Anakinra injection (Kineret) is being evaluated for treating systemic-onset juvenile idiopathic arthritis (JIA).1 At the recent European League Against Rheumatism meeting, De Jager et al presented results of a small open-label study in which 11 of 13 patients enrolled achieved a 90% reduction in the American College of Rheumatology pediatric criteria (ACRPed90), which occurred within three weeks of initiating treatment with anakinra.2 At one year follow-up, all 11 children were still in remission. A more rigorous study with better controls needs to be performed to truly evaluate the effect of anakinra on systemic-onset JIA before more widespread use can be recommended.
Belimumab (Benlysta) has received a priority review from the FDA as a potential new treatment for systemic lupus erythematosus (SLE).3 The FDA is expected to make a decision on the drug on December 9, 2010, which is the Prescription Drug User Fee Act target date.4 The Biologics License Application was filed on June 9, 2010, which includes data from two phase III clinical trials involving 1,684 autoantibody positive patients with SLE. A Marketing Authorization Application (MAA) was filed with the European Medicines Agency (EMA) on June 4 for potential approval and use in European countries.
Calcitonin oral tablets are undergoing phase III clinical trials for the treatment of postmenopausal osteoporosis.5 Tarsa Therapeutics is investigating this once daily tablet to potentially add to the armamentarium of injectable and intranasal calcitonin products.
Canakinumab (Ilaris, ACZ885), administered as a one-time subcutaneous injection was shown to significantly reduce gout flares in a 16-week study.6 Canakinumab is a recombinant, human anti-human-interleukin-1β monoclonal antibody that is already FDA approved to treat cryopyrin-associated periodic syndromes in patients four years of age and older, including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome.7 Further study is needed to fully evaluate the efficacy of this agent in treating gout patients.
The C.A.R.E.S. Alliance, a patient safety organization, was launched on September 8, 2010, to help curb the problem of misuse, abuse, and unintentional overdose associated with the use of opioid medications.
CH-4051 is an orally active, antifolate agent currently undergoing phase II clinical trials.8 It is being evaluated in rheumatoid arthritis patients who have had an inadequate response to methotrexate. Patient screening began in October.
Duloxetine (Cymbalta) was evaluated as a potential treatment for chronic musculoskeletal pain by the Anesthetic and Life Support Drugs Advisory Committee of the FDA.9 The committee voted by a slim margin to recommend use of duloxetine for this purpose. Based on three studies using different doses of duloxetine, it performed slightly better than placebo in treating chronic low back pain but not osteoarthritis pain. As for safety, hepatotoxicity may be an issue. It also appears to be associated with an increased risk of Stevens Johnson syndrome and toxic epidermal necrolysis.