Patients With Atopic Dermatitis Treated With Upadacitinib: Factors Related to Achieving Minimal Disease Activity

Abstract

Abstract: Background: Atopic dermatitis (AD) is a chronic skin condition that may require systemic treatments like traditional immunosuppressants or advanced therapies such as upadacitinib, a JAK1-selective inhibitor. Minimal disease activity (MDA), a novel concept combining patient–clinician decision-making, offers a comprehensive measure of disease management, yet its use in real-world drug efficacy studies is limited.

Objective: This study aimed to assess the proportion of patients achieving MDA based on pruritus (MDAp) after 16 and 52 weeks of upadacitinib treatment and to explore factors associated with MDA achievement.

Methods: A prospective observational study was designed, including patients with moderate-to-severe AD starting treatment with upadacitinib for the first time. MDAp was defined as ≥90% improvement in the Eczema Area Severity Index and Worst Pruritus Numerical Rating Scale score ≤1.

Results: Fifty-three patients participated; mean age was 33.53 years (standard deviation 15.40), and 58.5% were women. MDAp was achieved by 62.3% of patients at week 16 and 46.2% at week 52. Patients achieving MDAp at week 16 were older, had shorter disease duration, and had less prior systemic corticosteroid use.

Conclusions: Upadacitinib demonstrated efficacy in achieving MDAp in moderate-to-severe AD. Clinical and therapeutic factors identified in this study could help predict treatment success.

Capsule Summary

Upadacitinib was effective in achieving minimal disease activity (MDA) in over two-thirds of patients with moderate-to-severe atopic dermatitis by week 16, demonstrating substantial early treatment efficacy.

Early MDA achievement was associated with older age, shorter disease duration, and less prior use of systemic corticosteroids, suggesting these factors may predict better treatment outcomes.

INTRODUCTION

Atopic dermatitis (AD) is a chronic inflammatory skin condition affecting over 20% of children and up to 17% of adults¹ that causes recurrent eczematous lesions and intense itching, significantly impacting patients’ quality of life.² Itching has been described by patients as the most troublesome aspect of the disease, and also as the primary reason for their most recent visit to a healthcare provider; in fact, its reduction was their key treatment priority.³ The severity of AD ranges from mild to severe, with management typically beginning with topical treatments like corticosteroids or calcineurin inhibitors. While topical therapy is sufficient for many, patients with moderate-to-severe AD often require systemic treatments like traditional immunosuppressants (eg, cyclosporine, methotrexate, azathioprine, mycophenolate-mofetil). In recent years, advanced therapies, including monoclonal antibodies (dupilumab, tralokinumab, lebrikizumab) and oral JAK inhibitors (upadacitinib, abrocitinib, baricitinib), have transformed AD management.⁴

Upadacitinib, a JAK1-selective inhibitor, was approved for moderate-to-severe AD in patients aged 12 years or older (weighing ≥40 kg).⁵ Clinical trials have demonstrated its superiority to placebo⁶ and dupilumab,⁷ achieving at least 75% improvement in the Eczema Area and Severity Index (EASI-75) by week 16. Upadacitinib also provides rapid symptom relief, with improvements being evident as early as week 1⁷ and sustained efficacy^8,9 through 52 weeks, making it one of the most effective systemic therapies available.

The advent of new drugs has revolutionized AD treatment, raising both patient and clinician expectations. In this competitive market, new therapies are scrutinized for their effectiveness. Traditionally, disease severity and treatment success were assessed using physician-administered tools. However, a novel concept called minimal disease activity (MDA) integrates the “treat-to-target” approach with collaborative decision-making between patients and clinicians. MDA allows patients to prioritize aspects of AD most relevant to them (eg, itching, skin appearance, sleep, mental health), while clinicians use objective measures like EASI, SCORing Atopic Dermatitis (SCORAD), Investigator’s Global Assessment (IGA), or body surface area. Together, they define personalized targets for disease control.^10-12 MDA provides a comprehensive assessment of disease management by incorporating patient perspectives alongside clinical evaluations. However, real-world studies on drug efficacy using MDA remain limited, highlighting the need for further research in this innovative approach.

This study aims to evaluate the proportion of patients achieving MDA based on pruritus (MDAp) after 16 and 52 weeks of treatment with upadacitinib and to explore the clinical and sociodemographic characteristics associated with MDAp achievement.

MATERIALS AND METHODS

Study Design and Participants

This prospective observational study was conducted from April 2022 to August 2024 at 2 tertiary-level hospitals. Participants included adolescents (≥12 years) and adults with moderate-to-severe AD diagnosed by a dermatologist, who were prescribed upadacitinib for the first time. Exclusion criteria included age <12 years, inflammatory bowel disease, other inflammatory cutaneous diseases, and lack of informed consent.

Outcomes and Measures

Based on the concept of MDA and recognizing the central role of itching in disease burden and treatment goals, ³ MDAp was established as the primary outcome of the study. MDAp (optimal control) was defined as ≥90% improvement in EASI (EASI-90) and Worst Pruritus Numerical Rating Scale (WP-NRS) ≤1 at weeks 16 and 52. “Moderate” control was defined as meeting EASI-75 and WP-NRS ≤4 at the same time points.

Clinical Assessment

AD severity was assessed using EASI, SCORAD, and IGA scales. Patient perspectives were evaluated with the Dermatology Life Quality Index (DLQI), WP-NRS, and Sleep Disturbances Numerical Rating Scale (SD-NRS) over the prior 7 days. Assessments occurred at baseline and follow-ups at weeks 16, 24, 36, and 52.

Other Variables

Demographic and clinical data, including age, sex, body mass index (BMI), family and personal medical history, atopic comorbidities, disease duration, and previous treatments, were collected through anamnesis and physical exams.

Ethics

This study was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the local ethics committee. Patients gave oral and written informed consent. Measures were taken to ensure the confidentiality and anonymity of patients’ personal information.

Statistical Analysis

Descriptive statistics summarized clinical and sociodemographic characteristics, with continuous variables expressed as mean (standard deviation [SD]) and qualitative variables as absolute (relative) frequencies. Normality was assessed using the Shapiro–Wilk test.

Patients were grouped by MDAp achievement at weeks 16 and 52. Continuous variables were compared using Student’s t test or Wilcoxon–Mann–Whitney test and categorical variables using chi-squared test or Fisher’s exact test as appropriate. The same analysis was conducted for groups achieving “moderate” control. Statistical significance was set at P < 0.05 and JMP® Pro Version 16.0.0 was used for analysis.

RESULTS

Demographic and Clinical Characteristics

Fifty-three patients with moderate-to-severe AD were included. Mean age was 33.53 years (SD 15.40), and 58.5% were women. Patients presented severe AD at baseline, with mean EASI score of ∼27 and WP-NRS ∼7. By week 16, clinical improvements were observed (mean EASI ∼3, WP-NRS ∼1), further improving by week 52 (mean EASI ∼2, WP-NRS ∼1). Detailed baseline characteristics are presented in Table 1, and all clinical outcomes from baseline to follow-up at weeks 16 and 52 are shown in Table 2.

Table 1.

Clinical and Sociodemographic Characteristics of the Study Population

Characteristics	Total Population (N = 53)
Age (years)	33.53 (15.40)
Sex (female, %)	31 (58.5%)
BMI (kg/m²)	24.44 (6.02)
Comorbidities
Asthma	19 (35.9%)
Allergic conjunctivitis	18 (34.0%)
Allergic rhinitis	24 (45.3%)
Food allergies	11 (20.8%)
Allergic contact dermatitis	5 (9.4%)
Family history of atopic dermatitis	19 (35.9%)
Disease duration (years)	21.83 (13.09)
Previous systemic treatments
Cyclosporine	48 (90.6%)
Oral corticosteroids	47 (88.7%)
Phototherapy	10 (18.9%)
Methotrexate	11 (20.8%)
Azathioprine	4 (7.6%)
Mycophenolate-mofetil	2 (3.8%)
Dupilumab	19 (35.9%)
Tralokinumab	3 (5.7%)
Baricitinib	3 (5.7%)
Abrocitinib	1 (1.9%)
Number of previous systemic treatments	2.87 (1.40)

Data are expressed as absolute (relative) frequencies and mean (standard deviation).

BMI, body mass index.

Table 2.

Clinical Disease Characteristics of the Study Population at Baseline and Follow-Up Visits

Characteristics	Total Population (N = 53)
Baseline disease severity
EASI	27.48 (8.27)
IGA	3.18 (0.60)
SCORAD	49.94 (19.58)
DLQI	16.50 (6.97)
Worst pruritus NRS	7.26 (2.13)
Sleep disturbances NRS	5.41 (2.95)
Disease severity after 16-week treatment
EASI	3.47 (5.25)
IGA	0.83 (0.94)
SCORAD	11.36 (17.00)
DLQI	0.79 (1.74)
Worst pruritus NRS	1.32 (1.90)
Sleep disturbances NRS	0.48 (1.39)
Disease severity after 52-week treatment
EASI	2.65 (3.86)
IGA	0.50 (0.71)
SCORAD	9.41 (13.43)
DLQI	1.6 (3.41)
Worst pruritus NRS	1.50 (2.28)
Sleep disturbances NRS	0.88 (1.89)

Data are expressed as absolute (relative) frequencies and mean (standard deviation).

DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, Numerical Rating Scale; SCORAD, SCORing Atopic Dermatitis.

Clinical Outcomes

Variables related to moderate and optimal control achievements at week 16 are detailed in Tables 3 and 4.

Table 3.

Clinical and Sociodemographic Characteristics According to Achieving Minimal Disease Activity Based on Pruritus at Week 16

Characteristics	Minimal Disease Activity Based on Pruritus at Week 16
Yes (n = 33)	No (n = 20)	P value
Age (years)	36.42 (17.14)	28.75 (10.75)	0.05
Sex (female, %)	18 (54.6%)	13 (65%)	0.45
BMI (kg/m²)	25.35 (6.42)	23.11 (5.40)	0.34
Comorbidities
Asthma	10 (30.3%)	9 (45.0%)	0.28
Allergic conjunctivitis	10 (30.3%)	8 (40.0%)	0.47
Allergic rhinitis	14 (42.4%)	10 (50.0%)	0.59
Food allergies	7 (21.2%)	4 (20.0%)	0.91
Allergic contact dermatitis	4 (12.1%)	1 (5.0%)	0.39
Family history of atopic dermatitis	13 (39.4%)	6 (30.0%)	0.49
Disease duration (years)	19.30 (13.32)	26 (11.87)	0.06
Previous systemic treatments
Cyclosporine	29 (87.9%)	19 (95.0%)	0.39
Oral corticosteroids	27 (81.8%)	20 (100.0%)	0.04
Phototherapy	6 (18.2%)	4 (20.0%)	0.87
Methotrexate	9 (27.3%)	2 (10.0%)	0.13
Azathioprine	1 (3.0%)	3 (15.0%)	0.11
Mycophenolate-mofetil	0 (0.0%)	2 (10.0%)	0.06
Dupilumab	10 (30.3%)	9 (45.0%)	0.28
Tralokinumab	2 (3.0%)	1 (10.0%)	0.29
Baricitinib	2 (3.0%)	1 (10.0%)	0.29
Number of previous treatments	2.61 (1.20)	3.30 (1.63)	0.11
Basal disease severity
EASI	27.53 (8.19)	27.39 (8.62)	0.95
IGA	3.16 (0.58)	3.22 (0.65)	0.74
SCORAD	49.46 (20.02)	50.80 (19.33)	0.82
DLQI	17.75 (6.04)	14.00 (8.42)	0.29
Worst pruritus NRS	7.34 (1.67)	7.11 (2.76)	0.75
Sleep disturbances NRS	5.20 (2.78)	5.79 (3.31)	0.58
Disease severity after 16-week treatment
EASI	0.44 (0.86)	8.48 (5.64)	<0.001
IGA	0.28 (0.53)	1.72 (0.75)	<0.0001
SCORAD	4.14 (9.85)	25.30 (19.44)	0.001
DLQI	0.5 (1.89)	1.67 (0.82)	0.05
Worst pruritus NRS	0.52 (1.25)	2.59 (2.09)	0.001
Sleep disturbances NRS	0.36 (1.33)	0.73 (1.56)	0.52
Improvement
EASI (%)	98.59 (2.80)	67.89 (20.59)	<0.0001
IGA	2.93 (0.72)	1.56 (1.03)	<0.0001
SCORAD (%)	94.00 (13.79)	50.56 (43.35)	0.004
DLQI	17.42 (6.40)	11 (5.77)	0.11
Worst pruritus NRS	6.93 (1.77)	4.35 (4.06)	0.02
Sleep disturbances NRS	4.89 (2.66)	5.6 (3.17)	0.56

Data are expressed as absolute (relative) frequencies and mean (standard deviation).

Performed tests: Student’s t test for independent samples, Mann–Whitney U test, chi-squared test, and Fisher’s exact test. Improvement of EASI and SCORAD was calculated as a percentage improvement. IGA, worst pruritus NRS and sleep disturbances NRS were assessed as subtractions.

BMI, body mass index; DLQI, Dermatology Life Quality Index; EASI Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, Numerical Rating Scale; SCORAD, SCORing Atopic Dermatitis.

Table 4.

Clinical and Sociodemographic Characteristics According to Achieving “Moderate” Control at Week 16

Characteristics	“Moderate” Control at Week 16		P value
Yes (n = 43)	No (n = 10)
Age (years)	34.98 (16.26)	27.30 (9.18)	0.06
Sex (female, %)	24 (77.4%)	7 (70.0%)	0.41
BMI (kg/m²)	24.66 (6.02)	23.70 (6.57)	0.75
Comorbidities
Asthma	15 (34.9%)	4 (40.0%)	0.76
Allergic conjunctivitis	14 (32.6%)	4 (40.0%)	0.65
Allergic rhinitis	20 (46.5%)	4 (40.0%)	0.71
Food allergies	10 (23.3%)	1 (10.0%)	0.35
Allergic contact dermatitis	5 (11.6%)	0 (0.00%)	0.25
Family history of atopic dermatitis	15 (34.9%)	4 (40.0%)	0.76
Disease duration (years)	21.19 (13.83)	24.60 (9.36)	0.36
Previous systemic treatments
Cyclosporine	39 (90.7%)	9 (90.0%)	0.95
Oral corticosteroids	37 (86.1%)	10 (100.00%)	0.21
Phototherapy	8 (18.6%)	2 (20.0%)	0.92
Methotrexate	10 (23.3%)	1 (10.0%)	0.35
Azathioprine	2 (4.7%)	2 (20.0%)	0.09
Mycophenolate-mofetil	0 (0.0%)	2 (20.0%)	0.003
Dupilumab	15 (34.9%)	4 (40.0%)	0.76
Tralokinumab	1 (2.3%)	2 (20.0%)	0.03
Baricitinib	2 (4.7%)	1 (10.0%)	0.51
Number of previous treatments	2.72 (1.18)	3.50 (2.07)	0.28
Basal disease severity
EASI	27.18 (7.67)	28.80 (10.89)	0.67
IGA	3.21 (0.57)	3.10 (0.74)	0.68
SCORAD	48.68 (19.23)	55.67 (21.31)	0.38
DLQI	16.11 (7.05)	18.00 (7.21)	0.62
Worst pruritus NRS	7.34 (2.08)	6.89 (2.42)	0.61
Sleep disturbances NRS	5.47 (2.88)	5.14 (3.48)	0.82
Disease severity after 16-week treatment
EASI	1.43 (2.00)	12.25 (5.92)	0.0002
IGA	0.53 (0.68)	2.11 (0.78)	0.0002
SCORAD	6.85 (12.33)	33.27 (20.41)	0.01
DLQI	0.71 (1.82)	1.33 (1.15)	0.47
Worst pruritus NRS	0.94 (1.63)	2.78 (2.28)	0.05
Sleep disturbances NRS	0.30 (1.20)	1.33 (1.97)	0.26
Improvement at week 16
EASI (%)	94.54 (8.08)	54.58 (21.95)	0.0002
IGA	2.77 (0.81)	1.11 (0.93)	0.0004
SCORAD (%)	86.90 (25.21)	38.89 (48.18)	0.06
DLQI	16.07 (6.99)	14 (5.66)	0.69
Worst pruritus NRS	6.4 (2.94)	4.11 (3.22)	0.08
Sleep disturbances NRS	5.04 (2.77)	5.6 (3.29)	0.74

Data are expressed as absolute (relative) frequencies and mean (standard deviation).

BMI, body mass index; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, Numerical Rating Scale; SCORAD, SCORing Atopic Dermatitis.

MDAp was achieved by 33 patients (62.3%) at week 16 and 46.2% at week 52. When comparing those achieving MDAp at week 16 to those who did not, achievers had less frequent prior systemic corticosteroid use, a tendency to be older, and to have shorter disease duration. After conducting a multivariate logistic regression model, it was observed that those achieving MDAp at week 16 had less frequent prior systemic corticosteroid use (P = 0.01), older age (P = 0.04), and a tendency to have shorter disease duration (P = 0.07).

Moderate control was achieved by 81% of patients at week 16 and 82% at week 52, with no significant differences between groups.

Patients achieving MDAp demonstrated greater DLQI improvements (DLQI week 16–baseline DLQI), with a mean reduction of 17.42 (SD 6.40) points compared with 11 (SD 5.77) in those not achieving MDAp (P = 0.11). For moderate control, DLQI reduction was 16.07 (SD 6.99) in achievers versus 14 (SD 5.66) in nonachievers (P = 0.69).

Adverse Events and Discontinuation

During follow-up, 33 adverse events occurred in 22 patients (41.5%), but only 6 of them led to discontinuation of treatment. The most common were acne-like eruptions (17%) and upper respiratory infections (9.4%). Other less frequent events included fatigue (5.7%), gastrointestinal discomfort (5.7%), facial erythema, oral herpes simplex, herpes zoster, and oral candidiasis (3.8% each). Rare adverse events, reported by only 1 patient (1.9%) each, were hair loss, cough, dyspnea on exertion, epistaxis, hypercholesterolemia, hypertransaminasemia, and lower limbs edema.

Treatment discontinuation occurred in 10 patients (18.9%): 4 due to lack of effectiveness and 6 due to adverse events (gastrointestinal discomfort in 3 [5.7%] patients; and dyspnea, hypertransaminasemia, and recurrent upper respiratory tract infection in 1 [1.9%] patient each).

Clinical and sociodemographic characteristics of patients who suspended upadacitinib were analyzed and compared with those who continued treatment (Supplementary Table S1). Most clinical characteristics were similar among both groups; statistically significant difference was found in SCORAD (the group who suspended treatment exhibited higher scores at baseline) and in previous treatment with methotrexate (patients who discontinued treatment had a higher frequency of previous use of methotrexate). The rest of the characteristics did not exhibit statistically significant differences. Additional information can be consulted in the supplementary table.

DISCUSSION

This study demonstrates upadacitinib’s effectiveness in managing moderate-to-severe AD, with ∼two-thirds of patients achieving MDAp at week 16 and almost half at week 52. Mean age of participants was ∼33 years, similar to that reported in other studies^13,14; they were predominantly female, in contrast to most reviewed articles.^14-16 Atopic comorbidities included allergic rhinitis (most frequent), asthma, allergic conjunctivitis, and food allergies, all reflecting results from comparable studies.^13,15,17-19 Disease duration averaged 22 years, aligning with previous research,¹³ though some reported longer duration.^{15B16 -18} Patients had used nearly 3 AD treatments before upadacitinib, with cyclosporine (∼90%) and systemic corticosteroids (∼88%) being the most common, analogous to similar studies.^13,15,19,20 Dupilumab was less frequently prescribed (∼36%) compared with other studies.^13,14,18-20

At baseline, patients exhibited moderate-to-severe AD with a significant impact on their quality of life, with an EASI score of ∼27 (resembling some studies,^13,14,17,18 but higher than that reported by other authors^15,16,19,21) and DLQI score of ∼17 (variable results in previous research^13,14,18,19). Many authors described considerably similar WP-NRS^{13,15,17,19,20} and SD-NRS^14,17 to our patients’.

Upadacitinib was effective in improving disease severity and pruritus by week 16, with reductions in EASI (∼24 points) and WP-NRS (∼6 points). Comparable studies reported similar^13-15,18 or worse^16,17,19,21 outcomes at this time point. By week 52, the effectiveness in reducing EASI and WP-NRS was similar or slightly more pronounced compared with other studies.^14-16,20,21 When compared with oral traditional immunosuppressants (including azathioprine, oral corticosteroids, cyclosporine, mycophenolate), high-dose upadacitinib (30 mg) proved to be more effective at improving disease severity and patient’s quality of life (including pruritus and sleep disturbances).²² Moreover, compared with other JAK inhibitors, high-dose upadacitinib was superior to abrocitinib and baricitinib.²³

In this study, we observed that >60% of patients reached MDAp after 16-week upadacitinib treatment and >40% after 52-week treatment. It seems maintaining MDAp over time is challenging, as it depends on patients’ subjective features, who tend to be less demanding initially, but become more exigent as they experience improvement. Additionally, as the number of drugs available on the market increases, the demands from clinicians and patients increase^25,26; this could explain why MDAp achievement declined at week 52 in this study. In addition, the proportion of patients reaching this endpoint was higher than in recent clinical trials, where it was reported that 20% of patients treated with upadacitinib reached MDA compared with only 10% of those treated with dupilumab.²⁴ MDA assessment, incorporating patient perspectives, emerged as an essential measure for treatment outcomes; unlike conventional metrics, it offers tailored goals, acknowledging individual patient needs, enhancing their satisfaction, and highlighting the importance of achieving optimal control over moderate control. Moreover, in our study, WP-NRS reduction was greater among MDAp achievers as well as DLQI improvement. Despite the fact that DLQI results did not reach statistical significance, they could suggest a trend toward better quality-of-life outcomes with MDAp.

Patients who achieved MDAp were generally older, had a shorter disease duration, and had less frequent prior use of systemic corticosteroids. These findings may be attributable to the immunopathological characteristics and endophenotypic variations of AD.²⁷ While Th2 upregulation is a hallmark of most forms of AD, adults exhibit a decline in Th2 and Th22 activation alongside increased activation of Th1 and Th17 pathways. Upadacitinib’s capacity to broadly inhibit key cytokines²⁸ across these immune axes could explain its efficacy in achieving MDAp among patients with these characteristics, which collectively suggest a predominance of adult-onset AD. Given that AD onset in adulthood inherently implies an older age, a shorter disease duration, and likely reduced exposure to systemic corticosteroids, these factors may contribute to the observed treatment response.

This study has certain limitations, including a limited sample size, the absence of a control group, and the predefined selection of pruritus as the patient-reported outcome measure, which did not allow patients to specify the most significant disease aspect to them. Nevertheless, our findings underscore not only the clinical benefits of upadacitinib in reducing disease severity and enhancing quality of life but also the potential of MDA as a transformative metric for AD management. Future research should focus on integrating patient-selected disease aspects into MDA assessments to promote a more individualized and comprehensive approach to disease control.

CONCLUSIONS

Upadacitinib was effective to induce MDAp in patients with moderate-to-severe AD in nearly two-thirds of patients after 16-week treatment, with approximately half of the patients maintaining MDAp after 52 weeks. Factors associated with higher rates of MDAp achievement were older age, shorter disease duration, and less frequent prior use of systemic corticosteroids.

Footnotes

SUPPLEMENTARY MATERIAL

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