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Readers continue to send in their questions about living with MS, and the editors of Making Strides—Mary Ann Picone, MD, Gail Hartley, MSN, NP, MSCN, and Patricia Kennedy, RN, CNP, MSCN—offer their expert responses.

Q. I heard of a pill to treat MS instead of a shot. Can you tell me more?

A. Mary Ann Picone (MAP): There are actually several oral therapies that are currently being investigated to treat MS. Laquinimod is an immunodulator under investigation that has been shown to prevent the development of EAE (experimental autoimmune encephalomyelitis, an animal model of MS) in mice. In a phase II study with people with relapsing-remitting MS (RRMS), laquinimod was effective in reducing the number of active lesions. More phase II studies were conducted to determine the safety and effectiveness of different doses of laquinimod, and other studies will have to be conducted before the drug can be evaluated by the US Food and Drug Administration (FDA) as a potential oral treatment for MS.

Teriflunomide is an oral therapy under investigation that has been shown to be effective in reducing lesions in people with RRMS in phase II clinical trials. Oral forms of cladribine and fumarate (BG-12) are also being investigated for use in MS. Both have shown efficacy in RRMS in previous trails. A phase III trial of oral cladribine is almost complete, and a US arm of the phase III trial of BG-12 is set to begin in the latter part of 2007.

Patricia Kennedy (PK): Fingolimod, or FTY720, is yet a fifth oral therapy being tested for use in RRMS.The drug binds to T cells and B cells, which are thought to be 2 cell types that can damage neurons when activated, and causes them to remain in the body’s lymph nodes instead of being released throughout the body where they may go on to attack myelin. Phase II studies on a small number of patients looked promising. A 2-year, phase III study will be conducted to determine dose, safety, and effectiveness against a placebo drug.

Gail Hartley (GH): While the early study results of these and other oral drugs are exciting, it is important to reiterate that all of these oral agents are still under investigation. There is no guarantee that any will become available for use in the treatment of MS. Complete data on their efficacy and safety will take several years, and after this has been established the FDA will still have to conduct its own review to determine if the drug(s) will be available in the US.

It is even more important to remember that the drugs currently available to treat MS are effective and safe. It is recommended that treatment start early and be maintained for the long term. So, as we look toward the future of MS treatment, we should be mindful of the treatments that can be taken now to keep the disease and the damage it causes under control.

Q. I read about the use of Androgel^® (testosterone gel) in men that improved cognitive function. Can you tell me more about the study and its results?

A. PK: A small study (10 men with RRMS) was conducted at UCLA using Androgel (testosterone gel).The results indicated that these patients had improved cognitive function and slowed brain tissue loss (atrophy). While the results look promising,* any small study needs to be followed by larger studies to verify the results. It is also important to remember that testosterone does have known side effects, so use for this purpose will need to be studied carefully. There is no study at this time showing benefit with testoterone in female patients.

GH: There has been great interest in the potential effects of both male and female hormones on MS. This is certainly a promising area of research and larger trials are being considered.

MAP: Testosterone has been shown to inhibit the development of EAE.This may be related to its effects on cytokines, particularly the enhancement of interleukin (IL)-10 cytokine production. IL-10 is an anti-inflammatory cytokine, inhibiting the production of other cytokines responsible for inflammation.

*Note: Formal results from the Androgel study have been published in the scientific journal Archives of Neurology [Sicotte NL, Giesser BS,Tandon V, et al. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007;64:683-688 [PubMed]].