What side effects are associated with this type of intervention?

IL-23 inhibitors, such as Guselkumab, generally have a good safety profile but can cause nasopharyngitis, headache, and injection site reactions. TNF-alpha inhibitors, like Golimumab, are associated with a reduced risk of myocardial infarction but can lead to serious infections, injection site reactions, and potential malignancies. Both classes of drugs require monitoring for adverse effects, especially infections and potential cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Psoriatic Arthritis, including TNF-alpha inhibitors and IL-23 inhibitors. TNF-alpha inhibitors such as adalimumab, etanercept, infliximab, certolizumab, and golimumab have been widely used and shown efficacy in reducing disease activity and improving function in PsA patients. IL-23 inhibitors like guselkumab have also been approved for PsA, offering an alternative mechanism of action by targeting the IL-23 pathway. These treatments have demonstrated significant clinical benefits, including reduced radiographic progression and improved patient outcomes.

What other types of research exist?

Promising novel alternatives to Guselkumab plus Golimumab for Psoriatic Arthritis patients in 2024 include IL-17 inhibitors (Secukinumab, Ixekizumab), JAK inhibitors (Upadacitinib), and newer IL-23 inhibitors (Risankizumab) and IL-17A inhibitors (Bimekizumab).

← Back to Search

Monoclonal Antibodies

Guselkumab + Golimumab for Psoriatic Arthritis (AFFINITY Trial)

Phase 2

Waitlist Available

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 one psoriatic plaque of >=2 centimeter (cm) diameter or nail changes consistent with psoriasis

Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)

Must not have

Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician

Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 weeks

Summary

This trial is testing if a combination of two drugs, guselkumab and golimumab, is more effective than one drug alone for people with psoriatic arthritis who haven't responded to other treatments. Both drugs help reduce inflammation by blocking specific proteins. Guselkumab is the first interleukin (IL)-23 inhibitor approved for the treatment of moderate-to-severe psoriasis.

Who is the study for?

This trial is for people with active psoriatic arthritis who haven't responded well to at least one or two prior treatments with anti-TNF-alpha drugs. Participants should have symptoms like swollen and tender joints, psoriasis plaques, or nail changes. They can't join if they've had more than two anti-TNF-alpha treatments, other inflammatory diseases that could affect results, known allergies to biologic meds, or a history of intolerance to the study drugs.

What is being tested?

The study tests whether combining Guselkumab and Golimumab is effective in treating psoriatic arthritis compared to using Guselkumab alone in those who didn’t respond adequately to previous therapies targeting TNF-alpha (a protein involved in inflammation).

What are the potential side effects?

Potential side effects may include allergic reactions due to proteins used in the medications, infections because these drugs can weaken the immune system's ability to fight germs, injection site reactions such as redness or pain, and possibly others based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My PsA didn't improve after 1 or 2 treatments with anti-TNF drugs.

Select...

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

Exclusion Criteria

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

Select...

I have been treated with golimumab or guselkumab, or I can't tolerate anti-TNF-alpha therapy.

Select...

I am allergic to certain biologic medications or proteins used in treatments.

Select...

I have been treated with more than 2 anti-TNF-alpha medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 42 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 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

Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24

Secondary study objectives

Diabetes Insipidus

Change from Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24

Percentage of Participants With AEs Leading to Discontinuation of Study Intervention

+12 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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: Guselkumab and GolimumabExperimental Treatment2 Interventions

Participants will receive subcutaneous (SC) guselkumab and golimumab.

Group II: Group 2: Guselkumab and PlaceboActive Control2 Interventions

Participants will receive SC guselkumab and placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guselkumab

2015

Completed Phase 4

~6080

Golimumab

2014

Completed Phase 4

~3610

0 / 6Eligibility 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

IL-23 inhibitors, like Guselkumab, target the interleukin-23 protein, reducing inflammation and immune response in Psoriatic Arthritis (PsA). TNF-alpha inhibitors, such as Golimumab, block the tumor necrosis factor-alpha, decreasing systemic inflammation, pain, and joint damage. These mechanisms are crucial for PsA patients as they directly address the underlying causes of their symptoms, potentially improving disease management and quality of life.

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.Guselkumab for the treatment of adults with moderate to severe plaque psoriasis.