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 tyrosine kinase inhibitors. These treatments can have side effects such as increased risk of infections, liver enzyme abnormalities, and gastrointestinal issues. Other treatments for Lupus, such as immunosuppressants and biologics, may cause side effects including nausea, headache, increased risk of infections, and potential allergic reactions. 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 treatment for systemic lupus erythematosus (SLE) in the past 60+ years. It has demonstrated significant, albeit modest, efficacy and a reassuring safety profile. There is no specific mention of other selective TYK2 inhibitors approved for lupus in the provided context.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Lupus patients in 2024 include Tofacitinib and Baricitinib, both of which are Janus kinase (JAK) inhibitors that have shown efficacy in treating autoimmune diseases. Additionally, Upadacitinib, another JAK inhibitor, has demonstrated positive outcomes in clinical trials for rheumatoid arthritis and may be considered for Lupus treatment.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Lupus (POETYK SLE-2 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 is safe and effective for people with moderate to severe lupus, a disease where the immune system attacks the body. The medication aims to reduce inflammation by targeting specific enzymes in the immune system.

Who is the study for?

This trial is for adults with active moderate to severe Systemic Lupus Erythematosus (SLE) who meet specific criteria, including a certain score on the SLEDAI-2K disease activity index and evidence of joint or skin involvement. Participants may be taking stable doses of steroids, antimalarials, or immunosuppressants but cannot have severe lupus nephritis, other autoimmune diseases except some exceptions, recent major infections, or more than one immunosuppressant.

What is being tested?

The study tests Deucravacitinib's effectiveness and safety against a placebo in treating SLE. Participants will randomly receive either the investigational drug or an inactive substance to compare outcomes between the two groups over time.

What are the potential side effects?

While not specified here, potential side effects could include typical reactions seen with immune-modulating drugs such as increased risk of infection, liver issues, blood cell count changes, nausea, headaches and possible allergic reactions.

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

~320

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 the TYK2 enzyme involved in cytokine signaling pathways critical for immune response. This specificity can potentially reduce disease activity with fewer side effects. Understanding these mechanisms helps Lupus patients and their doctors choose treatments that effectively manage symptoms while minimizing adverse effects.

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.