Tag: disease

27 Mar 2018

Manly MS Resistance?

Multiple sclerosis is often thought of as more of a female disease. This is because women are twice or even three times as likely to develop multiple sclerosis compared to men. This gender difference has led researchers to explore the influence of sex hormones in this disease.

Testosterone – which men typically have in higher amounts than found in women – is thought to play a role in this autoimmune disease of the brain and spinal cord. New research in animal models suggests that the presence of testosterone can lead to a “guardian molecule” patrolling the body. This guardian molecule is an immune compound called cytokine IL-33 that can prevent damage to the myelin sheath. In the animal research, myelin damage was even reversed by the presence of this guardian molecule. This is exciting, since myelin sheath damage leads to the movement problems and cognitive symptoms of multiple sclerosis in humans.

While it is not viable to increase testosterone levels in all women, it is possible to work on ways to activate the guardian molecule. This is an interesting new area of multiple sclerosis research that could bring real benefits in the near future to multiple sclerosis patients.

While a potential new treatment for MS related to understanding testosterone continues to be developed, there are numerous medications for this disease that are already available, including Ocrevus which was discussed this this recent blog: A Look Back at 2017’s FDA Approvals.

Source

Russi AE, el al, Male-specific IL-33 expression regulates sex-dimorphic EAE susceptibility. PNAS 2018 http://www.pnas.org/cgi/doi/10.1073/pnas.1710401115

20 Mar 2018

Hepatitis C and Diabetes: A Complicated Relationship

Guest blog by: Erica Yelton, Pharm.D., CSP, Pharmacy Center Manager, BioPlus Specialty Pharmacy

Hepatitis C and diabetes are both prevalent, global diseases with long-term implications in terms of morbidity and mortality. The World Health Organization reports that 170 million people are infected with hepatitis C and 347 million people suffer with diabetes. Most studies show that patients with hepatitis C are more susceptible to developing type 2 diabetes. It is estimated that up to 33% of chronic hepatitis C patients have type 2 diabetes. The connection between these diseases is seen in both developed and developing countries. The central component of developing insulin resistance is the intense inflammatory response to the hepatitis C virus (HCV) which disrupts the insulin signaling pathway. Also, inflammation causes pro-inflammatory cytokines to be released causing damage to beta cells. Beta cells are the producers of insulin in response to glucose. Studies have shown that HCV can directly and indirectly induce beta cell dysfunction.

On the reverse side, patients with type 2 diabetes are at a higher risk for complications from HCV. Patients with HCV and insulin resistance have been shown to have significantly worse outcomes. Some of these include decreased SVR rate, increased progression of fibrosis and cirrhosis, and increased risk of hepatocellular carcinoma. When insulin is increased, which happens in those with insulin resistance, it stimulates hepatic stellate cells which produce nonfunctional matrix and scarring, AKA fibrosis. This occurs in a dose dependent fashion. Insulin resistance also causes increased release of fatty acids from adipose and increased lipid deposition both of which are associated with fibrosis. Patients with diabetes are also at an increased risk for various malignancies including hepatocellular carcinoma. Insulin, insulin-like growth factor, and chronic inflammation have all been implicated in carcinogenesis.

To further complicate the scenario, interferon, which was once the mainstay treatment for HCV, is now known to cause type 1 diabetes! Interferon is a known potent immunomodulator and can contribute to autoimmunity. In most cases studied of patients who developed type 1 diabetes, the onset occurred during or shortly after treatment with interferon. To date, there are greater than 45 known cases. It is important to suspect type 1 diabetes in patients who present with polydipsia and polyuria after treatment with interferon. Since treatment regimens now steer away from interferon, it may be that the rate of type 1 diabetes as a complication of treatment decreases.

On one hand, HCV triggers diabetes and on the other hand, diabetes worsens hepatitis C outcomes. It is recommended to screen for diabetes in all HCV-infected patient regardless of age or medical history and especially important in patients with known autoimmune conditions. The complicated relationship between these two disease states will have to be addressed until hepatitis C is eradicated and even then, the lasting effects of complications will still have to be dealt with.

Source: Hammerstad SS, Grock SF, Lee HJ, et al. Diabetes and hepatitis C: a two-way association. Frontiers Endocrin 2015;14(6):134.

06 Mar 2018

Personalizing Crohn’s Disease Treatment

Guest blog by: Marianne Shenouda, Pharm.D., Clinical Pharmacy Specialist, BioPlus Specialty Pharmacy

Inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis, are chronic inflammatory diseases of the bowel. These diseases can develop as a result of genetic or environmental factors, such as smoking, diet, or any alteration of the normal human gut flora. These factors spur a progressive immune response, which in turn creates mucosal damage to the GI tract.

Symptoms of inflammatory bowel disease run the gamut from diarrhea, abdominal pain, and perianal fistulas to fatigue, weight loss, and/or bowel obstruction. While ulcerative colitis is more closely associated with changes to the inner lining of the colon, Crohn’s disease can affect any segment of the gastrointestinal tract: all the way from mouth to anus.

Treatment for Crohn’s disease focuses on two main types of medications: anti-inflammatory agents and biological treatments. The biological treatments include many medication options: Humira, Remicade, Cimzia, Stelara, Entyvio, and Tysabri. These medications work to alter the immune response of the immune system, by targeting specific proteins that cause inflammation. Humira, for example, targets a protein called TNF-alpha.

Crohn’s disease biological medications can bring great benefits to patients; but unfortunately it is not uncommon for a particular medication to become less effective over time. However, monitoring certain elements of the immune system can guide future treatment. Specifically, monitoring levels of adalimumab antibodies (ATAs) can allow determination if a patient needs a dose increase or if it is appropriate for the patient to switch to another medication within the same drug class. It appears that low trough concentrations may be reflective of a loss of response to Humira (trough levels less than or equal to 5 mcg/ml). In this case, testing for antibodies is suggested. For trough concentrations above 5 mcg/ml, the presence of antibodies are not likely, so the patient may benefit from an increased dose. It was also suggested that adalimumab concentration results above 35 mcg/mL should be drawn at a different time-point other than trough.

Overall ATA testing could lead to a more appropriate and cost-effective management strategy for patients with Crohn’s disease, which is part of an overall move to more personalized treatment of disease.

Sources:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991576/

https://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/64863

20 Feb 2018

Understanding NAFLD and NASH

Guest blog by: Monica Morgan, Pharm.D., CSP

As a specialty pharmacy that works with many patients during treatment for liver diseases, it’s not surprising that questions about nonalcoholic fatty liver disease (NAFLD) come up in our line of work. Although hepatitis C is our primary liver focus, both hepatitis C and NAFLD rank as the two most common causes of chronic liver disease. I’ll be sharing here about why NAFLD deserves some attention and understanding.

What are NAFLD and NASH?

NAFLD is a serious condition in which abnormal amounts of fat build up inside the liver. It’s likely that lifestyle and diet contribute to this process. Nonalcoholic steatohepatitis (NASH) is a type of NAFLD that causes inflammation and liver cell damage, along with fatty build-up in the liver. NASH can progress to scarring of the liver and ultimately to cirrhosis, with all the complications of cirrhosis (e.g., gastrointestinal bleeding, mental changes, liver failure, and liver cancer).

Can we treat NAFLD and NASH?

One of the first things that doctors currently recommend for improving the symptoms and outcomes in NAFLD is to lose weight, as this can reduce fat in the liver, inflammation, and fibrosis. Doctors recommend gradually losing 7 percent (or more) of your body weight over the course of a year or more. This gradual loss is important since rapid weight loss through very low calorie diets or fasting (eating and drinking nothing but water) can actually make NAFLD worse.

No medications have yet been approved to treat NAFLD and NASH; however, there are many therapies in the pipelines that could soon improve the outlook for these patients. Currently, there are varying degrees of success with off-label medications, endoscopic interventions, and bariatric surgery. But researchers are working hard to find other, more reliable treatment options.

There are an estimated 800 clinical trials of potential disease therapies in the works, including trials of the medications cenicriviroc from Allergan, selonsertib from Gilead Sciences, obeticholic acid from Intercept, elafibranor from Genfit, and Emricasan from Conatus Pharmaceuticals. There is hope that within the next couple of years we will have one (or more) FDA-approved treatment options for NAFLD and NASH.

Sources:

https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash

https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/treatment

https://www.medscape.com/viewarticle/872690

https://www.medicinenet.com/fatty_liver/article.htm

16 Jan 2018

Cost Concerns

The financial hardships of a serious illness can be daunting. Even for those with health insurance, the medical bills and pharmacy costs can accumulate, along with a potential loss of income while treating and recovering from a disease.

In a recent survey of nearly 500 people after successful colorectal cancer treatment, financial challenges were reported by four in 10 patients. This same proportion of people similarly noted that their concerns about home finances created stress, which of course piled on to the stress of facing cancer. These financial stressors correlated with a decrease in quality of life for patients.

Study after study shows that the financial burdens of treating serious health problems does in fact impact quality of life and even health outcomes. This financial burden – which is often referred to as financial toxicity – is a growing concern for patients and their families. In fact, patients may even delay treatment due to cost concerns. In one survey of 609 individuals with chronic hepatitis C, fully one-third were not currently being treated specifically due to cost concerns. This is unacceptable.

Overcoming financial challenges is one of the ways BioPlus Specialty Pharmacy supports our patients during the treatment process. Our patient financial assistance department works to ensure that financial barriers are overcome so patient treatment can both start and continue. In just three quarters of 2017 we connected oncology patients with $30 million in patient assistance, in the form of grants, co-pay assistance, and donations. We take our responsibility seriously in assisting and supporting patients with ways to connect with financial resources. In short, we aim to resolve financial toxicity issues while treating a patient’s disease.

Sources

Sharp L, O’Leary E, O’Ceilleachair A, Skally M, Hanly P. Financial impact of colorectal cancer and its consequences: associations between cancer-related financial stress and strain and health-related quality of life. Dis Colon Rectum 2018;61:27-35.

Survey: Hepatitis C patients delay treatment due to cost concerns. Health UnionOctober 4, 2017.