Tralokinumab Effective for Eczema Among Older Patients, Those with Severe Comorbidities

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Tralokinumab treatment of atopic dermatitis is both efficacious and safe among patients aged ≥65 years, new findings suggest, as well as among individuals impacted by severe comorbidities.¹

These conclusions resulted from research led by Luca Potestio, from the section of dermatology at the University of Naples Federico II department of clinical medicine and surgery in Italy. Potestio et al. noted that real-world data is essential given the fact that clinical trial subjects frequently diverge from those reported within routine clinical practice settings.

“Indeed, real-life subjects exhibit a broader range of characteristics, whereas the stringent inclusion and exclusion criteria employed in clinical trials can limit the representation of diverse clinical scenarios and individual variability,” Potestio and colleagues wrote. “In this context, the aim of our study was to evaluate the effectiveness and safety of tralokinumab for the management of (special populations) affected by (eczema).”²

Study Design

The research team conducted their retrospective study in 2 centers, assessing patients with atopic dermatitis, also known as eczema, who were treated with tralokinumab at the University Federico II of Naples and the University Magna Graecia of Catanzaro. They enrolled subjects in the age range of 18 years and older who had been treated with this drug for 24 weeks minimum.

In order to be labeled as special populations or “SP’s,” subjects included in the study were required by the investigators to have a comorbidity or to be 65 years of age or older. SP classification criteria included severe neurological, cardiovascular, psychiatric, or pulmonary conditions, as well as a history of cancer or any severe infections.

All study participants were given tralokinumab, with dosage based on the label and beginning with 600 mg dose at baseline (given as 4 injections of 150 mg). This would later be followed by a dose of 300 mg, with 2 injections of 150 mg every other week.

The research team assessed tralokinumab’s efficacy by implementing the Eczema Area Severity Index (EASI) and the Pruritus–Numerical Rating Scale (P-NRS). Life quality was evaluated using the Dermatology Life Quality Index (DLQI). The team gathered clinical and demographic information, along with P-NRS, EASI, and DLQI scores, at the point of baseline and then reevaluated following 4 and then 16 weeks of therapy.

For each subject, the research team gathered demographic information as well as clinical data including eczema-related comorbidities, concomitant conditions, general medical history, prior treatments for the skin disease, and medications or procedures.

The investigators collected data related to safety as well, recording any novel clinical symptoms seen by participants or noted during physical examinations.

Statistical significance of improvements in clinical signs (EASI, P-NRS, DLQI) was determined by the team at the 4-week, 16-week, and 24-week mark as compared with baseline. They evaluated significance using Student’s t-test, considering a significant p-value < .05.

Findings

The investigators had looked at 27 individuals noted as SPs, concluding that there were notable EASI and P-NRS score improvements occurring at the 4-week mark. They also reported that continued progress was observed up to the 24-week mark, adding that 23 of these individuals were over the age of 65 years.

The research team noted that among the older subjects, 21.74% did not have any significant concomitant conditions. The team’s findings also indicated a substantial DLQI score reduction at each follow-up interaction compared to baseline, expressing that this suggested positive effects of tralokinumab on participants’ quality of life.

Specifically, the investigators found that DLQI scores dipped from 14.52 ± 6.48 at the 4-week mark to 5.52 ± 4.89 at the 16-week mark. They added that an additional dip to 2.12 ± 2.51 was observed by the 24-week mark (P < .0001 for both). There were no adverse events reported in the study.

“Main strengths of our study are the data accuracy and the homogeneity of clinical evaluation,” they wrote. “However, main limitations should be stated such as the retrospective design, the reduced follow-up period, the reduced cohort, and the lack of a control group.”

References

1. ^{Potestio L, Patruno C, Dastoli S, Brescia C, Napolitano M. Tralokinumab for the Treatment of Adult Atopic Dermatitis in Special Populations. J Asthma Allergy. 2024;17:791-799
   https://doi.org/10.2147/JAA.S474411.}
2. ^{Cinelli E, Fabbrocini G, Megna M. Real-world experience versus clinical trials: pros and cons in psoriasis therapy evaluation. Int J Dermatol. 2022;61(3):e107–e108. doi:10.1111/ijd.15644.}