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Brodalumab

Brodalumab, also known by the brand name Siliq, is an interleukin-17 receptor A antagonist being studied in clinical trials for various inflammatory conditions. This article summarizes key findings from recent trials examining brodalumab’s efficacy and safety in treating psoriasis, hidradenitis suppurativa, and axial spondyloarthritis. The trials demonstrate brodalumab’s potential as a treatment option for patients who have not responded well to other therapies.

Table of Contents

What is Brodalumab?

Brodalumab is a medication used to treat certain skin conditions. It’s also known by its brand name Siliq[1]. Brodalumab is a type of drug called a monoclonal antibody, which is a laboratory-made protein that mimics the immune system’s ability to fight off harmful antigens such as viruses. Specifically, it’s a human monoclonal IgG2κ antibody that targets a part of the immune system called interleukin-17 receptor A (IL-17RA)[2].

What Conditions Does Brodalumab Treat?

Brodalumab is primarily used to treat the following conditions:

  • Psoriasis: This is a chronic autoimmune condition that causes rapid buildup of skin cells, resulting in scaling on the skin’s surface[3].
  • Hidradenitis Suppurativa (HS): Also known as acne inversa, this is a chronic skin condition characterized by painful, swollen bumps that usually appear in areas where skin rubs together, such as the armpits, groin, and under the breasts[4].

How Does Brodalumab Work?

Brodalumab works by blocking a specific part of the immune system called interleukin-17 receptor A (IL-17RA). In conditions like psoriasis and hidradenitis suppurativa, the immune system is overactive, leading to inflammation and skin symptoms. By blocking IL-17RA, Brodalumab helps to reduce this inflammation and improve skin symptoms[2].

How is Brodalumab Administered?

Brodalumab is administered as a subcutaneous injection, which means it’s injected just under the skin. The typical dosing schedule is as follows:

  • For psoriasis: 210 mg injected at weeks 0, 1, and 2, followed by 210 mg every 2 weeks thereafter[3].
  • For hidradenitis suppurativa: 210 mg injected at weeks 0, 1, and 2, followed by 210 mg every week for up to 24 weeks in some studies[5].

It’s important to note that the medication should not be injected into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by the condition being treated[5].

Efficacy of Brodalumab

Clinical trials have shown promising results for Brodalumab in treating both psoriasis and hidradenitis suppurativa:

  • For Psoriasis: Studies have used measures such as the Psoriasis Area and Severity Index (PASI) and the static Physician’s Global Assessment (sPGA) to evaluate efficacy. A significant number of patients achieved clear or almost clear skin (sPGA score of 0 or 1) after 16 weeks of treatment[3].
  • For Hidradenitis Suppurativa: Efficacy is often measured using the Hidradenitis Suppurativa Clinical Response (HiSCR), which is defined as a 50% reduction in the total number of abscesses and inflammatory nodules, with no increase in abscesses or draining fistulas. Studies have shown promising results at 16 and 24 weeks of treatment[5].

Safety and Side Effects

As with all medications, Brodalumab can cause side effects. Common side effects may include:

  • Headache
  • Joint pain
  • Fatigue
  • Diarrhea
  • Throat pain
  • Nausea
  • Muscle pain

More serious side effects, although rare, can include increased risk of infections and suicidal thoughts or behaviors. It’s important to discuss all potential risks and benefits with your healthcare provider[3][5].

Ongoing Research

Research on Brodalumab is ongoing, particularly in its use for hidradenitis suppurativa. Some current studies are exploring:

  • Alternative dosing schedules for hidradenitis suppurativa[4].
  • The effectiveness of Brodalumab in patients who have failed other biologic therapies[1].
  • Potential biomarkers that could predict response to treatment[4].

These ongoing studies aim to further understand the drug’s efficacy, safety, and optimal use in different patient populations.

References

[ { “id”: “ref1”, “order”: “1”, “url”: “https://clinicaltrials.gov/study/NCT04979520” }, { “id”: “ref2”, “order”: “2”, “url”: “https://clinicaltrials.gov/study/NCT04149587” }, { “id”: “ref3”, “order”: “3”, “url”: “https://clinicaltrials.gov/study/NCT03403036” }, { “id”: “ref4”, “order”: “4”, “url”: “https://clinicaltrials.gov/study/NCT04249713” }, { “id”: “ref5”, “order”: “5”, “url”: “https://clinicaltrials.gov/study/NCT03910803” } ]
Condition Key Findings Dosing Primary Outcomes
Psoriasis Effective in patients who failed other biologics; high rates of skin clearance 210 mg Q2W PASI 100, sPGA 0/1
Hidradenitis Suppurativa Promising results in moderate to severe HS; reduction in inflammatory lesions 210 mg weekly or Q2W HiSCR, changes in biomarkers
Axial Spondyloarthritis Under investigation for efficacy in axSpA Not specified ASAS 40 response
Safety Generally well-tolerated; monitoring for adverse events ongoing N/A Incidence of adverse events, antibody development

FAQ

  • What conditions is brodalumab being studied for in clinical trials? Brodalumab is being studied in clinical trials for several inflammatory conditions, including moderate to severe plaque psoriasis, hidradenitis suppurativa, and axial spondyloarthritis.
  • How is brodalumab administered? Brodalumab is typically administered as a subcutaneous injection. The dosing regimen varies by study, but common doses are 210 mg every 2 weeks or 210 mg weekly.
  • What are some of the primary outcomes being measured in brodalumab trials? Primary outcomes often include measures of disease improvement, such as the Psoriasis Area and Severity Index (PASI) score for psoriasis, the Hidradenitis Suppurativa Clinical Response (HiSCR) for hidradenitis suppurativa, and the Assessment of SpondyloArthritis international Society (ASAS) response for axial spondyloarthritis.
  • Are there any notable side effects or safety concerns with brodalumab? While brodalumab appears to be generally well-tolerated, researchers are monitoring for adverse events and evaluating safety in the clinical trials. Some studies are specifically looking at the incidence of treatment-emergent adverse events.
  • How does brodalumab compare to other biologic therapies? Some trials are studying brodalumab in patients who have failed treatment with other biologics, particularly IL-17A therapies. This suggests brodalumab may be effective for patients who haven't responded well to other treatments.

Ongoing Clinical Trials on Brodalumab

  • Study on Adjustable Brodalumab Dosage for Patients with Moderate-to-Severe Plaque Psoriasis Weighing 120 kg or More

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Czechia France Germany Greece Hungary +3

Glossary

  • Brodalumab: A human monoclonal antibody that targets the interleukin-17 receptor A (IL-17RA), used to treat inflammatory conditions like psoriasis and being studied for other diseases.
  • Psoriasis: A chronic autoimmune condition that causes rapid buildup of skin cells, resulting in scaling on the skin's surface.
  • Hidradenitis Suppurativa (HS): A chronic skin condition characterized by painful, inflamed lesions in areas where skin rubs together, such as the armpits, groin, and under the breasts.
  • Axial Spondyloarthritis (axSpA): An inflammatory arthritis affecting the spine and sacroiliac joints, causing back pain and stiffness.
  • PASI (Psoriasis Area and Severity Index): A tool used to measure the severity and extent of psoriasis, combining the assessment of the severity of lesions and the area affected into a single score.
  • HiSCR (Hidradenitis Suppurativa Clinical Response): A measure of treatment response in hidradenitis suppurativa, defined as a ≥50% reduction in inflammatory lesion count with no increase in abscesses or draining fistulas.
  • ASAS (Assessment of SpondyloArthritis international Society): A set of criteria used to assess improvement in patients with axial spondyloarthritis.
  • Interleukin-17 (IL-17): A pro-inflammatory cytokine involved in the pathogenesis of various inflammatory diseases.
  • Subcutaneous injection: A method of administering medication by injecting it into the tissue layer between the skin and the muscle.
  • Biomarker: A measurable indicator of a biological state or condition, often used to assess the effectiveness of a treatment.