Clazakizumab (CLZ), a humanized monoclonal antibody, is an interleukin 6 (IL-6) blocker currently undergoing Phase 2b clinical trials for treating moderate to severe active RA and psoriatic arthritis.2 Recently, a randomized, double-blind, placebo-controlled, dose-ranging multicenter safety and efficacy trial evaluated the efficacy of three doses of CLZ in adults with psoriatic arthritis with or without methotrexate (MTX).3
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Explore This IssueMarch 2015
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Patients with an inadequate response to nonsteroidal antiinflammatory drugs (NSAIDs) and/or disease-modifying antirheumatic drugs (DMARDs) were randomized to receive CLZ 25 mg, 100 mg, 200 mg or placebo with or without MTX every four weeks for 24 weeks. ACR20 was the primary endpoint measured at Week 16. Secondary endpoints at Week 24 included ACR 20/50/70 and PASI 75 response rates, changes in HAQ-DI and DAS28 (CRP), as well as dactylitis and enthesitis scores. Approximately 75% of patients were receiving MTX, and a total of 165 patients were treated and analyzed. The primary endpoint was met with significantly higher ACR20 response rates in the CLZ 100 mg-treatment arm vs. placebo (52% vs. 29%).
There was a numerically higher response in the CLZ 25 mg and CLZ 200 mg treated groups at Week 16, 46% and 29%, respectively. ACR 20/50/70 response rates were higher than placebo for all CLZ treatment arms at Week 24; however, no clear dose response was identified. PASI 75, HAQ-DI, DAS28 (CRP) and the number of dactylitic digits and enthesitis scores all had mean decreases from baseline to Week 24 compared with placebo-treated patients.
Serious adverse events were similar across most treatment groups (5%), except in the CLZ 200 mg–treated group (10%); CLZ 200 mg was associated with more study discontinuations. Overall, CLZ was well tolerated, and there were no differences from placebo in relation to laboratory safety data. No serious infections, TB, malignancies, gastrointestinal perforations or unusual adverse events were seen during the study.
Hydrocodone bitartrate extended-release capsules (Zohydro ER) will soon be available as a new formulation with BeadTek abuse-deterrent properties.4 The manufacturer has ongoing human abuse liability studies to further characterize the abuse-deterrent properties of the new formulation, which will be submitted to the FDA in the second half of this year. The excipients in BeadTek immediately form a viscous gel when crushed and then dissolved in liquids or solvents.
Transitioning of patients currently on therapy to the new BeadTek formulation is expected to occur in the second quarter of this year without disruption.