Epratuzumab, an intravenous (IV), anti-CD22 monoclonal antibody, is being studied for the treatment of moderate-to-severe systemic lupus erythematosus (SLE).9 In a recent study, white women with a mean age of 40 (n=227), positive antinuclear antibodies, and scores of six or higher on the SLE Disease Activity Index were enrolled. Initially, 45% were on immunosuppressive agents, including azathioprine, methotrexate (MTX), or mycophenolate mofetil, and 47% were also receiving antimalarials. The mean baseline corticosteroid dose was 14 mg. The British Isles Lupus Assessment Group index-based Combined Lupus Assessment was used to measure disease activity. Twice as many epratuzumab-treated patients who received a cumulative dose of 1,200 mg over 12 weeks had a response rate compared with placebo-treated patients (43% versus 21%, P=0.02). At least one adverse event was exhibited by 75% of patients, which was most often a headache or a minor infection. Fewer than 10% of patients experienced a serious adverse event. Like rituximab, epratuzumab depletes B cells, causing a partial depletion of approximately 30%. A phase III clinical trial is now evaluating four doses of 600 mg (total 2,400 mg) given weekly every three months for up to a year.
An sNDA has been submitted for hydrocodone bitartrate extended-release capsules, an investigational treatment for chronic pain.10 This product is a potentially novel, oral, single-entity extended-release formulation of hydrocodone (without acetaminophen) for managing moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. If approved, this agent could be the first nonacetaminophen-containing single-entity hydrocodone therapy.
In early May, an FDA advisory panel voted 18 to 4 in favor of approving lorcaserin, a potentially new treatment for obesity.11 Modest weight loss was identified in overweight and obese individuals in the clinical studies, but not to the degree that was expected. Additionally, the incidence of valvulopathy was low in the studies and was not long term. The advisory panel members made some suggestions for lorcaserin if approved. They asked that the manufacturers conduct follow-up studies to assess cardiovascular effects or recommend receiving an echocardiogram prior to drug prescribing. At press time, the FDA was expected to make a final decision by the end of June.
Secukinumab, an IV interleukin-17 targeting monoclonal antibody, recently appeared promising in the treatment of ankylosing spondylitis in a phase II clinical study presented at the British Society of Rheumatology meeting.12 Twenty-three patients received two infusions, and by Week 6, 61% (n=14) exhibited at least a 20% improvement. Patients received two IV 10-mg/kg doses on Days 1 and 22. These patients could have used up to three disease-modifying antirheumatic drugs (DMARDs) in the past. Of these patients, half had previously received treatment with an anti–tumor necrosis factor–alpha (TNF-α) agent. Ninety-two percent of treated patients completed the study, with 35% showing at least a 40% improvement in the assessment of SpondyloArthritis International Society response criteria including pain, spinal mobility, and function. Patients that received prior anti-TNF therapy had a lower 20% response rate (30% versus 85% of those that had previously not received anti-TNF agents). Adverse effects were mostly mild infections.
