More options for ankylosing spondylitis including Taltz

Only and first treatment to take ASAS40 as primary endpoint, shows exceptional efficacy

Less complication with cardiovascular condition, “Should be used like TNF-α inhibitor”

The interleukin 17A (IL-17A) inhibitor drugs are taking over the spotlight in the ankylosing spondylitis treatment market.

 

Besides the first-in-class Cosentyx (secukinumab), Taltz (ixekizumab) was released to the South Korean market with its strong evidences.

 

Some specialists predict the guideline, initially recommending the drug to be used after using tumor necrosis factor-alfa (TNF-α) inhibitor, could be changed.

 

One of the most frequently diagnosed rheumatic diseases, ankylosing spondylitis mostly uses a nonsteroidal anti-inflammatory drug (NSAID).

 

But a biologic drug is recommended for patients with high disease activity.

 

Humira (adalimumab) and Remicade (infliximab) are TNF-α inhibitors, a most commonly used biologic treatment type.

 

Although the drugs are recommended first with their credible amount of clinical data, 30 percent of the patients apparently do not respond to TNF-α inhibitor.

 

Professor Hong Seung-jae at Kyung Hee University Medical Center (Department of Rheumatology) says only one out of three patients maintain the treatment, two years after using biologic treatment.

 

40 percent of the patients suspend the treatment before starting the second cycle, because of insufficient efficacy.

 

And now IL-17A inhibitors are emerging as a new option.

 

16 years after a first TNF-α inhibitor was approved, Novartis’ Cosentyx was released as a new drug to treat patients with ankylosing spondylitis.

 

And Eli Lilly’s Taltz followed with a same indication, and joined the competition in the South Korean market as received the National Health Insurance (NHI) reimbursement in last October.

 

Taltz’s strengths in treating ankylosing spondylitis are exceptional level of efficacy and safety.

 

To confirm the efficacy and safety in treating the disease, the COAST-V study had patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and the COAST-W study had patients who previously had an inadequate response or were intolerant to TNF inhibitors.

 

Both studies chose more stringent primary endpoint, unlike other preceding clinical trials on ankylosing spondylitis, which was the Assessment of Spondyloarthritis International Society 40 (ASAS40) response showing over 40 percent improvement in the patients’ symptoms.

 

The trials were the only and first studies to have set ASAS40 as a primary endpoint.

 

Patients achieving ASAS40 at week 16

The Taltz group in two studies achieved 48 percent and 25 percent of the ASAS40 response at week 16, respectively, and 53 percent and 34 percent at week 52.

 

The results indicated statistically meaningful improvement compared to the placebo group.

 

Taltz also resulted in statistically significant outcome in secondary endpoints—objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), as well as patient-reported outcome (PRO).

 

And a head-to-head COAST-V study compared the drug against a TNF-α inhibitor Humira, frequently used to treat patients with ankylosing spondylitis.

 

Ultimately, the Taltz patient group showed higher response rate compared to the Humira patient group.

 

Moreover, Taltz has notable safety profile.

 

A TNF-α inhibitor is banned on patients with severe heart failure, whereas Taltz can be used regardless of the underlying condition.

 

Professor Hong Seung-jae elaborated, “Once-biweekly administered Taltz is more convenient than other once-weekly drugs, and it is known for its high ASAS40 response proving the efficacy.

 

And because it does not have the safety issue the TNF-α inhibitors, the drug can be administered to patients with heart failure.” When the clinical records of Taltz accumulate in the future, the professor thinks the reimbursement and treatment guideline can be easily changed.

 

Currently, Taltz is indicated for use in both first and second-line treatment, but the NHI reimbursement is granted only for using when a patent shows no response to a TNF-α inhibitor.

 

Also, the guideline by the Assessment of SpondyloArthritis International Society/ European League against Rheumatism (ASAS/EULAR) recommends using TNF-α inhibitor with more extensive clinical data, and then recommends an IL-17A inhibitor if the patient does not react to the TNF-α inhibitor.

 

Professor Hong expressed his anticipation in the prospective changes in the reimbursement standards, and said “The healthcare reimbursement standard and overseas guideline categorize the drug as a second-line treatment, as it lacks sufficient amount of clinical data in South Korea.

 

But the data is accumulating globally, and some experts claim the drug should be used at a same level with TNF-α inhibitor.” Meanwhile, relevant experts project other biologic treatment could become a variable in the expansion of an IL-17A inhibitors in the ankylosing spondylitis treatment market.

 

Currently, various Janus kinase inhibitors, such as tofacitinib and upadacitinib, are in process of conducting clinical trials targeting ankylosing spondylitis.

 

Specifically, upadacitinib (brand name Rinvoq) was indicated in EU to treat patients with ankylosing spondylitis, showing off its intention to join the scene.

 

Unlike other biologic treatments, orally taken JAK inhibitor could be preferred more.