What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis (PsA) include biologic agents such as TNF inhibitors (e.g., adalimumab, etanercept, infliximab), IL-17 inhibitors (e.g., secukinumab, ixekizumab), and IL-23 inhibitors (e.g., guselkumab, tildrakizumab, risankizumab). The known side effects of these treatments can include increased risk of infections, injection site reactions, and potential exacerbation of pre-existing conditions like hepatitis. TNF inhibitors may also be associated with a risk of malignancies and demyelinating diseases. IL-17 inhibitors have been linked to inflammatory bowel disease events, while IL-23 inhibitors like guselkumab generally have a favorable safety profile but still require monitoring for infections and liver function abnormalities.

What prior FDA approvals exist?

Several biologic agents and kinase inhibitors have been approved by the FDA for the treatment of Psoriatic Arthritis. Guselkumab, an IL-23 inhibitor, is one such drug that has shown efficacy in treating PsA. Other similar biologics include ustekinumab, which targets IL-12/23, and secukinumab and ixekizumab, which inhibit IL-17. Additionally, TNF inhibitors like adalimumab, etanercept, and infliximab have been widely used. Janus kinase (JAK) inhibitors such as tofacitinib have also been approved for PsA treatment. These treatments aim to reduce inflammation and improve symptoms in patients with PsA.

What other types of research exist?

Promising alternatives to Guselkumab for Psoriatic Arthritis patients include IL-17 inhibitors such as Secukinumab and Ixekizumab, which have demonstrated significant improvements in joint and skin symptoms. Additionally, JAK inhibitors like Tofacitinib and Upadacitinib have shown efficacy in patients with inadequate responses to TNF inhibitors. These therapies offer novel mechanisms of action and have been effective in clinical trials.

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Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis (STAR Trial)

Phase 4

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4

Must not have

Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor

Has previously received any biologic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing guselkumab, a medication that reduces inflammation, in patients with psoriatic arthritis affecting the spine. It works by blocking a protein called IL-23 to help reduce symptoms and inflammation. Guselkumab is the first IL-23 specific inhibitor approved for the treatment of moderate-to-severe psoriasis.

Who is the study for?

This trial is for individuals with active psoriatic arthritis axial disease, diagnosed at least 6 months ago. Participants must have at least 3 swollen and tender joints, elevated CRP levels, MRI-confirmed PsA axial disease, a BASDAI score of ≥4, spinal pain VAS score of ≥4, and may have plaque psoriasis or nail changes. Those who've had biologic treatments or suffer from other inflammatory diseases like RA or lupus can't join.

What is being tested?

The study tests the effectiveness of Guselkumab in reducing symptoms and inflammation in patients with PsA axial disease compared to a placebo. Patients will receive either Guselkumab or an inactive substance (placebo) through subcutaneous injections to see if there's an improvement in their condition.

What are the potential side effects?

Potential side effects of Guselkumab include allergic reactions, injection site reactions such as redness and swelling, upper respiratory infections due to immune system suppression by the drug, headache and fatigue. The exact side effects experienced can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have active psoriasis with a plaque larger than 2 cm or nail changes.

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My back pain and stiffness are severe, scoring at least 4 out of 10.

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I have PsA with swelling and tenderness in at least 3 joints and high CRP levels despite previous treatments.

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I have been diagnosed with psoriatic arthritis for at least 6 months.

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My MRI shows Psoriatic Arthritis in my spine or sacroiliac joints.

Exclusion Criteria

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

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I have taken a JAK inhibitor medication before.

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I have received biological therapy before.

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I haven't taken any immune system suppressing drugs in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24

Secondary study objectives

Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24

Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24

Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24

+16 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: Placebo followed by GuselkumabExperimental Treatment2 Interventions

Participants will receive matching placebo and will cross over to receive guselkumab SC.

Group II: Group 2: GuselkumabExperimental Treatment1 Intervention

Participants will receive guselkumab SC.

Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions

Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

Placebo

1995

Completed Phase 3

~2670

0 / 8Eligibility 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 often target specific pathways involved in the disease's inflammatory process. IL-23 inhibitors like guselkumab work by blocking the IL-23 cytokine, which is crucial for the proliferation and survival of Th17 cells that drive inflammation in PsA. This helps reduce symptoms and prevent joint damage. IL-17 inhibitors, such as secukinumab, target the IL-17 cytokine, another key player in the inflammatory cascade. TNF-alpha inhibitors, like adalimumab, block the TNF-alpha cytokine, which is involved in systemic inflammation. These treatments are essential for PsA patients as they help manage symptoms, reduce inflammation, and prevent long-term joint damage, improving overall quality of life.