Tocilizumab (Actemra), an interleukin (IL)-6 receptor blocker, has been FDA approved to treat children age two years and older who have active systemic juvenile idiopathic arthritis.5 It can be used as monotherapy or in combination with methotrexate (MTX). In clinical trials, there were 112 patients aged 2 to 17 years who were treated with the drug. Patients either had an inadequate response to NSAIDs or corticosteroids or were not able to take them. Patients received tocilizumab infusions every two weeks, with 85% responding to the drug versus a 24% response rate to placebo. In the follow-up period, there were three cases of macrophage activation syndrome.
Pipeline Agents
ACZ885 (canakinumab), a fully human monoclonal antibody, is undergoing phase 3 clinical trials in patients with severe gouty arthritis.6 In two pivotal studies of more than 450 patients, canakinumab demonstrated superior pain relief and reduced the risk of new attacks by up to 68% compared with injectable triamcinolone acetonide.7 There is evidence that excessive production of IL-1β plays a role in the inflammatory process of gouty arthritis and related conditions. ACZ885 works by neutralizing IL-1β, thus inhibiting inflammation. The agent is currently approved in Europe and the United States to treat cryopyrin-associated periodic syndrome.
Certolizumab pegol (Cimzia) will undergo a head-to-head trial versus adalimumab (Humira) in a first-ever industry-sponsored study investigating two anti–tumor necrosis factor α (TNF-α) agents in treating RA.8 The study will include patients with moderate to severe RA who have not had an adequate response to MTX and are anti–TNF-α therapy naive.
EX101 (alendronate) has had its New Drug Application (NDA) filed for this new formulation of alendronate.9 EX101 is a buffered effervescent tablet of alendronate for once-weekly administration to treat postmenopausal women and increase bone mass in men with osteoporosis.
Fulranumab is currently in phase 2 clinical trials to improve pain and functioning in patients with moderate to severe knee and hip OA.10 It is a human recombinant monoclonal antibody against human nerve growth factor (NGF). According to results from the recent American Pain Society Annual Meeting in May, patients age 40 to 80 years had improvements in pain, functioning, and pain interference with sleep when they received the once monthly or bimonthly injection of fulranumab. These are recent study results; however, in December the FDA placed all agents in the anti-NGF class (including fulranumab) on hold because they may be associated with a possible increased risk of rapidly progressive OA or osteonecrosis, conditions which can lead to the need for joint replacements.11 In May, the FDA released phase 2 trials of fulranumab to treat cancer pain.12