Aquascaperepair

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.

Get expert advice on gathering safely from Harvard Health Publishing. Spoiler alert: vaccination is key to helping keep everyone healthy. Below, our faculty contributors share their own plans and advice for safely enjoying the holidays this year while answering three important questions.

Roger Shapiro, MD

Associate professor of immunology and infectious diseases, Harvard T.H. Chan School of Public Health, Boston

What are your plans this year for gathering — or not gathering — with family or friends during Thanksgiving and other winter holidays, and why?

Unlike 2020, my family will be gathering for Thanksgiving in 2021. Everyone in the family is vaccinated, and most are now boosted as well. We are all comfortable with the protection that being vaccinated brings, and there is agreement that if a COVID-19 exposure were to occur, it is unlikely to cause severe illness.

What advice can you offer people planning to gather in person to reduce the chance of getting or spreading the virus that causes COVID-19?

Everyone who can get vaccinated should be vaccinated, and those who qualify for a booster should get one. Children 5 to 11 may not have their second shot by Thanksgiving but can certainly be fully vaccinated by Christmas. If there are unvaccinated members of your family, your situation is no different than in 2020: gathering is unsafe for the unvaccinated because the first exposure to this virus can be lethal without protection from a vaccine. Additionally, people who are unvaccinated are more likely to be infected before traveling, so they are more likely to bring the virus to the table, possibly causing illness (even if mild) among those who are vaccinated. For families that are all vaccinated and wishing to further reduce the possibility of transmission, taking a rapid antigen test prior to gathering can add a layer of protection.

For people planning to travel to gatherings, what would you advise?

If you are all vaccinated, enjoy the return to a normal holiday season. Vaccines are your main source of protection. If you want to add additional protection, you can consider using rapid antigen tests just before gathering to confirm that everyone is negative. If there are immunocompromised members of your family who may not be fully protected by a vaccine, you should discuss the risks case-by-case with your doctor.

Suzanne Salamon, MD

Chief of clinical programs in gerontology, Beth Israel Deaconess Medical Center, Boston

What are your plans this year for gathering — or not gathering — with family or friends during Thanksgiving and other winter holidays, and why?

Let me start by saying my 99-year-old mother lives with us, and even though she’s had her third shot of the COVID vaccine, I’m very concerned about immune status. I also have a two-year-old granddaughter who cannot yet get the vaccine. So, everyone’s immune status is not equal. Certainly older people, even those who’ve had their third shot, may not have the same immune status as a 35-year-old.

We have really curtailed the size of our Thanksgiving dinner to under 10 people, since the CDC recommends smaller groups. Nobody wants to see people sitting at home alone during the holidays, but we have to make it as safe as possible for those who are there.

What advice can you offer people planning to gather in person to reduce the chance of getting or spreading the virus that causes COVID-19?

COVID cases are on the rise now in many places, even though a month ago the numbers were trending down. Unfortunately, we need to be more vigilant once again.

Many people are afraid to insult family and friends by asking them about vaccine status before they come. Tell people that you really want to see them, but some family or friends may be immune-suppressed or at higher risk if they get COVID-19, and you’re trying to make the gathering safe for everyone. That’s why I’d ask people to let you know their COVID vaccine status. Even after the two-vaccine series, research is showing diminished antibodies after six months, which may put people at higher risk for getting and/or spreading the virus. I would ask people who are not vaccinated not to come.

When people gather, ventilation is really important in reducing the concentration of any virus that might be present. Have the gathering outside or on a screened porch, if at all possible. We hosted Thanksgiving last year in our garage. We left the garage doors open and set up small tables and little space heaters for warmth. People could be social yet stay separated, and ventilation was great. You can decorate small tables with colorful plastic tablecloths and candles, even put down a rug. If you’re inside, windows and doors can be kept open, which will help move the air around. Have some small space heaters and sweaters available.

Ask everyone to bring a mask, or keep a box of masks available. Wear masks while you’re all chit-chatting until you sit down to dinner. In the bathroom, have a roll of paper towels or paper guest towels rather than a cloth towel, and leave the fan on for ventilation.

For people planning to travel to gatherings, what would you advise?

Planes are thought to be very safe. In the air terminal, sit apart from people. Keep your mask on during the flight.

Traveling by car is pretty safe. If you get out to go to the bathroom or get coffee, wear a mask and wash your hands. Traveling by bus or train is tricky, because even though there is a mask requirement, people will take off their masks. Be sure to wear your own mask. I personally double-mask. Two surgical masks block out a lot and can be a bit more comfortable than the N95 masks we wear in the hospital. A plastic face shield over the mask may be a good idea for added protection.

John J. Ross, MD

Hospitalist with specialty in infectious diseases, Brigham and Women’s Hospital, Boston

What are your plans this year for gathering — or not gathering — with family or friends during Thanksgiving and other winter holidays, and why?

We are having an unmasked, multigenerational, fully-vaccinated, traditional Thanksgiving dinner at my in-laws, just like the Before Times.

What advice can you offer people planning to gather in person to reduce the chance of getting or spreading the virus that causes COVID-19?

Everyone in attendance should have a primary COVID vaccination. Getting vaccinated against COVID reduces the risk of hospitalization or death due to COVID by more than 90%. It also reduces your risk of death from any cause. People who are eligible for booster shots should get them. That includes anyone over 65, and people over 18 with underlying medical conditions, high occupational risk, or those who live in high-risk settings such as group homes, shelters, and long-term care facilities.

Certain vaccinated people are more likely to get breakthrough COVID. This includes people of advanced age, and those with serious medical conditions or weak immune systems. These people should be extremely cautious around those who are not vaccinated or partly vaccinated. I would recommend that they mask around unvaccinated people, physically distance, and use extra ventilation (opening windows, or ideally moving the whole shebang outdoors). Rapid antigen tests may also be helpful in the setting.

For people planning to travel to gatherings, what would you advise?

For those who have long distances to travel, I would recommend flying if possible. Airplanes have excellent ventilation, and masks are mandatory. While masks are also required on trains, they are not as well ventilated as planes, and train travel has been associated with significant COVID risks.

Amy Sherman, MD

Division of infectious diseases, associate physician, Brigham and Women’s Hospital, Boston

What are your plans this year for gathering — or not gathering — with family or friends during Thanksgiving and other winter holidays, and why?

This Thanksgiving, my fiancé and I are driving to New Jersey and New York (with our dog!) to visit our families. We will have dinner with 14 others from my close family — larger than last year’s Thanksgiving, but smaller than pre-COVID years. Everyone has been vaccinated, and most have received a third dose. We will then visit with my fiancé’s 94-year-old-grandma, choosing to see her independently instead of bringing her to a large gathering.

Although no measures can absolutely make an indoor gathering 100% safe, we will apply layers of protective measures to reduce risk, with vaccinations as the base layer. Additionally, everyone will get tested for the virus that causes COVID-19 before gathering, limit exposure risks in the week before Thanksgiving, avoid public transportation, and drive instead of flying. When we’re together, we’ll spend time outdoors as much as possible. Maybe this year will bring new traditions — an outdoor bonfire instead of nighttime movie marathons, or Friday morning jogs instead of Jazzercise with my aunt!

What advice can you offer people planning to gather in person to reduce the chance of getting or spreading the virus that causes COVID-19?

We are in a much better place this year compared to last year. Connecting with family and friends is important for our mental health and well-being. However, we still need to be cautious, especially when gatherings include people who are older, immunocompromised, or at risk of severe COVID-19. We also have seen recent outbreaks in school-age kids who are not yet vaccinated. I would encourage your family and friends to get vaccinated if they haven’t already. For those family members at higher risk, consider smaller and more intimate gatherings, or do hybrid in-person/Zoom meetings. And layer up with the other risk reducing strategies I suggested!

For people planning to travel to gatherings, what would you advise?

Avoid public transportation if possible. If this is not possible, wear a mask on the bus, train, or airplane, even if you’ve been vaccinated. Vaccinations decrease the severity of disease, but you still could become infected and transmit the virus to others.

Read more advice on gathering for winter holidays this year, such as who can and should get a COVID-19 vaccine booster, whether to take a rapid test or PCR test before spending time with family or friends, how to navigate tricky relationships, and healthy eating through the holiday season.

How well are you protecting yourself against heart disease, the nation’s leading cause of death? A check of five important numbers can give you a good idea.

“For my patients, I typically look at their blood pressure, blood sugar, LDL cholesterol and triglycerides values, and their waist circumference,” says Harvard Heart Letter editor-in-chief Dr. Deepak L. Bhatt, who directs interventional cardiovascular programs at Harvard-affiliated Brigham and Women’s Hospital. Those values provide a picture of a person’s overall health and, more specifically, what factors they may need to address to lower their chance of a heart attack or stroke, he says.

Below are the ideal values for each measurement, along with why they’re important and targeted advice for improving them. Universal suggestions for improving all five measurements appear at the very end.

How do your heart health numbers stack up?

While the ideal values are good goals for most people, your doctor may recommend different targets based on your age or other health conditions.

Blood pressure

Less than 120/80 mm Hg

Blood pressure readings tell you the force of blood pushing against your arteries when your heart contracts (systolic blood pressure, the first number) and relaxes (diastolic blood pressure, the second number). Your blood pressure reflects how hard your heart is working (when you’re resting or exercising, for example) and the condition of your blood vessels. Narrowed, inflexible arteries cause blood pressure to rise.

Why it matters to heart health: High blood pressure accelerates damage to blood vessels, encouraging a buildup of fatty plaque (atherosclerosis). This sets the stage for a heart attack. High blood pressure forces the heart’s main pumping chamber to enlarge, which can lead to heart failure. Finally, high blood pressure raises the risk of strokes due to a blocked or burst blood vessel in the brain.

What helps: A diet rich in potassium (found in many vegetables, fruits, and beans) and low in sodium (found in excess in many processed and restaurant foods); minimizing alcohol.

LDL cholesterol

Less than 100 mg/dL

A cholesterol test (or lipid profile) shows many numbers. Doctors are usually most concerned about low-density lipoprotein (LDL) cholesterol, particles that makes up about two-thirds of the cholesterol in the blood.

Why it matters to heart health: Excess LDL particles lodge inside artery walls. Once there, they are engulfed by white blood cells, forming fat-laden foam cells that make up atherosclerosis.

What helps: Limiting saturated fat (found in meat, dairy, and eggs) and replacing those lost calories with unsaturated fat (found in nuts, seeds, and vegetable oils).

Triglycerides

Less than 150 mg/dL

Perhaps less well-known than cholesterol, triglycerides are the most common form of fat in the bloodstream. Derived from food, these molecules provide energy for your body. But excess calories, alcohol, and sugar the body can’t use are turned into triglycerides and stored in fat cells.

Why it matters to heart health: Like high LDL cholesterol, elevated triglyceride values have been linked to a higher risk of heart attack and stroke.

What helps: Limiting foods that are high in unhealthy fats, sugar, or both; eating foods rich in omega-3 fatty acids (such as fish); avoiding alcohol.

Blood sugar

Less than 100 mg/dL

High blood sugar defines the diagnosis of diabetes. Type 2 diabetes is most common. It occurs when the body develops insulin resistance (insulin enables cells to take in sugar) and does not produce enough insulin to overcome the resistance.

Why it matters to heart health: High blood sugar levels damage blood vessel walls and cause sugar (glucose) to attach to LDL. This makes LDL more likely to oxidize — another factor that promotes atherosclerosis. Excess sugar in the blood also makes cell fragments called platelets stickier so they’re more likely to form clots, which can trigger a heart attack or stroke.

What helps: Avoiding sugary beverages and foods high in sugar; eating whole, unprocessed grains instead of foods made with refined grains (white flour, white rice).

Waist circumference

Whichever number is lower:

Less than half your height in inches

OR

Women: Less than 35 inches

Men: Less than 40 inches

Measure your waist around your bare abdomen just above your navel (belly button). A big belly — what doctors call abdominal or visceral obesity — usually means fat surrounding internal organs.

Why it matters to heart health: Visceral fat secretes hormones and other factors that encourage inflammation, which triggers the release of white blood cells involved in atherosclerosis.

What helps: Consuming fewer calories, especially those from highly processed foods full of sugar, salt, and unhealthy types of fat.

Universal advice to improve all five measures of heart health

If one or more of your numbers is above ideal levels, you’re far from alone. Most Americans are overweight or obese and have bigger-than-healthy bellies. Excess weight and waist circumference affect blood pressure, LDL cholesterol, triglycerides, and blood sugar. Eating a healthy, plant-based diet can help. Regular exercise also helps: aim for at least 30 minutes of moderate-intensity exercise like brisk walking most days. Other lifestyle habits that can lower your heart disease risk include getting seven to eight hours of sleep nightly and managing your stress level.

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.

Follow me on Twitter @NeelamDesai_MD