Month: December 2020

Psoriasis is a chronic disease in which skin cells rapidly divide, causing the skin to develop rough, red, scaly patches. Plaque psoriasis is the most common form: affected skin has sharply defined, inflamed patches (plaques) with silvery or white scales, often near an elbow or on the shins and trunk.

The cause of psoriasis isn’t known, but there are a number of treatment options. Possibly you’ve seen a glossy, happy ad for one of these treatments, a drug called Skyrizi. It’s been in heavy rotation and in 2020, hit number four on a top 10 list for ad spending by a drug company.

Splashing in blue water

A woman in a bathing suit sprints down a dock and jumps into the water with several friends. There’s lots of smiling and splashing. A voiceover says “I have moderate to severe plaque psoriasis. Now, there’s Skyrizi. Three out of four people achieved 90% clearer skin at four months after just two doses.”

Then, the voiceover moves to warning mode: “Skyrizi may increase your risk of infections and lower your ability to fight them. Before treatment your doctor should check you for infections and tuberculosis. Tell your doctor if you have an infection or symptoms such as fever, sweats, chills, muscle aches, or cough, or if you plan to or recently received a vaccine.”

As these warnings are delivered, we’re treated to uplifting pop music — “nothing is everything,” a woman sings — while attractive young people flail about in the water.

“Ask your doctor about Skyrizi,” a voice instructs. Did I mention a plane is skywriting the drug’s logo? I guess it’s putting the “sky” in Skyrizi.

What is Skyrizi?

Skyrizi (risankizumab) is an injectable medication that counteracts interleukin-23, a chemical messenger closely involved in the development of psoriasis. The standard dosing is two injections to start, followed a month later by two injections once a month, and then two injections once every three months.

Did you catch that “injectable” part? This is not a pill. If you missed that point while watching the commercial, it’s not your fault. The word “injection” appears once, written in faint letters at the very end of the commercial.

By the way, the FDA has only approved this drug for moderate to severe — not mild — plaque psoriasis. The studies earning approval enrolled people with psoriasis on at least 10% of their skin and two separate measures of severity.

What the ad gets right

• The ad states that 75% of people with moderate to severe psoriasis experienced 90% clearance of their rash within four months after only two doses of Skyrizi. This reflects the findings of research studies (such as this one) that led to the drug’s approval.
• The recommendations regarding screening for infections (including tuberculosis) and telling your doctor if you’ve gotten a recent vaccine are appropriate and should be standard practice. By lowering the ability to fight infection, this drug can make current infections worse. It may reduce the benefit of certain vaccines, or increase the risk of infection when a person gets a certain type of vaccine called a live-attenuated vaccine.

And the theme song? People with visible psoriasis often cover up their skin due to embarrassment or stigma. The rash isn’t a contagious infection or a reflection of poor health, but other people may react as if it is. So, an effective treatment could potentially allow some to forego covering up and show more skin: it means “everything” to someone suffering with psoriasis to cover “nothing.” Thus, a theme song is born.

What else do you need to know?

A few things about this ad may be confusing or incomplete, including:

• Currently, each dose of Skyrizi is actually two injections. So, a more accurate way to summarize its effectiveness would be to say that improvement occurred within four months after four injections (rather than “just two doses”).
• Like most newer injectable medications, this one is quite expensive: a year's supply could cost nearly $70,000. The drug maker offers a patient assistance program for people with low income or limited health insurance, but not everyone qualifies. Health insurance plans generally require justification from your doctor for medications like Skyrizi, and your insurer may decide not to cover it. Even if covered, this prior approval process can delay starting the medication, which may still be expensive due to copays and/or deductibles.
• There is no mention of the many other options to treat psoriasis, some of which are far less costly. These include medications that do not have to be injected (such as oral methotrexate or apremilast), and UV light therapy (phototherapy). And there are other injectable medications. So, ask your doctor about the best options for you.

The bottom line

Some people appreciate the information provided by medication ads. Others favor a ban on such advertising, as is the case in most other countries. And recently, two advocacy groups asked the FDA not to allow drug ads to play music when the risks of drug side effects are presented, arguing that it distracts consumers from focusing on this important information.

Since these ads probably are not going away anytime soon, keep in mind that they may spin information in a positive light and leave out other important information altogether. So, be skeptical and ask questions. Get your medication information from your doctor or another unbiased, authoritative source, not a company selling a product.

Regardless of how you feel about medical advertising, it’s hard to hate the Skyrizi theme song. Feel free to sing along.

In the US, breast cancer is the most commonly diagnosed cancer in women, and the second leading cause of cancer-related deaths. Each year, an estimated 270,000 women — and a far smaller number of men — are diagnosed with it. When caught in early stages, it’s usually highly treatable.

A promising new form of targeted treatment may expand options available to some women with early-stage breast cancer linked to specific genetic glitches. (Early-stage cancers have not spread to distant organs or tissues in the body.)

The BRCA gene: What does it do?

You may have heard the term BRCA (BReast CAncer) genes, which refers to BRCA1 and BRCA2genes. Normally, BRCA genes help repair damage to our DNA (genetic code) that occurs regularly in cells throughout the human body.

Inherited BRCA mutations are abnormal changes in these genes that are passed on from a parent to a child. When a person has a BRCA mutation, their body cannot repair routine DNA damage to cells as easily. This accumulating damage to cells may help pave a path leading to cancer. Having a BRCA1 or BRCA2 mutation — or both — puts a person at higher risk for cancer of the breast, ovaries, prostate, or pancreas; or for melanoma. A person’s risk for breast cancer can also be affected by other gene mutations and other factors.

Overall, just 3% to 5% of all women with breast cancer have mutations in BRCAgenes. However, BRCA mutations occur more often in certain groups of people, such as those with triple negative breast cancer (TNBC), Ashkenazi Jewish ancestry, a strong family history of breast and/or ovarian cancer, and younger women with breast cancer.

Inherited BRCA mutations and breast cancer types

Certain types of breast cancer are commonly found in women with BRCA gene mutations.

• Estrogen receptor-positive, HER2-negative cancer: Women with a BRCA2 mutation usually develop ER+/HER2- breast cancer — that is, cancer cells that are fueled by the hormone estrogen but not by a protein known as HER2 (human epidermal growth factor 2).
• Triple negative breast cancer: Women with a BRCA1 mutation tend to develop triple negative breast cancer (ER-/PR-/HER2-) — that is, cancer cells that aren’t fueled by the hormones estrogen and progesterone, or by HER2.

Knowing what encourages different types of breast cancer to grow helps scientists develop new treatments, and helps doctors choose available treatments to slow or stop tumor growth. Often this involves a combination of treatments.

A new medicine aimed at early-stage BRCA-related breast cancers

The OlympiA trial enrolled women with early-stage breast cancer and inherited BRCA1/BRCA2 mutations. All were at high risk for breast cancer recurrence despite standard treatments.

Study participants had received standard therapies for breast cancer:

• surgery (a mastectomy or lumpectomy)
• chemotherapy (given either before or after surgery)
• possibly radiation
• possibly hormone-blocking treatment known as endocrine therapy.

They were randomly assigned to take pills twice a day containing olaparib or a placebo (sugar pills) for one year.

Olaparib belongs to a class of medicines called PARP inhibitors. PARP (poly adenosine diphosphate-ribose polymerase) is an enzyme that normally helps repair DNA damage. Blocking this enzyme in BRCA-mutated cancer cells causes the cells to die from increased DNA damage.

Results from this study were published in the New England Journal of Medicine. Women who received olaparib were less likely to have breast cancer recur or metastasize (spread to distant organs or tissues) than women taking placebo. Follow-up at an average of two and a half years showed that slightly more than 85% of women who had received olaparib were alive and did not have a cancer recurrence, or a new second cancer, compared with 77% of women treated with placebo.

Further, the researchers estimated that at three years:

• The likelihood that cancer would not spread to distant organs or tissues was nearly 88% with olaparib, compared to 80% with placebo.
• The likelihood of survival was 92% for the olaparib-treated group and 88% for the placebo group.

The side effects of olaparib include low white cell count, low red cell count, and tiredness. The chances of developing these were low.

The bottom line

Olaparib is already approved by the FDA to treat BRCA-related cancers of the ovaries, pancreas, or prostate, and metastatic breast cancer. FDA approval for early-stage breast cancer that is BRCA-related is expected soon based on this study. These findings suggest taking olaparib for a year after completing standard treatment could be a good option for women who have early-stage breast cancer and an inherited BRCA gene mutation who are at high risk for cancer recurrence and, possibly, its spread.

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