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On June 27, Centocor submitted a BLA for golimumab to treat adults with active RA, psoriatic arthritis, and ankylosing spondylitis. Golimumab is administered as a monthly SC injection. An IV infusion therapy is also being investigated. Additionally, an application was submitted in Europe for the same indications.16

The FDA has sent a complete response letter to Roche regarding their BLA application for IV tocilizumab (Actemra), submitted to treat adult patients with moderate to severely active RA.17 Five trials involving more than 4,000 patients have been conducted, with one still ongoing. In the completed Phase 3 trials, primary endpoints have been met.18

Monitoring and Management

Other than avoiding use of a statin, there are no known therapies to prevent statin-induced myopathy.1,3 CoQ10 supplementation lacks strong scientific support for improving statin-induced myopathy and therefore is not widely recommended.1,2

Routine CK monitoring is not recommended, but baseline CK level may be obtained prior to commencing statin therapy in high-risk patients, or those already on agents known to cause myopathy.1,7 Symptoms of myalgia should be monitored during statin therapy with an attempt to use the lowest dose.1 Consider obtaining a CK level in patients with muscle-related symptoms. Discontinue the statin if a patient has a CK level > 10 X ULN with muscle soreness, tenderness, or pain. Evaluate muscle symptoms six to 12 weeks after starting therapy and at each follow-up appointment.3

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The role of other causes of myopathy (e.g., hypothyroidism, trauma, seizures, infection, drug abuse, dermatomyositis, strenuous activity) should be ruled out. A thyroid-stimulating hormone level and a careful neurologic examination should be obtained, as well as a lipid panel.1,4,11 The use of other medications and herbal therapies should also be ascertained. If specific rheumatologic disorders are suspected, more specific tests should be ordered (e.g., ESR, ANA, CRP, anti-Jo antibody).4 Both myalgia and arthralgia are reversible upon drug discontinuation, usually within two to three weeks.8 Remember to also follow liver enzymes in these patients, obtaining them initially and then approximately every 12 weeks thereafter, then annually or more frequently if needed.3

In patients who report intolerable myalgia regardless of CK levels, discontinue the statin. A rechallenge with that or another statin may be attempted. In patients with moderate to severe CK elevations or rhabdomyolysis, the statin should be discontinued. Use of a lower-dose hydrophilic statin is still considered risky.4 Patients with clinically significant rhabdomyolysis need to be hospitalized for intravenous (IV) hydration and urine alkalinization.1 Many patients intolerant of statins will be intolerant of ezetimibe.1,4 Bile acid sequestrants and resins may be the safest choice for these to lower cholesterol.1,4

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