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- 2026-03-17 20:53:41
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- ‘Rinvoq’ tries AD reimbursement following ‘Olumiant’
- by Eo, Yun-Ho Oct 12, 2021 05:50am
- Companies have been actively seeking insurance benefits for their JAK inhibitors in atopic dermatitis. According to industry sources, Abbvie Korea has also applied for the reimbursement of its ‘Rinvoq (upadacitinib)’ in atopic dermatitis after its indication expansion, following Lilly Korea’s reimbursement application for ‘Olumiant (baricitinib) in May. Rinvoq had been additionally approved for atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis on October 5th. Also, with the application for Pfizer Korea’s ‘Cibinqo (abrocitinib)’ in process in addition to the two drugs, whether a viable new treatment option will be introduced to the field of atopic dermatitis following Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ is receiving attention. For Dupixent, discussions are ongoing with the health insurance authorities on whether the drug’s reimbursement should be extended to cover pediatric·adolescent patients with atopic dermatitis. Rinvoq became the second JAK inhibitor following Olumiant to be approved to treat atopic dermatitis, a field that had few treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents 12 years or older. Rinvoq’s efficacy was verified through the Heads Up study, a head-to-head trial between Rinvoq and Dupixent. Study results showed that 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at Week 16 in the areas. EASI 75 rates at Week 1 in all 4 areas were higher for Rinvoq and continued until Week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. However, the safety issue of JAK inhibitors as a whole is on the board. Based on the post-marketing safety study of Xeljanz, the US FDA had issued a Dear HCP letter warning of the risk of heart attacks in JAK inhibitors such as Xeljanz, Olumiant, and Abbvie's 'Rinvoq (upadacitinib).’ Whether this issue can be resolved and the drugs can settle as a treatment option in the field of atopic dermatitis remains to be seen.
- Company
- SK Bioscience will also produce COVID-19 vaccines next year
- by Chon, Seung-Hyun Oct 12, 2021 05:49am
- At an agreement ceremony held in Brussels, Belgium on the 5th, SK Bioscience President Ahn Jae-yong (right side of the picture) and CEPI CEO Richard Hatcht are signing a contract to use the Andong L House facility SK Bioscience will also entrust production of COVID-19 vaccines from global pharmaceutical companies next year. SK Bioscience announced on the 5th that it has signed an extension contract for the use of Andong L House facilities with CEPI in Brussels, Belgium. It will extend the period of using some of the undiluted production facilities in Andong, which were signed in June last year and are about to expire at the end of this year, to the end of 2022 for the production of COVID-19 vaccines by CEPI-supported companies. The contract said that by the end of next year, three of SK Bioscience's facilities in L-house will be used first to entrust production of the COVID-19 vaccine developed by a company supported by CEPI. The two companies agreed to continue close cooperation to overcome the current pandemic situation and expand cooperation in research on various infectious diseases that have frequently occurred recently and the development of vaccines accordingly. SK Bioscience participated in the world's efforts to prevent the spread of COVID-19 infection and discussed "1 Euro" with only symbolic meaning as an initial down payment to maintain friendly cooperation with international organizations such as CEPI and COVAX facilities. CEPI has decided to continue to utilize SK Bioscience's facilities as a public goal to secure fair vaccine access by supplying additional COVID-19 vaccines around the world through the COVAX facility. COVAX facility currently plans to supply a total of 2 billion doses of COVID-19 vaccine to the world by the first quarter of next year. SK Bioscience plans to accelerate the development of its own COVID-19 vaccine, which is currently in phase 3 clinical trials, in close cooperation with CEPI. The COVID-19 vaccine candidate GBP510 jointly developed by SK Bioscience and Institute for Protein Design (IPD) and using GlaxoSmithKline's Pandemic Technology is currently in phase 3 clinical trials. CEPI cooperated with the Bill & Melinda Gates Foundation from the initial development stage of the GBP510 and provided SK Bioscience with up to USD 213.7 million in development funds. GBP510 was selected as the first target of the 2nd generation COVID-19 vaccine project operated by CEPI last year to support differentiated COVID-19 vaccine candidate materials. When GBP510 is commercialized, hundreds of millions of vaccinations will be supplied worldwide, including underdeveloped countries. SK Bioscience and CEPI are additionally discussing the development of GBP510 in preparation for variations and research on booster shots. "The additional facility use contract with SK will provide an opportunity to approach the promise of COVAX facilities to protect vulnerable populations through fair vaccine supply, while further strengthening the relationship between CEPI and COVAX facilities and South Korea," said Richard Hatchett, CEO of CEPI. Ahn Jae-yong, president of SK Bioscience, said, "The proven production system and technology shown by global companies during consignment production of the COVID-19 vaccine led to an extension contract with CEPI." Next year, we will secure and supply our own COVID-19 vaccine, which will serve as a hub for global vaccine supply, he said.
- Company
- Dupixent reimbursement in pediatric AD is being discussed
- by Eo, Yun-Ho Oct 08, 2021 05:57am
- Discussion on prescribing ‘Dupixent’ to pediatric patients with atopic dermatitis is now showing visible progress. According to industry sources, the National Health Insurance Service has started expert inquiries to start discussions on applying insurance benefits to the lower-dose (200mg) formulation of Sanofi-Aventis Korea’s Dupixent (dupilumab). This is 7 months since the company had applied for reimbursement in April. Accordingly, other processes including its deliberation date by the disease subcommittee, etc. are expected to be soon set. The lower-dose Dupixent was approved in Korea in adolescent patients aged 12 or older with severe atopic dermatitis who are less than 60kg. After an initial dose of 400mg, the patient is administered 200 mg every other week. Since then, Sanofi added the indication for treating pediatric patients aged 6 to 11 with severe atopic dermatitis for its low-dose formulation and then applied for its reimbursement listing. The health insurance benefit for Dupxient is approved for adult patients aged 18 or older with 3+ years of medical history with severe chronic atopic dermatitis that meets all three standards: ▲ unable to control symptoms even with first-line topical therapy for 4 or more weeks; ▲ cannot use systemic immunosuppressants due to no response or side effects despite 3 or more months of use; ▲ had an EASI (Eczema Severity Assessment Index) of 23 or higher before using Dupixent. This is for the 300mg dose. The efficacy and safety of 200mg Dupixent were verified through the LIBERTY AD ADOL clinical trial. 251 adolescent patients with severe atopic dermatitis patients who were treated with Dupixent 200mg and 300mg showed a 66% improvement in the size of lesion and severity at week 16, as well as clinically significant improvement in their quality of life index. 75% of the group that was administered Dupixent in combination with topical corticosteroids, achieved EASI 75 (EAST improvement of 75%) at week 16, demonstrating a more significant improvement compared to the 26.8% of the placebo group. Since Dupixent, other JAK inhibitors used for autoimmune diseases like rheumatoid arthritis have also been seeking to enter the atopic dermatitis treatment market. In June, Lilly Korea submitted a reimbursement application for ‘Olumiant (baricitinib),’ and Abbvie Korea has recently added an AD indication for its ‘Rinvoq (upadacitinib).’ Also, Pfizer applied for domestic approval of ‘Cibinqo (abrocitinib)’ recently.
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- PARP inhibitor Zejula, which is partially covered
- by Oct 08, 2021 05:57am
- PARP inhibitor Zejula could be reimbursed as the primary maintenance therapy for ovarian cancer. However, it is pointed out that "regulatory agencies should change their perspectives" due to benefit standards. Kim Jaewon, professor of obstetrics and gynecology at Seoul National University Hospital, is taking Korea on the 7th. At the Zejula online meeting held by the restriction, he pointed out, "It is regrettable that only ovarian cancer patients with BRCA mutations have recognized primary maintenance benefits. This is in accordance with the stereotypes of regulators, and we need to change our perspective like in the United States." Earlier, the Health Insurance Review and Assessment Service recognized the clinical usefulness of primary maintenance therapy only for BRCA positive. Regulatory authorities believe that Zejula can be used regardless of the BRCA mutation, but the application of benefits is insufficient. Professor Kim Jaewon The underlying PRIMA clinical results showed that Zejula showed a median progression-free survival (mPFS) of at least twice as long as that of placebo groups in the entire patient group, regardless of BRCA mutation and covalent recombinant deficiency (HRd) (21.9 months vs. 10.4 months). The risk of disease progression and death also decreased by 57%. The effect was highest in the BRCA-positive patient group. The mPFS of BRCA-positive patients in the HRd patient group was 22.1 months in the Zejula-administered group and 10.9 months in the placebo group. However, even in the BRCA negative patient group, mPFS satisfies statistical significance to 19.6 months in the administration group and 8.2 months in the placebo group, allowing Zejula to extend the progression-free survival period regardless of the BRCA mutation. Jang Hyun-ah of Takeda Pharmaceutical Korea said, "In terms of PRIMA results, Zejula showed consistent treatment effects regardless of biomarkers, including patients in high-risk groups." She also explained, "We also confirmed that the dose can be adjusted and used according to the patient's condition, and that even if the capacity is low, there is no difference in effect and the safety profile improves." The reason for dissatisfaction with the disapproval of benefits in the BRCA negative group is that more than 80% of ovarian cancer patients do not have a BRCA mutation. Patients are suggesting expanding their salaries so that many people can take the first PARP inhibitor that can be used regardless of BRCA mutation. Professor Kim Jae-won also said, "There are quite a few patients who benefit from HRp, not HRd, without biomarker mutations." He said, "A similar thing happened in the United States five to six years ago, but the PARP inhibitor was accepted by changing the perspective to an advanced survival period according to the characteristics of ovarian cancer. "I think the government should cover all of them regardless of mutations with insurance benefits because many of them can be cured if they use drugs," he said. 제줄라 국내 허가사항과 급여 현황(자료: 한국다케다제약)
- Company
- Lynparza was approved for pancreatic cancer/ prostate cancer
- by Oct 08, 2021 05:56am
- PARP inhibitor "Lynparza (Olaparib)" has expanded its indications to pancreatic and prostate cancer. AstraZeneca Korea announced on the 7th that it has been approved by the MFDS for Lynparza's indications for pancreatic and prostate cancer. As a result, Lynparza can be used for ▲ maintenance therapy in adult patients with gBRCA mutated pancreatic cancer who have not undergone chemotherapy for at least 16 weeks after receiving 1st platinum-based chemotherapy and ▲ for treating adult patients with BRCA mutated metastatic castration-resistant prostate cancer who have previously progressed after treatment of new hormone treatments. The approval for pancreatic cancer and prostate cancer indications was based on clinical studies of POLO3 and PROfound4, respectively. In a POLO phase 3 study evaluating the efficacy of Lynparza maintenance therapy in pancreatic cancer patients with reproductive cell BRCA (gBRCA), the median progression-free survival period (PFS) of the Lynparza administration group was 7.4 months, nearly doubling compared to placebo (3.8 months). Approval for prostate cancer indications was based on the results of sub-analysis of patients with BRCA1/2 mutation in a PROFUND phase 3 study [3] in patients with HRR mutation metastatic castration resistant prostate cancer. In this study, Lynparza reduced the risk of disease progression and death by 78% in patients with BRCA1/2 mutation among the target patients, and the median radiological progression-free survival period (rPFS) was 9.8 months, showing improved results than enzalutamideAAbiraterone of 3.0 months. In addition, the median overall survival period (OS) of the enzalutamideAAbiraterone group was 14.4 months, while the Lynparza administered group recorded 20.1 months, lowering the risk of death by 37%. "Lynparza is the first ARP inhibitor to expand indications in two carcinomas, pancreatic cancer and prostate cancer, showing clinical usefulness in two carcinomas that had high incomplete demand," said Myung Jin, executive director of the anticancer drug division. In particular, metastatic pancreatic cancer and metastatic castration-resistant prostate cancer are all the more meaningful in that treatment options have been limited, he said.
- Company
- Latecomer JAKi ‘Rinvoq’ now has the most indications
- by Oct 08, 2021 05:56am
- The latecomer JAK inhibitor, Abbvie’s ‘Rinvoq,’ is seeking to overturn the market landscape by greatly expanding its indications. Whether the drug can break the two-way lead battle between Xeljanz and Olumiant, is gaining attention. According to the Ministry of Food and Drug Safety, Abbvie’s ‘Rinvoq (upadacitinib)’ received additional approval for psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis indications. With the original rheumatoid arthritis indication, Abbvie’s drug is now approved for 4 indications in total. More specifically, Rinvoq is indicated for the treatment of adults and patients over the age of 12 with moderate to severe atopic dermatitis. In ankylosing spondylitis, Rinvoq can be used to treat adult patients who show inadequate responses to existing treatments. Also, in psoriatic arthritis, the drug can be used as monotherapy or combination therapy in patients who are intolerant or do not respond appropriately to disease-modifying anti-rheumatic drugs (DMARDs). In particular, the drug became the second JAK inhibitor after Olumiant to be approved for atopic dermatitis, a condition that has limited treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents aged 12 or older. With the addition of Rinvoq, biologic treatment options for atopic dermatitis have now increased to three in the market that used to be dominated by Sanofi Aventis’s ‘Dupixent.’ Abbvie has been actively targeting the atopic dermatitis treatment market, conducting a head-to-head trial between Rinvoq and Dupixent. In the Phase 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at week 16 in the areas. At EASI 76 at week 1 in all 4 areas was higher for Rinvoq, and lasted so until week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. Rinvoq is a latecomer JAK inhibitor that was introduced in Korea in June last year. This is 2.6 years later than Olumiant and 6 years later than Xeljanz. During this period, Xeljanz had overtaken the market by expanding the area to rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and releasing an extended-release formulation. Then, Olumiant started to show strength in rheumatoid arthritis and divided the JAK inhibitor market into a two-way race. Also, Olumiant became the first to receive approval for atopic dermatitis, pioneering a new market. According to the market research institution IQVIA, Xeljanz enjoyed the sole lead old 14.7 billion won in sales in 2019. Its sales in 2020 were 16.2 billion won. Olumiant only sold 2.2 billion in 2019, but its sales rose greatly to 9 billion last year. In the first half of this year, Xeljanz (including the XR formulation) sold 7.8 billion, and Olumiant sold 5.6 billion, greatly narrowing the gap. Rinvoq, which started to record sales at the end of last year, sold 600 million won in the first half of this year. Its sales have been rising with the rapid reimbursement, however, the degree of growth is yet too small to catch up with Xeljanz nor Olumiant. However, Rinvoq suddenly increased its indications to 4 and change the future landscape. With the added indications, Rinvoq now owns the most amount of indications among JAK inhibitors. Pfizer plans to approach the atopic dermatitis market with a different JAK inhibitor other than Xeljanz. Unlike Xeljanz, which mainly inhibits JAK3, ‘Cibinqo (abrocitinib)’ mainly targets JAK1. Pfizer is known to have applied for Cibinqo’s approval and is being reviewed. However, the safety concern that remains in all JAK inhibitors is the issue. Based on the post-marketing safety study of Xeljanz, the US FDA concluded that it may increase the risk of severe heart disease such as heart attacks, etc. The FDA did not limit the boxed warning requirement to just Xeljanz, but expanded the alert to all JAK inhibitors and requested all three products to contain black box warnings. If this safety concern is not resolved, and the scope of treatment becomes restricted, this may affect and shrink the entire JAK inhibitor market.
- Company
- Roche and Lilly to launch RET targeted cancer drugs in Korea
- by Eo, Yun-Ho Oct 06, 2021 06:06am
- Two types of RET targeted anticancer therapies are concurrently seeking domestic entry. According to industry sources, Roche Korea's Gavreto (pralsetinib)’ and Lilly Korea ‘Retevmo (selpercatinib)’ are under review for domestic approval. Both are anticancer drugs that target RET (Rearranged during transfection) gene fusions. The drugs not only inhibit primary RET fusions and mutations but also secondary RET mutations that cause resistance to treatment, and are receiving much attention on whether they will be able to address unmet needs in various types of cancer. Retevmo became the first to receive global approval by a few months. Retevmo received marketing authorization from the US FDA in May last year, and Gavreto in September. Retevmo was approved for the Non-small Cell Lung Cancer (NSCLC) and thyroid cancer indications, whereas Gavreto was first approved as a lung cancer treatment, then approved for the thyroid cancer indication in December of the same year. Although the drugs were initially approved for lung cancer and thyroid cancer indications, the companies are expected to actively pursue more indications for RET inhibitors in the future. RET gene fusions are present at a low frequency in colorectal cancer, breast cancer, pancreatic cancer, and EGFR-positive NSCLC. Like NTRK (Neurotrophic tyrosine receptor kinase) targeted therapies like ‘Rozlytrek (entrectinib)’ etc., RET inhibitors have the potential to be used as tumor-agnostic, personalized treatment. Meanwhile, Retevmo’s efficacy was verified through the Phase I/II LIBRETTO-001 study. Retevmo’s overall response rate (ORR) was 64% in 105 RET-gene positive patients with small cell lung cancer who have previously received platinum-based chemotherapy. Also, 81% of the patients who showed treatment response showed a response for at least 6 months. Also, Retevmo recorded a high ORR of 84% in 39 RET-gene positive, treatment-naive patients. In 143 medullary thyroid cancer patients that have previous treatment experience with ‘cabozantinib’ or ‘vandetanib,’ etc., the ORR was 69%. And 76% of the patients maintained treatment response for at least 6 months. In other RET-gene positive thyroid cancer, the ORR of patients with radioactive iodine-refractory (RAI) was 79%, 87% of which showed continued treatment response for over 6 months. Gaverto was initially approved as a lung cancer treatment based on the ARROW study. In the study, Gavreto showed an ORR of 57 % and a complete response (CR) rate of 5.7 % in NSCLC patients that were previously treated with platinum-based chemotherapy (87 patients). Also, ORR was 70% and CR 11% in newly treated patients (27 patients).
- Company
- Evrysdi (PO) is differentiated due to its low price
- by Oct 06, 2021 06:06am
- Roche's "Evrysdi (Risdiplam)," the second treatment for spinal muscular atrophy (SMA) in Korea, signaled its launch after about a year of approval. With the differentiation of the only PO drug and low prices, fierce competition in the SMA market was predicted. "Evrysdi is the first oral drug among SMA treatments and is applicable to patients with difficulty in treating SMA, and has confirmed its effectiveness and safety in patients of a wide range of ages and types," Roche Korea stressed at an Evrysdi meeting on the 5th. Evrysdi (Risdiplam) is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. Spinal muscular atrophy (SMA) is a rare genetic disease in which the SMN1 gene is inherently deficient or mutated, resulting in gradually shrinking muscles. It is known that about one per 10,000 newborns worldwide, and about 30 patients (based on 300,000 newborns) occur every year in Korea. Three new drugs were released in Korea in three years, starting with Biogen's Spinraza in SMA diseases, which had no cure so far. Evrysdi is the second new drug approved in November last year and is the only PO drug. It has been almost a year since the license was granted, but it has not yet been released on the market. As a result, it was delayed than Novartis' Zolgensma, which was belatedly approved. Novartis applied for Zolgensma's benefit in June. Evrysdi began the registration process only in July, eight months after the permit. Roche is expected to officially release Evriesdi after completing the registration process. It is expected to be reimbursed well as Spinraza, which is already more expensive, has been reimbursed. Evriesdi is also known to be likely to follow RSA ( the Expenditure Cap) applied to Spinraza. Lee Seung-hoon, director of Roche Korea, said, "We are currently trying to get reimbursed within the same range as Spinraza." He explained, "I think access to insurance is more important than anything else because receiving rapid treatment for patients has a great impact on the prognosis." Roche explained that it is the only PO drug and that the relatively low cost is Evrydi's strength. Spinraza prices exceed 90 million won, and Zolgensma, which is negotiating benefits, is a "one-shot" treatment that costs more than 2 billion won per time. Evrysdi's final drug price has not been determined, but it is much lower than the prices of Zolgensma and Spinraza. In particular, it is expected to be cheaper for infants and toddlers. Jung-hyun Chang of Roche Korea said, "Unlike other products, Evrysdi's dosage is determined by age and weight, so we expect infants and toddlers under the age of 2 to be treated at a much lower price than adults, greatly reducing the burden of drug costs." Evriesdi can be self-administered at home, which can reduce the socioeconomic burden, he added. Attention is also being paid to which drugs medical staff and patients will choose. Lee Yoon-jung, a professor of pediatrics at Kyungpook National University, emphasized "patient accessibility." Fast diagnosis and treatment are of paramount importance because SMA's symptoms deteriorate rapidly within a short period of time and the slower the treatment, the less effective it is. Professor Lee said, "No matter how active treatment is, the disability often remains no matter how active the treatment is," adding, "As diagnosis and initial administration are very important, we need to consider what drugs can speed up the initial administration as much as possible."
- Company
- Yoo Byung-Jae took office as the new president of Novartis
- by Oct 06, 2021 06:05am
- Yoo Byung-Jae, the new CEO of Novartis Korea Yoo Byung-Jae took office on the 1st as the new president of Novartis Korea. New President Yoo is an expert who has accumulated organizational management and management skills in the global healthcare industry for 15 years. Until recently, he served as president of North Asia, including South Korea, Taiwan, and Hong Kong, at Johnson & Johnson Medical, exceeding his target performance every year. It is evaluated that it has created business excellence and led organizational development by growing in all business fields. New President Yoo said, "I am happy to join Novartis, which leads the global pharmaceutical industry, based on our innovative portfolio." "We will do our best to provide patients with various innovative treatments, including the cellular therapy portfolio that Novartis is currently focusing on, contribute to the innovative ecosystem of the domestic healthcare industry, and become a socially trusted company," he said. The new president Yoo, a graduate of Korea University's business administration department and Harvard Business School, joined the marketing team of Johnson & Johnson Medical's blood vessel division in 2006. Since then, he has been in charge of marketing leaders in orthopedic departments in the United States, the United Kingdom, and Australia, and has successfully led various business fields since returning to Korea in 2010. In addition, he gained brand management experience in famous consumer goods companies such as Coca-Cola and Unilever, and worked as a management consultant for Boston Consulting Group.
- Company
- “Dupixent, a trusted AD treatment without safety concerns"
- by Oct 05, 2021 05:58am
- The biologic agent ‘Dupixent (dupilumab)’ holds an 'unrivaled' position in the treatment of severe atopic dermatitis. In the AD treatment environment that had used immunotherapies that bring a high burden of side effects, the introduction of a safe and effective option has greatly improved the symptoms and quality of life in AD patients. Due to its strong effect, requests for reimbursement to be extended to cover the pediatric and adolescent indications have been flooding. Unlike systemic immunosuppressants, Dupxient selectively inhibits IL-4, IL-13 signals, the key drivers of type 2 inflammation, and therefore is known as a drug that can be safely used without concern over side effects. Dailypharm met with Dong Hun Lee, Professor of Dermatology at the Seoul National University Hospital to hear about the effect and safety of Dupixent. The following is a full QA with Professor Lee. Professor Dong Hun Lee-How has the introduction of Dupixent changed the atopic dermatitis treatment environment? =Before Dupixent, we mainly prescribed immunosuppressants such as cyclosporine and methotrexate, etc. to treat severe atopic dermatitis. Atopic dermatitis is a chronic condition that requires continued treatment and management, however, immunosuppressants have limitations in their treatment efficacy or have side effects that occur with long-term use that prohibit continuous use. This is why major practice guidelines do not recommend continued use of cyclosporin for over 1-2 years. In addition to clinical trials that demonstrated Dupixent’s superior efficacy, the company also recently disclosed the drug’s long-term safety data in adult patients with moderate-to-severe atopic dermatitis. Also, in clinical practice, Dupixent generally showed a good effect in patients whose symptoms were not controlled by immunosuppressants such as cyclosporine. Unlike other immunosuppressants that require regular monitoring every 1-3 months after administration, no separate blood tests are required for the use of Dupixent. In this aspect, patients may see this convenience in administration as a benefit. -Dupixent is being reimbursed applied the special calculation system in adults, but it has been pointed out that the set standards are too strict. What is your opinion on this? =First, I would like to say that I am glad and thankful that many patients with severe AD are now benefiting through the reimbursement and special calculation system. The EASI score that is used to assess the severity of AD only considers a patient’s symptoms and the extent (area) of eczema. However, adult AD patients with atopic dermatitis mainly show symptoms on exposed areas such as the face, neck, and hands, and even though the area is small, the quality of life is greatly reduced and itching is severe and requires aggressive treatment. To address this, the Korean Atopic Dermatitis Association presented an atopic dermatitis severity guideline that comprehensively reviews the Dermatology Life Quality Index (DLQI) and Numerical Rating Scale (NRS) score, in addition to the EASI score to assess the severity. -Recently, Dupixent was approved for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 6 to 11 in addition to adults and adolescents. What were the limitations of previous treatment options for pediatric patients with moderate-to-severe atopic dermatitis? What should be considered when expanding Dupixent reimbursement to pediatric patients in the future? = Prevalence of AD is around 10% in children and 3% in adults. Like adult patients with AD, pediatric patients also often have severe symptoms and are prescribed systemic immunosuppressants or Dupixent. However, long-term use of systemic immunosuppressants is not recommended in major guidelines because of the risk of side effects with long-term administration. The burden of disease, school, peer relationships, and the increased burden of care borne by the family is larger for pediatric and adolescent patients. Considering the specificities, such as the importance of initial treatment and a relatively small number of patients who will be needing reimbursement, I do hope that the reimbursement standards are relieved to cover these patients. -Recently, a JAK inhibitor, ‘Olumiant,’ was approved in Korea for AD, with more JAKis to come. Some companies developing JAK inhibitors have been taking active steps to such as conducting head-to-head clinical trials with Dupixent in AD. How do you see the use of JAK inhibitors will go in the treatment of AD? =JAK(Janus kinase) inhibitors block a range of cytokines related to inflammatory responses by acting on the JAK signal pathway. Its MOA works broader than Dupixent but narrower than other immunosuppressants such as cyclosporine in blocking inflammatory responses. Although clinical trial results for the use of JAK inhibitors in AD are available, no real-world data is yet available. We would need to wait and observe these results from the field. Therefore it is yet difficult to make short- and long-term comparisons of JAK inhibitors and Dupxient. -I would like to know your opinion on the safety issue that recently arose for JAK inhibitors. The FDA’s black box warning does not include Dupixentl. Is Dupixent safe in this respect? =The US FDA’s recent Dear healthcare Professional letter indicated that the use of the JAK inhibitor ‘tofacitinib’ in rheumatoid arthritis patients raises the risk of cardiovascular disease compared to the use of TNF inhibitors. However, the JAK inhibitor in question is not approved for atopic dermatitis, and JAK inhibitors do not need to be avoided as a whole as drugs in the same class can also have different efficacy and safety. However, in consideration of the commonality in MOA of JAK inhibitors, continued monitoring as well as caution when prescribing the class in high-risk patients may be needed until further data is available. In the case of Dupixent, the 3-year long-term safety data of the drug in adult patients have been recently added to the product label. Also, patients in Korea who have been using the drug for over 3 years with the ‘Early Access Program (EAP)' before it was approved in Korea, are continuing their treatment in satisfaction until now. No notable adverse reactions have been observed in patients who received Dupxient long-term, therefore no separate monitoring is required for its prescription, such as blood tests. Also, patients do not prefer such additional tests. -What common characteristics do patients who do not respond to Dupixent have? =It is effective in most patients, however, there were occasional cases where the effect was relatively small in patients who have high lgE or LDH levels that reflect the severity of disease or in overweight patients. However, the level of non-response was not particularly noteworthy. Also, almost no notable side effects were observed in patients that were prescribed Dupixent. Symptoms such as conjunctivitis or facial redness did appear, but at a controllable level.
