far we do not have well defined data on the familial cases. The importance of genetic susceptibility will become more apparent when we have data on HLA linkage and genomic studies for Indian patients. As mentioned earlier, environmental factor plays a significant role. This is also reflected in the studies on Indians who have migrated to the west.
What are the latest developments in the treatment of MS? How advanced is India in the treatment of MS?
The recent years have witnessed tremendous advances in the field of therapy for MS. Anti-inflammatory agents — Corticosteroids are given in the acute phase for rapid improvement. These do not alter the course of the disease. Several classes of drugs (Disease Modifying Agents — DMA) are available to reduce the relapses. Beta-interferrons and Glatiramer injections have been used for several years as DMA and have a good margin of safety. They provide benefit to reduce relapses by about 40 per cent. For those who fail on these DMAs or for those who have more aggressive disease, more effective drugs like Natalizumab are available. Oral agents are being tested and Fingolimod was approved recently as DMA in the US and in some other countries.
Except for Fingolimod, all other DMA drugs have been introduced in India. Regrettably, as these agents are costly and as majority of the patients have to bear the cost themselves, only a minority can take advantage of these therapies. Besides as these drugs are effective only to reduce the relapses, treatment is prolonged. The treatment has to be initiated early in the inflammatory stage of MS. As yet we do not have drugs for repair and regeneration of axonal damage and regain of the lost function.
We do have drugs for some symptomatic relief. The treatment has a multidisciplinary approach with involvement of other medical personnel, physiotherapist, trained nurse assistant, counsellor and other support staff.
| The Magic Pen |
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AVONEX PEN was approved based on data from a Phase 3b study in which approximately nine out of 10 patients used the device successfully. Ninety-four percent of patients in the study also expressed a preference for AVONEX PEN over the AVONEX Prefilled Syringe. AVONEX PEN was approved in the European Union and Canada in 2011. The efficacy and safety of AVONEX PEN was evaluated in an open-label, multicenter, Phase 3b study (n=70). Efficacy was assessed through objective and subjective assessments of key aspects of patients’ use of AVONEX PEN. Additional features of AVONEX PEN include: a protective injector shield that conceals the needle prior to injection; automated needle insertion and medication delivery; and a diameter and length designed to stabilise AVONEX PEN during the injection procedure. In addition, AVONEX PEN incorporates a safety lock, which helps prevent injection error and a display window that confirms complete delivery of the medication. |
Suggest some effective ways for neurologists to help the patients cope with MS?
Fortunately we have an active Multiple Sclerosis Society of India with several chapters in India providing the necessary help to the patients and care givers.
The great need for us in India is to increase awareness, have insurance coverage and financial support for the patients to take advantage of the available drugs. We need specialised MS clinics with dedicated nurses and support staff for the neurologists to provide better care for MS patients.
How will the new pen form version of the injection— interferon beta-1a (Avonex) help in better MS management?
Considering the rising incidences of MS in the country, the pen version of avonex with a smaller needle is a major development as it will help improve patients’ adherence to MS treatment. At the same time, it will also lessen the anxiety and fear of pain in patients towards injections. This concept of pen will definitely be well accepted by the patients as well as the market.