Tremfya to bring generation shift in the IL inhibitor market

Tremfya Marketing Team at Janssen Korea

IL-23 inhibitor Tremfya’s reimbursement extended to psoriatic arthritis from May

Generation shift from Stelara to Tremfya in progress…competition among latecomers fierce

“Tremfya has advantage in providing a lasting long-term effect…will provide various customized data to meet the needs of each patient

The competition among latecomers is intensifying in the interleukin inhibitor market with the scope of their indications expanding to psoriatic arthritis.

 

The leader in this market is Janssen’s IL-12/23 inhibitor, ‘Stelara (Ustekinumab).’ Although 10 years have passed since its approval, the drug still boasts a growth rate in the 30% range.

 

Based on IQVIA, sales of Stelara recorded ₩36.1 billion last year.

 

Janssen’s new goal in the market is to successfully make a generation change and replace Stelara with its follow-up drug, ‘Tremfya (guselkumab),' the first-in-class IL-23 inhibitor that was released in Korea in 2018.

 

However, Tremfya is being challenged in the market by the second IL-23 inhibitor ‘Skyrizi (risankizumab)’ that entered the market.

 

Therefore, making the successful generational shift from Stelara to Tremfya without losing any market share to other companies’ competitors is an important task at hand for Janssen.

 

▲ JungHyun Lee, Tremfya Marketing Manager at Janssen Korea

Janssen Korea’s Tremfya Marketing Team has been working quickly to achieve this goal.

 

The three members of the Tremfya Team at Janssen Korea have been focusing on conducting marketing activities for the psoriatic arthritis indication that was granted insurance benefits last month.

 

In an interview with Dailypharm, Product Manager Jung-Hyun Lee, who had been in charge of Tremfya since it started preparations for marketing authorization at the end of 2016, said, “There are many treatments including Tremfya available for plaque psoriasis, and awareness on the availability of theses drugs have now increased significantly among psoriasis patients.

 

Just as we have concentrated on marketing Tremfya in plaque psoriasis last year, we plan to concentrate on carrying out activities to make known the importance of early diagnosis and treatment in psoriatic arthritis this year.” Lee pointed to the low disease awareness of psoriatic arthritis as the reason for this year’s specific focus of interest.

 

PM Hye-Ji Kang who newly joined the Tremfya Marketing Team this year, said, “It is important for patients with psoriasis to manage comorbidities such as psoriatic arthritis.

 

Therefore, we need to raise awareness of psoriatic arthritis so that doctors and patients can suspect and allow for early diagnosis and treatment of their condition when joint pain occurs while maintaining skin symptom improvement in their course of treatment.” In addition to Tremfya, the IL-17 inhibitors Cosentyx (secukinumab) and Taltz (ixekizumab) are also approved for use in psoriatic arthritis.

 

Also, Skyrizi added a psoriatic arthritis indication in January this year.

 

Although Skyrizi is yet to be approved for reimbursement, Janssen may not rest assured as Abbvie is speeding up its reimbursement expansion process for Skyrizi.

 

Ultimately, it is in the hands of Tremfya’s Marketing Team to highlight the characteristics of Tremfya that differentiate the drug from other IL-17 inhibitors, while appealing to the strengths of Tremfya compared to the other same class IL-23 inhibitor.

 

Lee said, “Inhibiting radiographic progression of joint damage is considered the most important indicator in treating psoriatic arthritis because there is no way to reverse damage in the joints.

 

Tremfya administered every 4 weeks has demonstrated statistically significant inhibition of radiographic progression of joint structural damage compared to placebo.” Lee added, “In over 70% of the cases, psoriasis skin symptoms appear before psoriatic arthritis, and as treatment effect in the main disease of psoriasis is most important until arthritis progresses, Tremfya’s long-term effect in maintaining skin clearance indicates how our drug brings greater treatment benefit than its competitors.” The lasting long-term effect of Tremfya that was mentioned by Lee was demonstrated through a 5-year long-term clinical trial and a 5-year real-world data on domestic patients, evidencing the differentiated benefit of Tremfya over the latecomers.

 

Another positive aspect of Tremfya is that a survey on patients with severe psoriasis in the Asia-Pacific region including Korea showed that patients consider lasting, long-term effects as most important.

 

▲ Hye-JeeKang, Tremfya Marketing PM at Janssen Korea

Also, the company had demonstrated the superiority of Tremfya through a head-to-head trial.

 

Janssen’s ECLIPSE study that directly compared the efficacy between the first-in-class IL-23 inhibitor Tremfya and the IL-17 inhibitor Cosentyx showed that Tremfya’s mechanism of action allows for psoriasis lesions to not recur and provides long-lasting improvement of skin symptoms.

 

Kang said, “Only Tremfya was found to maintain regulatory T cells that are involved in lesion recurrence and reduce the rise of resident memory T-cells.

 

The trial was informative in understanding the different mechanisms of action between classes.

 

Through such data, the IL-17 and IL-23 inhibitors are being differentiated in the field, and IL-23 inhibitors, as a higher level mechanism than IL-17 inhibitors, have provided convenience to the patients with their longer dosing interval.” Of course, opposing data also exists.

 

Novartis’ ARROW trial is one example.

 

However, no statistically significant difference was found in the proportion of patients that achieved a “clear” or “almost clear” status of the target plaques at Week 16, which was the primary outcome measure of the trial.

 

Kang explained, “Results from the ARROW trial show no statistical difference between the two drugs, therefore, it is difficult to say there is a difference between the two drugs based on that data.

 

Also, the study was conducted on only 40 patients in the short term of 16 weeks, different from the large-scale ECLIPSE trial that was conducted for one year on 1,048 patients.” On how the drug is different from Skyrizi, a same-class drug, the marketing team pointed out that Tremfya is the only ‘fully human monoclonal antibody.’ In antibody drugs, reducing immunogenicity by minimizing the sequence of other species such as mice is important as it can cause side effects and reduce the efficacy of a drug.

 

If the humanized monoclonal antibody Skyrizi has nearly a 90% human-generated nucleotide sequence, Tremfya has a 100% human-generated nucleotide sequence.

 

Lee also added that the team will continue to strengthen Tremfya’s status in the market through the provision of various customized data.

 

Lee said, “With most drugs now being able to provide clear skin, the needs of the patients and medical are becoming more specific and subdivided.

 

Some wish for the occasional lesions or itching to go away after skin clearance, others wish to get rid of the pigmentation left after treatment.

 

We will work to provide customized data to fit the needs of these patients.”