Tralokinumab

Tralokinumab is a human monoclonal IgG4 antibody which, unlike dupilumab, binds specifically to the interleukin-13 cytokine (IL-13). IL-13 plays a key role in the pathogenesis of atopic dermatitis and bronchial asthma. Blocking IL-13 prevents the interaction with the receptor and prevents the subsequent downstream IL-13 signaling. The therapeutic success with tralokinumab in atopic dermatitis (but not in asthma) supports the hypothesis that blocking the cytokine IL-13 alone is sufficient to improve the symptoms of atopic dermatitis.

Tralokinumab is eliminated by non-saturable proteolysis.

The half-life is 22 days. This is consistent with the typical estimate for human IgG4 monoclonal antibodies directed against soluble cytokines. In ECZTRA 1, ECZTRA 2, and ECZTRA 3, a clearance of 0.149 l/day was determined by population PK analysis.

In Phase I studies with intravenous administration, clearance was determined to be between 0.179 and 0.211 l/day.

Asthma: Tralokinumab was primarily developed for the treatment of severe, uncontrolled asthma. The efficacy and safety of tralokinumab could not be sufficiently proven. Further testing in this clinical picture was therefore discontinued (Panettieri RA Jr et al. 2018).

Atopic dermatitis: In contrast, tralokinumab rapidly and persistently relieved the symptoms of atopic dermatitis in a Phase II study (Wollenberg A et al. 2019). Tralokinumab achieved good effects both as monotherapy and in combination with topical corticosteroids in adults with moderate to severe atopic dermatitis.

In June 2018, a Phase IIb study was published showing that the monoclonal antibody tralokinumab successfully relieved symptoms in patients with moderate to severe AD. This study also examined the effect of tralokinumab on health-related quality of life compared to placebo in 52 adult patients. Patients treated with the antibody showed statistically significant and clinically relevant improvements in almost all aspects of health-related quality of life compared to placebo from week 12 onwards (Silverberg J et al. 2018).

Tralokinumab has been approved for the treatment of moderate to severe atopic dermatitis in adults since June 2021. A post hoc analysis of the long-term study "ECZTEND" shows that long-lasting control of atopic dermatitis on the head and neck can be achieved with tralokinumab (Chovatiaya T et al. 2025). 80.6% of patients achieved a Head&Neck EASI -75 stable over 4 years! The genito-anal area was free of appearance in 67% of patients within 3 months (Wiley-Pharma Nachrichten DDG 2025)

Tralokinumab (^Adtralza® ) has been approved since 2022 for patients aged 12 and over with moderate to severe atopic dermatitis (AD).

Hypersensitivity: If a systemic hypersensitivity reaction (immediate or delayed) occurs, the use of tralokinumab should be discontinued and appropriate therapy initiated.

Conjunctivitis: Patients treated with tralokinumab who develop conjunctivitis that does not resolve after standard treatment should undergo ophthalmologic evaluation.According to the assessment from current European guidelines on atopic dermatitis, fewer acute complications are expected ungtner tralokinumab than, for example, drug therapy with dupilumab.

Helminthosis: Patients with known helminthosis were excluded from participation in clinical trials. It is not known whether tralokinumab affects the immune response to helminthosis by inhibiting the IL-13 pathway. Patients with existing helminthosis should be treated before initiating tralokinumab therapy. If patients become infected during tralokinumab therapy and do not respond to treatment for helminthosis, treatment with tralokinumab should be interrupted until the infection has resolved.

Pregnancy: To date, there is limited experience with the use of tralokinumab in pregnant women. Animal studies revealed no evidence of direct or indirect adverse health effects related to reproductive toxicity. As a precaution, use of tralokinumab during pregnancy should be avoided.

Lactation: It is not known whether tralokinumab passes into breast milk or is absorbed systemically after ingestion. A decision must be made as to whether to discontinue breastfeeding or to refrain from treatment with tralokinumab. Both the benefit of breastfeeding for the child and the benefit of the therapy for the woman should be considered.

Tralokinumab is injected subcutaneously into the thigh or abdomen, outside a 5 cm area around the belly button. If administered by another person, the injection may also be given in the upper arm.

The recommended dose for adults is 600 mg of tralokinumab (four injections of 150 mg each) as a starting dose, followed by 300 mg (two injections of 150 mg each) every two weeks as a subcutaneous injection.

The most common adverse reactions with the use of tralokinumab are:

• Upper respiratory tract infections; mainly reported as colds (23.4%)
• Injection site reactions (7.2%)
• conjunctivitis (5.4%)
• allergic conjunctivitis (2.0%)

The following interactions should be considered when using tralokinumab:

• Inactivated vaccines: The immune responses to inactivated vaccines were investigated in a study in adults with atopic dermatitis. As there were no differences in antibody responses, patients treated with tralokinumab may receive inactivated vaccines or inactivated vaccines at the same time.
• Live vaccines and live attenuated vaccines: Live vaccines and live attenuated vaccines must not be used concomitantly with tralokinumab as clinical safety and efficacy have not been established. It is therefore recommended to update the vaccination status of patients with live vaccines and live attenuated vaccines according to current vaccination recommendations prior to treatment with tralokinumab.

Tralokinumab must not be used in case of hypersensitivity to the active substance or any of the other ingredients of the medicinal product.

Vaccinations: Live vaccines and live attenuated vaccines must not be used concomitantly with tralokinumab, as clinical safety and efficacy have not been established! The immune responses to tetanus vaccine and meningococcal vaccine have been studied. It is recommended to update the vaccination status of patients with live vaccines and live attenuated vaccines according to current vaccination recommendations prior to treatment with tralokinumab.

Tralokinumab is available on the market as ^Adtralza®. It has a placebo-level safety profile. In the initial phase up to 16 weeks, the safety profile of ^Adtralza® was at placebo level. No new signals emerged during long-term use. The conjunctivitis rate remained permanently low. Long-term safety is particularly relevant in view of the long-term therapy that is usually required. ^Adtralza® provides patients with long-term disease control, a good long-term safety profile and thus significantly improved quality of life.

Trafficability: Tralokinumab has no or negligible effect on trafficability and ability to operate machinery.

1. Blair HA (2022) Tralokinumab in Atopic Dermatitis: A Profile of Its Use. Clin Drug Investig 42: 365-374.

2. Chovatiya R et al. (2025) Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. Am J Clin Dermatol 26:587-601.

3. Summary of Product Characteristics Adtralza, LEO Pharma, as of October 2022

4. Panettieri RA Jr et al. (2018) Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy 10: 473-490.

5. Panettieri RA Jr et al. (2018) Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomized, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med 6:511-525.
6. Parker JM et al. (2018) A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med 197:94-103.
7. Russell RJ et al. (2018) MESOS study investigators. Effect of tralokinumab, an interleukin-13 neutralizing monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomized, placebo-controlled phase 2 trial. Lancet Respir Med 6: 499-510.
8. Silverberg J et al: Treatment with tralokinumab improves healthrelated quality of life in adult patients with moderate to severe atopic dermatitis: results from a Phase 2b, randomized, double-blind, placebo-controlled study. EADV 2018; Abstract P0281.
9. Wollenberg A et al. (2019) Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol 143:135-141.
10. Wollenberg A et al.(2022) European guideline (EuroGuiDerm) on atopic eczema: part I - systemic therapy. J Eur Acad Dermatol Venereol 36:1409-1431.