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Drug to treat alopecia – condition made famous by Jada Pinkett Smith – approved by the FDA 

A drug to treat severe alopecia, an autoimmune disorder that causes hair loss, has been approved by the Food and Drug Administration (FDA).

The condition, which has become more widely known recently with Hollywood  actress Jada Pinkett Smith and Democratic congresswoman Ayanna Pressley revealing they have been diagnosed with the condition, affects more than 300,000 people in the United States every year.

Now, those affected have treatment option – in the form of an oral tablet – for the first time. 

On Monday, the FDA approved a drug called baricitinib as the first oral tablet for treating severe alopecia areata.

Alopecia causes either temporary or permanent patchy hair loss that can affect any hair-bearing site of the body, leading to emotional distress. 

The approval for use against alopecia was based on the results of two randomized, controlled clinical trials involving a total 1,200 adults with severe alopecia. 

After 36 weeks, almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair.

BEFORE: A drug to treat severe alopecia, an autoimmune disorder that causes hair loss, has been approved by the Food and Drug Administration (FDA). Pictured is an individual during Week 0 of the trial

AFTER: After 36 weeks of the trial, almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair

AFTER: After 36 weeks of the trial, almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair

Hair loss among women is painful, depressing and embarrassing, according to Pinkett Smith and other celebrities who have gone public with their conditions.

The subject has rushed into the public consciousness after Pinkett Smith’s husband Will Smith slapped comedian Chris Rock for making a joke about her bald head at the Oscars earlier this year. 

Pinkett Smith spoke out for the first time in 2018 about her diagnosis of alopecia, a medical term referring to the loss of hair.

Democratic Congresswoman Ayanna Pressley, who went public with her diagnosis in 2020, has also recently spoken out about her experience with the condition. 

The subject of hair loss has rushed into the public consciousness after Jada Pinkett Smith's husband Will Smith slapped comedian Chris Rock for making a joke about her bald head at the Oscars earlier this year

The subject of hair loss has rushed into the public consciousness after Jada Pinkett Smith’s husband Will Smith slapped comedian Chris Rock for making a joke about her bald head at the Oscars earlier this year

Pinkett Smith turned her husband Will Smith's Oscar-night blowup (pictured) into a teachable moment about the disorder which in some cases, can impact a person's sense of identity

Pinkett Smith turned her husband Will Smith’s Oscar-night blowup (pictured) into a teachable moment about the disorder which in some cases, can impact a person’s sense of identity

Baricitinib, which is made by US pharmaceutical company Eli Lilly and known by the trade name Olumiant, belongs to a class of drugs called Janus kinase inhibitors. It works by interfering with the cellular pathway that leads to inflammation.

‘Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,’ said FDA official Kendall Marcus in a statement.

‘Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.’

Each trial split participants into three groups: a placebo group, a group that received a two-milligram dose every day, and a group that received a four-milligram dose every day.

After 36 weeks, almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair, compared to around 23 percent of the lower dose group, and five percent of the placebo group.

Rep. Ayanna Pressley, D-Mass., who went public with her diagnosis in 2020, took to Twitter following the Oscar slap incident to shine light on the subject

Rep. Ayanna Pressley, D-Mass., who went public with her diagnosis in 2020, took to Twitter following the Oscar slap incident to shine light on the subject

'Let's talk about what it's like to live with #alopecia,' she posted earlier this year, continuing the conversation. She's pictured in 2019 before she revealed her struggle with the disorder

‘Let’s talk about what it’s like to live with #alopecia,’ she posted earlier this year, continuing the conversation. She’s pictured in 2019 before she revealed her struggle with the disorder

Around 45 percent of people in the higher dose group also saw significant eyebrow and eyelash regrowth.

The most common side effects included upper respiratory tract infections, headaches, acne, high cholesterol, and increase of an enzyme called creatine phosphokinase.

Prior treatments for alopecia included topical or oral drugs, but these have been considered experimental and none was approved.

Baricitinib was previously approved for treatment of rheumatoid arthritis, and during the Covid pandemic its license was extended to the treatment of hospitalized Covid patients.

Each trial split participants into three groups: a placebo group, a group that received a two-milligram dose every day, and a group that received a four-milligram dose every day

Each trial split participants into three groups: a placebo group, a group that received a two-milligram dose every day, and a group that received a four-milligram dose every day

After 36 weeks, 40 percent of those on the higher dose grew back 80 percent of scalp hair, compared to 23 percent of the lower dose group, and five percent of the placebo group

After 36 weeks, 40 percent of those on the higher dose grew back 80 percent of scalp hair, compared to 23 percent of the lower dose group, and five percent of the placebo group

Around 45 percent in the higher dose group saw significant eyebrow and eyelash regrowth

Around 45 percent in the higher dose group saw significant eyebrow and eyelash regrowth

Prior treatments included topical or oral drugs, but were considered experimental

Prior treatments included topical or oral drugs, but were considered experimental

The most common side effects included upper respiratory tract infections, headaches, acne, high cholesterol, and increase of an enzyme called creatine phosphokinase

The most common side effects included upper respiratory tract infections, headaches, acne, high cholesterol, and increase of an enzyme called creatine phosphokinase

What is the difference between alopecia and age-related hair loss? 

Alopecia areata is caused by the body’s immune system attacking hair follicles.

The follicles hold hair in place, so when they are damaged the hair starts to fall out.

It usually causes circle or oval-shaped patches of baldness and can lead to someone becoming completely hairless. 

The disease can occur at any time in life and is unpredictable, with experts still uncertain what in a genetic makeup causes it.

Meanwhile, age-related hair loss is caused by hereditary factors.

In men it is called male pattern hair loss and women it is called female pattern hair loss.

Genes inherited from either parent cause the follicles to shrink over time and eventually stop growing hair. 

It can start in teenage years but is more common in later life.

It is not caused by an immune response and therefore is not affected by drugs aiming to suppress the body’s defense system.

Earlier this year, Pinkett Smith turned her husband Will Smith’s Oscar-night blowup into a teachable moment about the disorder which in some cases, can impact a person’s sense of identity.

‘Considering what I’ve been through with my own health and what happened at the Oscars, thousands have reached out to me with their stories,’ Pinkett Smith said on an episode of ‘Red Table Talk.’

The actress said she chose to use ‘this moment to give our alopecia family an opportunity to talk about what it’s like to have this condition’ and what it is. Her guests included the mother of a 12-year-old girl, Rio Allred, who was bullied over her hair loss and died by suicide, and a physician who explained the different types of the disorder.

Before tackling the subject, Pinkett Smith addressed events at the March 27 Academy Awards. She and husband Will Smith, a best-actor nominee, were in the audience as presenter Chris Rock cracked a joke at Pinkett Smith’s expense.

‘Jada, I love you. G.I. Jane 2, can´t wait to see it,’ Rock said. Pinkett Smith had a closely shaved head similar to that of Demi Moore in the 1997 movie.

Smith strode from his front-row seat to the stage and slapped Rock, shocking the comedian and the audience. Smith, who returned to his seat and later accepted the Oscar for ‘King Richard,’ subsequently apologized to Rock but was banned from the ceremony for 10 years by the film academy. 

Pressley, who went public with her diagnosis in 2020, took to Twitter following the incident to shine light on the subject. 

‘Let’s talk about what it’s like to live with #alopecia,’ she posted. ‘The deeply vulnerable & difficult moments that our families see. Appreciation post for those who hold us down & support us when we’re at our lowest points. They see us, fully.’

As Hollywood inches towards a healthier balance between female beauty ideals and the lived reality, more actresses have begun speaking out about the impact of losing their hair — due to stress, hormonal changes after giving birth and even Covid-19.

Baricitinib, which is made by US pharmaceutical company Eli Lilly and known by the trade name Olumiant, belongs to a class of drugs called Janus kinase inhibitors

Baricitinib, which is made by US pharmaceutical company Eli Lilly and known by the trade name Olumiant, belongs to a class of drugs called Janus kinase inhibitors

‘This is so not glamorous, but it’s true: I need to take longer showers so that I can collect the hair that falls out and throw it away so I don’t clog the drain. Why do actresses never talk about that?’ Selma Blair told People magazine in 2011 after giving birth.

Alyssa Milano, who says she lost her hair after being infected with coronavirus, said it had affected her whole sense of self.

‘It’s hard, especially when you’re an actor and so much of your identity is wrapped up in those things like having long silky hair and clean skin.’

Actress Ricki Lake wrote on Instagram in 2020 that she had struggled for her whole life with hair loss.

‘It has been debilitating, embarrassing, painful, scary, depressing, lonely, all the things. There have been a few times where I have even felt suicidal over it.’

Oscar winner Viola Davis said she had tried to hide the effects of her alopecia with wigs.

‘I had a wig I wore around the house. I had a wig that I wore to events. I had a wig that I wore when I worked out,’ she told an interviewer.

‘I never showed my natural hair… I was so desperate for people to think that I was beautiful.’

Davis, who has been more open about the subject in the last decade, even included it in the series ‘How to Get Away with Murder,’ when her character, a strong-willed lawyer and teacher, removes her wig exposing her very short hair.

The National Alopecia Areata Foundation (NAAF) have called for more people to learn about the condition.

It said alopecia areata, a specific type of balding caused by an autoimmune disorder that makes hair often fall out in clumps, affects about seven million people in the United States and about 147 million worldwide.

‘Alopecia areata does not discriminate and can affect anyone at any age and may be a temporary or life-long condition. Many people living with the condition are suffering, and we must do better to support this community and erase the stigma, discrimination, and societal barriers that persist.’

WHAT IS ALOPECIA AREATA? 

Alopecia areata – a patchy version of alopecia – is an autoimmune condition in which the immune system causes hair to fall out.

It can affect hair on any part of the body and can happen to anyone at any age – it can be triggered by stress.

The hair usually begins to fall out in patches and leave bald, smooth areas.

It is not possible for doctors to predict how much hair someone will lose, nor can they tell if the hair will ever grow back.

Alopecia areata cannot be cured but if only patches of hair are lost there is an approximately 60 to 80 per cent chance of it growing back within a year.

However, there is no guarantee it will grow back and doctors cannot predict whether it will, nor how much hair will be lost.  

If hair does grow back, it can take months or years and usually starts as sparse white hairs in the bald patches which can eventually thicken and regain their colour. 

Regrowth is less likely if all someone’s hair falls out.

Source: British Skin Foundation 

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