9 New Treatments for Psoriatic Arthritis in Development
Key takeaways:
Several phase 3 studies are underway for new psoriatic arthritis (PsA) treatments. Sonelokimab, vunakizumab, and ivarmacitinib are just a few examples. Most of the new medications being studied are under-the-skin injections or oral pills.
Sotyktu (deucravacitinib) and Ilumya (tildrakizumab) are FDA-approved medications for psoriasis. Now, they’re also being studied as possible new PsA treatments. Tirzepatide (Mounjaro, Zepbound), a popular medication for Type 2 diabetes and weight loss, is also being studied for PsA.
Many medications are already approved to treat PsA. Your rheumatologist will likely prescribe you one or more medications based on the affected parts of your body, the severity of your symptoms, and your insurance coverage status.
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Table of contents
Psoriatic arthritis (PsA) is an autoimmune disorder that causes inflammation in the skin, joints, and spine. These symptoms can be quite painful if left untreated. So if you or a loved one are living with PsA, your healthcare professional may have prescribed one or more medications as a source of relief.
While many effective PsA medications are already available, finding the right fit can be tricky. That’s why it’s always exciting when promising new medications hit the market. Having more treatment options at your disposal can make a big difference in managing your symptoms.
Which new treatments for psoriatic arthritis are in advanced stages of clinical trials?
If your PsA medication doesn’t relieve your symptoms, or if you’re having trouble tolerating side effects, you may be looking for another treatment option.
Health experts are hard at work researching new PsA treatment options in phase 3 clinical trials. They’re also studying FDA-approved psoriasis medications to see if they work for PsA, too. Phase 3 studies are traditionally the last step before a pharmaceutical company can submit their drug for FDA approval.
Let’s dive in to see what the future may hold for nine new PsA treatments in the works.
Note: Most clinical trials use the ACR20 criteria from the American College of Rheumatology to evaluate how effective PsA medications are. This is a grading scale that aims to see if people taking study medications have at least a 20% improvement in their PsA symptoms. As a general rule, if a medication offers less than a 20% improvement, it’s not considered to be effective.
1. Sotyktu
Sotyktu (deucravacitinib) is a once-daily oral tablet; it was first approved in September 2022 for psoriasis. It belongs to a group of medications called tyrosine kinase 2 (TYK2) inhibitors. These medications lower inflammation by blocking a protein called TYK2.
Sotyktu’s manufacturer is now looking to see if it’s a good option for PsA in two phase 3 studies. One study is comparing Sotyktu to placebo (a pill with no medication) among people who haven’t received a biologic medication for PsA before. The other study has a similar goal, but it also includes people who have previously received a TNF inhibitor like Humira (adalimumab). TNF inhibitors are a type of biologic.
Psoriatic arthritis (PsA) treatments: Learn about the different medications used to treat psoriatic arthritis to help you find the best fit for your needs.
Early signs of PsA: Review these images that can help you identify PsA early so you can seek treatment.
Managing painful symptoms: One woman shares how she learned how to break free from feeling like she’s a prisoner in her own body.
Initial results were released in December 2024. In both studies, a significant number of people receiving Sotyktu achieved an ACR20 response after about 4 months. Sotyktu’s manufacturer is planning on sharing this data more widely in the coming months. An FDA approval application for PsA may follow suit.
2. Ilumya
Ilumya (tildrakizumab) shares a similar story to Sotyktu. It’s already approved for psoriasis, and now it's being studied for PsA. This biologic is injected every 3 months and lessens inflammation by blocking a protein called IL-23.
So far, a phase 2 study found that people who received Ilumya for PsA had better symptom improvements than those who took a placebo.
Two phase 3 trials for PsA are now underway to confirm these effects. INSPIRE 1 and INSPIRE 2 are 6-month studies that are comparing Ilumya to placebo among people who didn’t respond to a TNF inhibitor in the past or have never received one. Initial results will likely be released in 2025.
3. Tirzepatide
As Mounjaro, tirzepatide is an effective Type 2 diabetes treatment. As Zepbound, it’s useful for chronic weight management and obstructive sleep apnea. And its list of potential uses continues to grow.
This dual GIP/GLP-1 receptor agonist is now being studied in combination with Taltz (ixekizumab) for PsA. Taltz is a biologic medication that’s approved for several autoimmune disorders, including PsA. This phase 3 trial is exploring whether combining tirzepatide with Taltz can improve PsA symptoms more effectively than Taltz alone. Researchers will also look into the duo’s effects on weight loss.
Adults with PsA who are also considered overweight or obese will be included in the study. It should wrap up by August 2026.
4. Netakimab
Netakimab (BCD-085) is a biologic injection that’s currently approved for PsA in Russia. It manages inflammation by blocking IL-17A and IL-17F proteins. It’s typically given every few weeks.
The bulk of netakimab’s supporting data comes from a phase 3 study called PATERA. This 1-year study compared netakimab to placebo and included close to 200 people living with PsA. About 95% of participants in the netakimab group had an ACR20 response, which is encouraging.
At this point, it’s unclear whether netakimab’s manufacturer, Biocad, will be applying for U.S. approval for PsA. But on their website, Biocad states that they’re currently preparing international applications for netakimab.
5. Simponi biosimilars (BAT2506, ATV05)
A company called Bio-Thera Solutions is studying BAT2506 as a biosimilar to Simponi (golimumab), which is an injectable TNF inhibitor that’s approved to treat PsA. Biosimilars and biologics are comparable to generic and brand-name medications; they’re very similar terms of efficacy and safety. But biosimilars may be more affordable than reference (“brand name”) biologics.
BAT2506 is being compared to Simponi in a phase 3 study to see how similar their ACR20 responses are. The study finished up in late 2023, but results haven’t been shared yet.
Another Simponi biosimilar, called AVT05, is also in the works. Its manufacturer, Alvotech, applied for approval in Europe in November 2024. A decision is expected by late 2025. At this time, it’s not clear when Alvotech will pursue FDA approval.
6. Sonelokimab
Sonelokimab is a new type of antibody-based medication that’s being studied for PsA in adults. It’s given every 4 weeks and lessens inflammation by blocking multiple IL-17 proteins. Its manufacturer claims that it’s smaller than other types of antibody medications, allowing “it to better penetrate and treat difficult-to-reach inflamed tissues.”
On the heels of positive phase 2 data, this under-the-skin injection is now being evaluated in a pair of phase 3 clinical trials (IZAR-1, IZAR-2). Researchers are looking to see how well different doses of sonelokimab reduce PsA symptoms after about 4 months of treatment. Initial data should be available in the first half of 2026.
7. Vunakizumab
Vunakizumab, or SHR-1314, is another IL-17 inhibitor that’s injected under the skin. It’s approved to treat psoriasis in China, and it’s also showing promise for PsA.
A phase 3 study is now underway to see how well vunakizumab works to lessen PsA symptoms in adults. The main goal of the study is to see how many people obtain an ACR20 response after about 6 months. The study started in November 2024, and it’s set to run through mid 2026.
At this time, it’s unclear if or when vunakizumab’s manufacturer will pursue FDA approval.
8. Ivarmacitinib
Ivarmacitinib, also known as SHR0302, is an oral Janus kinase (JAK) inhibitor. It’s being studied for a variety of health conditions, including PsA, rheumatoid arthritis, eczema, and more.
Ivarmacitinib’s phase 3 trial for PsA was designed to compare different daily doses of ivarmacitinib to placebo. Researchers aimed to examine the oral tablet’s safety and effectiveness over an 11-month period.
The study was scheduled to end by the end of 2024, but results haven’t been shared yet.
9. Zasocitinib
Zasocitinib, also known as TAK-279, works similarly to Sotyktu. It’s a TYK2 inhibitor that’s formulated as a once-daily oral tablet. It’s in advanced stages of development for psoriasis and PsA, and it’s also being studied for ulcerative colitis and Crohn’s disease.
Zasocitinib’s PsA potential was most recently evaluated in a phase 2 trial. Over half of people who took the medication had an ACR20 response after 3 months of treatment, compared to placebo.
Two phase 3 studies are now on deck. They’re scheduled to start in March 2025, and they should run through 2028. Researchers will look to see how well zasocitinib reduces PsA symptoms in adults, regardless of whether they’ve previously used biologic medications for severe symptoms.
When will new psoriatic arthritis drugs be available to the public?
This is still to be determined. It’s not always possible to pinpoint exact dates that new medications will be available. This all depends on when a pharmaceutical company sends their data to the FDA for review. The FDA also needs time to thoroughly review all of the submitted information to make sure a particular medication is safe and effective.
Typically, the FDA reviews submitted drug applications within 10 months.
What medications are already approved for psoriatic arthritis?
Several medications are already FDA approved to treat PsA. They can be broken down into three main groups: traditional disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, and targeted DMARDs. They come as pills, injections, and infusions, and they each lessen inflammation in their own way.
Depending on your situation, your rheumatologist may prescribe one or more of these PsA medications:
Non-biologic DMARDs like methotrexate
Biologic DMARDs like Humira
Targeted DMARDs like Xeljanz (tofacitinib)
Nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen (Advil, Motrin), aren’t approved to treat PsA. But they’re often prescribed off-label for inflammatory symptoms when they flare up. Oral and injectable corticosteroids can also come in handy to manage flares.
Frequently asked questions
Yes, several oral pills are FDA approved to treat PsA. Rinvoq (upadacitinib) is one popular example. Xeljanz may be taken once or twice a day depending on the formulation, and Otezla (apremilast) is taken twice daily. Additionally, some oral medications may be prescribed off-label for the condition, such as select non-biologic DMARDs.
One PsA medication isn’t better or more successful than the rest. They each have their pros and cons, and what works well for one person may not work well for someone else. If you see a rheumatologist, they’ll likely choose a treatment plan that’s based on the part(s) of your body that are affected, how severe your symptoms are, and your insurance coverage status. Previous medications you’ve tried also play a role.
The bottom line
Researchers are studying several new treatments for psoriatic arthritis (PsA) in clinical trials, including sonelokimab, vunakizumab, and ivarmacitinib. Many of these medications are designed as under-the-skin injections or oral pills. Experts are also evaluating FDA-approved psoriasis treatments like Sotyktu (deucravacitinib) and Ilumya (tildrakizumab) to determine if they can manage PsA symptoms. Tirzepatide (Mounjaro, Zepbound), a popular Type 2 diabetes and weight loss medication, is also being studied for PsA.
Newly approved medications will add to the existing options for treating PsA — giving you more ways to manage your symptoms.
Why trust our experts?
References
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