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Atopic dermatitis: Rinvoq gains FDA approval

  • In mid-January, the Food and Drug Administration (FDA) approved Rinvoq to treat people aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who do not respond to or cannot take other systemic medications.
  • Half of those with moderate-to-severe AD taking Rinvoq in clinical trials experienced almost clear or clear skin after 16 weeks and significant itch reduction.
  • However, some common side effects observable in clinical trials include infections affecting the nose or throat, acne, herpes infections, low white blood cell count, and nausea.
  • Due to safety data with Xeljanz indicating an increased risk of health issues, the FDA issued a black box warning to inform individuals taking Rinvoq of these potential side effects, as the two drugs work similarly in the body.

AD is a common disease in the United States, affecting an estimated 10% of people. Sometimes, AD goes away after childhood, but other individuals may have lifetime symptoms.

It is a chronic disease due to an overactive immune system affecting the skin barrier.

Although experts do not entirely understand what causes AD, they believe genetic and environmental factors both play a part.

Dr. Tien Nguyen, FAAD, a board certified dermatologist at First OC Dermatology in California, in an interview with Medical News Today, explained:

“The most common problem with AD is dry skin. It’s the itch that drives the rash, and the rash makes you itch more — you […] wind up having secondary infections and cannot have a good night’s sleep.”

Triggers, such as stress, exposure to pollen or pet dander, or skin irritants, including household cleaners, may cause worsening of symptoms or a disease flare.

Unmet treatment need

Although there is no cure, treatment recommendations depend on disease severity. For those with mild AD, dermatologists recommend stress reduction, a nutritious diet, getting enough sleep, baths, regular use of moisturizers, and avoiding triggers as a first step.

If there is an inadequate response, dermatologists treat atopic dermatitis with skin medications, such as corticosteroids, nonsteroidal topicals, such as crisaborole ointment (Eucrisa), pimecrolimus cream (Elidel), tacrolimus ointment (Protopic), or coal tar.

Ultraviolet light therapy, or phototherapy, can help people whose AD does not respond to topical prescription medications.

In those with moderate-to-severe AD, prescription topicals and phototherapy alone may not suppress symptoms, requiring the use of drugs that work throughout the body, or “systemic therapies.”

The common systemic therapies for treating moderate-to-severe AD include an injectable medication called dupilumab (Dupixent) and oral immune-suppressing medications, such as cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil.

Even though systemic therapies are effective, some people with severe disease may not find them effective. They may also experience side effects that impact their quality of life. This unmet need led to the approval of a new class of oral medications to treat refractory, moderate-to-severe AD.

How effective is Rinvoq?

On January 14, 2022, the FDA approved Rinvoq to treat people aged 12 years and older with refractory, moderate-to-severe AD who do not respond to or cannot take previous oral or injectable systemic medications.

Rinvoq is an oral medication that belongs to the Janus kinase (JAK) inhibitor class. Rinvoq had previous approval to treat rheumatoid arthritis and psoriatic arthritis.

JAK inhibitors limit the production of immune system signaling proteins called “cytokines,” which drive the overactive immune response observable in AD. The FDA approved Rinvoq based on the effectiveness and safety results from the Measure Up 1, Measure Up 2, and AD Up clinical trials.

Measure Up 1 and Measure Up 2 included people with moderate-to-severe AD aged 12 years and older from many clinical centers worldwide. Researchers randomly assigned participants to receive 15 milligrams (mg) of Rinvoq orally, 30 mg of Rinvoq orally, or a placebo for 16 weeks.

After 16 weeks, compared with placebo, a significantly higher percentage of participants in the Rinvoq groups achieved a:

  • 75% decrease in the Eczema Area and Severity Index (EASI-75) score — a higher score indicates a greater extent and severity
  • clear or almost clear skin as defined by the Validated Investigator’s Global Assessment for Dermatitis score
  • four-point or more improvement in itch severity scale based on the Worst Pruritis Numerical Rating Scale

Researchers used a similar study design in AD up, except that all participants received topical corticosteroids in addition to Rinvoq or a placebo for 16 weeks.

In the third trial — AD up — the results mirrored those obtained in the first two.

Dr. Nguyen explained, “[After] 16 weeks on [Rinvoq], about half of the patients were clear to almost clear (versus placebo). The data shows substantial itch relief as early as the second week on the trunk.”

How safe is Rinvoq?

Some of the most common side effects observable in clinical trials include nose or throat infections, acne, herpes infections, low white blood cell count, nausea, increased creatinine phosphokinase (a measure of muscle damage), allergic reactions, weight gain, and flu-like symptoms.

Safety data from trials of tofacitinib (Xeljanz) — a drug that works similarly to Rinvoq — shows an increased risk of heart attack, stroke, cancer, blood clots, and death. Long-term safety data is not yet available for Rinvoq.

For this reason, the FDA placed a black box warning, the strongest FDA warning available, on Rinvoq. This warning requires the manufacturer to inform people using this medication of these potential side effects.

Dr. Nguyen explained to MNT, “[Since Rinvoq] is an immunosuppressant, we have to screen for any active infection such as silent hepatitis, latent tuberculosis, [or] ongoing underlying malignancy. We need baseline blood tests to make sure that everything is okay.”

He added, “The frequency of the blood monitoring depends if there’s any abnormality in any labs, including elevated lipids and abnormal liver functions. Even with completely normal labs, […] the FDA recommends quarterly labs […] to be prescribed and monitored by a competent provider.”

Shared decision-making

In addition to recommended lab monitoring, appropriate patient selection and shared decision-making are essential to minimize the risks of Rinvoq therapy.

Dr. Eric L. Simpson, MCR, a professor of dermatology and director of clinical research in the Department of Dermatology at Oregon Health & Science University in Portland, explains in a National Eczema Association webinar:

“JAK inhibitors all improve itch rapidly within days, the skin rash, and the quality of life. For some of these severe patients, it can be extremely helpful. [However,] if they have a history of blood clots, history of cancer, or a history of severe infection needing hospitalization, I may not use a JAK inhibitor.”

He adds, “But if I have an otherwise healthy person that hates shots or [is] not doing well with Dupixent (dupilumab), I think a JAK inhibitor makes […] sense. Because I’m giving those patients cyclosporine, methotrexate, prednisone [and] I feel they’re safer and more effective [than those].”

Dr. Simpson emphasizes the importance of talking with a healthcare professional about long-term safety risks of shingles, serious infection, malignancy, cardiac problems, and blood clots.

He adds, “Dermatologists need to help our patients understand these rare risks and benefits. They could provide […] really great benefits — we just need to learn how to use them safely.”

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