Teriflunomide (Aubagio) is a once daily oral disease modifying therapy approved for treating patients with relapsing forms of multiple sclerosis (MS). One of the limitations of its use is its black box warning for potential fetal harm due to birth defects noted in rats and rabbits. Women who are of childbearing age who are not using reliable birth control are advised to not use teriflunomide.

At the Consortium of Multiple Sclerosis Centers annual meeting on May 30, I presented a poster describing 81 pregnancies in female patients and 20 pregnancies in partners of male patients in nine teriflunomide clinical studies. Of these pregnancies, none of the 20 babies born to female patients and 12 live births in partners of male patients had any structural or functional problems. The mean known birth weight and mean gestational age were normal, as was the miscarriage rate.

These findings are consistent with ..

A small pilot study from the University of Southern California suggests a pulse adrenocorticotropic hormone (ACTH) therapy could be effective in patients with breakthrough multiple sclerosis attacks while on beta-interferon. “Breakthrough” attacks that occur after starting a disease modifying therapy (DMT).

The study compared the safety and benefits of monthly pulse ACTH to monthly methylprednisone (MP) pulse in patients on beta-interferon. Over 15 months, researchers found that those treated with ACTH had fewer relapses and fewer psychiatric side effects. ACTH gel is currently used to treat MS relapses, but researchers note it may be able to alter the body’s immune responses beyond producing steroids.

As I discussed with the Medscape reporter, Megan Brooks, last week, the results of this study are ....

Multiple sclerosis is unique among neurological diseases in that there are currently eight treatments for this one condition that have received approval by the U.S. Food and Drug Administration (FDA). Five of these drugs require subcutaneous or intramuscular injection, two are administered intravenously, and fingolimod, the newest agent on the block, is given orally. None are considered curative, but these disease-modifying therapies (DMT) have led to a reduction in relapse rates and the progression of disability.

Despite this progress, each of the drugs comes with side effects, including flu-like symptoms with the interferons, lipoatrophy with glatiramer, progressive multifocal leukodystrophy (PML) with natalizumab, and congestive heart failure or leukemia with mitoxantrone. As the first oral agent for MS, fingolimod created great expectations prior to FDA approval. Its popularity, however, has been surprisingly limited, presumably due to the potential for unknown long-term risks. The occur rence of PML with natalizumab demonstrated to MS neurologists and patients the potential risks associated with new drugs.

Additional DMTs in the pipeline may increase MS-management effectiveness in coming years, although safety will continue to be a major consideration in the use of these drugs. For instance, oral cladribine was on the verge of FDA approval in early March when the agency referred the drug back for more safety studies. This drug is already used in intravenous form for the management of hairy cell leukemia, but it is being studied for use with remitting relapsing MS because of its apoptotic effects on lymphocytes. If cladribine is ultimately approved for use, the risk of infection and neoplasms may limit its use.

Other oral agents being studied include: