Real-World Use of Baricitinib in Patients with Atopic Dermatitis in Spain: DAMA-S Study, A Retrospective Chart Review

Abstract

Introduction

Baricitinib has shown positive results in clinical trials both from efficacy and safety outcomes; however, there is still a need to further understand its use in routine practice in Spain.

Methods

This observational study aimed to describe treatment patterns, persistence, and effectiveness of baricitinib among adult patients with atopic dermatitis (AD) in Spain. A retrospective chart review was carried out in 13 hospitals across Spain. Effectiveness was described using the Eczema Area and Severity Index (EASI), the Investigator’s Global Assessment (IGA), and the Itch and Sleep numerical rating scales (NRS) recorded as part of routine clinical practice. Persistence to treatment was estimated using Kaplan–Meier curves.

Results

Seventy-four patients were included and followed for a mean of 42.1 (standard deviation, SD 21.4) weeks. At baseline, over half of the patients had severe AD, with an EASI > 21 (63%) and an IGA-4 (56.8%). Patients had received a mean of 2.4 (SD 1.2) prior systemic treatments and were prescribed baricitinib mainly due to lack of effectiveness of previous treatment. Most patients were prescribed baricitinib as the sole systemic treatment for AD and did not receive any other systemic treatment during the follow-up. During the study period, 39.2% of patients discontinued baricitinib, mainly due to lack of effectiveness. At week 16, 69.7% of patients who remained on treatment and had a measurement available achieved a ≥ 75% improvement from baseline in the EASI (EASI75) response and 79.3% an IGA score of 0 or 1.

Conclusions

Among patients who remained on treatment, baricitinib showed meaningful clinical improvements in routine clinical practice in Spain. Our findings highlight rapid and sustained clinical improvements, aligning with that observed in other real-world studies.

Infographic available for this article.

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-026-01737-7.

Infographic

Key Summary Points

Why carry out this study?

Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by intense pruritus, sleep disturbances, and psychological distress, which affect patients’ quality of life.

The DAMA-S study comprised adults with moderate-to-severe AD, to address the current evidence gap regarding baricitinib treatment patterns, effectiveness, and persistence in routine clinical practice in Spain.

What was learned from the study?

Baricitinib persistence was 85.1%, 75.7%, and 58.4% at weeks 16, 24, and 52, respectively.

By week 16, 69.7% of patients who remained on treatment achieved a ≥ 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) and 79.3% reached an Investigator’s Global Assessment (IGA) score of 0 or 1, and by week 24 these proportions were 65.4% and 63.6%, respectively.

Baricitinib shows effectiveness in patients with AD who remain on treatment in routine care in Spain.

Digital Feature

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Introduction

Atopic dermatitis (AD) is a chronic, inflammatory skin disease that is highly symptomatic and has a heterogeneous presentation. Patients experience intense pruritus, skin pain, sleep disturbances, and mental health symptoms impacting their quality of life (QoL). Comorbidities, especially allergic conditions such as asthma and rhinitis, and psychological conditions such as anxiety may affect the prognosis of AD [1, 2]. Globally, prevalence varies but may reach 10%. In Spain, the estimated point prevalence is 7.2% [3]. Treatment aims to reduce symptoms and prevent exacerbations. For patients with moderate-to-severe AD, options include topical therapies, phototherapy, and systemic treatments such as oral corticosteroids, conventional immunosuppressants, targeted biologic therapies, and Janus kinase inhibitors (JAKi) [4, 5].

Baricitinib, an oral selective JAK1/JAK2 inhibitor, was the first oral selective JAKi approved by the European Medicines Agency for the treatment of moderate-to-severe AD in adult patients who are candidates for systemic therapy. It can be given as monotherapy or with topical corticosteroids (TCS) [6]. The BREEZE-AD trials demonstrated the efficacy and safety of baricitinib, alone or with TCS, among adult patients with moderate-to-severe AD, showing superiority over placebo in improving several clinical signs and symptoms of AD, with an acceptable safety profile [7–10].

Despite the robust evidence from clinical trials, their findings may not always translate directly to real-world effectiveness settings. Real-world evidence studies offer essential insights into how treatments work in broader, more varied population. Given the limited information available to date in this context in Spain, the DAMA-S study (Real worlD use of bAricitinib in patients with atopic derMAtitis in Spain) aimed to describe treatment patterns, persistence, and effectiveness of baricitinib among adult patients with AD in Spain. Any references to effectiveness should be interpreted as within‑patient effects, and not as comparative effectiveness.

Methods

Study Design and Patients

The DAMA-S study was a post-authorization, observational, descriptive, retrospective chart review study with no control cohort conducted in the dermatology departments of 13 hospitals across Spain from April 2022 to August 2023.

The study population comprised patients aged ≥ 18 years with a confirmed diagnosis of AD, who were prescribed baricitinib at the participating sites during the inclusion period, had a baseline Eczema Area and Severity Index (EASI) and Investigator’s Global Assessment (IGA) assessments, and at least one follow-up visit. Patients in a clinical trial during treatment with baricitinib (n = 1) or whose medical record was not available for data extraction (n = 0) were excluded. The study was designed and conducted in accordance with the ethical principles set out in the Declaration of Helsinki and was approved by the Hospital Universitario Fundación Alcorcón Ethics Committee (Code 23/58). All included patients provided written informed consent for the collection of their medical data and its use as part of this observational research study.

The study design is shown in Fig. 1. Data spanning from AD diagnosis to the day before the date of baricitinib initiation (index date) was used to describe the patients’ medical history and previous AD treatments. During follow-up, data on AD treatments, baricitinib persistence, and AD severity measures were collected from available clinical visits occurring at 4 ± 2, 8 ± 2, 16 ± 4, 24 ± 4, and 52 ± 8 weeks. The study design provided the potential for at least 16 weeks of follow-up for all patients. Each patient was monitored until the earliest occurrence of one of the following events: loss to follow-up (can be before week 16), the date of the visit at 16 weeks (± 4 weeks) if the patient has discontinued baricitinib before that date, the date of discontinuation of baricitinib after being on baricitinib for at least 16 weeks, or the date of data extraction for each patient. Hence, assessments beyond week 16 were considered exploratory.

Fig. 1.

DAMA-S study design. AD atopic dermatitis, EASI Eczema Area and Severity Index, IGA Investigator’s Global Assessment. *End of follow-up: The earliest of i) the date of the visit at 16 ± 4 weeks if the patient discontinued baricitinib before that date, ii) the date of discontinuation of baricitinib after being on baricitinib for at least 16 weeks, iii) the date of loss to follow-up, or iv) the date of data extraction for each patient

Treatments

Use of baricitinib was described by reason for initiation, initial dose, dosing changes, time on treatment, and reason for discontinuation. Previous and concomitant treatments for AD were also collected. Systemic treatments evaluated included corticosteroids, conventional immunosuppressants, biological targeted therapy, and JAKi, while topical treatments assessed were TCS and topical calcineurin inhibitors (TCI). Concomitant treatments and treatments given in the previous month to baricitinib initiation were also described by time on treatment.

Effectiveness

The selection of outcome measures was informed by a feasibility assessment. AD severity was assessed using the EASI and the IGA scores. EASI is a validated clinician-reported instrument measuring the severity and extent of AD clinical signs. The EASI score is classified as absent (0), mild (0.1–7.0), moderate (7.1–21.0), severe (21.1–50.0), and very severe (50.1–72.0). The IGA score is a validated clinician-reported measure which evaluates patient’s eczema based on severity of erythema, infiltration, papulation, and oozing/crusting and is categorized in 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe) [11–13]. AD symptoms assessed included pruritus and sleep disturbances, using the patient-reported measures Itch numerical rating scale (NRS) and the Sleep NRS [14, 15].

Statistical Analysis

Continuous variables were described as mean with standard deviation (SD) and median with 25% quartile (Q1) and 75% quartile (Q3). Categorical variables were summarized as frequency and percentages.

Persistence on baricitinib was estimated using Kaplan–Meier analyses up to week 52. Differences in persistence by baseline characteristics and prescription patterns were assessed up to week 16 using univariable Cox proportional hazards models.

Effectiveness was assessed through treatment responsiveness and changes in severity from baseline among responders (patients that were still on baricitinib) that had at least one postbaseline assessment at any time. Effectiveness outcomes were evaluated among patients with valid data to provide a description of at least one of the effectiveness endpoints (n = 65). Responsiveness at the assessment point classified patients as responders when there was no evidence of permanent discontinuation of baricitinib (persistence, temporary discontinuations, or losses to follow-up). Changes in severity due to baricitinib were assessed up to week 24 among patients still on baricitinib (responders) with at least one postbaseline effectiveness assessment at any time during follow-up. The summary statistics of effectiveness measures were provided at each time point. In addition, the mean absolute change from baseline, and the proportion of patients achieving EASI75 (≥ 75% reduction in EASI score from baseline) or an IGA score of 0 or 1 were calculated for responders with an available assessment at each time window. No imputation methods were applied.

Statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).

Results

Study Population

Seventy-four patients were included in the study, with a mean follow-up duration of 42.1 (SD 21.4) weeks. No patients were lost to follow-up.

Patients’ characteristics at baseline are presented in Table 1. Patients had a mean age of 36.8 (SD 14.6) years, 54.1% of the patients were female, and 58.1% had a normal body mass index (BMI). The majority of the patients had at least another comorbidity (74.3%), the most common being asthma and seasonal allergy (both 29.7%).

Table 1.

Sociodemographic and clinical characteristics

	Overall N = 74
Age at baseline, mean (SD); n	36.8 (14.6); 74
Sex, n (%)
Female	40 (54.1)
Male	34 (45.9)
BMI at baseline (kg/m2), mean (SD); n	25.78 (6.41); 31
BMI classification at baseline, n (%)
Unknown or missing	43
Underweight (< 18.5 kg/m2)	2 (6.5)
Normal weight (18.5–24.9 kg/m2)	18 (58.1)
Overweight (25.0—29.9 kg/m2)	7 (22.6)
Obese (> 29.9 kg/m2)	4 (12.9)
Patients with a family history of AD, n (%); n unknown	15 (20.3); 19
Patients doing regular physical activity/sport, n (%); n unknown	20 (27.0); 35
Patients with alcohol consumption habit, n (%); n unknown	10 (13.5); 30
Patients with smoking habit, n (%); n unknown	15 (20.3); 23
Patients with comorbidities, n (%); n unknown	55 (74.3); 3
Comorbidities,a n (%)
Asthma	22 (29.7)
Seasonal allergy	22 (29.7)
Dust mite allergy	17 (23.0)
Contact dermatitis	17 (23.0)
Food allergy	14 (18.9)
AD duration at baseline (years)
n (missing)	66 (8)
Mean (SD)	10.8 (11.5)
Median (Q1; Q3)	6.0 (1.0; 18.0)
EASI score at baseline
n (missing)	73 (1)
Mean (SD)	23.8 (9.4)
Median (Q1; Q3)	23.0 (21.0; 27.0)
EASI severity category at baseline, n (%)
Missing	1
Mild (EASI 0.1–7.0)	5 (6.8)
Moderate (EASI 7.1–21.0)	22 (30.1)
Severe (EASI 21.1–50.0)	44 (60.3)
Very severe (EASI 50.1–72.0)	2 (2.7)
IGA severity category at baseline, n (%)
Almost clear (IGA-1)	1 (1.4)
Mild (IGA-2)	5 (6.8)
Moderate (IGA-3)	26 (35.1)
Severe (IGA-4)	42 (56.8)
Itch NRS at baseline, mean (SD); n	7.3 (2.3); 44
Sleep NRS at baseline, mean (SD); n	4.3 (3.9); 27

AD atopic dermatitis, BMI body mass index, EASI Eczema Area and Severity Index, IGA Investigator Global Assessment, NRS numerical rating scale, Q1 quartile 1, Q3 quartile 3, SD standard deviation

^aMultiple response

At baseline, 63% of the patients had a EASI score > 21, and over half (56.8%) had an IGA-4. Regarding the severity of AD symptoms, the mean baseline Itch NRS and Sleep NRS scores were 7.3 (SD 2.3) (n = 44) and 4.3 (SD 3.9) (n = 27), respectively.

Treatments Description

Before Baricitinib Prescription

Prior to baricitinib initiation, 93.2% of patients had received at least one systemic treatment with a mean of 2.4 (SD 1.2) prior systemic treatments. These were primarily conventional immunosuppressants (81.1%), systemic corticosteroids (58.1%), and targeted biologic therapies (37.8%). Regarding topical treatments, 86.5% of patients had received TCS and 41.9% had received TCI (Table 2).

Table 2.

Atopic dermatitis treatments received before baseline

	Overall N = 74
Patients receiving systemic treatments before baseline, n (%)
No	5 (6.8)
Yes	69 (93.2)
N. of previous systemic treatments per patient, mean (SD)	2.4 (1.2)
Time from AD diagnosis to first AD systemic treatment (months), median (Q1; Q3); n	11.0 (0.0; 161.0); 49
Type of systemic treatment,a n (%)
Conventional immunosuppressants	60 (81.1)
Cyclosporin	58 (78.4)
Methotrexate	9 (12.2)
Azathioprine	8 (10.8)
Mycophenolate mofetil	1 (1.4)
Systemic corticosteroids	43 (58.1)
Prednisone	40 (54.1)
Other systemic corticosteroids	3 (4.1)
Unknown systemic corticosteroid	1 (1.4)
Targeted biologic therapy	28 (37.8)
Dupilumab	21 (28.4)
Tralokinumab	7 (9.5)
Other targeted biologic therapy	3 (4.1)
JAK inhibitors	8 (10.8)
Upadacitinib	8 (10.8)
Abrocitinib	1 (1.4)
Other systemic treatments	2 (2.7)
Use of topical treatment before baseline, n (%)
Yes	64 (86.5)
No	7 (9.5)
Unknown	3 (4.1)
Patients receiving TCS before baseline, n (%); n unknown	64 (86.5); 3
Patients receiving TCI before baseline, n (%); n unknown	31 (41.9); 4

AD atopic dermatitis, JAK Janus kinase, Q1 quartile 1, Q3 quartile 3, SD standard deviation, TCI topical calcineurin inhibitors, TCS topical corticosteroids

^aMultiple response

Baricitinib Prescription

The mean duration from the first systemic treatment to the prescription of baricitinib was 30.5 (SD 30.6) months. Baricitinib was mainly prescribed due to lack of effectiveness of previous treatments (87.8%), followed by adverse reactions or intolerance due to prior treatment (both 5.4%). Nearly all patients (97.3%) started on baricitinib at 4 mg, with 6.8% reducing their dose during follow-up (see Table S1 in the electronic supplementary material for details).

Concomitant AD Treatments

As shown in Table 3, 56 patients (75.7%) were prescribed baricitinib as the sole systemic treatment. Among them, 37.5% discontinued baricitinib during follow-up.

Table 3.

Atopic dermatitis treatment patterns at baseline and during follow-up

	Overall N = 74
Patients prescribed baricitinib as the only AD systemic treatment, n (%)	56 (75.7)
Status at end of follow-up
Ongoing baricitinib in monotherapy	35 (62.5)
Discontinued baricitinib	21 (37.5)
Patients already on AD systemic treatment (baricitinib as add-on), n (%)	9 (12.2)
Type of concomitant systemic treatmenta
Conventional immunosuppressants	8 (88.9)
Cyclosporin	8 (88.9)
Azathioprine	2 (22.2)
Methotrexate	1 (11.1)
Systemic corticosteroids	6 (66.7)
Prednisone	4 (44.4)
Other systemic corticosteroids	2 (22.2)
Targeted biologic therapy	2 (22.2)
Dupilumab	2 (22.2)
Other systemic treatments	1 (11.1)
Status at end of follow-up
Discontinued all systemic treatments including baricitinib	5 (55.6)
Ongoing baricitinib in monotherapy	3 (33.3)
All systemic treatments ongoing	1 (11.1)
Patients on baricitinib and concomitant systemic treatment added at baseline or after, n (%)	6 (8.1)
Type of concomitant systemic treatmenta
Systemic corticosteroids	6 (100.0)
Prednisone	5 (83.3)
Prednisolone	1 (16.7)
Conventional immunosuppressants	3 (50.0)
Cyclosporin	3 (50.0)
Azathioprine	1 (16.7)
Methotrexate	1 (16.7)
Targeted biologic therapy	2 (33.3)
Dupilumab	2 (33.3)
Tralokinumab	1 (16.7)
JAK inhibitors	1 (16.7)
Upadacitinib	1 (16.7)
Status at end of follow-up
Ongoing baricitinib in monotherapy	5 (83.3)
Discontinued all treatments including baricitinib	1 (16.7)
Other patterns, n (%)	3 (4.1)
Unknown	2 (66.7)
Combination of other patterns	1 (33.3)

AD atopic dermatitis, JAK Janus kinase

^aMultiple response

Nine patients (12.2%) were already on other systemic treatments when baricitinib was introduced (add-on), primarily cyclosporin (88.9%) and prednisone (44.4%). At the end of follow-up, five of these patients had discontinued all systemic treatments including baricitinib, while three remained on baricitinib in monotherapy, and one patient remained on all systemic treatments.

Six patients (8.1%) were prescribed another concurrent systemic treatment either at baseline or during follow-up. At the end of the follow-up, five of these patients remained on baricitinib as the sole systemic therapy, while the remaining patient discontinued all systemic treatments.

Regarding topical treatments, 63.5% of the patients received at least one concomitant topical treatment during follow-up (data not shown).

Baricitinib Persistence

Persistence on baricitinib was 85.1%, 75.7%, and 58.4% at week 16, 24, and 52, respectively (Fig. 2). Overall, 29 patients (39.2%) discontinued baricitinib during follow-up. Lack of effectiveness was the reason for discontinuation reported for all patients who discontinued treatment (37.8%), except in one case for an adverse reaction (1.4%). Generally, baricitinib persistence did not appear to differ by baseline characteristics or prescription patterns up to week 16 (see Table S2 in the electronic supplementary material for details).

Fig. 2.

Time on treatment: overall Kaplan–Meier curve

Effectiveness

Eczema Activity and Severity Index (EASI)

Among responders with available assessments at the different time points, the mean EASI score decreased from 23.8 (SD 9.8) at baseline to 5.8 (SD 6.9) and 6.5 (SD 9.3) at weeks 16 and 24, respectively (Fig. 3). At weeks 16 and 24, the mean absolute changes from baseline were 16.5 (SD 10.2) and 16.6 (SD 11.0), and 69.7% and 65.4% of patients who remained on treatment had attained an EASI75 response, respectively (Fig. 4). Refer to Table S3 in the electronic supplementary material for details.

Fig. 3.

Summary statistics for the EASI score at baseline and follow-up. EASI Eczema Area and Severity Index. Note 1: N is the total number of patients who continued on baricitinib and had an EASI assessment available at the different time points. Note 2: Mean score is shown for each assessment week

Fig. 4.

Proportion of patients with a ≥ 75% improvement from baseline in the EASI score (EASI75) during follow-up. Note: N is the total number of patients who continued on baricitinib and had an Eczema Area and Severity Index (EASI) assessment available at baseline and the different time points

Investigator Global Assessment (IGA)

At baseline, there were no patients with IGA-0, and 1.5% of patients had IGA-1, while 33.8% and 56.9% had IGA-3 and IGA-4, respectively. During follow-up, the proportion of patients with IGA 0 or 1 exceeded 50% at all time points assessed among responders with available assessments, reaching 79.3% at week 16 (Fig. 5).

Fig. 5.

Proportion of patients by the IGA score at baseline and during the follow-up. IGA Investigator’s Global Assessment. Note: N is the total number of patients who continued on baricitinib and with an IGA at the different time points

AD Symptoms

At baseline, the mean Itch NRS was 7.3 (SD 2.3), whereas at week 16, the mean Itch NRS score was 2.6 (SD 2.8), with a mean absolute change from baseline of 5.1 (SD 3.6). The Itch NRS score remained low at week 24 (mean 3.1 (SD 3.6); mean absolute change 3.6 (SD 3.6)) (Fig. 6).

Fig. 6.

Summary statistics for Itch NRS scores at baseline and follow-up. Note: N is the total number of patients who continued on baricitinib and with an Itch Numerical Rating Scale (NRS) assessment at the different time points

The mean Sleeping NRS score at baseline was 4.3 (SD 3.9), and at week 16, the mean score decreased to 0.5 (SD 0.9) with a mean absolute change from baseline of 4.5 (SD 3.1) (Fig. 7).

Fig. 7.

Summary statistics for Sleep NRS scores at baseline and follow-up. Note: N is the total number of patients who continued on baricitinib and with a Sleep Numerical Rating Scale (NRS) assessment at the different time points

See Table S4 in the electronic supplementary material for further details.

Discussion

This study provides valuable real-world data on the use of baricitinib in patients with AD, featuring the largest sample size reported to date in Spain and one of the largest among other observational studies in Europe and Asia [16–23]. By examining AD severity and symptoms, as well as baricitinib persistence, at multiple time points, it contributes additional real-world data to the existing literature. Our findings suggest baricitinib is a well-tolerated treatment for moderate-to-severe AD in routine clinical practice. Among responders, more than half of the patients experienced a significant clinical improvement.

At baseline, the majority of the patients in our study presented with moderate-to-severe AD (63% EASI > 21, 56.8% IGA-4) and severe pruritus. Most patients had previously used topical AD treatments, and most had received at least one systemic treatment, averaging 2.4 prior systemic treatments. Nearly 40% of the patients had been treated with biologics and around 10% with JAKi. This pattern is in accordance with the SmPC [6].

Most patients were prescribed baricitinib as the only systemic treatment for AD, and almost two-thirds also received TCS and TCI. This prescribing pattern aligns with the BREEZE-AD7 findings, which demonstrated enhanced efficacy when baricitinib is combined with TCS [7], and follows the SmPC’s recommendation to use TCI for sensitive areas if needed [6].

During follow-up, 39.2% of patients discontinued baricitinib, primarily due to lack of effectiveness and only one discontinuation due to an adverse reaction. These results are similar to other observational studies [19, 21, 23], and results from a pooled safety analysis, although methodological differences should be considered [10]. The latter, which included patient-level safety data from eight trials, reported a discontinuation rate of 4.6% due to adverse events among 2531 patients with AD (2247 patient-year). Among the observational studies, De Greef et al. [21] (n = 19) conducted a retrospective study in Belgium with a median follow-up of 54.4 weeks, where 36.8% of patients discontinued treatment due to lack of effectiveness—a rate similar to that observed in our cohort. In the Netherlands, Boesjes et al. [19] (n = 51) found that 33.3% discontinued baricitinib due to ineffectiveness, and 9.8% due to adverse events after a 16-week follow-up. In France, Reguiai et al. [23] (n = 88) found that 46.7% of patients remained on treatment after 1 year, with discontinuations mainly due to lack of effectiveness and only one discontinuation due to side effects.

Regarding baricitinib effectiveness, the distribution of valid assessments at the different time points is very irregular, with only around 50% or less of the responders having valid assessments. At week 16, 69.7% of the responders with an available assessment (50.8% of responders) achieved an EASI75 response. These findings reflect the observational nature of our study, which includes patients treated in routine clinical practice, without strict inclusion criteria, predefined visit schedules, or protocol-driven management. The effectiveness results observed among patients who remained on baricitinib treatment demonstrate clinically meaningful improvements in disease severity and symptoms beside baseline heavily pretreated population and severe disease activity. While direct comparisons with randomized clinical trials are not appropriate due to differences in study design and patient populations, our data provide complementary real-world evidence supporting the use of baricitinib in adult patients with moderate-to-severe atopic dermatitis in Spain. This pattern is also evidenced when considering the results from the post hoc analysis of BREEZE-AD7, where baseline body surface area (BSA) ≤ 40% and pruritus ≥ 7 points were predictors of better response to baricitinib, with an EASI75 of 69% [24]. This matches the baseline Itch NRS observed in our study. However, the DAMA-S study was designed before these findings became available, and BSA was not collected, as participating investigators indicated that it is not routinely recorded in clinical practice in Spain. Thus, effectiveness in this subgroup and whether this could lead to a better persistence were not assessed. Future studies including this and other relevant tests would be informative.

Since the results from the BREEZE-AD clinical trials, several real-world studies evaluating baricitinib in AD have been published, including one conducted in Spain by Navarro-Triviño et al. [17] and seven more in Europe [16, 19, 21–23, 25, 26]. Navarro-Triviño et al. (n = 13) found a mean reduction in EASI score dropping from 22.4 at baseline to 5.1 at 16 weeks [17]. In Portugal, Freitas et al. (n = 42) reported a 57.1% EASI75 response at week 12, which remained steady at week 24, yet was lower than in our study [22]. In Germany, Rogner et al. (n = 12), reported a median baseline EASI of 16.9, with mean reductions of 10.7 points at week 4 and 17.8 points at week 12 [16]. In the Netherlands, Boesjes et al. observed a decrease in the mean EASI score of 18.3 at baseline (n = 51) to 11.1 at week 16 (n = 36) [19]. Outside Europe, Cho et al. (n = 28) reported a mean baseline EASI score of 33.1, with 71.4% achieving an EASI75 response by week 16 [20].

Our study also highlights baricitinib’s rapid symptom relief, consistent with significant pruritus improvement as early as the day after starting treatment observed in clinical trials [7, 27]. Pruritus and its derived sleep alterations are among the most burdensome AD symptoms, so managing these symptoms is key in the treatment of AD and is linked to improved QoL [8, 28, 29].

Overall, the results from the DAMA-S study point in the same direction as those previously reported in the BREEZE AD clinical trials, considering that any observed differences need to be interpreted with caution due to the differences in the study design, as well as the differences in topical treatment and strict conditions regarding data censoring of the clinical trials.

There are some limitations to the DAMA-S study that should be considered. Firstly, the retrospective nature of the design that only allows the use of data already collected in patients’ clinical records. Secondly, all patients initiating baricitinib with the possibility of achieving 16 weeks of follow-up were included; patients discontinuing before 16 weeks of follow-up were also included. However, the data collection period may have finished before the collection of data at 24 and 52 weeks for some patients. Furthermore, not all patients had clinical visits or assessments available at the pre-specified time points, resulting in 66%, 42%, 38%, and 43% of responders without an EASI score at weeks 4, 8, 16, and 24, respectively. Effectiveness was described only among responders, which may introduce a positive bias and overestimate treatment effectiveness. No imputation was applied for missing data, so the impact of baricitinib discontinuations cannot be fully evaluated. Despite this, responders with available scores generally showed AD severity improvement and symptoms relief. Future research should address the lack of standardized collection of effectiveness measurements in clinical records, including the systematic inclusion of patient-reported outcomes to better evaluate these aspects.

Conclusion

This study identifies baricitinib as a systemic treatment option for moderate-to-severe AD, providing a daily oral dosing regimen, clinical improvement among responders, and a manageable safety profile. These findings are consistent with the effectiveness observed in real-world settings and suggest that, among patients who remained on treatment, baricitinib may provide meaningful clinical benefit in routine clinical practice in Spain.

Supplementary Information

Below is the link to the electronic supplementary material.

Authors Contribution

Enrique Gómez de la Fuente, Enrique Herrera, Iñigo Martinez-Espronceda Esquerdo, David Vidal Sarró, Ignasi Figueras-Nart, Juan F. Silvestre Salvador, Yolanda Gilaberte, Sergio Santos Alarcón, Esther Serra-Baldrich, and Monica Munera Campos, contributed to the study conception, design, data collection, as well as, critically reviewed the manuscript for important intellectual content and approved the final manuscript. Rosa M. Moro, Silvia Díaz-Cerezo, Sebastian Moyano, Irene Talavera-Rodríguez, and Mercedes Núñez contributed to the study conception, design, data collection, analysis, interpretation of the study, and critically reviewed the manuscript for important intellectual content and approved the final manuscript.

Funding

This study and the journal’s Rapid Service Fee were funded by Eli Lilly and Company, Indianapolis, IN, USA.

Data Availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Declarations

Conflicts of Interest

Enrique Gómez de la Fuente has received speaker honoraria, and support for attending meeting and/or travel from Lilly, Abbvie, Sanofi, Pfizer, and Leo Pharma; and has participated on a data safety monitoring board (DSMB) or advisory board for Lilly, Abbvie, Sanofi, and Pfizer. At the time of the study, Enrique Gómez de la Fuente worked at Hospital Fundación Alcorcón (Madrid, Spain). His current affiliation is Hospital Ramón y Cajal (Madrid, Spain). David Vidal Sarró has received consulting fees and speaker honoraria from Lilly. Ignasi Figueras-Nart has received consulting fees, speaker honoraria, and support for attending meetings and/or travel from Lilly, Novartis, Sanofi, Abbvie, Leo Pharma, Vifor Pharma, and Pfizer. Juan F. Silvestre Salvador has received consulting fees from AbbVie, Almirall-Hermal, Lilly, Galderma, Leo Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; speaker honoraria and participated on a DSMB or Advisory Board for AbbVie, Almirall-Hermal, Lilly, Galderma, LEO Pharma, Pfizer and Sanofi-Genzyme; and support for attending meetings and/or travel from AbbVie, Almirall-Hermal, Lilly, Pfizer and Sanofi-Genzyme. Yolanda Gilaberte received consulting fees from Lilly, Cantabria Labs, Leo Pharma, Isdin, UCB and Almirall; received speaker honoraria from Sanofi, Pfizer, Abbvie, Cantabria Labs, Eucerin, Lilly, Leo Pharma and Incyte; support for attending meeting and/or travel from Sanofi and Eucerin; and has acted as leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for the European Academy of Dermatology and Virology (EADV) and the European Society of Photodermatology. Sergio Santos Alarcón has received speaker honoraria, and payment for expert testimony from; and has participated on a DSMB or Advisory Board for Almirall, Abbvie, Amgen, Pfizer, Novartis, Janssen-Cilag, Lilly, Leo Pharma, UCB Pharma, Pierre Fabre, Isdin, and Sanofi. Esther Serra-Baldrich has received grants or contracts from Galderma, Sanofi, Incyte and Leo Pharma; speaker honoraria from Sanofi, Galderma, Pfizer, Abbvie, Lilly and Leo Pharma; support for attending meeting and/or travel from Sanofi and Pfizer; and has participated on a DSMB or Advisory Board for Sanofi, Galderma, Pfizer, Abbvie, Lilly, and Leo Pharma. Rosa M. Moro, Silvia Díaz-Cerezo, Sebastián Moyano and Mercedes Núñez are full time employees at Lilly and minor owners of Lilly shares. Enrique Herrera, Iñigo Martínez-Espronceda Esquerdo, Mónica Munera Campos and Irene Talavera-Rodríguez declare that they have no competing interests.

Ethical Approval

The study was designed and conducted in accordance with the ethical principles set out in the Declaration of Helsinki and was approved by the Hospital Universitario Fundación Alcorcón Ethics Committee (Code 23/58). All patients provided written informed consent for the collection of their medical data and its use as part of this observational research study.