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Abrocitinib monotherapy in refractory atopic dermatitis: A case series
*Corresponding author: Teghveer Singh, Department of Dermatology, Base Hospital Delhi Cantt & Army College of Medical Sciences, Delhi, India. tegveersingh@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Srivastava S, Singh T, Sharma P. Abrocitinib monotherapy in refractory atopic dermatitis: A case series. Indian J Skin Allergy. doi: 10.25259/IJSA_15_2026
Abstract
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that significantly impairs quality of life. A subset of patients remains refractory to conventional systemic and biologic therapies. In this prospective case series, five patients with moderate-to-severe AD refractory to conventional systemic and biologic therapies received oral abrocitinib 100 mg once daily as monotherapy for 12 weeks. Disease severity and pruritus were assessed using Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), and Peak Pruritus Numerical Rating Scale (PP-NRS) at baseline, 4, 8, and 12 weeks. All five patients achieved at least 75% reduction in EASI scores by week 12, with marked decreases in SCORAD and PP-NRS. No serious adverse events occurred; one patient developed hypertriglyceridemia, and one experienced nasopharyngitis. Abrocitinib monotherapy demonstrated rapid and clinically meaningful improvements in disease severity and pruritus with a favorable short-term safety profile in this small cohort of patients with refractory AD. Larger, controlled studies are needed to confirm these findings.
Keywords
Abrocitinib
Atopic dermatitis
Janus kinase inhibitor
Refractory eczema
INTRODUCTION
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease characterized by pruritic eczematous lesions. It arises from complex interactions among genetic susceptibility, immune dysregulation, and environmental triggers.[1,2] Although topical corticosteroids, calcineurin inhibitors, phototherapy, and systemic immunosuppressants are standard treatments, many patients fail to achieve disease control or experience adverse effects.[3-5]
Recent insights have identified the Janus kinase (JAK)-signal transducer and activator of transcription pathway as a key mediator of AD-related inflammation.[6,7] Abrocitinib, an oral selective JAK1 inhibitor, modulates key cytokine pathways implicated in AD pathogenesis and has demonstrated efficacy in randomized controlled trials involving patients with moderate-to-severe AD.[7,8] However, evidence on its use as a standalone monotherapy in treatment-refractory AD, particularly in real-world clinical practice, remains limited.[8]
In this case series, we describe three adult and two pediatric patients with refractory AD treated with abrocitinib monotherapy, highlighting clinical outcomes as assessed by eczema area and severity index (EASI), scoring AD (SCORAD), and peak pruritus numerical rating scale (PP- NRS).
Objectives
The objective of the study is to evaluate the effectiveness and short-term safety of oral abrocitinib 100 mg once daily as monotherapy in patients with moderate-to-severe AD refractory to conventional treatments, using EASI, SCORAD, and PP-NRS as outcome measures.
Study design
This was a prospective, single-center, interventional case series conducted at a tertiary dermatology center in northern India between January-October 2025.
Inclusion criteria
Patients aged ≥12 years with a diagnosis of AD based on modified Hanifin and Rajka criteria, an EASI score >25, and disease refractory to conventional treatment were eligible. Treatment-refractory AD was defined according to Kim et al.[9] as failure to achieve EASI50 after at least 3 months of appropriate systemic immunosuppressive therapy and optimized topical treatment. One patient who had previously received a JAK inhibitor (baricitinib) was also included.
Investigations before abrocitinib
All patients were investigated with a hemogram, liver and renal function test, clotting profile, lipid profile, chest X-ray, interferon gamma response assay, and viral markers.
Exclusion criteria
Patients with active infections, latent tuberculosis, hepatitis, HIV, pregnancy, malignancy, or uncontrolled comorbidities were excluded from the study.
Intervention
Abrocitinib was administered orally at a dose of 100 mg once daily for 12 weeks. A dose of 100 mg once daily was selected because it is an approved dose for adolescents and adults and was considered appropriate in view of body weight, safety considerations, and real-world prescribing practices at our institution. Dose escalation to 200 mg was not undertaken because satisfactory clinical responses were achieved without treatment-limiting adverse effects. No systemic or biologic co-therapy was used during the study period. Patients were permitted to use emollients; topical anti-inflammatory agents were discontinued.
Clinical assessment
Disease severity and pruritus were assessed at baseline and at weeks 4, 8, and 12 using the EASI, SCORAD, and PP-NRS by two trained dermatologists.
End point
The primary endpoint was clinical response at week 12, defined as achievement of at least a 75% reduction in EASI score (EASI 75) from baseline. Secondary endpoints included changes in SCORAD and PP-NRS scores over time and/or the occurrence of any serious adverse events. These patients were continued on abrocitinib beyond 12 weeks.
Patient consent and ethics
The study was approved by the Institutional Ethics Committee (IEC-2024/005, dated December 01, 2024). Written informed consent and assent for minors were obtained for treatment and publication of images/case details from all five patients in a consent form.
CASE SERIES
Case 1
A 35-year-old female with a 2-year history of AD presented with severe, widespread subacute eczematous lesions accompanied by intense pruritus. Previous systemic treatment, including cyclosporine (4 mg/kg), to which she did not have a good response. She was on baricitinib 4 mg daily, the response to which was satisfactory and sustained for 16 weeks. However, she had an exacerbation of disease while on baricitinib and had a baseline EASI of 32.3, SCORAD of 68.1, and PP-NRS of 9 before starting abrocitinib [Figure 1]. Abrocitinib 100 mg once daily was initiated as monotherapy. By week 4, the patient reported a marked reduction in pruritus, improved sleep, and visible lesion healing. At week 12, EASI had decreased to 6.3 (81% improvement), SCORAD to 18, and PP-NRS to 2. Significant clinical improvement at week 12 was evident [Figure 2]. Hypertriglyceridemia was seen at week 12. The levels increased from 98 mg/dL at baseline to 162 mg/dL. The patient was advised to undergo dietary modification. Abrocitinib was continued.
Case 2
A 12-year-old female with infantile AD along with asthma presented with generalized xerosis and lichenified plaques. She had an inadequate response to methotrexate 10 mg/week and had taken oral steroids on several occasions during exacerbation of the disease. Omalizumab was also administered, considering the Th2 endotype and suboptimal control.[10] Baseline EASI was 28.1, SCORAD was 62.2, and PP- NRS was 8 during her assessment for abrocitinib [Figure 3].
Abrocitinib was started at 100 mg daily. Within 8 weeks, lesions improved and pruritus resolved. At week 12, EASI was 5.1, SCORAD was 15.1, and PP-NRS was 2 [Figure 4]. The patient experienced a single episode of nasopharyngitis after 3 weeks of treatment, which was managed with antibiotics and steam inhalation. Abrocitinib was not stopped during this episode.
Case 3
A 13-year-old male with recalcitrant AD unresponsive to topical therapies, phototherapy, and methotrexate 10 mg/week was shifted to abrocitinib. Baseline EASI was 25.2, SCORAD was 52.5, and PP-NRS was 8 [Figure 5]. Abrocitinib 100 mg daily was initiated. By week 12, a substantial reduction in lesion severity and itch was noted. At week 12, EASI improved to 7.5, SCORAD to 17.6, and PP-NRS to 2 [Figure 6]. No adverse events were observed.
Case 4
A 25-year-old male presented with childhood-onset AD. Acute flare of the disease was poorly responsive to adequate dosages of cyclosporine (4 mg/day). Baseline EASI, SCORAD, and PP-NRS were 25.1, 54.4, and 7, respectively. Abrocitinib 100 mg was initiated. At week 12, EASI improved to 6.2, SCORAD to 13.5, and PP-NRS to 3. No adverse events were observed.
Case 5
A 27-year-old female with recalcitrant childhood-onset AD was also started on abrocitinib 100 mg once a day. Baseline EASI, SCORAD, and PP-NRS were 26.7, 59.5, and 8, respectively. At week 12, EASI improved to 7.2, SCORAD to 15.2, and PP-NRS to 2. No adverse events were observed.
RESULTS
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Patient characteristics [Table 1]:
Table 1: EASI, SCORAD, and PP-NRS at baseline, 4, 8, and 12 weeks while on treatment with abrocitinib.Demographic data Baseline Cases Age
(years)Sex Duration of atopic dermatitis (years) Prior treatment with a Janus kinase inhibitor Prior treatment with conventional immunosuppressants SCORAD EASI PP-NRS Case 1 35 F 2 Baricitinib Cyclosporine 68.1 32.3 9 Case 2 12 F 7 - Methotrexate 62.2 28.1 8 Case 3 13 M 5 - Methotrexate 52.5 25.2 8 Case 4 25 M 15 - Cyclosporine 54.4 25.1 7 Case 5 27 F 15 - Methotrexate 59.5 26.7 8 Week 4 Week 8 Week 12 SCORAD EASI PP-NRS SCORAD EASI PP-NRS SCORAD EASI PP-NRS Case 1 43.2 13.4 6 32.2 8.3 5 18 6.3 2 Case 2 41.1 19.6 5 30.7 11.2 4 15.1 5.1 2 Case 3 38.3 15.2 5 21.4 10 4 17.6 7.5 2 Case 4 33.7 11.3 5 25.6 9.3 4 13.5 6.2 3 Case 5 38.2 15.5 6 27.4 11.2 5 15.2 7.2 2 EASI: Eczema area and severity index, SCORAD: Scoring atopic dermatitis, PP-NRS: Peak pruritus numerical rating scale, M: Male, F: Female
Patients had an age bracket of 12–35 years with a mean age of 22.4 years. 3 patients were females, and there were 2 males in the study.
The mean duration of AD was 8.8 years.
One case had received a JAK inhibitor previously (baricitinib).
Methotrexate was given to three patients, and cyclosporine was given to two patients. All patients had received a short course of oral corticosteroids at some point during the illness.
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Efficacy outcomes [Tables 2 and 3]:
Table 2: Mean EASI, SCORAD, and PP-NRS at baseline, 4, 8, and 12 weeks while on treatment with abrocitinibScores Baseline Week 4 Week 8 Week 12 Mean SCORAD 59.34 38.9 27.46 15.88 Mean EASI 27.48 15 10 6.46 PP-NRS 8 5.4 4.4 2.2 EASI: Eczema area and severity index, SCORAD: Scoring atopic dermatitis, PP-NRS: Peak pruritus numerical rating scale
Table 3: Individual percentage reductionsCase EASI
reduction (%)SCORAD
reduction (%)PP-NRS
reduction (%)1 80.5 73.6 77.8 2 81.9 75.7 75.0 3 70.2 66.5 75.0 4 75.9 75.2 57.1 5 73.0 74.5 75.0 EASI: Eczema area and severity index, SCORAD: Scoring atopic dermatitis, PP-NRS: Peak pruritus numerical rating scale, %: Percentage
Percentage reduction = baseline score-week 12 score/baseline score ×100.
All five patients achieved EASI 75 by week 12. Mean EASI improved from 27.48 to 6.46 at the end of 12 weeks. Overall improvement percentages were 76.49%. (27.48−6.46/27.48 × 100).
Noticeable pruritus improvement was observed by the first scheduled assessment at week 4, with a mean PP- NRS improving from 8 to 2.2 by the end of week 12.
Mean SCORAD improved from 59.34 to 15.88 at the end of 12 weeks. Overall improvement percentages were 73.23%. (59.34−15.88/59.34 × 100).
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Safety outcomes:
Case 1 developed hypertriglyceridemia, and Case 2 developed nasopharyngitis.
No serious adverse events or treatment discontinuations were observed.
DISCUSSION
In this prospective case series of five patients with moderate- to-severe AD refractory to multiple systemic and, in some cases, biologic/JAK inhibitor therapies, oral abrocitinib 100 mg once daily as monotherapy resulted in rapid and substantial improvements in disease severity and pruritus. All patients achieved at least EASI 75 by week 12, with marked reductions in SCORAD and PP-NRS and no serious adverse events. These findings are consistent with the efficacy and safety observed in randomized controlled trials such as JADE MONO-1, JADE MONO-2, and JADE COMPARE.[11-13]
The rapid improvement in pruritus was notable within days, as JAK1 inhibition effectively reduces interleukin-31-mediated itch, improving sleep and breaking the itch-scratch cycle.[14] All patients experienced a significant reduction in pruritus and improved sleep by 4 weeks, suggesting a meaningful improvement in quality of life.
The favorable safety profile observed aligns with pooled long-term data showing low rates of thromboembolic and laboratory adverse events.[15]
Some comparative studies and network meta-analyses have reported higher short-term response rates for certain efficacy endpoints with abrocitinib compared with dupilumab; however, interpretation should consider differences in study design, populations, and outcome measures.[16]
To our knowledge, there are limited published real-world data focusing specifically on abrocitinib monotherapy in treatment- refractory AD, and our series adds to this emerging evidence.
Limitations
It is a small case series (n = 5) from a single tertiary center, which limits the generalizability of the findings and precludes any causal inferences. Second, all patients received a fixed dose of 100 mg once daily; we did not evaluate the efficacy or safety of other approved doses (50 mg or 200 mg). Third, the follow- up period was limited to 12 weeks, and long-term durability of response and delayed adverse events could not be assessed.
CONCLUSION
In this prospective case series of five patients with refractory moderate-to-severe AD, abrocitinib 100 mg once daily was associated with clinically meaningful improvements in EASI, SCORAD, and PP-NRS scores over 12 weeks, with no serious adverse events observed. Given the small, uncontrolled nature of this study, these findings should be considered exploratory and hypothesis-generating. Larger controlled studies are needed to better define the effectiveness and safety of abrocitinib monotherapy in treatment-refractory AD.
Ethical approval:
The research/study was approved by the Institutional Review Board at Base Hospital Delhi Cantt & Army College of Medical Sciences, number 2024/005, dated December 01, 2024.
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given consent for their images and other clinical information to be reported in the journal. The patient understands that the patient’s names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Conflicts of interest:
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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