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Kyntheum (BRODALUMAB)
Kyntheum works by blocking the interleukin-17 receptor, a protein that plays a key role in inflammation.
At a glance
| Generic name | BRODALUMAB |
|---|---|
| Sponsor | Valeant Luxembourg |
| Drug class | Interleukin-17 Receptor A Antagonist [EPC] |
| Target | Interleukin-17 receptor |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Brodalumab is human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25. IL-17RA is protein expressed on the cell surface and is required component of receptor complexes utilized by multiple IL-17 family cytokines. Blocking IL-17RA inhibits IL-17 cytokine-induced responses including the release of pro-inflammatory cytokines and chemokines.
Approved indications
- Non-radiographic axial spondyloarthritis
- Plaque psoriasis
Boxed warnings
- WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [ see Warnings and Precautions ( 5.1 )]. Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions ( 5.2 )]. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning. • Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. ( 5.1 , 6.1 ) • Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. ( 5.1 ) • Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. ( 5.1 ) • Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. ( 5.1 ) • SILIQ is available only through a restricted program called the SILIQ REMS Program. ( 5.2 )
Common side effects
- Infections
- Neutropenia
- Injection site reactions
- Influenza
- Arthralgia
- Headache
- Fatigue
- Oropharyngeal pain
- Nausea
- Myalgia
- Diarrhea
- Suicidal ideation or behavior
Key clinical trials
- Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis (PHASE4)
- Psoriasis Longitudinal Assessment and Registry
- Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight (PHASE4)
- Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
- An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects (PHASE4)
- LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis
- A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers (PHASE4)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |