The oral drug baricitinib (Olumiant, from Lilly) has generated great expectation due to its good results against alopecia areata, to the point of having received the nickname of miracle pill.
But drug research holds new promise for this and other types of alopecia.
The drug, which has already received the approval of both the European Medicines Agency (EMA) and its American counterpart (FDA), is an immunomodulator that comes from the rheumatoid arthritis vademecum, is used in Covid-19 and has an indication recent in atopic dermatitis.
In the case of alopecia areata, it was the first janus kinase (JAK) inhibitor to demonstrate efficacy.
These drugs block the activity of a specific family of enzymes that interfere with the pathway that leads to inflammation.
Phase III trials in patients with severe alopecia, who had
at least 50% hair loss on the scalp
for more than six months, show that it is capable of achieving at least 80% hair coverage in between 35% and 32% of patients with the 4 mg dose, and around 22% and 17% with the 2 mg dose.
In these trials, the rates with placebo reached 5% and 3%, respectively.
Details of the studies were published in
The New England Journal of Medicine
"The approval of baricitinib is a milestone in this disease, since it is the
first specific treatment
for this alopecia, and it will provide a very useful therapeutic tool,"
says Sergio Vañó
, coordinator of the Spanish Academy of Trichology Group Spanish Department of Dermatology and Venereology (AEDV) and director of the Trichology Unit of the Ramón y Cajal Hospital in Madrid.
"This is a drug with a favorable effectiveness and safety profile, as shown in clinical trials."
, a specialist in Trichology at the Barcelona Clinic, considers that "it marks a before and after" for these patients.
"Alopecia areata, despite being an autoimmune disease, has been a
big underdog in terms of drug development
for many years ," she explains.
"Until now, what we use the most are corticosteroids, minoxidil and immunosuppressive treatments. However, sometimes, in extensive or universal alopecia areata we do not achieve complete regrowth or when we do, we do not manage to maintain that repopulation in the weather".
Without forgetting the issue of safety: "Treatments with corticosteroids and immunosuppressants have long-term associated side effects, and we must always make a
correct risk-benefit assessment
. Especially considering that it is an autoimmune disease that initially affects only the hair follicle".
Nor is baricitinib without side effects.
In the United States, the drug is presented with a
about the risk of serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis.
In Dermatology, baricitinib is already used in Spain for the treatment of atopic dermatitis, as well as in selected patients with alopecia areata thanks to off-label use.
"It has the advantage that
we already know its safety profile
and how patients should be managed," says Combalia.
For whom it is?
An issue to take into account at the time of access will be its
(the price set by Health for atopic dermatitis is around 1,000 euros per month).
Vañó understands that if financing is obtained in Spain, the first beneficiaries will be "selected patients", according to criteria such as the severity of the alopecia and the lack of response to other treatments.
"In principle, it will be indicated for those patients with
extensive, total or universal alopecia areatas, who have not responded
to previous treatments," adds the Clínic dermatologist.
Alopecia areata is a common disease, with an estimated prevalence of between 1% and 2%, taking into account that this definition includes both patients with a small plaque and those with total hair loss.
But the eventual availability of an effective treatment
can increase diagnoses
and the demand for care: "When new therapies arrive, many patients who had not been treated for years come back to consult, hoping to receive a treatment that may be successful."
Combalia highlights the importance of obtaining better treatments for a disease that has a high emotional impact: "To a greater or lesser extent, the quality of life of patients with alopecia areata is always affected," he warns.
"Furthermore, we know that in genetically predisposed patients, the onset of alopecia areata
is associated with stress and anxiety
, and losing hair makes this wheel worse."
Along with baricitinib, more drugs from the same family are in development for alopecia areata.
"There are many drugs that inhibit the JAK pathway in the final phases of clinical trials prior to their probable approval, such as
deuterated ruxolitinib and ritlecitinib
," indicates Vañó.
"Together with these drugs, many companies are betting on new therapies in alopecia areata, which will make new therapeutic tools available."
Among these, the family of sphingosine phosphate receptor modulators stands out, "specifically, the drug
Regarding research and development in other types of alopecia, Vañó highlights in androgenic alopecia the use of
oral and sublingual minoxidil
dutasteride and bicalutamide microinjections
Finally, in cicatricial alopecia, the expert from the Academy of Dermatology highlights "the use of
JAK inhibitors for lichen planus pilar and folliculitis decalvans
, as well as the use of oral minoxidil and platelet-rich plasma."
One of the most outstanding recent advances in the pharmacological treatment of alopecia is oral minoxidil for androgenetics: "Its use has increased a lot with a very positive response," says Vañó.
"It can be said that it is the
moment of alopecia
, due to the advances that are taking place", says Combalia.
"For example, in androgenetic alopecia we have gone from topical treatment with alpha 5 reductase inhibitors to using many other therapies and combinations, such as mesotherapy with alpha 5 reductase inhibitors, oral hair growth stimulators or plasma rich in platelets, which
allow us to achieve therapeutic success on many occasions
and delay the need for a hair transplant".
Alopecia areata has been considered one of the types most in need of new effective treatments, which is why "the arrival of drugs that inhibit the JAK pathway is going to be a
," says Vañó.
Better therapeutic options for scarring alopecia are also lacking, dermatologists agree.
frontal fibrosing alopecia
, says Combalia.
"He is a type that we are seeing a lot, whose etiopathogenesis is not clear, and therapeutics is not very well defined," explains the dermatologist.
"More research is needed to determine what the cause is and to be able to offer patients more therapeutic solutions."
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