What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis include biologic agents such as TNF-alpha inhibitors (e.g., adalimumab, etanercept, infliximab), IL-12/23 inhibitors (e.g., ustekinumab), and oral treatments like methotrexate. TNF-alpha inhibitors can lead to infections, injection site reactions, and potential cardiovascular benefits. IL-12/23 inhibitors like ustekinumab may cause serious infections but have not shown increased risks for malignancies or TB. Methotrexate can cause gastrointestinal distress, hepatotoxicity, hematologic toxicity, and pulmonary toxicity, requiring regular monitoring. Deucravacitinib, a selective TYK2 inhibitor, is being studied for its efficacy and safety, with long-term data still being collected.

What prior FDA approvals exist?

The FDA has approved several biologic agents and kinase inhibitors for the treatment of Psoriatic Arthritis (PsA). These include TNF inhibitors such as adalimumab, etanercept, and infliximab, as well as IL-12/23 inhibitors like ustekinumab, and IL-17 inhibitors such as secukinumab and ixekizumab. Additionally, JAK inhibitors like tofacitinib have also been approved. While Deucravacitinib, a selective TYK2 inhibitor, is currently under study, it represents a novel approach targeting a different pathway compared to the existing treatments.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Psoriatic Arthritis patients include: <ol> <li>Secukinumab (IL-17A inhibitor) - Shown to be effective in improving joint and skin symptoms, with sustained benefits and a favorable safety profile.</li> <li></li> </ol> Ixekizumab (IL-17A inhibitor) - Demonstrated efficacy in treating moderate to severe plaque psoriasis and PsA. 3. Upadacitinib (Selective JAK1 inhibitor) - Displayed rapid and favorable efficacy in rheumatoid arthritis, with ongoing studies for PsA. 4. Tofacitinib (JAK inhibitor) - Used for refractory cases and has shown potential in managing PsA symptoms.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Psoriatic Arthritis

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have completed the week 52 treatment for the optional open-label long-term extension period

Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening

Must not have

Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis

History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called deucravacitinib to see if it can help people with psoriatic arthritis who haven't tried advanced treatments. The medication works by reducing joint swelling and pain by blocking inflammation. Deucravacitinib is a new oral drug that has shown good results in previous studies for psoriasis.

Who is the study for?

This trial is for individuals with active psoriatic arthritis who haven't used biologic disease-modifying anti-rheumatic drugs. They should have at least 3 swollen and tender joints, a diagnosis of PsA for 3+ months, an active skin lesion or history of plaque psoriasis, and certain levels of inflammation markers in their blood.

What is being tested?

The study tests the effectiveness and safety of Deucravacitinib compared to a placebo in treating psoriatic arthritis. Participants will be randomly assigned to receive either the drug or placebo to assess long-term effects.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with similar medications include liver issues, infections due to weakened immune systems, nausea, headaches, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have finished a year-long treatment in a previous study phase.

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I have been diagnosed with psoriatic arthritis for at least 3 months.

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My X-rays show at least one erosion in my hand or foot joints due to PsA.

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I have active arthritis with at least 3 swollen and 3 tender joints.

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I have been diagnosed with Psoriatic Arthritis.

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I have active psoriasis or a history of it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune condition like lupus or multiple sclerosis.

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I have or had joint inflammation not caused by PsA, like gout or rheumatoid arthritis.

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I do not have plaque psoriasis currently.

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I have taken approved or experimental drugs for Psoriatic Arthritis or Psoriasis.

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I have been diagnosed with active fibromyalgia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Upper respiratory tract infection

Cough

Pyrexia

Mouth ulceration

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DeucravacitinibExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~160

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psoriatic Arthritis (PsA) treatments target specific pathways involved in the inflammatory process. Deucravacitinib, a selective TYK2 inhibitor, blocks the TYK2 enzyme, which is crucial in the signaling pathways of cytokines like IL-23, IL-12, and Type I interferons, thereby reducing inflammation and immune response. TNF inhibitors (e.g., adalimumab, infliximab) block tumor necrosis factor-alpha, a key cytokine in inflammation. IL-17 inhibitors (e.g., secukinumab, ixekizumab) target the IL-17 pathway, reducing inflammation and joint damage. IL-12/23 inhibitors (e.g., ustekinumab) block these interleukins, which are involved in the differentiation and activation of T-cells. These mechanisms are crucial for PsA patients as they directly reduce the inflammatory processes that cause joint pain, swelling, and damage, improving overall quality of life.

[Targeted treatment in spondyloarthritis].