Guselkumab for Psoriatic Arthritis

Overseen By Mehrnaz Aghili

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: Guselkumab

Must not be taking: Corticosteroids, Estrogen, Tamoxifen, others

Disqualifiers: Hepatitis B, Hepatitis C, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Guselkumab, a biologic medication, can help individuals with both psoriatic arthritis (PsA) and nonalcoholic fatty liver disease (NAFLD). The researchers aim to assess the medication's effects on the liver, joints, and skin in these patients. Individuals with PsA symptoms, such as swollen joints or skin plaques, who are beginning Guselkumab treatment and have been diagnosed with NAFLD, might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of how Guselkumab can benefit patients with both PsA and NAFLD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must not have changed your regular medication regimen in the last three months and cannot have used systemic or chronic steroids in the 8 weeks before the study.

Is there any evidence suggesting that Guselkumab is likely to be safe for humans?

Studies have shown that guselkumab is generally safe for people with psoriatic arthritis (PsA). Earlier research identified upper respiratory infections as a common side effect, occurring in less than 1% of participants. Research also shows that guselkumab helps reduce symptoms and slow joint damage in PsA patients.

Long-term studies have found that the treatment remains safe and effective over time. The data suggest that guselkumab does not cause severe side effects for most people. Prospective trial participants might find reassurance in this history of use in PsA regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Guselkumab is unique because it targets a specific part of the immune system involved in psoriatic arthritis. While most treatments for PsA, like methotrexate and TNF inhibitors, work broadly on the immune system, guselkumab specifically blocks a protein called interleukin-23 (IL-23). This targeted approach could mean fewer side effects and potentially better control of symptoms, which is why researchers are excited about its potential.

What evidence suggests that Guselkumab might be an effective treatment for Psoriatic Arthritis?

Research has shown that guselkumab effectively treats psoriatic arthritis (PsA). Over 40% of patients using guselkumab experienced significant improvement in joint and skin symptoms. By blocking a protein called IL-23, it helps reduce inflammation. Guselkumab has also proven to prevent further joint damage in PsA. Compared to other PsA treatments, it often works better on skin symptoms. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with Psoriatic Arthritis (PsA) who also have Nonalcoholic fatty liver disease (NAFLD). Participants should show active signs of PsA, like swollen joints or skin plaques. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the severity of conditions.

Inclusion Criteria

I am starting Guselkumab for Psoriatic Arthritis as recommended by my rheumatologist.

My regular medications have been the same for the last 3 months and I haven't taken steroids in the last 8 weeks.

Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants

Exclusion Criteria

I do not have chronic liver disease, HIV, or plan to become pregnant, and my life expectancy is over 5 years.

I have been treated with specific immune-targeting drugs or more than 2 TNF blockers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Guselkumab therapy to assess its impact on NAFLD and PsA

24 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab

Trial Overview The study tests Guselkumab therapy's effects on NAFLD and PsA severity. It involves two visits from participants to assess how this biological therapy impacts liver health as well as joint and skin symptoms associated with PsA.

How Is the Trial Designed?

Group I: psoriatic arthritis patients Experimental Treatment 1 Intervention

Adults with active PsA and diagnosed NAFLD

Guselkumab is already approved in United States, European Union for the following indications:

Approved in United States as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study of 285 adults with psoriatic arthritis who had previously not responded to tumor necrosis factor inhibitors, guselkumab significantly improved joint symptoms, with 44.4% of patients achieving a 20% improvement in their condition (ACR20) compared to 19.8% in the placebo group at week 24.

Guselkumab demonstrated a favorable safety profile, with low rates of serious adverse events (3.7%) and no deaths or opportunistic infections reported, indicating it is a safe treatment option for patients with TNFi-resistant psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Coates, LC., Gossec, L., Theander, E., et al.[2022]

Guselkumab is an approved treatment for moderate-to-severe plaque psoriasis, specifically designed to inhibit interleukin 23 (IL-23), which plays a key role in the inflammatory process of the disease.

By blocking IL-23 from binding to its receptor, guselkumab disrupts the IL-17 pathway, which is crucial for the activation of type 17 helper T cells, thereby reducing inflammation and symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. Markham, A.[2019]

In a phase II trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms of enthesitis and dactylitis compared to placebo, with these improvements sustained through week 56.

Patients who switched from placebo to guselkumab treatment experienced similar benefits in enthesitis and dactylitis as those who received guselkumab from the start, indicating its effectiveness regardless of when treatment began.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. Mease, PJ., Gladman, DD., Deodhar, A., et al.[2021]

In a phase 2a trial involving 149 patients with active psoriatic arthritis, guselkumab significantly improved symptoms, with 58% of patients achieving at least a 20% improvement in their condition compared to only 35% in the placebo group, demonstrating its efficacy as a treatment.

Guselkumab was well tolerated over 44 weeks, with a similar rate of adverse events (36% in the treatment group vs. 33% in the placebo group), indicating a favorable safety profile for this novel therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Deodhar, A., Gottlieb, AB., Boehncke, WH., et al.[2020]

Guselkumab is a human monoclonal antibody that selectively blocks IL-23, which is important in the development of psoriasis and psoriatic arthritis, and it was approved for treating active psoriatic arthritis based on data from two phase-3 studies (DISCOVER-1 and -2).

This treatment represents a new therapeutic option for patients with active psoriatic arthritis, demonstrating both efficacy and safety, and it is the first selective IL-23 inhibitor to receive FDA approval for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis in Adults. Boehncke, WH., Brembilla, NC., Nissen, MJ.[2021]

In the DISCOVER-2 trial, guselkumab was tested in biologic-naive patients with active psoriatic arthritis, demonstrating significant efficacy in reducing disease activity compared to placebo.

The study's double-blind, randomized, placebo-controlled design ensures robust results, highlighting guselkumab as a promising treatment option for patients who have not previously received biologic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis. Schattner, A.[2020]

Guselkumab (GUS) demonstrated a favorable safety profile in patients with psoriatic arthritis (PsA), showing low adverse event (AE) rates for both TNFi-naïve (139.7/100 patient-years) and TNFi-experienced patients (174.0/100 patient-years) over a period of up to 2 years.

The safety outcomes, including rates of serious AEs and treatment discontinuation, were consistent between GUS-treated patients and those receiving placebo, indicating that GUS is a safe treatment option for PsA regardless of prior TNFi use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. Rahman, P., Boehncke, WH., Mease, PJ., et al.[2023]

Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.

Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. Al-Salama, ZT., Scott, LJ.[2019]

In the phase 3b COSMOS trial, guselkumab, an IL-23 inhibitor, was effective in reducing disease activity in adults with active psoriatic arthritis who had inadequate responses to tumor necrosis factor inhibitors, showing significant decreases in inflammatory markers like CRP and IL-17 levels by Week 24.

Participants treated with guselkumab exhibited a notable improvement in clinical response, with higher baseline levels of IL-22 and IFNɣ associated with better outcomes, indicating a potential biomarker for treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. Schett, G., Chen, W., Gao, S., et al.[2023]

Citations

1. jnj.com jnj.com/media-center/press-releases/new-data-show-tremfya-guselkumab-is-the-only-il-23-inhibitor-proven-to-significantly-inhibit-progression-of-joint-structural-damage-in-active-psoriatic-arthritis

New data show TREMFYA® (guselkumab) is the only IL-23 ... More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24. Improvement in both joint and skin symptoms ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07220824

NCT07220824 | A Study of Guselkumab in Participants ... The purpose of this study is to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10070072/

Comparative effectiveness of guselkumab in psoriatic arthritis Guselkumab demonstrates better skin efficacy than most other targeted PsA therapies, including upadacitinib.

4. tremfyahcp.com tremfyahcp.com/plaque-psoriasis/efficacy-in-joints/

Efficacy in Active PsA: Moderate to Severe Plaque PsO Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis.

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/guselkumab-improves-outcomes-in-psa-with-severe-disease-activity/

Guselkumab Shows Long-Term Efficacy in Biologic-Naïve ... Treatment with guselkumab demonstrates rapid and sustained efficacy among biologic-naïve adults with psoriatic arthritis (PsA) and severe ...

6. tremfyahcp.com tremfyahcp.com/psoriatic-arthritis/safety/

Safety Profile In Active PsA | TREMFYA® (guselkumab) HCP Most common adverse reactions associated with TREMFYA® include: plaque psoriasis and psoriatic arthritis adverse reactions (≥1%): upper respiratory infections, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906417/

Long-Term Safety of Guselkumab in Psoriatic Disease Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic ...

8. jrheum.org jrheum.org/content/early/2021/08/11/jrheum.201532

Pooled Safety Results Through 1 Year of 2 Phase III Trials ... Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis · Article · Figures & Data ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02319759

NCT02319759 | Efficacy and Safety Study of Guselkumab ... The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA). Detailed ...