Taltz challenges Humira in head to head clinical trial treating psoriatic arthritis

Eli Lilly and Company shared new data from its 52-week, head-to-head biologic clinical trial pitting its Taltz (ixekizumab) against AbbVie’s longtime blockbuster Humira (adalimumab) in patients with psoriatic arthritis who had not yet tried a biologic.

Here’s the bottom line for those of you who just want the answers without all the “show your work” analysis:

> Both treatments provide strong results in psoriatic arthritis, with about half of patients achieving a full 50% improvement in psoriatic arthritis symptoms after one year.

> Both treatments provide major improvement in psoriasis symptoms, but Taltz provides superior performance. After one year, roughly two-thirds of Taltz patients maintained complete skin clearance, and roughly one-third maintained complete skin clearance with Humira alone (the Humira figure rose to 44% if Humira was taken with methotrexate).

> Adding methotrexate to Taltz conferred no benefit in psoriatic arthritis or psoriasis. Humira plus methotrexate improved Humira’s performance in both psoriasis and psoriatic arthritis, although previous research has mostly found the addition of methotrexate to Humira did not confer a benefit in psoriatic arthritis.

> CONCLUSION: Both of these products are wonderful gifts to the psoriatic disease community.

For those who want more detailed information on this study, keep reading on. Others may want to continue reading more broadly about psoriasis and psoriatic arthritis treatments.

By way of background, Humira, a TNF-alpha inhibitor, is a longtime market champ. Taltz, an IL-17 inhibitor, is one of the hot new upstarts. And note that in psoriatic arthritis trials, the psoriasis symptoms may be, on the whole, on the moderate side of “moderate to severe.”

Here are some of the results we found most interesting:

• In studies such as this one, the study sponsor picks the goal in advance. Lilly, knowing the ability of Taltz to deliver superlative results in many cases, set the goal as which treatment would, after one year, have the most patients achieve a 50% improvement in a set of psoriatic arthritis symptoms (ACR50), and a 100% improvement in a measure of psoriasis symptoms (PASI 100, complete skin clearance). This was an aggressive goal: for years, the standard goals in clinical trials for psoriatic arthritis and psoriasis have been ACR20 and PASI 75, respectively. With that trial design, Taltz surpassed Humira. It did so because of the PASI 100 component. Almost two-thirds of Taltz patients maintained complete skin clearance at the one year mark (versus just over one-third for Humira).
• But in the domain of a wide range of psoriatic arthritis symptoms, it was a statistical tie between Taltz and Humira.

• One of the most interesting items that emerges from the data is that adding methotrexate to Taltz provided no benefit. Now remember: we are NOT doctors, and you should NOT alter your treatment regimen on your own based on “stuff you read on the internet” – even from us. So if you are on Taltz and methotrexate together, keep taking them both (but do bring it up the next time you see your dermatologist or rheumatologist). We have not yet seen this mentioned in media reports about this study, but it leaps off the page when you look at it.
• Another interesting note is that in this study, we saw the opposite with Humira. Humira did consistently better when paired with methotrexate. If you like your Humira but it is not quite fixing you to your satisfaction, you could ask your doctor about adding methotrexate (if you have no medical reason to stay off methotrexate, two of the most important of which are liver problems, or being a woman who is pregnant or trying to conceive). Roughly speaking, when methotrexate was taken alongside Humira in this study, the pair helped about one-third more people than Humira alone. Important contrary note: Most (but not all) research looking at this question has found no significant difference between Humira alone (monotherapy) for psoriatic arthritis, versus Humira plus methotrexate, but this new data could keep that debate alive. (There is also a possibility that adding methotrexate later to Humira confers no benefit, but starting them simultaneously might provide significant benefit.)

Humira and methotrexate are already in the psoriatic disease Hall of Fame. Taltz appears headed there as well.

[Last updated 6-7-2020]