The pharmaceutical world is abuzz with exciting news about yet another drug whose off-label use has been FDA-approved to treat a completely different condition. Olumiant was initially developed to treat rheumatoid arthritis – but has now achieved full approval from the FDA as a brand-new treatment for alopecia areata.
The announcement of the approval of Olumiant specifically as a treatment for Alopecia Areata stated that “the US Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the US each year. Today’s action marks the first FDA approval of a systemic treatment (i.e., treats the entire body rather than a specific location) for alopecia areata.”
Baricitinib is a type of Janus kinases (JAKs) inhibitor released by Eli Lilly & Company as a treatment for rheumatoid arthritis in 2012. JAK inhibitors belong to a family of medicines called DMARDs (disease-modifying antirheumatic drugs). Other than Olumiant, the FDA approved two other JAK inhibitors, Xeljanz (tofacitinib) and Rinvoq (upadacitinib), to treat rheumatoid arthritis.
Understanding alopecia areata
Alopecia areata is an autoimmune disorder. The immune system erroneously identifies hair follicles as foreign invaders. The result is a sudden hair loss, showing up in round or oval bald patches on the scalp or other hairy surfaces of the body. The American Academy of Dermatology defines the most frequent symptoms as:
- A smooth round or oval bald patch on the scalp with no signs of irritation like swelling or discoloration. Spotty hair loss (multiple patches) can develop if the hair loss continues. The patches can vary in size. If the condition progresses, it can cause widespread hair loss, but this is less common. Occasionally, alopecia areata can progress, causing loss of all hair on the scalp (alopecia totalis). Alopecia totalis is more common in children and young adults but can occur at any age.
- Hair loss on the beard instead of the scalp. This hair loss may be patchy or cause a well-defined bald spot.
- Alopecia areata can cause loss of eyebrows as well as eyelashes. Usually, people develop patchy hair loss on both eyebrows, but some lose most or all their eyebrows. If there is a loss of eyelashes, it usually develops on both eyes, causing some eyelashes on both the upper and lower eyelids to fall out.
- Instead of developing one or more patches of hair loss, some people develop a band or strip of bald skin on their scalp (ophiasis). It usually appears at the back of the head and can extend to the temples.
- Nail changes are also seen in 10% to 20% of people with alopecia areata. Tiny dents are the most common, and there may also be red nails, ridges that run the length of the nails, nails that become so rough they feel like sandpaper or brittle nails that split.
- Alopecia universalis is a rare condition in which people lose all the hair on their body. They often also develop brittle, crumbling nails, which can be painful.
The Academy says that alopecia areata cannot be cured. However, this new treatment for alopecia areata can help people regrow their hair.
What role do JAK molecules play?
The four members of the Janus kinases family (JAK1 – JAK3 and Tyk2) are one subgroup of the non-receptor protein tyrosine kinases. JAKs serve as critical communication channels that transmit signals that control cells’ function, development, and growth. The JAK/STAT pathway is involved in the control of processes like stem cell maintenance. In rheumatoid arthritis and alopecia, the pathway plays a vital role in the inflammatory response.
When JAK molecules become overactive, they can inadvertently trigger the immune system, resulting in unwanted inflammation characteristic of conditions like rheumatoid arthritis and alopecia areata.
What is the JAK’s function in triggering the immune response?
JAKs control communication between the exterior and interior of cells through the JAK-STAT pathway. When everything works as it should, these molecules help maintain a delicate balance that keeps the immune system working correctly.
JAKs receive many molecular signals, including cytokines, which carry messages from the immune system. Cytokines are small proteins secreted by nearly every cell to regulate and influence immune response. The release of pro-inflammatory cytokines instructs the JAK-STAT pathway to activate immune cells and also prompts the release of further cytokines. The term “cytokine storm” explains inflammation as a sudden release of cytokines to stimulate an inflammatory process.
If a person suffers from rheumatoid arthritis, the body makes too many cytokines. It is a chronic, autoimmune condition in which the immune system mistakenly perceives the body’s cells as foreign invaders and launches an inflammatory attack against them. This primarily affects the joints, causing swelling and stiffness, and can lead to damage and deformities over time.
In people suffering from alopecia areata, JAK3 molecules are overexpressed in the epidermis. The epidermis is the layer immediately below the outer skin where hair follicles grow. JAK3 expression is markedly increased in the epidermis in the case of people with alopecia areata. Olumiant is especially effective because it works to inhibit JAK3 explicitly. Some other JAK3 inhibitors, such as topical tofacitinib, have been used to treat psoriasis, alopecia areata, and atopic dermatitis. However, Olumiant is the first systemic treatment that can be administered via oral doses.
Do JAK inhibitors like Olumiant offer a new treatment for alopecia areata?
The introduction of treating alopecia areata with a JAK inhibitor like Olumiant (baricitinib) was a significant breakthrough. Before this, the treatment options available for this condition had been quite limited and often failed to offer substantial benefits.
Olumiant operates by inhibiting specific JAK enzymes, which modulate the immune response that culminates in hair loss in alopecia areata. It is a targeted approach that promises to bring a significant reprieve for people who suffer from the condition. It gives them the possibility of hair regrowth, with all that implies for their self-confidence.
The approval by the FDA resulted from extensive research and clinical trials, which have yielded positive outcomes. Doctors are welcoming the arrival of the official endorsement of this new treatment for alopecia areata since many had been monitoring the trial results and had been confident enough to start prescribing Olumiant as an off-label treatment for alopecia areata because of the lack of any alternatives.
Why you should be sourcing your Olumiant from IsraelPharm.
Firstly, all the drugs we supply are sourced from a registered manufacturer, guaranteeing quality. Although we supply baricitinib with the label Unamity rather than Olumiant, it is manufactured by Eli Lilly & Company for marketing outside of the USA, and the only difference is in the name.
By law, we have to conform to the strict standards set for licensed pharmacies operating under the supervision of the Israeli Ministry of Health. IsraelPharm can only dispense drugs under the supervision of our registered pharmacist from our licensed pharmacy. All drugs we supply are registered in the Israeli National Drugs Registry. We can only supply against a prescription from a licensed physician and only in the permitted quantities and strengths.
The second important point is that under the Israeli universal health care system, which the government highly subsidizes, the price of all approved drugs sold by any pharmacy is capped. It is usually between fifty to eighty percent lower than the retail prices in local US pharmacies.
For direct comparison, look at the prices of the three JAKi drugs we have dealt with in this article:
|Drug||Dosage||Average US price||IsraelPharm price|
|Olumiant (brand Unamity)||2 mg – 14 tablets
4 mg – 14 tablets
|Rinvoq||15 mg – 28 tablets||$6,062||$890|
|5 mg – 28 tablets
11 mg – 28 tablets
What are the main adverse effects of Olumiant?
Olumiant (baricitinib) is generally considered safe and effective for treating alopecia areata. However, like any medication, it may cause side effects. Common side effects of Olumiant include upper respiratory tract infections, nausea, and an increased risk of infections. Other potential side effects include:
- Cardiovascular events: According to the FDA, Olumiant may increase the risk of blood clots, heart attack, or stroke. If you have a history of heart disease, inform the doctor prescribing this drug. People with a history of heart disease should be closely monitored while taking Olumiant.
- Gastrointestinal problems: Olumiant may cause stomach pain, diarrhea, or other digestive issues. Contact a doctor if you experience severe or persistent stomach problems while taking Olumiant.
- Increased risk of cancer: There have been reports of an increased risk of cancer, including lymphoma, in people taking Olumiant. The risk of cancer associated with Olumiant is still under investigation, and more research is needed to understand the link fully.
- Liver problems: Olumiant may cause liver damage or inflammation. If you experience symptoms such as yellowing of the skin or eyes, abdominal pain, or dark-colored urine, contact a doctor immediately.
A rare but more serious event may be an allergic reaction. Symptoms of an allergic reaction may include hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. In this case, go immediately to an emergency health center or hospital and inform them that you have taken baricitinib.