12 Jun 2018

Skip the Chemo?

Breast cancer treatments have made impressive strides in terms of increasing survival rates for patients; however, a huge new study reveals that chemotherapy may not be as important of a factor for some women with breast cancer as previously thought. In fact, in some categories of breast cancer, most patients who received chemotherapy may not have actually benefitted from it. In other words, these patients would have survived just as well without the addition of chemotherapy.

This new research, which was discussed at the American Society of Clinical Oncology and published in the New England Journal of Medicine, could lead to an overhaul of the decision making process, as experts rely on better research-based guidelines to decide which patients should (and which shouldn’t) have chemotherapy added to their plan of care.

Chemotherapy generally brings painful side effects for patients, although those can certainly be worth it if life is extended. In a decade-long study of more than 10,000 women with breast cancer, there was no benefit of chemotherapy for patients with the most common type of breast cancer. Specifically, this common type of breast cancer is characterized as hormone-receptor–positive, HER2-negative, axillary node–negative breast cancer with a midrange 21-gene recurrence score. Women with this most common breast cancer did not garner benefits from chemotherapy, as opposed to surgery and hormone therapy. (There were exceptions; however, for some younger women and some women older than age 50.)

What Does This All Really Mean?

Up to 70% of women with the most common type of breast cancer don’t need chemotherapy (which means these women can also skip the nausea, hair loss, and anemia that chemotherapy generally brings with it).

This new study adds to our understanding of breast cancer treatment and continues to create a clearer picture of how to personalize treatment based on each individual’s specific tumor qualities.

The take-away is this: each year in the U.S. there are now 70,000 women with breast cancer who might be able to skip chemotherapy and still have the same chance of beating this disease. Of course, it’s best for patients to discuss with their oncologists about what is the best course of treatment for their specific situation.

Source

Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. New Engl J Med June 3, 2018 DOI: 10.1056/NEJMoa1804710

05 Jun 2018

New Hope in Ulcerative Colitis

Xeljanz (tofacitinib) garnered a lot of interest back in 2012 when it was developed and approved for the treatment of rheumatoid arthritis. Then, in 2017, studies found that this oral medication also treated psoriatic arthritis and FDA approval was added for that indication.

Last week, yet another FDA approval for Xeljanz came: this medication now has an expanded FDA approval for adults with moderately to severely active ulcerative colitis. This makes Xeljanz the first oral prescription option for ulcerative colitis. In other words, this is big news and a potential game changer for the nearly one million Americans with this form of inflammatory bowel disease. All of the other FDA-approved treatments for chronic ulcerative colitis involve either intravenous infusion or subcutaneous injection. So, clearly, an oral alternative is welcome news to many patients.

This latest FDA approval was spurred after results from three clinical trials in patients with ulcerative colitis showed remission for patients on Xeljanz in up to 47% of patients taking the medication long term. Safety data was collected, with the more common adverse effects being diarrhea, elevated cholesterol levels, and headache. Although there are some less common adverse effects that led to Xeljanz coming with a box warning for serious infections and malignancy. Xeljanz cannot be used at the same time as biological therapies or with potent immunosuppressants (e.g., azathioprine and cyclosporine).

Inflammatory bowel diseases, which include both ulcerative colitis and Crohn’s disease, are chronic inflammatory diseases of the bowel. They can develop as a result of genetic or environmental factors (e.g., smoking, diet, or any alteration of the normal human gut flora) that trigger an immune response, which in turn creates mucosal damage to the GI tract.

Symptoms of inflammatory bowel disease range 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.

The BioPlus Specialty Pharmacy team is ready to help patients and their health care providers access Xeljanz for ulcerative colitis.

Source

Press release. FDA approves new treatment for moderately to severely active ulcerative colitis. FDA May 30, 2018.

29 May 2018

Autoimmune Diseases: Facing More Than One

Multiple sclerosis is an autoimmune disease. The family of autoimmune diseases include such diseases as lupus, rheumatoid arthritis, Crohn’s disease, type 1 diabetes, and ulcerative colitis. Unfortunately, someone with one autoimmune disease has an increased risk of also developing a second disease in this category. For example, there is a trend for someone with multiple sclerosis to be at risk for the inflammatory bowel disease of Crohn’s disease (and vice versa).

This elevated risk of several autoimmune diseases occurring in certain individuals continues to be researched. For example, recently birth cohort patterns were studied to better understand this issue. One important finding from this study was that the risk of an autoimmune disease may not only be accounted for by internal risk factors (e.g., genetics), but external factors can also be at play.

It appears that exposure to certain environmental risk factors during an early period in life can increase the risk of both Crohn’s disease and multiple sclerosis. These risk factors might be similar or even be the same factors influencing both of these diseases. Although more remains to be understood on this issue, what is currently known is that autoimmune diseases overall are more likely in those consuming a typical Western diet which is higher in salt and saturated fats (the type of fat found in animal foods, such as red meat), as well as those with certain bacterial and viral infections early in life or exposed to certain medications (e.g., procainamide or hydrolyzine).

While these connections between autoimmune diseases continues to be uncovered, one important take-away in the meantime for patients who have one autoimmune disease is this: be aware of the increased risk of developing an additional autoimmune disease. Symptoms of a second autoimmune disease should be discussed with a health care provider.

Source

Sonnenberg A, Ajdacic-Gross V. Similar birth-cohort patterns in Crohn’s disease and multiple sclerosis. Mult Scler 2018;24(2):140-149. doi:10.1177/1352458517691620.

22 May 2018

HCV Testing and Treatment: The Time is Now

There are nearly 4 million Americans with chronic hepatitis C infections, yet only 9% of them have been successfully treated, according to some estimates. The gap between these numbers becomes more shocking when paired with the fact that current hepatitis C treatments have been shown to cure 94-98% of all hepatitis C virus (HCV) genotypes. In addition, even when second-line therapies are needed for patients who failed primary therapy, those therapies are effective in 96% of patients. In other words, almost all of HCV-infected Americans can be cured!

Treating HCV patients remains a high priority because when this disease continues unchecked, it often leads to liver cancer and liver failure. Curing patients of HCV reduces all-cause mortality from 26% down to 8.9%, not to mention the improvements patients experience in terms of quality of life, ability to work, and mental health.

There are two core demographic groups comprising most of today’s HCV infections: Baby Boomers and 20-29 year olds. The former tend to have been infected many years ago in their past while the latter are often associated with more recent opioid use.

A push for greater testing in both of these two groups is warranted. Evidence suggests that only half of those with HCV are aware of their infection status. Health care providers are at the front line for getting HCV-infected patients tested and treated, which is especially important for harder-to-reach people, such as IV drug users, patients in federally qualified health centers, and other urban and rural populations.

When it comes to hepatitis C, now is clearly the time for both testing and treatment. Rely on BioPlus for the latest information in current treatments and ways to connect patients to funding sources to access treatment.

Source

Kerr CA, Aron JS. Treating chronic hepatitis C infection: A call to action for primary care providers. Medscape Jan 17, 2018.

15 May 2018

How Sweet It’s Not: Crohn’s and Splenda

More than 1.5 million Americans suffer from inflammatory bowel diseases, which include both Crohn’s disease and ulcerative colitis. Each year, another 70,000 individuals hear this diagnosis. With Crohn’s disease, the key troubling symptoms are diarrhea, abdominal pain, weight loss, and fatigue. The disease is thought to develop when the immune system mistakenly attacks the digestive system.

There are treatments to manage the disease, although a cure remains elusive. In the meantime, it can be helpful to consider one’s diet. Certain foods can trigger symptoms, although which foods are triggers can vary by individual. It can take some time and attention to determine which foods are best avoided. Although in general the following foods are commonly reported by those with Crohn’s disease to serve as triggers:

  • Alcohol
  • Oils/fats
  • Soda
  • Coffee
  • Dairy
  • High-fiber foods
  • Red meat

It can be useful to keep a food diary (including symptom tracking) to sleuth out which foods could be problematic for each individual.

Now there’s another “problem food” researchers are eyeing in terms of triggering Crohn’s flare-ups. An animal model study conducted at Case Western Reserve University School of Medicine reports that the artificial sweetener sucralose – known as Splenda – intensifies gut inflammation in animals with a disease like Crohn’s, but doesn’t cause any problems in animals without the disease. This study backs up the anecdotal reports from people with Crohn’s: about one in ten note that artificial sweeteners make them feel worse.

For now, it seems prudent for anyone with Crohn’s disease to avoid Splenda, unless they have used the artificial sweetener without negative effects. And if symptoms do develop, then Splenda should be considered as a potential trigger food.

Source

Rodriguez-Palacios A, Harding A, Menghini P, et al. The artificial sweetener Splenda promotes gut proteobacteria, dysbiosis, and myeloperoxidase reactivity in Crohn’s disease-like ileitis. Inflam Bowel Dis 2018 DOI: 10.1093/ibd/izy060

08 May 2018

Patient Access = Patient Treatment

When medications exceed the financial resources of a patient, it can create a seemingly insurmountable barrier to accessing important treatment. It’s pretty hard to get better if you can’t fill (or refill) your prescribed medications. Here at BioPlus we spend a lot of time thinking about patient access to treatment, which is why we’ve long had a patient financial assistance program to help patients overcome financial roadblocks to their treatment.

Did you know that someone with cancer is 2.5 times more likely than another person from the general population to file for bankruptcy? This is how serious the financial challenges of a health crisis can be. It gets worse, though. When severe financial distress results in bankruptcy, that itself becomes a risk factor for worsened survival times. Although there is variation, based on the type of cancer a person has, about 3% of cancer patients end up bankrupt. These patients, in turn, are nearly 80% more likely to die than non-bankrupt cancer patients.

By now you’re probably getting the idea that research clearly connects the dots between the patient portion of the cost of medication and whether or not patients can start or refill their prescriptions. Furthermore, the connection between adherence and patient outcome is clearly known: non-adherent patients face worse health outcomes and greater disease complications. And, as you also probably know, we’re in the business of helping patients get better.

Our financial assistance department is a key part of our overall service of RxExpress – which makes BioPlus faster than most other specialty pharmacies for taking a prescription from hot-off-the-prescriber’s-pad to a patient’s hands. It all starts with our 2-Hour Patient Acceptance Guarantee that streamlines the first step of the specialty pharmacy process. Our 2-Day Ready 2 Ship program follows close behind, which gets prescriptions ready to ship in just two days. The financial assistance for our patients is an integral part of this entire process.

The financial assistance department at BioPlus assists and supports patients with ways to connect with financial resources, helping patients access foundation grants and co-pay assistance programs. Looking over the past year, for example, our financial assistance team connected patients with $35 million of financial assistance, which allowed many patients with financial barriers to be able to start and continue their important treatment. We’re aiming even higher this year.

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.

Ramsey SD, Bansal A, Fedorenko CR, et al. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol 2016;34(9):980-6.

Lathan CS, Cronin A, Tucker-Seeley R, et al. Association of financial strain with symptom burden and quality of life for patients with lung or colorectal cancer. J Clin Oncol 2016 JCO632232. [Epub ahead of print]

01 May 2018

Beyond Skin: Psoriasis and Health Risks

More than 7 million Americans experience psoriasis, the skin condition that creates dry, scaly, painful, and itchy patches of skin. Typical locations for psoriasis include the joints, face, neck, trunk, arms, hands, feet, and scalp.

The problem with psoriasis does not end at the skin. One in every three people with psoriasis also develop psoriatic arthritis, in which joint pain adds to the misery of this condition. Several studies also indicate that psoriasis can be associated with a higher risk of cardiovascular disease. This unfortunate association seems to be stronger in those with more severe cases of psoriasis. This means that people with psoriasis (and their health care providers) should be particularly alert to signs of cardiovascular disease, as well as work to minimize other cardiovascular risk factors.

Similarly, new research has found that people with more severe psoriasis – such as psoriasis covering more than 10% of their body area – are at an increased risk of also developing type 2 diabetes. This association holds true in the research, even after adjusting for other diabetes risk factors, such as age, gender, and body weight. As with cardiovascular disease, people with more severe psoriasis should aim to reduce their other risk factors for type 2 diabetes.

Psoriasis is known to have a genetic component, as well as to be worsened by stress, infections, certain medications, and cold weather. Medications to treat psoriasis include:

  • topical corticosteroids
  • vitamin D analogues
  • topical retinoids
  • phototherapy
  • oral retinoids
  • methotrexate
  • cyclosporine
  • immune-mediating biologics (e.g., Enbrel, Remicade, Humira, Stelara, Otezla, Cosentyx, and Taltz)

BioPlus Specialty Pharmacy is here and ready to help psoriasis patients access medications to improve their quality of life.

Sources

Jindal S, Jindal N. Psoriasis and cardiovascular diseases: A literature review to determine the causal relationship. Cureus 2018;10(2):e2195.

Wan M, et al. Psoriasis and the risk of diabetes: A prospective population-based cohort study. J Am Acad Dermatol 2018;78:315-22.

24 Apr 2018

Become a Fish Fan

Earlier this year I wrote a blog about the benefits of a Mediterranean diet – a big component of this being regular consumption of fish – for those with rheumatoid arthritis. Anyone concerned about their risk of multiple sclerosis will also be interested to hear about how a Mediterranean diet brings benefits.

Including fish in the diet regularly could make multiple sclerosis less likely due to an anti-inflammatory effect. Research indicates that even as little as 1-3 fish meals each month, combined with daily omega-3 supplements, can reduce the chances that a person develops multiple sclerosis. Omega-3s are the healthy fats found in fish.

When researchers compare people with high and low fish intake, clear differences emerge in terms of which of them later develops multiple sclerosis. High intake, for this research, was characterized as 1 serving of fish each week plus daily omega-3 supplements. Low intake meant no supplementation and less than 1 serving of fish per month.

The high fish intake group was found to have a 45% lower risk of multiple sclerosis (as well as the similar condition called clinically isolated syndrome).

This is a remarkable benefit from eating a diet that is a sound choice for overall health. In fact, I switched to a Mediterranean diet myself more than six months ago due to the heart-healthiness of it. It was an adjustment from my prior eating style, but it wasn’t long before it became my ‘new normal’ – I made the change for my heart, but it’s great to know that my joints and risk of MS will also benefit from this diet.

Fish with the highest level of omega-3s include salmon, sardines, lake trout, and albacore tuna. Omega-3s can be found in flaxseed and walnuts for those who don’t care for fish.

Source

Press release. Eating fish may be tied to a reduced risk of MS. Am Acad Neur March 1, 2018.

17 Apr 2018

Introducing New Prostate Cancer Treatment, Available from BioPlus

A new medication has joined the ranks of potential treatment for prostate cancer. The FDA recently approved Janssen’s Erleada™ (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but continues to grow despite treatment with hormone therapy (castration-resistant). BioPlus Specialty Pharmacy can help patients get started with Erleada and support them during the treatment process.

Erleada is only available through a limited distribution network of specialty pharmacies, which now includes BioPlus. This oral medication earned FDA approval months ahead of the scheduled decision date and is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. The FDA’s fast approval turnaround of Erleada was based on clinical trials of this medication showing a 72% reduction in risk of metastasis or death. There are currently 2.9 million American men who were previously diagnosed with prostate cancer who are still alive. This medication will only be increasing this impressive number.

For men, prostate cancer remains the second most common type of cancer. Only skin cancer is more prevalent. Over the course of his lifetime, one in every seven men will develop prostate cancer and one in 39 men will die of prostate cancer. The difference in those numbers means that lots of men are surviving this disease and with Erleada now available those survival numbers should continue to go up.

Source

Press release. FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint. U.S. Food and Drug Administration February 14, 2018.

10 Apr 2018

Crohn’s Disease: Heading Toward its 100th Birthday

Could a cure for Crohn’s disease be in the future? There are several research directions that are moving forward with hopeful results, although a “cure” appears to remain an unsatisfying way in the distance. Crohn’s disease – as a specific type of inflammatory bowel disease – was first described back in 1932. As we head toward the centennial of naming this disease, researchers continue to work hard on new treatment options, as well as the long hoped for cure, by that anniversary.

Since 1932, the core treatment options for Crohn’s disease have included corticosteroids, aminosalicylates, thiopurines, and methotrexate. Only in the past two decades did new therapy agents start to appear: three tumor necrosis factor antagonists, two anti-integrins, and an anti-interleukin 12/23 antibody. Clearly, however, much work remains to be done, since as many as 25% of patients do not respond to these treatment options.

This is where an investigational once-daily, oral medication comes in: filgotinib, which is being developed by Galapagos. Filgotinib is a selective JAK1 inhibitor. JAK1 is an enzyme necessary in the inflammation process. Early research indicates effectiveness of filgotinib in the treatment of moderate-to-severe Crohn’s disease.

In one study, the group of 128 Crohn’s disease patients taking filgotinib found that 47% reached clinical remission by week 10 of treatment (compared to 23% of the placebo group). This is the most hopeful outcome that’s been seen in research for quite some time. Additional research continues to be conducted with filgotinib, including for long-term safety.

Sources

A cure for Crohn’s disease by 2032. Lancet 2017;389:226.

Ananthakrishnan AN. Filgotinib for Crohn’s disease—expanding treatment options. Lancet 2017;389:228-9.

Vermeire S, Schreiber S, Petryka R, et al. Clinical remission in patients with moderate-to-severe Crohn’s disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet 2017;389:266-75.