'Discussing Rinvoq based on Korean RWD'

Rapid onset of action is a key benefit of Rinvoq

Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center

JAK inhibitor, proved to be effective in patients with high eosinophil counts

Reimbursement is needed for switching, which aligns better with the current clinical reality.

Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center

The value of Real World Data (RWD) increases in areas where the development of new treatment options has been slow, primarily due to insufficient medical field experience and limited information beyond randomized controlled trials (RCT).

 

Atopic dermatitis is one of the fields that has seen a shortage of new drugs in the past.

 

However, in recent years, there have been notable shifts in prescription patterns, with the inclusion of JAK inhibitors and interleukin inhibitors.

 

Amidst ongoing developments, Korean researchers have unveiled RWD research findings related to the JAK inhibitor 'Rinvoq (upadacitinib)' in Korean patients.

 

The study, led by Professor Ahn Ji Young from the Department of Dermatology at the National Medical Center, involved a retrospective analysis of the medical records of 85 atopic dermatitis patients who were treated with Rinvoq for a minimum of 16 weeks between Oct.

 

2021 and Dec.

 

2022 at the National Medical Center.

 

As as result, Rinvoq demonstrated clinically significant improvements in patients with moderate to severe symptoms, as indicated by evaluation parameters including the Eczema Area and Severity Index (EASI), Pruritus numerical rating scale (pNRS), Life Quality Index (LQI), Patient-Oriented Eczema Measure (POEM).

 

DailyPharm sat with Professor Ahn for an interview.

 

-What was the background for conducting the RWD research in Korea? RCTs were available, but there could be disparities between RCT data and data collected from patients in real-world clinical settings.

 

Furthermore, overseas data frequently originate from research that primarily involves Caucasian populations.

 

While the drug dosage may be the same, variations can arise in the medical environment and conditions between Asian or Korean patients and those in other countries.

 

There are also situations that cannot be satisfied solely through overseas clinical studies.

 

Considering these factors, the objective was to acquire data customized for Korean patients.

 

With this data, it will be possible to share information with medical professionals in Korea, potentially leading to more effective patient treatments in the future.

 

-What was the research design? This research was not originally planned as part of the study but was conducted retrospectively after the data had already been collected.

 

Once a substantial volume of patient data had been gathered, we analyzed the data from these patients, covering periods from the start of treatment up to 2, 4, and 16 weeks, in order to monitor changes in the patients' conditions.

 

In addition, we assessed various parameters including pNRS, DLQI, POEM, ADCT, and others.

 

Furthermore, we examined the types of side effects experienced by patients during treatment and identified which drugs had proven effective for those who showed improvement.

 

We evaluated various conditions to determine which aspects indicated a positive response in patients.

 

The research findings showed that Rinvoq demonstrated a rapid onset of action during the early stages of treatment, particularly in patients with elevated eosinophil counts.

 

This research has allowed us to identify points that could be beneficial for patients.

 

-Can eosinophil count possibily be a biomarker? Yes.

 

Patients with high eosinophil counts may experience positive effects from Rinvoq treatment, and we concluded that this outcome can be explained through a specific mechanism.

 

-What were the conditions of patients? Based on the data from patients with atopic dermatitis lasting for 16 weeks or more between 2021 and 2022 at the National Medical Center, it was found that there was a slightly higher proportion of males among these patients.

 

Typically, these patients had developed atopic dermatitis during childhood.

 

Approximately 19% of patients developed the condition after reaching adulthood.

 

Many patients often mention that they developed atopic dermatitis after reaching adulthood.

 

However, upon further inquiry, it is common to find that these patients actually experienced atopic dermatitis during childhood, but it improved during that time and then worsened again after they became adults.

 

-Any other prominent results, in addition to eosinophil counts? Based on the research results, we examined which parts of the body showed the most improvement.

 

In terms of the body, there was overall improvement.

 

There were concerns about the effect of interleukin inhibitors like "Dupixent (dupilumab)" on the condition of the head and neck, but Rinvoq showed improvement across various body parts.

 

In terms of symptoms, lichenification and excoriation were more common in the acute phase, especially lichenification tended to become hardened in the chronic phase.

 

These symptoms improved rapidly, and patients expressed high satisfaction with these improvements.

 

-Can it be seen as the characteristics of JAK inhibitor? Rather than categorizing it as a JAK inhibitor, it is seen more as a distinctive feature of Rinvoq.

 

Among Korean and Asian atopic dermatitis patients, lichenification is often observed, so the improvement of lichenification is a highly significant aspect.

 

Although not yet conclusive, with more data in the future, it may be possible to say that this drug is particularly effective for Asians.

 

However, the issue is that there was a significant occurrence of acne.

 

While it typically appears in clinical trials at around 10%, in this research, it was observed in nearly 40% of cases.

 

Additionally, It was observed that the incidence of acne decreased with an increase in age.

 

-What are the benefits of Rinvoq found from the research? The key benefits include rapid onset of action and its effectiveness in improving itching.

 

In real-world clinical practice, Rinvoq is the preferred treatment option when patients suffer from itching, -Are all JAK inhibitor and interleukin products covered by insurance?

 

Are there any frustrations regarding the current reimbursement criteria? One of my frustrations would be the switching.

 

Doctors affiliated with the Korean Atopic Dermatitis Association might agree to this.

 

It's indeed a challenging situation when a patient is unable to switch to another medication, even when the initially prescribed drug proves to be ineffective.

 

Since accurate biomarkers are not available, medical professionals often face difficulty in determining the most suitable medication for a patient right from the start.

 

Therefore, switching should be reimbursed.