What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly those targeting intracellular signaling pathways like Deucravacitinib (a selective TYK2 inhibitor), include various kinase inhibitors. Known side effects of these treatments can include increased risk of infections, gastrointestinal disturbances, liver enzyme abnormalities, and hematologic issues such as anemia and leukopenia. Additionally, some patients may experience headaches, hypertension, and elevated cholesterol levels. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Belimumab is the only FDA-approved biologic treatment for systemic lupus erythematosus (SLE) in the past 60 years. It has demonstrated modest efficacy and a reassuring safety profile in clinical trials and real-world settings. Other biologic agents like rituximab have been studied but did not show significant differences in efficacy or safety compared to placebo. Deucravacitinib, a selective TYK2 inhibitor, is currently being studied for its effectiveness and safety in treating moderate to severe SLE.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Lupus patients in 2024 include Anifrolumab (an anti-IFNAR1 monoclonal antibody), Belimumab (a monoclonal antibody targeting BLyS), and Voclosporin (a calcineurin inhibitor). These treatments have shown efficacy in clinical trials and offer different mechanisms of action that may benefit patients with SLE.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lupus (POETYK SLE-1 Trial)

Phase 3

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called deucravacitinib to see if it can help people with moderate to severe Systemic Lupus Erythematosus (SLE). The medication works by calming down the immune system and reducing inflammation. The goal is to find out if it is safe and effective for these patients.

Who is the study for?

This trial is for adults with active moderate to severe Systemic Lupus Erythematosus (SLE) who have a certain level of disease activity. Participants must have been diagnosed at least 24 weeks prior and be on stable SLE medication. Those with lupus overlap syndromes, recent serious infections, multiple immunosuppressants, or unstable neuropsychiatric manifestations cannot join.

What is being tested?

The study tests the effectiveness and safety of Deucravacitinib versus a placebo in treating SLE. It aims to see if Deucravacitinib can help manage symptoms better than an inactive substance without any therapeutic effect.

What are the potential side effects?

While specific side effects for Deucravacitinib are not listed here, common drug-related side effects in trials may include nausea, headaches, possible increased risk of infection due to immune system suppression, and potential liver issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Cough

Pyrexia

Mouth ulceration

Upper respiratory tract infection

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: DeucravacitinibExperimental Treatment1 Intervention

Group II: Arm 2: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~310

Do I qualify?Apply below to find out

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

Common treatments for lupus, such as hydroxychloroquine, glucocorticoids, and immunosuppressive agents like azathioprine, work by modulating the immune system to reduce inflammation and prevent tissue damage. Hydroxychloroquine interferes with antigen presentation and cytokine production, while glucocorticoids suppress overall immune activity. Immunosuppressive agents inhibit the proliferation of immune cells. Deucravacitinib, a selective TYK2 inhibitor, targets intracellular signaling pathways involved in the immune response, specifically the JAK-STAT pathway, which is crucial in the pathogenesis of lupus. Understanding these mechanisms helps lupus patients and their doctors choose treatments that effectively control disease activity and minimize organ damage.

Treat-to-target in systemic lupus erythematosus: advancing towards its implementation.The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.New Trials in Lupus and where Are we Going.