### ORIGINAL RESEARCH ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_0_Picture_2.jpeg) # **Retrospective Analysis of Lebrikizumab in the Management of Atopic Dermatitis: Insights from Real‑World Practice** Nikolaos Stavropoulos · Daniel Myszkowski · Dennis Braß · Vasileios Dervenis · Effmia Poungoura · Eggert Stockfeth Received: October 28, 2025 / Accepted: December 8, 2025 © The Author(s) 2026 # ABSTRACT *Introduction***:** Atopic dermatitis (AD) is a chronic, relapsing infammatory disease, significantly impacting a patient's quality of life. To date, a substantial proportion of patients present an insuffcient response to available treatment options. Lebrikizumab, a monoclonal antibody targeting interleukin 13, has shown a promising clinical beneft in phase 3 trials, however, real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited and mostly restricted to Asian populations. Aim of this study was to evaluate the real-world effectiveness and safety of lebrikizumab in patients with AD. *Methods***:** This retrospective study included 35 patients from a largely homogenous Central European population with moderate to severe Atopic Dermatitis treated with lebrikizumab at the Dermatology Department of the St. Josef-Hospital in Bochum between December 2023 and April 2025. Eczema area and severity index (EASI), SCORing Atopic Dermatitis (SCORAD), peak-pruritus (PP)-numerical rating scale (NRS) and dermatology life quality index (DLQI) were assessed during the treatment. *Results***:** Lebrikizumab reduced all clinical indices by week 4, with improvements maintained through week 16. At week 24, the achievement rates for EASI-50 (50% reduction in EASI), EASI-75 (75% reduction in EASI) and EASI-90 (90% reduction in EASI) were 100%, 75% and 75%, respectively, and the SCORAD-50 (50% reduction in SCORAD) response rate was 64.2%. The proportions of patients achieving a ≥ 4-point reduction in the PP-NRS and in the DLQI at week 24 were 55.8% and 91.6%, respectively. No new safety signals were observed. *Conclusion***:** Lebrikizumab demonstrated favorable real-world effectiveness and safety over 24 weeks in patients with moderate-tosevere AD, supporting its use in routine clinical practice. **Keywords:** Dermatitis; Eczema; Effectiveness; Interleukin-13; Lebrikizumab; Pruritus; Realworld evidence; Safety N. Stavropoulos (\*) · D. Myszkowski · D. Braß · V. Dervenis · E. Poungoura · E. Stockfeth Department of Dermatology, Venereology and Allergology, Skin Cancer Center, Ruhr-University Bochum, Gudrunstrasse 56, 44791 Bochum, Germany e-mail: nikolaos.stavropoulos@klinikum-bochum.de ### **Key Summary Points** ### *Why carry out this study?* Lebrikizumab, an interleukin-13 inhibitor, has demonstrated effcacy and safety in phase 3 trials (ADvocate 1 and 2; ADhere) for patients with moderate-to-severe atopic dermatitis (AD). However, real-world evidence on newly approved therapies remains limited. This retrospective analysis provides one of the frst real-world evaluations of the effectiveness, safety, and tolerability of lebrikizumab in patients with moderate-to-severe AD, including individuals previously treated with systemic therapies. ### *What was learned fom the study?* Lebrikizumab led to clinically meaningful improvements in EASI, SCORAD, PP-NRS, and DLQI by weeks 4, 16, and 24. The treatment demonstrated a favorable safety profle, with good overall tolerability. These real-life data deepened knowledge on effectiveness of brodalumab particularly in patients with factors likely to infuence effectiveness. Real-world outcomes were consistent with phase 3 clinical trial results, supporting lebrikizumab as an effective and safe therapeutic option in routine clinical practice, including for patients with diffcult-to-treat atopic dermatitis. # INTRODUCTION Atopic dermatitis (AD) is a chronic, relapsing infammatory disease that imposes a signifcant burden on patients' quality of life[\[1](#page-13-0)]. A substantial proportion of patients exhibit suboptimal responses to standard therapeutic regimens, including topical agents, phototherapy, and systemic immunosuppressants, all of which may also be associated with notable adverse effects [\[1](#page-13-0), [2\]](#page-13-1). The pathogenesis of atopic dermatitis is mainly determined by a type-2-immune response, with IL-13 playing a central role in this process [[3\]](#page-13-2). IL-13 is a pivotal cytokine in the pathogenesis of AD, contributing to skin barrier impairment, chronic infammation, and pruritus. Lebrikizumab, a monoclonal antibody that specifcally targets interleukin-13 (IL-13) [\[4\]](#page-13-3), offers a novel therapeutic approach for the treatment of moderate to severe AD. It hinders the assembly of the IL-13Rα1/IL-4Rα heterodimer receptor complex, effectively preventing IL-13 bioactivity. It possesses strong binding affnity, a slow dissociation rate, and thus effciently neutralizes IL-13. Nonetheless, lebrikizumab does not disrupt the body's natural process of clearing excess IL-13 [\[5](#page-13-4)]. By selectively inhibiting IL-13, Lebrikizumab provides a more targeted and potentially safer therapeutic mechanism compared to the broader immunosuppressive agents currently in use [[6,](#page-13-5) [7\]](#page-13-6). Although randomized controlled trials (RCTs) have demonstrated the effcacy and safety of lebrikizumab, emerging real-world data increasingly support its performance in routine clinical settings. Recent observational studies from Japan and Europe have reported rapid and sustained improvements in Eczema Area and Severity Index (EASI) scores, pruritus, and quality-oflife measures, along with a favorable tolerability profle in both biologic-naïve and treatmentexperienced patients. These early real-world fndings reinforce the therapeutic potential of IL-13 inhibition beyond controlled trial environments [\[8](#page-13-7)[–11\]](#page-13-8). Following the approval of lebrikizumab in December 2023, real-world evidence from European populations remains limited. To address this gap, the present retrospective study evaluates the clinical outcomes of patients with moderate-to-severe atopic dermatitis treated with lebrikizumab in a real-world setting. The aim is to provide robust insights into its practical effectiveness, safety profle, and patient-reported outcomes in everyday clinical practice. ### **Aim of the Study** The aim of this study was to evaluate the realworld effectiveness and safety of lebrikizumab in patients with moderate-to-severe AD. # METHODS ### **Study Design and Patient Cohort** This retrospective, monocentric, observational study was conducted at the Department of Dermatology, St. Josef-Hospital, Bochum, between December 2023 and April 2025. To investigate a homogeneous patient population in line with the approved indication for lebrikizumab, the following inclusion criteria were applied retrospectively based on available medical records: (1) patients aged 18 years or older with a body weight of at least 40 kg, (2) a diagnosis of moderate-to-severe atopic dermatitis confrmed by a dermatologist prior to the initiation of lebrikizumab therapy, (3) treatment with lebrikizumab following EMA approval, administered in accordance with the approved dosing regimen and (4) availability of at least 24 weeks of clinical follow-up data**.** Exclusion criteria comprised: (1) ongoing off-label treatment for atopic dermatitis and (2) concomitant use of other biologics during the observation period. In total, 40 patients initiated lebrikizumab during the study period. Five patients discontinued treatment before reaching week 24 due to insuffcient treatment response and personal preference and therefore did not meet the minimum follow-up requirement; these patients were excluded from the fnal analysis, resulting in a study population of 35 patients. All patients received lebrikizumab 500 mg (two × 250 mg) at weeks 0 and 2, followed by 250 mg every two weeks. From week 16 onward, dosing intervals were individualized according to clinical response: patients achieving adequate disease control switched to every-four-week dosing, while those with persistent activity continued biweekly treatment. From week 24, all patients received 250 mg every four weeks. Clinical study visits were performed at baseline, week 4, week 16 and week 24. With each visit to the clinic the EASI, SCORing Atopic Dermatitis (SCORAD), Dermatology Life Quality Index (DLQI) and peak-pruritus (PP)-numerical rating scale (NRS) were assessed and documented. The selection of assessment tools differed among visits, refecting individual physician preferences in routine clinical practice. To protect patient confidentiality, all data included in this report were fully anonymized. ### **Ethical Approval** The study was conducted in accordance with the ethical principles of the Declaration of Helsinki [\[12\]](#page-13-9) and approved by the Westfalen-Lippe Ethics Committee (reference 2025–563-f-S). Because of the retrospective nature of the study, the requirement for informed consent was waived. ### **Outcome Variables** The primary objective of this study was to assess the improvement in skin and symptoms measured by comparing the EASI and SCORAD in weeks 4,16, and 24 compared to baseline scores at week 0. The secondary objective was to evaluate the improvement of pruritus scores by means of PP-NRS, the improvement in quality of life (using the DLQI), the occurrence of adverse events as well as to record the number of patients achieving an EASI-90 (90% reduction in EASI) in weeks 4, 16, and 24. The PP-NRS was defned as the highest daily itch score reported by the patient during the previous week. This weekly PP-NRS score was recorded at each clinical visit and compared with baseline to evaluate changes in itch intensity over time. #### **Statistical Analysis** Data analysis was performed using the IBM SPSS v29.0 statistical package (IBM Corp). Characteristics of study participants were described using descriptive statistics, calculating the mean and standard deviation (SD), the interquartile range (IQR) and percentage distribution. EASI, SCORAD, PP-NRS and DLQI were assessed at baseline, weeks 4,16, and 24 and later on compared by determining the mean improvement at weeks 4,16, and 24 compared to baseline. Mean improvements compared to baseline were calculated and presented as observed. The sample size for each analysis is reported accordingly. To minimize potential bias, all data were presented exactly as recorded during the study, without any alterations or corrections. # RESULTS ### **Patient Demographics and Baseline Characteristics** The final study population consisted of 35 patients (48.6% female, 51.4% male) with moderate-to-severe atopic dermatitis from a largely homogeneous Central European cohort. The age range was 29–60 years. All individuals met the approved age and weight requirements (≥18 years and≥40 kg). Prior to initiating lebrikizumab, 17 patients (49%) had received at least one systemic therapy. The key demographic and clinical characteristics before and during lebrikizumab treatment are summarized in Tables [1](#page-4-0) and [2](#page-5-0). All patients had previously received conventional topical therapies, including emollients, high-potency corticosteroids, and topical calcineurin inhibitors, with some also undergoing UV-B phototherapy (2.9%). Seventeen patients (48.6%) had prior systemic treatment, refecting a population with refractory disease; these therapies included dupilumab (42.9%), tralokinumab (14.2%), baricitinib (14.2%), cyclosporine (8.6%), upadacitinib (5.7%), methotrexate (5.7%), azathioprine (2.9%) and extracorporeal photopheresis (2.9%) (Table [2\)](#page-5-0). Despite these interventions, patients continued to experience persistent AD fare-ups and complications. At the initiation of lebrikizumab therapy, patients had a median EASI score of 16.0 (8.0–24.0) and a SCORAD score of 40.7 (20.3–61.1). Regarding disease burden on quality of life, median baseline values for PP-NRS and DLQI were 7.5 (6.2–8.8) and 16.1 (11.2–21.0), respectively. Data on concomitant use of topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI), including frequency and amount, were not consistently documented. Patients were permitted to use topical therapies as needed before and during lebrikizumab treatment; therefore, changes in topical treatment use compared to baseline could not be reliably evaluated. Tables [1](#page-4-0), [2](#page-5-0), [3](#page-5-1) and Figs. [1](#page-8-0), [2,](#page-9-0) [3,](#page-10-0) [4](#page-11-0) summarize the baseline characteristics, previous therapies and clinical outcomes. #### **Effcacy Analysis by SCORAD and SCORAD‑50** Of all patients treated with lebrikizumab 81.5% achieved a clinically meaningful change for SCORAD (≥8.7-point improvement). The mean SCORAD improved from 40.7 (20.4–61.1) at baseline to 23.7 (7.1–40.3) at week 4, 15.6 (5–26.2) at week 16 and 17.4 (0.9–33.9) at week 24. At week 4, 46.43% of patients achieved a 50% reduction in SCORAD (SCORAD-50). At week 16, a SCORAD-50 was documented for 67.87% of patients and at week 24 those numbers showed a stable disease control with 64.29% of patients reaching SCORAD-50. #### **Effcacy Analysis by EASI, EASI‑50, EASI‑75 and EASI‑90** Looking at EASI scores at weeks 0, 4, 16 and 24 a similar improvement to the SCORAD could be observed in patients treated with lebrikizumab. Of all patients treated with lebrikizumab 87.5% achieved a clinically meaningful change for EASI (≥6.6-point improvement). Table 1 Baseline demographics, disease characteristics | Parameters | Values | |------------------------|------------| | Age, median (Range), y | 46 (29–60) | | Female, n (%) | 17 (48.6) | | Male, n (%) | 18 (51.4) | #### Clinical characteristics: | Measure | Baseline | Week 4 | Week 16 | Week 24 | |--------------------------------------|-------------|-------------|-------------|-------------| | EASIa
, mean, SD | 16.0 (8.0) | 4.9 (5.7) | 2.9 (4.0) | 1.3 (2.1) | | SCORADb
, mean, SD | 40.7 (20.4) | 23.7 (16.6) | 15.6 (10.6) | 17.4 (16.5) | | PP-NRSc
, mean, SD | 7.5 (1.3) | 4.3 (2.4) | 3.4 (2.1) | 3.6 (2.7) | | DLQId
, mean, SD | 16.1 (4.9) | 8.3 (6.3) | 5.4 (4.4) | 5.7 (4.7) | | Conjunctivitis (history), n (%) | 13 (37.1) | | | | | Conjunctivitise
(W4) | | | | | | Stablee
, n (%) | 4 (11.4) | | | | | Improvede
, n (%) | 6 (17.1) | | | | | Worsenede
, n (%) | 3 (8.6) | | | | | New-onset conjunctivitis (W4), n (%) | 1 (2.9) | | | | *IQR* interquartile range, *y* years, *EASI* Eczema Area and Severity Index, *SCORAD* SCORing Atopic Dermatitis, *PP-NRS* Peak Pruritus Numerical Rating Scale, *DLQI* Dermatology Life Quality Index, *n* absolute number of patients, *SD* Standard deviation, *W4* week 4 The EASI improved from 16.0 (8.0–24.0) at baseline to 4.9 (0–10.6) at week 4, 2.9 (0–6.9) at week 16 and down to 1.3 (0–3.4) at week 24. EASI-50 was achieved in 75% of patients in week 4, in 87.5% of patients in week 16 and 100% of patients in week 24. EASI-75 was documented for 50%, 75% and 75% of patients in weeks 4, 16, and 24, respectively. EASI-90 could be achieved in 37.5% of the study cohort in week 4, in 62.5% in week 16 and 75% in week 24. #### **PP‑NRS and DLQI** The Baseline PP-NRS score improved from 7.5 (6.2–8.8) at baseline to 4.3 (1.9–6.7) at week 4, 3.4 (1.3–5.5) at week 16 and 3.6 (0.9–6.3) at week 24. A reduction of ≥ 4 points on the PP-NRS was observed at week 4 in 38.8%, at week 16 in 63.8% and at week 24 in 55.8% (Tables [1](#page-4-0) and [3\)](#page-5-1). The DLQI improved from 16.1 (11.2–21) at baseline to 8.3 (2–14.6) at week 4, to 5.4 (1–9.8) at week 16 and to 5.7 (1–10.4) at week a Range 0–72 b Range 0–103 c Range 0–10 d Range 0–30 e Patients with history of conjunctivitis Table 2 Previous therapies | Patients with any prior systemic treatment, n
(%) | 17 (48.6) | |------------------------------------------------------|-----------| | Prior systemic treatments, n (%): | | | | | | Dupilumab, n (%) | 15 (42.9) | | Tralokinumab, n (%) | 5 (14.2) | | Baricitinib, n (%) | 5 (14.2) | | Upadaticinib, n (%) | 2 (5.7) | | Cyclosporine, n (%) | 3 (8.6) | | Methotrexate, n (%) | 2 (5.7) | | Azathioprine, n (%) | 1 (2.9) | | Extracorporeal photopheresis | 1 (2.9) | | Number of prior systemic treatments, n (%) | | | 1, n (%) | 9 (25.7) | | 2, n (%) | 4 (11.4) | | 3, n (%) | 0 (0) | | ≥4, n (%) | 4 (11.4) | 24. Finally, 69.4% achieved a reduction of ≥ 4 points on the DLQI scale at week 4, 88.8% at week 16 and 91.6% at week 24. In our patient cohort, 15 patients (42.9%) presented with head and neck dermatitis prior to initiating Lebrikizumab treatment. Following therapy, head and neck dermatitis improved in 8 patients (53.3%), and remained unchanged in 7 patients (46.7%). #### **Safety** Prior to lebrikizumab initiation, 13 patients (37.1%) reported pre-existing conjunctivitis. Following treatment, improvement of conjunctivitis was noted in 6 patients (17.1%), stable disease in 4 patients (11.4%), and worsening symptoms in 3 patients (8.6%). Additionally, one patient (2.9%) developed new-onset conjunctivitis during therapy. Table 3 Clinical and patient reported scores at 4 weeks, 16 weeks and 24 weeks afer starting Lebrikizumab treatment in the overall population | Efcacy outcome | Week 4 | Week 16 | Week 24 | |------------------------------------------------------|-----------|-----------|-----------| | EASI 50, n (%) | 6 (75) | 7 (87.5) | 8 (100) | | EASI 75, n (%) | 4 (50) | 6 (75) | 6 (75) | | EASI 90, n (%) | 3 (37.5) | 5 (62.5) | 6 (75) | | SCORAD 50, n (%) | 13 (46.4) | 19 (67.9) | 18 (64.2) | | ≥4-point improve
ment in the PP
NRS, n (%) | 14 (38.8) | 23 (63.8) | 20 (55.8) | | ≥4-point improve
ment on the DLQI
scale, n (%) | 25 (69.4) | 32 (88.8) | 33 (91.6) | *EASI* Eczema Area and Severity Index, *SCORAD* SCORing Atopic Dermatitis, *EASI-50* 50% reduction in EASI, *EASI-75* 75% reduction in EASI, *EASI-90* 90% reduction in EASI, *SCORAD-50* 50% reduction in SCORAD, *PP-NRS* Peak Pruritus Numerical Rating Scale, *DLQI* Dermatology Life Quality Index Two patients (5.7%) discontinued lebrikizumab after 24 weeks due to progressive hypereosinophilia, which was classifed as a serious adverse event (SAE). Both patients had previously been treated with dupilumab, which was also associated with elevated eosinophil counts. The frst patient, a 62-year-old female, experienced persistent hypereosinophilia accompanied by respiratory symptoms under both therapies, necessitating treatment discontinuation. The second patient, a 53-year-old male with a history of allergic rhinoconjunctivitis and asthma, developed symptomatic hypereosinophilia with worsening respiratory symptoms during lebrikizumab therapy, with eosinophil counts rising up to fvefold from baseline. In both cases, discontinuation of the study drug was required to prevent further deterioration. Symptoms resolved following treatment withdrawal. # DISCUSSION Currently, limited real-world data are available on the effcacy and safety of lebrikizumab in patients with moderate-to-severe atopic dermatitis (AD) who are eligible for systemic treatment [\[8–](#page-13-7)[11\]](#page-13-8). Our real-world fndings are in line with and further extend the currently available evidence on lebrikizumab use outside clinical trials. In the prospective Japanese study by Hagino et al. (2025), substantial improvements in EASI and pruritus were observed within 16 weeks, closely matching the rapid and progressive reductions in EASI, SCORAD, PP-NRS and DLQI seen in our cohort by weeks 4–24 [\[10](#page-13-10)]. These observations are consistent with our data, particularly the high EASI-75 (75%) and EASI-90 (62.5%) response rates at week 16. Importantly, our fndings extend beyond the previously reported time frame, demonstrating that these improvements were maintained through week 24, with stable response rates of 75% for both EASI-75 and EASI-90. Comparable results were also reported in the Italian multicentre real-world study, which documented signifcant improvements in EASI, itch intensity, and quality of life during the frst 16 weeks of treatment [[8](#page-13-7)]. Our fndings likewise confrm high responder rates and marked reductions in patient-reported outcomes. Guttman-Yassky et al. (2023), who evaluated pooled clinical trial and early real-world safety data, noted that lebrikizumab maintains a favourable safety profle in routine practice, with conjunctivitis remaining generally mild and manageable [\[9\]](#page-13-11). This is consistent with our fndings, where most ocular symptoms improved or remained stable under therapy. Silverberg et al. (2022) demonstrated, in one of the earliest realworld comparative analyses, that lebrikizumab achieves clinical improvements comparable to or exceeding other biologics in moderate-tosevere AD, particularly regarding itch reduction, again refected in the signifcant PP-NRS and DLQI improvements found in our cohort [\[11\]](#page-13-8). Notably, while previous real-world studies rarely reported clinically significant eosinophilia, two patients in our cohort developed progressive symptomatic hypereosinophilia requiring treatment discontinuation. Both had a history of eosinophilic complications under previous IL-4/13 pathway blockade with Dupilumab, suggesting an underlying predisposition rather than a new safety signal specifc to lebrikizumab. This highlights the importance of monitoring eosinophil counts and respiratory symptoms in selected patients. Taken together, our results strongly align with the emerging global real-world experience, confrming the effectiveness and tolerability of lebrikizumab while contributing important additional insights into eosinophil-related safety considerations in European clinical practice. Biologic therapies targeting the type 2 infammatory pathway have been linked to an increased incidence of conjunctivitis in patients with atopic dermatitis [[13](#page-13-12)]. In our retrospective cohort, a history of conjunctivitis was documented in 13 (37.1%) of patients prior to starting lebrikizumab treatment. Systematic assessment of active conjunctivitis on the exact day of lebrikizumab initiation was not available. Following therapy, conjunctivitis improved in 6 (17.1%), remained stable in 4 (11.4%), and worsened in 3 (8.6%) of patients. Only one patient (2.9%) developed new-onset conjunctivitis during therapy. These fndings suggest that, in contrast to earlier reports of increased conjunctivitis incidence with other type 2 biologics, lebrikizumab may have a more favorable profle regarding ocular involvement. However, due to the retrospective nature of the study and the small sample size, further prospective data are needed to confrm this trend [[13\]](#page-13-12). While data on head and neck dermatitis during lebrikizumab treatment remain limited, it is important to consider the complex and multifactorial reasons behind the observed moderate effcacy of combined IL-4/IL-13 blockade, such as with dupilumab, on head and neck dermatitis. Factors including regional skin microbiome differences, barrier function variations, and local immune responses may contribute to this phenomenon [[14](#page-13-13)]. In this context, our fndings regarding the effects of selective IL-13 inhibition on head and neck involvement with ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_7_Figure_1.jpeg) ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_7_Figure_2.jpeg) ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_7_Figure_3.jpeg) ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_7_Figure_4.jpeg) Fig. 1 Time-course response for EASI clinical outcomes. Percentage of patients achieving EASI-50 (a), EASI-75 (b), and EASI-90 (c), and mean change from baseline in EASI score (d) through 24 weeks. *EASI* Eczema Area and Severity Index, *EASI-50* 50% reduction in EASI, *EASI-75* 75% reduction in EASI, *EASI-90* 90% reduction in EASI, *LEBRI* lebrikizumab ◂ lebrikizumab provide valuable insight into possible differential therapeutic outcomes. Among the patients in our cohort with head and neck dermatitis at baseline (n = 15), improvement was observed in 8 (53.3%) following initiation of lebrikizumab. This suggests that selective IL-13 inhibition may be effective for some patients with this diffcult-to-treat manifestation, though confrmation in larger, prospective cohorts is needed. One potential explanatory model involves the role of *Malassezia furfur*, a skin commensal fungus regulated by T helper cell–mediated immune mechanisms. *Malassezia* hypersensitivity has been implicated in persistent head and neck dermatitis during IL-4/IL-13 pathway inhibition, suggesting that regional microbial factors may infuence treatment response [\[15\]](#page-13-14). Whether similar mechanisms play a role during selective IL-13 inhibition is currently unknown. At present, it remains unclear to what extent differences between IL-4/IL-13 dual blockade and IL-13–specifc inhibition account for the effcacy observed with lebrikizumab. Further studies are required to elucidate the underlying mechanisms and to clarify how microbial factors such as *Malassezia* contribute to regional treatment outcomes. Notably, one patient with psoriasis vulgaris and prior biologic exposure exhibited psoriasiform lesions suspected to refect an immune shift from Th17- to Th2-driven infammation. Initiation of lebrikizumab led to marked regression of the lesions and an overall favorable disease course. While clinical signs are essential for evaluating treatments for AD, patient-reported outcomes are equally important due to the substantial psychosocial impact of the disease. Lebrikizumab has been associated with signifcant improvements in patient-reported measures, particularly in alleviating pruritus-related discomfort and enhancing quality of life [[16](#page-13-15)]. In this cohort, treatment with lebrikizumab was generally well tolerated. Adverse events were infrequent and mostly mild. Three patients (8.6%) reported a worsening of a pre-existing conjunctivitis and one patient (2.9%) developed new-onset conjunctivitis during therapy. This is consistent with the safety profle reported in phase 3 clinical trials, where lebrikizumab was associated with a low incidence of serious adverse events and treatment discontinuation [\[6](#page-13-5)] [[17](#page-13-16)]. The clinical improvements observed in this real-world cohort are generally in line with outcomes reported in pivotal phase 3 trials of lebrikizumab, which documented rapid onset of action, marked reductions in EASI scores, and a favorable tolerability profle over comparable treatment period [[16\]](#page-13-15). The frequency of treatment-emergent conjunctivitis in our analysis was similar to, or in some cases lower than, that described in the ADvocate 1 and ADvocate 2 studies [\[16\]](#page-13-15). It should be noted that real-world populations often differ from randomized controlled trial cohorts in terms of comorbidities, previous treatment exposure, and disease heterogeneity, factors that may infuence treatment response. Overall, the consistency between our fndings and trial data supports the generalizability of lebrikizumab's effcacy and safety profle, while also providing additional context on ocular outcomes and head/neck involvement in routine clinical practice. Effcacy was evident by week 4 and continued to improve through week 24. Because week 4 represented the frst scheduled follow-up in this retrospective analysis, earlier benefts may have gone undocumented. Direct comparisons with other approved systemic therapies are limited by differences in study design, endpoints, and patient populations, but our fndings contribute important complementary data for clinical decision-making. ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_9_Figure_1.jpeg) ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_9_Figure_2.jpeg) Fig. 2 Time-course response for SCORAD clinical outcomes. Percentage of patients achieving SCORAD-50 (a) and mean change from baseline in SCORAD score (b) through 24 weeks. *SCORAD* SCORing Atopic Dermatitis, *SCORAD-50* 50% reduction in SCORAD, *LEBRI* lebrikizumab ### LIMITATIONS Lebrikizumab appears to have a favorable safety profile, although no formal statistical comparisons with other therapies were conducted. Limitations of this analysis include the relatively small sample size, the absence of a placebo group, and the lack of an active comparator arm. Additional limitations include the retrospective design of the study and the inconsistent ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_10_Figure_1.jpeg) ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_10_Figure_2.jpeg) Fig. 3 Percentage of patients achieving a≥4-point improvement on the DLQI scale (a) and mean change from baseline in DLQI score (b). *DLQI* Dermatology Life Quality Index, *LEBRI* lebrikizumab documentation of concomitant topical therapies. These factors limit the ability to directly compare lebrikizumab with other targeted therapies or conventional immunosuppressants. Additionally, as this assessment is based on realworld data, potential biases in outcome reporting and measurement cannot be excluded. ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_11_Figure_1.jpeg) ![](https://assets.reachrx.ai/images/10.1007%E2%98%8Ds13555-025-01630-9/_page_11_Figure_2.jpeg) Fig. 4 Percentage of patients achieving a≥4-point improvement on the PP-NRS (a) and mean change from baseline in mean PP-NRS (b). *PP-NRS* Peak Pruritus Numerical Rating Scale, *LEBRI* lebrikizumab ### CONCLUSIONS In this real-world data analysis, lebrikizumab monotherapy demonstrated clinical effectiveness and a favorable safety profle in patients with moderate-to-severe atopic dermatitis over a 24-week period. Treatment led to signifcant improvements in both physical symptoms and health-related quality of life, including marked reductions in pruritus and enhancements in DLQI scores. Importantly, meaningful clinical responses were observed despite the high proportion of patients who had previously received multiple systemic therapies, underlining the utility of lebrikizumab in a diffcultto-treat population. Adverse events were infrequent, and treatment discontinuation rates remained low. These fndings are consistent with previous clinical trial data and support the role of lebrikizumab as a well-tolerated and effective long-term treatment option targeting IL-13 in patients with uncontrolled atopic dermatitis. *Medical writing, editorial and other assistance .* Artifcial intelligence tools (ChatGPT) were used solely for linguistic editing. All scientifc content, data interpretation, and conclusions were generated and verifed by the authors. No medical writing, editorial, or other external support was received. *Author Contributions.* All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for the integrity of the work, and have given their approval for this version to be published. Eggert Stockfeth and Nikolaos Stavropoulos contributed to the study concept and design and drafted the manuscript. Daniel Myszkowski conducted the statistical analyses of the data. Nikolaos Stavropoulos, Dennis Braß, Vasileios Dervenis and Effmia Poungoura contributed to acquisition, analysis, or interpretation of the data and critical revision of the manuscript. *Funding.* Sponsorship for this study and Rapid Service Fee were funded by Almirall Deutschland, Almirall Hermal GmbH, Scholtzstraße 3, 21465 Reinbek. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications including atopic dermatitis in Europe. The publication presents views of the author and not necessarily Almirall Pharma. *Data Availability.* Patient-level data and supporting clinical documentation, including the study protocol (with amendments), blank case report forms, statistical analysis plan, and clinical study report, are available upon reasonable request to qualifed researchers. All patientlevel data will be anonymized, and study documents will be appropriately redacted to ensure participant confidentiality and compliance with data protection regulations. The data that support the fndings of this study are available from the corresponding author upon reasonable request. #### *Declarations* *Conflicts of interest.* Nikolaos Stavropoulos has received honoraria for participation in advisory boards, in clinical trials, support for conferences and meetings and/or as a speaker from LEO Pharma, Galderma, Almirall, Johnson&Johnson, Pfizer, Abbvie, and Astra Zeneca. Eggert Stockfeth has received lecture fees from Almirall, Leo, Pierre Favre and Philips. Vasileios Dervenis has received honoraria as a speaker for Abbvie, Almirall, Leo Pharma and support for conferences and meetings by Almirall, Pfzer, Johnson&Johnson, Galderma. Dennis Braß and Effmia Poungoura have received support for conferences and meetings by Pfzer, Johnson&Johnson, Almirall and Galderma. Daniel Myszkowski declares no confict of interest. *Ethical approval.* The study was conducted in accordance with the ethical principles of the Declaration of Helsinki [[12\]](#page-13-9) and approved by the Westfalen-Lippe Ethics Committee (reference 2025–563-f-S). Because of the retrospective nature of the study, the requirement for informed consent was waived. *Open Access.* This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. 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