Sirukumab for Rheumatoid Arthritis: the Phase III SIRROUND-D Study

Shawn Yee, Mercer University College of Pharmacy

Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints. Disease-modifying antirheumatic drug (DMARD) therapy, such as methotrexate (MTX) is commonly used for the treatment of RA. However, for patients unresponsive or refractory to this therapy, a newer treatment with monoclonal antibodies (mAb) is being further studied. [1]

One of the proposed underlying mechanisms of RA includes the activity of interleukin-6 (IL-6) in the joints, where higher levels of IL-6 is associated with joint damage and inflammation. [1,2] Therefore, inhibiting the activity of IL-6 with drug therapy is thought to improve RA symptoms and overall disease progression. [1] Previous studies analyzing the effect IL-6 receptor antagonism with monoclonal antibodies such as tocilizumab and sarilumab found success with improving RA outcomes, and showed reduction in RA symptoms, improved physical function and reduced the rate of RA progression. [3,4,5,6]

In a previous phase II trial, sirukumab (selective IL-6 cytokine human mAb), showed efficacy in patients refractory to MTX therapy. [7] The phase III trial is summarized below. [1]

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Naproxen Plus Muscle Relaxants vs. Naproxen Alone for Lower Back Pain

Shanterra Grable, Mercer University College of Pharmacy

In Americans under 45 years old, back pain is the leading cause of disability. It is estimated that anywhere from 60 to 80 % of the United States suffer from low back pain. This can affect flexibility, stability, and strength that can cause pain and discomfort, which can lead to chronic or temporary disability. [1]

While there is moderate evidence to show that a combination of  NSAIDS and muscle relaxants can be beneficial in treating acute back pain, it is not known which medications improve patient perceptions of pain. The mechanism in which muscle relaxants aid in relieving back pain is unknown but is thought to be related to their general analgesic effects in the central nervous system and not directly on skeletal muscles. The two muscle relaxants used in the following study, orphenadrine and methocarbamol, are prescribed in over 250,000 emergency room visits annually; however, there is little evidence to suggest that these two muscle relaxants are effective in treating low back pain.  [2]

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ACE Inhibitors and Statins in Adolescents with Type-1 Diabetes

Julia Lvovich, Mercer University College of Pharmacy

Type 1 diabetes most frequently occurs in children and adolescents, although this autoimmune disease can occur at any age. In type 1 diabetes, beta cells are destroyed by the body’s own immune system, causing a complete insulin dependence. Due to the early onset of disease and difficulty of glycemic control, type 1 diabetic patients are at an increased risk of long-term complications, such as diabetic kidney disease. [1]

During early stages of diabetic kidney disease, kidneys begin removing trace amounts of albumin from the blood and may lead to microalbuminuria. It is suggested that an increase in albumin excretion during adolescence predicts the development of microalbuminuria and diabetic kidney disease. [1] Currently, there is no established clinical criteria for early interventions based on microalbuminuria; however, it is suggested that management may prove beneficial for type 1 diabetics. In adult diabetic (type 1 and 2) patients, microalbuminuria is managed by angiotensin-converting enzyme (ACE) inhibitors; however, in adolescents there is a lack of evidence to support the use of preventative measures to reduce the incidence of and progression to diabetic kidney disease. [2,3]
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Fremanezumab for the Preventative Treatment of Chronic Migraine

Shawn Yee, Mercer University College of Pharmacy

Migraine headache is a neurological disorder that manifests as recurrent attacks of pulsating head pain, with or without visual disturbances. Migraines are moderate to severe in pain and can be debilitating, leading to a lower quality of life. [1] The current Neurology Guideline suggests divalproex sodium, sodium valproate, topiramate, metoprolol, propranolol, and timolol are effective for migraine prevention and can be used to reduce migraine frequency and severity. [2]

Chronic migraine is seen in about 2% of the general population, and in comparison with episodic migraine, it is associated with decreased quality of life and increased headache-related burden. Therefore, preventing the onset could reduce the burden of chronic migraine and is an ongoing area of research. [3]

Fremanezumab is a humanized IgG2a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP). In a phase II trial, the number of migraine and headache days were significantly lower with fremanezumab treatment, and no serious treatment-related adverse events occurred. [4] Below is a summary of phase III trial. [5]

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Are we Closer to Having an Ebola Vaccine?

Shanterra Grable, Mercer University College of Pharmacy

Ebola Virus Disease (EVD), also called Ebola hemorrhagic fever, was first discovered in 1976 in South Sudan and the Democratic Republic of Congo. The transmission of Ebola can be attributed to close contact with infected persons by healthcare workers and lack of infection control precautions. Traditional burial practices that involve direct contact with the deceased can also account for Ebola transmission. It is important to note that if not treated, someone with Ebola remains infectious as long as the virus is in the person’s blood. [1] Treatment of Ebola is nonspecific and involves supportive care, rehydration with fluids, and symptom management. [2]

In March 2014, west Africa had its largest Ebola virus outbreak, and multiple countries were also affected including the United States. Although it is currently under control, the Center for Disease Control continues to search for ways to further prevent the spread of the infection such as through vaccination. [2] There are no approved Ebola vaccines or treatments available. However, a phase 2 placebo-controlled trial conducted in the height of the most recent outbreak to evaluate the safety and immune response of two new Ebola vaccines. The results were recently published and summarized below. [3]  

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The Impact of Burst Exercise on Cardiometabolic Status of Patients Newly Diagnosed with Type Two Diabetes

Julia Lvovich, Mercer University College of Pharmacy

Exercise and diet are the cornerstones of treatment for type II diabetes. With proper adherence to non-pharmacologic therapy, it is suggested that symptoms of type two diabetes and micro and macrovascular complications may be controlled. According to the American Diabetes Association (ADA), “patients should undertake at least 150 min/week of moderate to vigorous aerobic exercise spread out during at least three days during the week, with no more than two consecutive days between bouts of aerobic activity”. [1] The ADA programs typically focus on long-duration, less intense types of exercise. Sustained exercise programs are associated with reduced blood glucose levels and body mass index (BMI) and improved lipid profiles. [1]

Contrary to the ADA programs, a growing amount of studies support a movement towards high-intensity interval training (HIIT) in people with type II diabetes. High-intensity interval training is defined as alternating between high intensity exercise (≥70 maximal aerobic capacity) and rest or active recovery. [2] This method has shown to be time efficient, but it is difficult to find the right regimen due to the patient population being older, obese, sedentary, and unwilling. Continuous burst-exercise regimen is one of the high-intensity exercise methods used; however, it has not been compared to moderate intensity continuous training. The study below was conducted to fill the gap in the knowledge. [2]

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Symptomatic Treatment of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting: Randomized, Double Blind Trial

Shawn Yee, Mercer University College of Pharmacy

Antibiotic resistance with urinary pathogens such as E. coli is becoming a global concern, which may be largely attributed to inappropriate and overuse of antibiotics. Finding ways to minimize antibiotic use while still effectively treating infections is an important responsibility tasked not only to physicians but also to pharmacists to reduce antibiotic resistance. [1]

Uncomplicated lower urinary tract infections (UTI) are common in women, and about 50%  will have at least one infection in their lifetime. This infection is also commonly seen in the outpatient or ambulatory (~20%) setting, and antibiotics are the mainstay of therapy. [1,2] It is suggested symptoms of UTI may be associated with increase in proinflammatory factors such as prostaglandins, which may be alleviated with non-steroidal anti-inflammatory drugs (NSAIDs), and a previous trial showed that compared ibuprofen (NSAID) was noninferior to ciprofloxacin for symptomatic treatment in uncomplicated UTI. [1,3]

To further confirm the aforementioned trial, two larger trials were conducted. The first study compared from Germany compared fosfomycin to ibuprofen in the treatment of uncomplicated lower UTIs in women. The results showed that about two-thirds of the patients receiving ibuprofen recovered without the use of an antibiotic, and ibuprofen was somewhat effective for symptom treatment. [4] The second study from Switzerland that compared diclofenac to norfloxacin is summarized below. [1]

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