New federal regulations will require additional planning to prevent disruption in workflow and to avoid gaps in pain management. Research gaps exist related to opioid efficacy and management, including lack of effectiveness studies on long-term benefits and harm of opioids for use in chronic non-cancer pain (CNCP).10 Patients on chronic opioid therapy should be managed according to best practices and universal precautions, such as screening for depression and not using concomitant sedative-hypnotics or benzodiazepines.11 Strategies to provide optimal care to CNCP need to be balanced with efforts to mitigate opioid prescription abuse.
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Explore This IssueJanuary 2015
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Brodalumab Drug Update
The monoclonal antibody, brodalumab, met its primary endpoints in a late-stage study in adult patients with moderate-to-severe plaque psoriasis compared with ustekinumab and placebo.12 Brodalumab targets an interleukin (IL) 17 receptor to inhibit inflammatory signaling. The AMAGINE-2 trial included more than 1,800 patients who were randomized to receive either brodalumab 140 mg, brodalumab 210 mg, ustekinumab or placebo every two weeks for 12 weeks. Patients in the brodalumab arms were then re-randomized to receive one of four different maintenance brodalumab regimens. PASI 100 was achieved in 44% of brodalumab 210 mg-treated patients, and 34% of patients in a prespecified weight-based group also achieved PASI 100, vs. 22% of ustekinumab-treated patients. PASI 75 scores were more comparable between the different groups. Brodalumab-treated patients (77–86%) achieved PASI 75, and 70% of ustekinumab-treated patients achieved PASI 75 vs. 8% of placebo-treated patients.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
Mary Choy, PharmD, CGP, RPh, is an associate professor at the Touro College of Pharmacy in New York and a clinical pharmacist at Metropolitan Hospital in New York.
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- Sharma TS, Harrington TM, Olenginski TP. Aim for better gout control: A retrospective analysis of preventable hospital admissions for gout. Arthritis Rheumatol. 2014;66(11):Suppl. Abstract 2322.
- Goldfien R, Herrinton L Monitoring methotrexate and leflunomide treatment for liver toxicity: The Kaiser Permanente experience. Arthritis Rheumatol. 2014;66(11):Suppl. Abstract 1360.
- Panchal S, Flint J, van de Venne M, et al. A systematic analysis of the safety of prescribing anti-rheumatic immunosuppressive and biologic drugs in pregnant women. Arthritis Rheumatol. 2014;66(11):Suppl. Abstract 1358.
- National Survey on Drug Use and Health. U.S. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality. 2014 Sep. http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.pdf.
- Drug Enforcement Administration. Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II. 2014 Aug 22. http://www.regulations.gov/#!documentDetail;D=DEA-2014-0005-0588.
- FDA. Opioid drugs and risk evaluation and mitigation strategies (REMS). 2014 Oct 9. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.
- FDA. List of long-acting and extended-release opioid products required to have an opioid REMS. 2013 Apr 22. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251735.htm.
- FDA. FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties. 2014 Nov 20. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm423977.htm.
- Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline. J Pain. 2009;10:147–159.
- Franklin GM. Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology. Neurology. 2014;83(14):1277–1284.
- Barber J. Amgen, AstraZeneca’s brodalumab meets primary endpoints of third Phase III trial in moderate to severe plaque psoriasis. 2014 Nov 25. http://www.firstwordpharma.com/node/1248329?tsid=33&tsid=17#axzz3KDqIyQjQ.