Latecomer JAKi ‘Rinvoq’ now has the most indications

seeks to overturn market dominated by Xeljanz and Olumiant

Adds psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis indication … becomes the JAK inhibitor with the most indications

Xeljanz and Olumiant currently leads the market… Will Rinvoq, which occupies 1/10 of the market, change the landscape?

Safety concern over severe heart disease remains… the whole market may retract due to safety issue

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.