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Key drug for rheumatoid arthritis and severe covid is in short supply

2021-09-01T00:36:19.945Z


The advance of the pandemic causes a great shortage of Actemra, a drug that treats rheumatoid arthritis and severe COVID-19.


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(CNN) -

Renée Melendez has more reason to be frustrated with the unvaccinated than the renewed spread of Covid-19.


This Virginia woman says that she and her entire family got vaccinated as soon as the vaccine was available to them.

You are immunosuppressed and susceptible to becoming seriously ill if you catch COVID-19.

She has lupus and rheumatoid arthritis, and it is these illnesses that add an extra layer to her frustration and anger.

To keep the symptoms of her rheumatoid arthritis under control, so she can function every day, once a month she is infused with a biologic called Actemra, also known as tocilizumab.

But now, due to the pandemic and the recent increase in cases, it is not available.

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"We did our part to protect ourselves, our community, by trying to help combat this by getting vaccinated," Meléndez said.

"It is unfortunate that the ignorance and laziness, for lack of better words, of other people who avoided getting vaccinated and ended up in the hospital with covid now affect me."

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Reuse of drugs to treat covid-19

In June, the US Food and Drug Administration (FDA) granted Actemra an emergency use authorization for use in hospitalized patients for COVID-19.

This monoclonal antibody can reduce the inflammation that aggravates the disease in patients.

Treatment with the antibody blocks an inflammatory protein called IL-6 that causes damage in rheumatoid arthritis.

That same protein plays a role in some of the complications for people with severe COVID-19 infections.

The latest increase in cases has caused a global shortage.

Genentech, the company that makes Actemra, doesn't have enough for everyone who needs it.

Days ago, the company said demand for the drug increased more than 400% over pre-covid levels in just two weeks.

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In the United States, supplies of various dose levels of this drug have been exhausted since last Monday.

A life preserver and a change of life

For patients with covid-19, the drug can save their lives.

For patients with rheumatoid arthritis, like Meléndez, it can be life changing.

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"It gave me back the ability to have a fully functional life," Meléndez said.

"Before it was so serious that simple things like brushing my teeth, combing my hair, opening a bottle of water, unbuttoning my pants, going to a restaurant or eating were a challenge. Standing up and walking was difficult. arthritis and I'm barely 47 years old. "

Without medication, even for a month, people can experience debilitating flare-ups.

"There are thousands of patients who take Actemra monthly to help (fight) their inflammatory diseases," said Dr. Marcus Snow, chair of the Rheumatic Care committee at the American College of Rheumatology, who works at the University of Nebraska Medical Center.

"The people who need these drugs have gone through major trials and tribulations to get to the point where they need these drugs, and suddenly there is a shortage is scary for many people."

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Steven Taylor, executive vice president for mission and strategic initiatives at the Arthritis Foundation, said that while other medications are available, they are not easily interchangeable.

"It's not easy to switch drugs, especially when you're taking a serious drug like Actemra," Taylor said.

"You probably don't want to be bouncing around."

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The American College of Rheumatology said it has received "a number" of emails from concerned members.

The organization sent out a notice about the shortage last week, as did the Arthritis Foundation.

Genentech will expand its manufacturing

On Thursday, Genentech sent a notice to customers saying it was "working with the greatest possible urgency to accelerate replenishment and increase manufacturing capacity and supply whenever possible."

The company said the drug should be available for distribution starting Monday, August 30, but "as supplies remain tight, Genentech anticipates more intermittent shortages in the coming months if the pandemic continues at its current rate."

A subcutaneous injectable form of Actemra that has not been licensed to treat COVID-19 is still available for patients with rheumatoid arthritis.

Snow suggested that patients ask their doctors about it.

It is unclear if insurance would cover it.

And for hospitalized covid-19 patients, there are some alternatives if Actemra is not available.

The World Health Organization (WHO) recommended in June the use of Actemra to treat covid-19 patients.

Concerned for them now, she has asked Roche, Genentech's parent company, to ensure that there is a fair allocation of current stocks for all countries.

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"We also strongly encourage Roche to facilitate technology transfer and knowledge and data sharing to expand access to this important treatment," WHO said in its statement.

Roche said it would not enforce its patents in low- and middle-income countries during the pandemic to allow more companies to make the drug.

Doctors Without Borders complained that this was not enough, arguing that the drug is "inaccessible and unaffordable for the majority of the world."

More pandemic shortages

This is not the first shortage in the pandemic.

Supply chains were disrupted when factories had to shut down to prevent the virus from spreading, and COVID-19 put real demand stress on an already fragile system at the outset, according to Erin Fox, an expert on food shortages. Medication who serves as the Senior Director of Medication Information and Support Services at the University of Utah Health.

"All it takes is a small spike in demand and we have problems," Fox said.

Due to the uncertainty of demand peaks, some centers also hoarded some drugs.

Genentech recently said it would not accept return orders, which should reduce hoarding, Fox said.

According to Michael Ganio, senior director of pharmaceutical practice and quality at the American Society of Health Systems Pharmacists, the way pharmaceutical companies typically operate can also cause problems.

"Like any other manufacturer, they are going to produce enough for what they think they need for the year. Nobody wants to have extra inventory lying around," Ganio said.

Ganio said the American Society of Health System Pharmacists has also heard reports of a shortage of in-line filters used with intravenous lines.

There has been more demand for them due to the increasing use of the Regeneron antibody cocktail used to treat people with COVID-19.

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Some electrolyte products have also suffered from chronic shortages, he said.

Even before the pandemic, drug shortages were considered a "real public health challenge," according to the FDA, and have been going on for decades.

There is currently a shortage of at least 110 drugs, according to the FDA.

The American Society of Health System Pharmacists counts 183.

"It's very frustrating. In shortage after shortage, the manufacturer doesn't have a plan for when they can't supply the product. It's often 'good luck, we don't have it,'" Fox said. "All decisions are made first about the business and Unfortunately, there is no requirement to make anything, no matter how much it saves lives. "

In its 2020 report to Congress, the FDA said it is "doing everything in its power to help prevent and alleviate" outages and shortages and worked with manufacturers to avoid 199 stockouts, but for now that doesn't help. to patients like Meléndez.

"I know I can't be the only person sitting here today with nerves on edge," Meléndez said.

"I want to make sure they don't forget us."

monoclonal antibodies Arthritis Covid-19

Source: cnnespanol

All news articles on 2021-09-01

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