FDA Approves Two Meds for New Use

Rheumatoid arthritis and ankylosing spondylitis medications approved by FDA

/ Author:  / Reviewed by: Dominique Brooks, M.D Beth Bolt, RPh

(RxWiki News) New options developed this week for patients coping with two very different arthritic conditions. The US Food and Drug Administration (FDA) has approved two medications for treatment of both rheumatoid arthritis and ankylosing spondylitis.

Otrexup, an injectable form of methotrexate, was approved for treatment of rheumatoid arthritis, which commonly strikes the fingers and wrists. 

Certolizumab pegol (Cimzia) was approved for treatment of ankylosing spondylitis, a type of arthritis of the spine.

"Ask your pharmacist about new arthritis medications."

According to the US National Library of Medicine (NLM), rheumatoid arthritis can cause pain, swelling, stiffness and loss of function in joints throughout the body, commonly in the wrist and fingers. 

Antares Pharma reported that this week, the FDA approved an injectable form of methotrexate (Otrexup) for treatment of certain adults with severe active rheumatoid arthritis.

Otrexup was also approved for certain adults with a severe form of the skin condition psoriasis and children with active polyarticular juvenile idiopathic arthritis — a condition in which rheumatoid arthritis affects several joints at the same time in a child.

The medication is self-administered using a single dose, disposable injector. Antares, Otrexup's producer, said that the medication will provide an option when the oral form of methotrexate isn't effective or causes too many side effects in a patient.

The results from Otrexup's clinical trials will be presented in late October at the American College of Rheumatology Annual Meeting in San Diego, California. Antares noted that the medication has been tied to organ toxicity and fertility issues and should not be used by cancer patients or pregnant women.

Also announced this week was approval of the medication certolizumab pegol (Cimzia) to treat adults with active ankylosing spondylitis — a form of arthritis that affects the spine. According to NLM, ankylosing spondylitis causes swelling between the vertebrae of the spine and in the joints between the spine and the pelvis. Over time, ankylosing spondylitis can severely limit movement.

According to Cimzia's producer, UCB, a pharmaceutical company based in Belgium, the approval was granted after a 12-week study involving 325 patients with axial spondyloarthritis (a family of conditions involving inflammation in joints of the spine and pelvis), 178 of whom had ankylosing spondylitis.

Participants received either a 200 milligram (mg) dose of Cimzia every two weeks, a 400 mg dose of Cimzia every four weeks or a placebo (an inactive sugar pill). Participants were assessed using the ASAS 20 — a measurement of improvement in factors like pain, function and inflammation used to measure the progress of ankylosing spondylitis patients.

At the study's end, the participants receiving Cimzia at either dose level faired better than the placebo group using ASAS 20.

Side effects were seen in 70.4 percent of the Cimzia participants and 62.6 percent of the placebo participants. UCB noted that the medication has been tied to infections and should not be used by people with tuberculosis, latent tuberculosis or certain bacterial, viral and fungal infections.

It is important that all patients discuss new medications with their doctors and pharmacists.

Review Date: 
October 18, 2013
Last Updated:
December 30, 2013