RA Drug Delivery Changes Offer Convenience, Easier Use
Self-injected Actemra and auto-fill methotrexate syringes could make living with RA easier.
The U.S. Food and Drug Administration (FDA) has approved new delivery methods for methotrexate and tocilizumab (Actemra), a move that will provide more convenient and easier-to-take treatment options for patients with certain types of inflammatory arthritis, including rheumatoid arthritis (RA).
In October 2013, the FDA approved a self-injectable version of tocilizumab (Actemra) for adults with moderate to severe RA who did not have enough relief with one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate.
The same month, the agency approved a single-dose auto-injector form of methotrexate (Otrexup) for adults with active severe RA and children with active polyarticular juvenile idiopathic arthritis (JIA) who do not respond to or cannot tolerate first-line therapies, including nonsteroidal anti-inflammatory drugs (NSAIDs).
Self-injected Actemra Reduces Clinic Trips
Actemra is a biologic drug that reduces RA-related inflammation by blocking interleukin-6 (IL-6), a protein that is overproduced in the joints of people who have the disease. It's been available by intravenous (IV) infusion since 2010. The approval of an easier-to-use, pre-filled Actemra syringe injection means patients can now take the medication at home.
“Any time a drug is given by IV you need a nurse or someone qualified to do the needle stick and then watch the medicine go in. This means a trip to a clinic and the cost and inconvenience associated with it,” says Donald Miller, PharmD, professor and chair of the pharmacy practice department at North Dakota State University in Fargo, N.D.
“It is more convenient to be able to auto-inject at home,” adds Ariel Teitel, MD, clinical associate professor in the department of medicine at the NYU School of Medicine in New York City.
The Actemra injection is given subcutaneously, which means the shot is given into a fatty layer just under the skin. It can be taken alone or in combination with methotrexate or other DMARDs. The pre-filled syringe should not be re-used.
The FDA’s approval is based on results from two phase III studies, one of which found the injectable and IV forms of Actemra to be comparable in safety and effectiveness. The other study found that Actemra injections plus DMARDs better reduce the number of tender and swollen joints and better slow disease progression than an inactive injection (placebo) plus DMARDs.
Actemra pre-filled syringes are expected to be available starting in November 2013.
Methotrexate: Faster Shot, No More Filling Syringes
Methotrexate is already available in a self-injected form. What makes Otrexup different is that it comes in a single-dose, pre-filled auto-injector. Pre-filled means patients or their caretakers will no longer have to draw up a syringe and fill it from a multi-dose vial. A patient can easily give his or her self the shot.
“The auto-injector makes the process more convenient, and it would increase the confidence of older patients with poor hand dexterity,” Miller says. “It also provides a quicker shot. That should be less painful and scary for kids.” Methotrexate is the cornerstone of treatment for kids with JIA.
Studies have found that, for some patients with rheumatoid arthritis, methotrexate injections may be more effective than the form taken by mouth.
Otrexup is expected to be available in early 2014.
Convenience at a Higher Cost?
The pre-filled self-injected Actemra will cost slightly more than the IV form, according to the drug manufacturer. The monthly cost of Actemra IV is between $1,250 and $2,500 a month, depending on your dose. It will cost between $1,400 and $2,800 a month for the self-injected form of Actemra, depending if you take it once a week or every other week.
Miller says the cost for Otrexup syringes may be considerably higher than for methotrexate syringes that patients fill themselves.