The issue of SE of JAK inhibitors should be given authority

to field experts

Shim Seung-cheol, professor of rheumatology at Chungnam National University Hospital

We should pay attention to the tendency of occurrence by drug and dosage rather than the side effects themselves

Detailed guidelines can be prepared if trends are confirmed through further research

Shim Seung-cheol, professor of rheumatology at Chungnam National University Hospital

The treatment results of rheumatoid arthritis have improved dramatically.

 

This is because doctors can use it a lot.

 

Following the advent of MTX in the late 1980s, TNF-alpha inhibitors changed the treatment paradigm of this disease.

 

Recently, JAK inhibitors that improved the shortcomings of TNF-alpha inhibitors have emerged.

 

JAK inhibitors, which have been attracting attention as next-generation treatments, have recently been at the center of controversy due to safety issues.

 

This is because concerns have been raised that the drug may cause cardiovascular side effects.

 

How do the prescription sites view the safety issue of JAK inhibitors? Shim Seung-chul, a professor of rheumatology at Chungnam National University Hospital, said, " We should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." He said, "If clinical data are added to confirm which patients are more likely to have drug side effects, detailed treatment guidelines for JAK inhibitors will be prepared." ◆ One in 10 patients is difficult to treat with MTX or TNF-alpha inhibitors Rheumatoid arthritis is an autoimmune disease.

 

Treatment is also carried out in a way that suppresses autoimmune phenomena.

 

The most traditional treatment is MTX.

 

It is a drug that suppresses lymphocytes and was initially more commonly used as a treatment for leukemia.

 

Since it was approved for the purpose of treating rheumatoid arthritis in 1988, it has been used for more than 30 years.

 

Since it was originally developed as an anticancer drug, there were many patients whose drug did not work.

 

In time, a better treatment was developed.

 

It is a TNF-alpha inhibitor.

 

It not only inhibits one target that causes autoimmune diseases but also inhibits several parts at the same time.

 

Since the advent of this drug, the treatment results of rheumatoid arthritis have improved dramatically.

 

The limitations of TNF-alpha inhibitors were also pointed out.

 

The number of patients who do not respond to this drug has gradually increased.

 

The disadvantage of injection was also pointed out.

 

Patients with mobility difficulties due to arthritis wanted to treat the disease more comfortably by reducing hospital visits.

 

JAK inhibitors have emerged.

 

The method of suppressing inflammation has also improved.

 

If existing drugs were a method of blocking inflammatory substances outside the cell, JAK inhibitors are a method of accurately targeting and suppressing substances within the cell.

 

Professor Shim said, "The use of MTX is effective in 70% of patients.

 

If there is no reaction here, using TNF-alpha inhibitors improves 70% of them.

 

He said, "10% of all patients were difficult to treat.

 

Unlike TNF-alpha inhibitors, the development of JAK inhibitors that block inflammatory signals in cells has made it possible to treat such patients.

 

◆MTX also experienced side effects of TNF inhibitors…JAK inhibitors can also be overcome Safety issues have recently emerged in JAK inhibitors, which have emerged with high expectations.

 

In 2021, the U.S.

 

Food and Drug Administration (FDA) warned of risks such as heart disease and cancer against JAK inhibitors, and the MFDS in Korea also distributed safety letters.

 

Eventually, the FDA decided to include risk information such as major cardiovascular events, thrombosis, and death in the box warning in the JAK inhibitor.

 

Professor Shim Seung-chul said, "The existing drugs have undergone a similar process," adding, "What is important is how well you manage side effects and treat diseases." "I think we can overcome the problems that are currently being raised," he said.

 

According to him, MTX has had side effects such as an increase in liver levels since its appearance.

 

Accordingly, drugs were used at the prescription site while simultaneously performing a liver biopsy.

 

As the experience of use accumulated, the drug has been set up to be prescribed in low doses when used for rheumatoid arthritis rather than anticancer drugs.

 

The same is true of TNF-alpha inhibitors.

 

Concerns have been raised that it causes tuberculosis in the early stages of its appearance.

 

These concerns were addressed by the use of anti-tuberculosis drugs.

 

In the case of JAK inhibitors, concerns about herpes zoster were raised at the beginning.

 

Professor Shim explains that the newly emerged cardiovascular risk can also be seen as an extension of this.

 

Professor Shim said, "We need to pay attention to the extent to which side effects occur frequently in certain patients, not in the side effects themselves," adding, "We expect that detailed treatment guidelines for JAK inhibitors will be prepared when more domestic clinical data are accumulated and drug side effects occur.

 

JAK inhibitors are limitedly used only when other drugs do not work.

 

If drugs are used sequentially, there will be no big problem.

 

I think we should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." There are three representative JAK inhibitors released in Korea.

 

In the case of Xeljanz, it is a general-purpose JAK inhibitor that inhibits all three inflammatory substances.

 

Olumiant inhibits two substances and Rinvoq SR inhibits one substance.

 

Professor Shim said, "There are currently various JAK inhibitors released, and further research is needed to find out the difference between general-purpose JAK inhibitors that suppress all inflammatory substances in cells and selective JAK inhibitors that suppress only certain substances."