Infliximab, Ustekinumab, and Guselkumab for Psoriasis
(PSOLAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on the safety of different treatments for psoriasis, a skin condition that causes red, itchy patches. It will evaluate the effectiveness of infliximab, ustekinumab, guselkumab, and other therapies. The trial also examines how these treatments impact patients' daily lives and any related joint pain (psoriatic arthritis). Individuals with psoriasis who are starting or already using medications like Tremfya (guselkumab) or IL-17 inhibitors (a type of medication for psoriasis) are suitable candidates for this study. Participants must attend regular follow-up visits and complete informed consent. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of new treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. It includes patients who are already on other therapies, so you might be able to continue your current treatment.
What is the safety track record for infliximab, ustekinumab, and guselkumab?
Research has shown that infliximab, ustekinumab, and guselkumab are generally safe for treating conditions like psoriasis.
For infliximab, studies involving thousands of patients indicate it is usually well-tolerated. However, it can weaken the immune system, making it harder to fight infections, and serious side effects have been reported, especially in older adults.
Ustekinumab has demonstrated a reliable safety record in studies for psoriasis and psoriatic arthritis. While it may increase the risk of infections, serious infections remain uncommon.
Guselkumab is also well-tolerated, with mild side effects like upper respiratory infections being the most common. Research shows no major safety differences between younger and older patients.
Overall, these treatments are generally safe but may increase the risk of infections. Patients should always discuss potential risks with a healthcare provider.12345Why are researchers excited about this trial's treatments?
The Psoriasis Longitudinal Assessment and Registry is a bit different from typical clinical trials because it’s not about a single treatment; instead, it’s focused on understanding psoriasis over time. Researchers are excited about this registry because it helps them gather comprehensive data on how psoriasis progresses and how patients respond to existing therapies. This can lead to better, more personalized treatment plans in the future. By tracking a wide range of patient experiences, researchers aim to identify patterns that could inform the development of new and improved treatments.
What evidence suggests that this trial's treatments could be effective for psoriasis?
This trial will compare the effectiveness of infliximab, ustekinumab, and guselkumab for psoriasis. Research has shown that infliximab effectively treats chronic plaque psoriasis, with 90% of patients experiencing clear or minimal symptoms. In one study, about 80% of psoriasis patients improved with infliximab treatment. Studies have also found that ustekinumab helps 7 out of 10 people achieve 75% clearer skin in just 12 weeks. Clinical trials demonstrated that 64% of patients treated with guselkumab had a 90% improvement in their skin symptoms at 16 weeks. These treatments have shown promising results in improving psoriasis symptoms.678910
Who Is on the Research Team?
Janssen Scientific Affairs, LLC Clinical Trial
Principal Investigator
Janssen Scientific Affairs, LLC
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment
Patient information is collected at the enrollment visit, including demographics, medical history, and details of past and current psoriasis treatments
Follow-up
Participants are monitored for safety and effectiveness, with data collected on physical examination, clinical disease status, Quality of Life assessments, and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Guselkumab
- Infliximab
- Ustekinumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Scientific Affairs, LLC
Lead Sponsor
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
Citations
study results
In clinical studies, at 16 weeks, patients had improvements in symptoms of plaque psoriasis including itching, burning, pain, stinging, and skin tightness.
Skin Clearance Data: Moderate to Severe Plaque PsO
Clearer skin is possible · 64% (102/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 16 · 71% (113/160) of patients receiving TREMFYA® ...
Guselkumab Efficacy and Safety for the Treatment of Low ...
Conclusions: Through Week 16, guselkumab was effective and well tolerated in participants with low BSA, moderate plaque psoriasis with ...
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jnjmedicalconnect.com
jnjmedicalconnect.com/products/tremfya/medical-content/tremfya-efficacy-outcomes-by-weight-in-adult-patients-with-plaque-psoriasis-or-psoriatic-arthritisTREMFYA - Efficacy Outcomes by Weight in Adult Patients ...
Super response (SR) status was defined as patients who received TREMFYA and achieved PASI 100 (absolute PASI = 0) response at weeks 20 and 28.
Guselkumab for Moderate to Severe Scalp Psoriasis ...
Conclusions and Relevance In this randomized clinical trial, after 3 doses of guselkumab, most participants achieved significant scalp clearance ...
Safety Profile for Moderate to Severe Plaque PsO
See the TREMFYA® (guselkumab) safety profile in adult patients with moderate to severe plaque psoriasis (PsO). See full Prescribing & Safety Info.
TREMFYA® (guselkumab)
TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for ...
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, ...
TREMFYA® (guselkumab) injection, for subcutaneous use
No overall differences in safety or effectiveness were observed between older and younger subjects who received TREMFYA.
Long-Term Safety of Guselkumab in Patients with Psoriatic ...
Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic ...
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