What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis, particularly those similar to Guselkumab (a selective IL-23 inhibitor), include other IL-23 inhibitors like tildrakizumab and risankizumab, as well as IL-17 inhibitors such as secukinumab and ixekizumab. The known side effects of these treatments generally include increased risk of infections, injection site reactions, and potential exacerbation of pre-existing conditions like inflammatory bowel disease. Long-term data have not shown a significant association with internal malignancies for IL-23 and IL-17 inhibitors. Patients should discuss the risk-benefit profile of these treatments with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Psoriatic Arthritis (PsA). Guselkumab, a selective IL-23 inhibitor, is one such agent. Other biologics include TNF inhibitors like etanercept, adalimumab, and infliximab, which target tumor necrosis factor-alpha (TNF-α). Additionally, IL-17 inhibitors such as secukinumab and ixekizumab, and IL-12/23 inhibitors like ustekinumab, have also been approved. These treatments work by targeting specific components of the immune system to reduce inflammation and halt disease progression in PsA patients.

What other types of research exist?

Promising novel alternatives to Guselkumab for Psoriatic Arthritis patients include: 1) Secukinumab (IL-17A inhibitor), which has shown significant improvement in joint and skin symptoms and physical function. 2) Ixekizumab (IL-17A inhibitor), which has demonstrated efficacy in reducing symptoms and radiographic progression. 3) Upadacitinib (JAK inhibitor), which has shown effectiveness in patients with inadequate response to TNF inhibitors. 4) Bimekizumab (IL-17A and IL-17F inhibitor), which has shown promising results in early studies.

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Monoclonal Antibodies

Guselkumab vs Golimumab for Psoriatic Arthritis

Phase 3

Waitlist Available

Led By Alexis Ogdie-Beatty, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study. Only use of a single OSM/csDMARD is allowed

Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints

Must not have

Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i)

Use of moderate to high dose glucocorticoids (>10 mg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare two medications, guselkumab and golimumab, in patients with psoriatic arthritis who did not respond well to their initial treatment. The goal is to see if switching to guselkumab is more effective than trying another similar medication. Guselkumab is used for treating moderate-to-severe plaque psoriasis in adults and has shown additional benefits in patients who did not respond well to other treatments.

Who is the study for?

This trial is for adults aged 18-80 with active psoriatic arthritis who haven't responded well to their first TNF inhibitor treatment. They must have at least one swollen joint or enthesitis site, be on a stable dose of certain oral medications if used, and not be pregnant or trying to conceive. Those previously treated with golimumab or other non-TNF biologics, or who've had serious side effects from TNF inhibitors can't join.

What is being tested?

The EVOLUTION study is testing whether guselkumab (an IL23 inhibitor) is more effective than golimumab (a second type of TNFi) in patients with PsA who didn’t respond well to an initial TNFi treatment. It's a double-blinded study where participants are randomly assigned to receive either guselkumab or golimumab.

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, allergic reactions, and possibly others that are common with treatments affecting the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I am on a stable dose of one specific oral medication for my condition.

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I have psoriatic arthritis with swelling or pain in my joints.

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I have been diagnosed with psoriatic arthritis according to CASPAR criteria.

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I am between 18 and 80 years old.

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I have at least one active psoriasis plaque.

Exclusion Criteria

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

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I have previously been treated with golimumab or similar medications.

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I am taking more than 10 mg of steroids daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

IGA Psoriasis

cDAPSA

Secondary study objectives

DLQI

HAQ-DI

PSAID-12

Side effects data

From 2016 Phase 4 trial • 205 Patients • NCT02092285

14%

COLITIS ULCERATIVE

10%

NASOPHARYNGITIS

HEADACHE

OROPHARYNGEAL PAIN

COLITIS

NAUSEA

PULMONARY EMBOLISM

ACCIDENTAL OVERDOSE

100%

80%

60%

40%

20%

Study treatment Arm

Golimumab

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: GUS and placebo (8 Weeks)Experimental Treatment1 Intervention

Guselkumab (GUS) and placebo (8 Weeks)

Group II: GUS and placebo (4 Weeks)Experimental Treatment1 Intervention

Guselkumab (GUS) and placebo (4 Weeks)

Group III: GOL and PlaceboActive Control1 Intervention

Golimumab (GOL) and placebo

0 / 7Eligibility 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 immune pathways to reduce inflammation and halt disease progression. Guselkumab, a selective IL-23 inhibitor, works by blocking the IL-23 cytokine, which is crucial in the inflammatory process of PsA. This inhibition helps reduce the activity of Th17 cells, which are implicated in the pathogenesis of PsA. Other common treatments include TNF inhibitors like golimumab, which block the tumor necrosis factor (TNF) involved in systemic inflammation. These targeted therapies are essential for PsA patients as they offer more precise control over the immune response, potentially leading to better management of symptoms and slowing of disease progression.