What Is Atopic Dermatitis?
Eczema, additionally referred to as atopic dermatitis, is a persistent inflammatory skin disease that produces redness, irritation, and itching. Atopic dermatitis is not always communicable and goes between flares and remissions. Managing the signs and symptoms is probably tough. However, there are treatment options available to help manage atopic dermatitis. A new treatment approach called Tralokinumab has emerged that is showing promising results in treating atopic dermatitis, which will be discussed further in this article.
What Is Tralokinumab?
Tralokinumab is a completely human IgG4 monoclonal antibody used to treat moderate to severe atopic dermatitis. It specifically targets and neutralizes the cytokine interleukin 13 (IL-13), thereby preventing its interaction with the IL-13 receptor and the resulting inflammatory effects associated with atopic dermatitis.
Is Tralokinumab Approved for Atopic Dermatitis?
Tralokinumab was approved by the European Union (EU) in June 2021 for the treatment of moderate to severe atopic dermatitis in adults when topical treatments are insufficient. It is made using recombinant DNA technology in mouse myeloma cells.
Tralokinumab-DRM) is another form of Tralokinumab, which is a biologic drug approved by the U.S. Food and Drug Administration (FDA) in December 2021 for adults (18+ years) with moderate to severe atopic dermatitis. It is recommended for people whose diseases cannot be sufficiently controlled by topical prescription therapies or in situations where those therapies are contraindicated.
The degree of skin involvement and the severity of symptoms like itch and rash typically determine how severe an atopic dermatitis is. However, even if the affected body surface is more limited, the disease can be considered moderate or severe if it significantly impacts the individual's quality of life.
Tralokinumab formulations contain interleukin-13 antagonists that behave as a regulator for allergic and inflammatory. They are well suitable for managing chronic inflammatory diseases like atopic dermatitis. They treat these conditions by regulating the immune response.
What Are the Guidelines for Tralokinumab?
The guidelines regarding dosage and administration for Tralokinumab are as follows.
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Tralokinumab is administered as a subcutaneous injection.
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For adults, the initial dose is 600 mg, followed by 300 mg every two weeks (fortnight).
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Clinicians can consider dosing every four weeks for patients who achieved clear or almost clear skin.
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If there is no response after 16 weeks of treatment, discontinuation may be considered.
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Tralokinumab may be used in conjunction with topical corticosteroids.
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Pre-filled syringes should be brought to room temperature for 30 minutes before injecting.
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Injection sites should be alternated between the thigh, abdomen, or upper arms and avoided in tender, bruised, erythematous, or damaged skin.
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Patients may self-inject Tralokinumab after receiving proper training.
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Missed doses should be administered as soon as possible and resumed at the regularly scheduled time thereafter.
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There is currently no specific treatment for overdose.
Additional Dosing Considerations:
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Elderly: Limited data is available for individuals older than 75 years. Therefore, dose adjustment recommendations for this population are not specified.
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Renal Impairment: Limited data exist regarding the use of Tralokinumab in individuals with severe renal impairment. Dose adjustment recommendations for this population are not specified.
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Hepatic Impairment: Limited data are available for individuals with severe hepatic impairment. Dose adjustment recommendations for this population are not specified.
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Increased Dosing Frequency in Obesity: In obese patients, lower trough concentrations of Tralokinumab have been observed. Therefore, when clear skin is achieved, reducing the dosage to every four weeks may not be appropriate. The prescribing clinician should consider the individual's response to treatment and adjust the dosing frequency accordingly.
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Reduced Dose in Pediatrics: In the phase III ECTRA 6 trial, lower doses (150 mg or 300 mg fortnightly) have shown effectiveness in adolescents. However, limited safety and efficacy data are available for pediatric patients.
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Limited Data in Pregnancy: Animal studies have not shown the harmful effects of Tralokinumab during pregnancy. However, due to limited human data, it is generally recommended to avoid the use of Tralokinumab while pregnant unless the potential advantages outweigh the risks.
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Breastfeeding: The excretion of Tralokinumab into human milk is unknown. When deciding whether to continue breastfeeding while receiving Tralokinumab, one should weigh the risks and benefits of the medication.
Is Tralokinumab Safe and Effective Long-Term?
Yes, it has been proven in clinical trials that Tralokinumab is safe and effective for long-term treatment of moderate-to-severe atopic dermatitis The findings are discussed below.
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Well-Tolerated: Tralokinumab was well tolerated by participants with moderate-to-severe AD over a 2-year period.
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Lower Incidence of Adverse Events (AEs): The exposure-adjusted incidence rate of AEs per 100 patient-years of exposure (PYE) in the ECZTEND trial was numerically lower than the incidence rate observed during the initial treatment period in pooled analyses of previous placebo-controlled trials.
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Similar or Lower Withdrawal Rates: The rate of AEs leading to withdrawal was either the same or lower in the ECZTEND trial compared to the initial treatment periods of previous trials.
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Comparable Safety Profile: The overall safety profile of Tralokinumab in the trial was comparable to that observed in previous trials.
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Events with Conjunctivitis: Conjunctivitis is a common side effect of atopic dermatitis. However, the incidence rate of conjunctivitis in the trial (4.5 events per 100 PYE) appeared lower than what has been reported in an open-label extension trial of another atopic dermatitis treatment, Dupilumab.
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No New Safety Signals: With cumulative exposure to Tralokinumab in the trial, no new safety signals emerged, suggesting that the long-term use of Tralokinumab does not present additional safety concerns.
Additionally, in five clinical trials involving a population of patients with moderate-to-severe atopic dermatitis, Tralokinumab demonstrated good tolerability and consistent safety findings. During prolonged treatment, the safety profile remained consistent with the initial treatment period, with no increase in the frequency of adverse events over time.
What Are the Adverse Effects of Tralokinumab?
Common adverse events more frequently associated with Tralokinumab include viral and upper respiratory tract infections, conjunctivitis, and injection-site reactions. Conversely, certain events occurred less frequently with Tralokinumab, such as skin infections requiring systemic treatment, eczema herpeticum, and opportunistic and serious infections.
Conclusion
To summarize, Tralokinumab is a treatment option for adult patients who have moderate-to-severe atopic dermatitis that is both safe and effective. Several clinical trials have proven its safety and efficacy. Therefore, it can be used safely. However, it is still important to contact a dermatologist to know whether Taralokinumab is the best option for an individual’s atopic dermatitis or not.
