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Upadacitinib in dermatologic therapy: Emerging evidence and expanding indications
*Corresponding author: Gopikrishnan Anjaneyan Department of Dermatology, Amrita Institute of Medical Sciences and Research Center, Kochi, Kerala, India. drgopikrishnana@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Nayak P, Sreenivaasan NG, Krishna R, Anjaneyan G. Upadacitinib in dermatologic therapy: Emerging evidence and expanding indications. J Skin Sex Transm Dis. doi: 10.25259/ JSSTD_190_2025
Abstract
Upadacitinib, a selective and reversible Janus kinase 1 (JAK1) inhibitor, suppresses pro-inflammatory cytokine signaling through the JAK-STAT pathway, yielding anti-inflammatory effects. The United States Food and Drug Administration approved upadacitinib in August 2019 for rheumatoid arthritis, in December 2021 for psoriatic arthritis, and in January 2022 for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older. A comprehensive literature search was conducted across PubMed, Scopus, and Google Scholar for articles published between January 2015 and December 2025 using combinations of keywords such as “Upadacitinib in dermatology,” “Upadacitinib in atopic dermatitis,” “upadacitinib AND psoriasis,” “upadacitinib AND alopecia areata,” and “efficacy of upadacitinib in dermatological conditions. Systematic reviews, randomized controlled trials, prospective and retrospective real-world studies, case series, and single-patient case reports focusing on cutaneous indications of upadacitinib and published in English were included, while non-dermatological indications, conference abstracts without full-text data, narrative reviews without original patient data, editorials, letters without extractable outcomes, and non-English articles were excluded. This review elucidates the therapeutic indications in cutaneous disorders, emphasizing its demonstrated efficacy, growing real-world use, recent generic availability in India, and its cost-effectiveness relative to other available biologics and small-molecule therapies.
Keywords
Alopecia areata
Atopic dermatitis
Janus kinase 1 inhibitor
Upadacitinib
Vitiligo
INTRODUCTION
Upadacitinib, a selective and reversible Janus kinase 1 (JAK1) inhibitor, suppresses pro-inflammatory cytokine signaling through the JAK-signal transducer and activator of transcription (STAT) pathway, yielding anti-inflammatory effects. The United States Food and Drug Administration (US FDA) approved upadacitinib in August 2019 for rheumatoid arthritis, in December 2021 for psoriatic arthritis, and in January 2022 for moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older.
A comprehensive literature search was conducted across PubMed, Scopus, and Google Scholar for articles published between January 2015 and December 2025 using combinations of keywords such as “Upadacitinib in dermatology,” “Upadacitinib in atopic dermatitis,” “upadacitinib AND psoriasis,” “upadacitinib AND alopecia areata,” and “efficacy of upadacitinib in dermatological conditions. Systematic reviews, randomized controlled trials, prospective and retrospective real-world studies, case series, and single-patient case reports focusing on cutaneous indications of upadacitinib and published in English were included, while non-dermatological indications, conference abstracts without full-text data, narrative reviews without original patient data, editorials, letters without extractable outcomes, and non-English articles were excluded. This review elucidates the therapeutic indications in cutaneous disorders, emphasizing its demonstrated efficacy, growing real-world use, recent generic availability in India, and its cost-effectiveness relative to other available biologics and small-molecule therapies.
MECHANISM OF ACTION
The JAK family, including JAK1, JAK2, JAK3, and TYK2, facilitates intracellular signaling from diverse cytokine receptors via the JAK-STAT pathway. JAK1 modulates key inflammatory cascades; JAK2 regulates hematopoiesis through erythropoietin and thrombopoietin receptors; and JAK3 supports immune homeostasis.[1] Upadacitinib is a selective, reversible JAK1 inhibitor that competitively binds to the adenosine triphosphate site of JAK1. It prevents activation and phosphorylation of downstream STAT proteins and subsequent suppression of pro-inflammatory gene expression. By preferentially inhibiting JAK1-dependent cytokines (Interleukin [IL]-4, IL-13, IL-22, and interferon-gamma [IFN-γ]), upadacitinib reduces immune activation and tissue inflammation while offering an improved safety profile compared with pan-JAK inhibitors, due to lower risks of JAK2-mediated cytopenia and JAK3-related immunodeficiency.[1]
Pharmacodynamic studies support this mechanism, demonstrating that the drug more potently inhibits IL-6– induced STAT3 phosphorylation (a marker of JAK1 activity) than IL-7-induced STAT5 phosphorylation (a marker of JAK1/3 activity). This differential inhibition pattern confirms its JAK1 selectivity, which underlies its therapeutic efficacy in chronic inflammatory and autoimmune disease.[2,3] Figure 1 depicts the mechanism of action of upadacitinib.
INDICATIONS
Upadacitinib is FDA-approved in dermatology only for moderate-to-severe AD in adults and adolescents ≥12 years. In contrast, its emerging off-label indications are guided by real-world clinical experience and by extrapolation from efficacy outcomes reported with other JAK inhibitors.
Atopic dermatitis
In susceptible individuals, exposure to allergens triggers the release of Th2 cytokines, activating JAK1/JAK2–STAT6/STAT3 in keratinocytes. This signaling blocks nuclear translocation of Aryl hydrocarbon receptor (AHR) and Ovo-like 1 (OVOL1), thereby suppressing filaggrin, loricrin, and involucrin, and resulting in barrier dysfunction. Upadacitinib inhibits JAK1, allowing AHR and OVOL1 to enter the nucleus, restore barrier proteins, and improve epidermal integrity.[3] Clinically, Upadacitinib has demonstrated rapid, durable control of moderate-to-severe AD with a predictable safety profile.
Durability and real-world relevance: Pooled analysis from the Measure Up 1 and 2 trials showed clinically meaningful improvements in itch, pain, sleep, and quality of life within 1–2 weeks, lasting through 52 weeks, especially at 30 mg.[4]
Intraclass superiority: Upadacitinib 30 mg exhibits rapid and sustained EASI75/EASI90 responses and itch reduction, outperforming abrocitinib 200 mg and baricitinib 4 mg.[5] In addition, patients with inadequate response to baricitinib improve rapidly after switching to upadacitinib 30 mg.[6]
Head-to-head efficacy comparison with dupilumab: In the HEADS UP trial, upadacitinib 30 mg achieved faster, higher Eczema Area and Severity Index (EASI)-75/EASI90 responses and substantial itch reduction than dupilumab, with rapid improvement seen after switching from dupilumab.[7-9] Table 1 summarizes and compares emerging therapeutic options for AD in terms of clinical efficacy, safety outcomes, and associated treatment costs.
| Parameter | Upadacitinib | Abrocitinib | Dupilumab |
|---|---|---|---|
| Dosing | 15 mg or 30 mg once daily oral | 100 mg or 200 mg once daily oral | 300 mg subcutaneous every 2 weeks |
| Availability (India) | Available | Available | Not available |
| Cost (approximate) | ₹4000-5000/month (30 mg dose) | ₹60,000–₹70,000/month (200 mg dose) | Upwards of ₹1–2 lakhs/month |
| Time to response | Rapid onset; meaningful improvement by week 1–2 | Rapid onset; clinical response seen by week 2–4 | Onset slower; significant improvements seen by week 4–16 |
| Efficacy | Highest rates of EASI75, EASI90, and EASI100; superior to dupilumab in head-to-head trial | High efficacy; better than placebo but slightly less than upadacitinib | Effective in moderate-to-severe Atopic dermatitis; inferior to JAK inhibitors in early response |
| Patient-reported outcomes | Rapid and sustained improvements in itch, pain, sleep, and daily activities over 52 weeks | Significant improvements in symptoms and quality of life by 12 weeks | Improvements sustained long-term; slower onset of itch relief compared to JAK inhibitors |
| Safety considerations | Acne, Herpes zoster, dose-dependent risk of lymphopenia, neutropenia, hyperlipidemia; routine blood monitoring suggested | Injection site reactions, conjunctivitis; generally, well-tolerated | |
EASI: Eczema Area and Severity Index, JAK: Janus kinase.
Vitiligo
Vitiligo pathogenesis involves CXCR3+CD8+ T cells and IFN-γ-mediated melanocyte destruction via the JAK1/2STAT pathway. JAK inhibitors block IFN-γ and CXCL10 signaling, preventing immune-induced melanocyte damage and promoting repigmentation. A Phase 2 randomized trial demonstrated significant facial and body repigmentation with 11 mg and 22 mg doses compared to placebo by week 24, with ongoing improvement through week 52.[10] Case series have demonstrated notable repigmentation with upadacitinib in both pediatric and treatment-resistant vitiligo.[11,12] Combination with a 308 nm excimer light enhanced outcomes for progressive facial vitiligo, yielding superior Vitiligo Area Scoring Index and quality-of-life benefits.[13] Immunological analysis revealed reduced CXCL9 levels, decreased CD4+/CD8+ Tcell ratios, and downregulation of Th1-like Tregs after treatment, supporting upadacitinib’s efficacy and immunomodulatory potential in non-segmental vitiligo.[14]
Alopecia areata
Upadacitinib demonstrates promising efficacy and safety for severe alopecia areata in adolescents and adults, including those without atopic comorbidities.[15,16] Retrospective case series and literature reviews showed significant hair regrowth and reductions in the Severity of Alopecia Tool scores over 6 months, with improvements observed as early as 4 weeks. Notably, patients with non-cutaneous atopic features or high-IgE profiles responded better.[17]
Palmoplantar pustulosis (PPP)
Upadacitinib has emerged as a promising option for PPP, particularly in patients unresponsive to conventional therapies. In a retrospective study of 28 patients resistant to conventional therapies, upadacitinib was shown to significantly reduce the PPP Area and Severity Index scores, from 13.86 ± 2.76 to 5.56 ± 1.08 (p <0.001), and improve the Dermatology Life Quality Index (DLQI) after 12 weeks.[18]Another prospective study found 41.9% of patients achieved complete pustule clearance by week 2, with all improving by week 4 compared to acitretin, highlighting upadacitinib’s potential as a safe, effective option warranting further trials.[19]
Hidradenitis suppurativa
Upadacitinib 30 mg daily showed significant efficacy versus placebo in a phase 2 trial for moderate-to-severe HS, with sustained benefits through week 40 across Hurley stages and prior TNF inhibitor use.[20] Proteomic studies indicate swift suppression of B-cell and IFN-γ chemokines in responders, alongside diminished inflammatory pathways such as IL-23, IL-10, and IL-12 signaling.[21]
Anecdotal efficacy in other conditions
Upadacitinib’s JAK1 preferential profile supports extrapolation to other inflammatory conditions historically treated with older generations of non-selective JAK inhibitors, offering comparable or greater anti-inflammatory efficacy with an enhanced safety profile. Upadacitinib may improve cutaneous lichen planus (LP) by suppressing IFN γ–STAT1 signaling and pathogenic CXCL13+ CD8+ T cells. A case series demonstrated substantial lesion improvement and symptom resolution within 4–6 months for recalcitrant cutaneous LP variants.[22] Comparable favorable outcomes were reported in oral LP.[23] Type 2 immune dysregulation drives recalcitrant pruritus in prurigo nodularis, where daily upadacitinib 15 mg produced rapid and sustained improvements in pruritus and DLQI; a 52-week multicenter trial confirmed maintained efficacy and safety.[24,25] Few recent reports also describe upadacitinib use in refractory pemphigus vulgaris and bullous pemphigoid, demonstrating rapid blister control, improvement in refractory mucosal erosions, and marked pruritus reduction in difficult-to-treat cases.[26-28] Table 2 discusses several anecdotal reports documenting the use of upadacitinib across diverse dermatological conditions beyond the established indications.[29-41]
| Condition | Anecdotal evidence for upadacitinib | Key outcomes/evidence |
|---|---|---|
| Hailey-Hailey disease[29] | Multiple case reports show clearance/remission with upadacitinib 15–30 mg daily | Sustained remission and rapid healing of recalcitrant lesions |
| Granuloma annulare (GA)[30,31] | Cases of generalized/recalcitrant GA cleared with upadacitinib, including pulse therapy | Marked improvement/resolution after failure of standard therapies |
| Pyoderma gangrenosum (PG)[32] | Upadacitinib led to healing and remission in refractory PG cases, especially in cases associated with rheumatoid arthritis | Complete healing after prior immunosuppressant failure |
| Dermatomyositis (including amyopathic variant)[33,34] | Case series and reports show cutaneous and systemic improvement, even in cases with prior JAK inhibitor failure | Upadacitinib may be more effective than nonselective agents due to enhanced targeting of type 1 IFN signaling |
| Chronic actinic dermatitis[35] | Case report of significant improvement/remission | Marked reduction in photosensitivity and dermatitis |
| Livedoid vasculopathy[36] | Ulcer healing, pain relief, improved quality of life | Accelerated response (achieving clinical remission in 24 days) compared to previously reported responses to baricitinib and rivaroxaban (6–8 weeks) |
| Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN)[37,38] | Few cases report describing the use of Upadacitinib in SJS/TEN overlap in addition to glucocorticoids. Multiple case reports with other JAK inhibitors | Rapid stabilization within 48 h, early re-epithelialization, and steroid tapering without relapse |
| Netherton syndrome[39-41] | A daily dose of 15 mg yielded significant therapeutic benefits within a short timeframe | Significant improvement in severe skin symptoms and pruritus; positive response after failure of other biologics (Secukinumab and Dupilumab) |
GA: Granuloma annulare, JAK: Janus kinase, PG: Pyoderma gangrenosum, IFN: Interferon, SJS: Stevens–Johnson syndrome, TEN: Toxic epidermal necrolysis.
MONITORING GUIDELINES
Baseline evaluation and subsequent monitoring for upadacitinib mirror established protocols used for other currently approved JAK–STAT inhibitors [Table 3].[42]
| Test | Timing/Frequency | Special instructions/notes |
|---|---|---|
| Complete blood count | Baseline; 1 month after treatment; every 3–6 months thereafter | Monitor for cytopenias |
| Lipid profile | Baseline: 12 weeks after treatment initiation | Repeat periodically if elevated; manage per lipid guidelines |
| Liver function test | Baseline | Stop the drug if drug-induced liver injury is suspected until it is excluded |
| Renal function test | Baseline | Discontinue the drug if creatinine clearance is 30–60 or <30 mL/min |
| Creatine phosphokinase | When the patient reports muscle pain or weakness | Evaluate for myopathy or rhabdomyolysis |
| Tuberculosis evaluation | Baseline; then annually | QuantiFERON-Gold test or T-SPOT, Chest X-ray Screen for active and latent TB; treat before therapy if positive |
| Viral hepatitis screening | Baseline | Hepatitis B: HBsAg, anti-HBs, and total anti-HBc (the triple panel) Hepatitis C: Anti-HCV antibody Contraindicated in active hepatitis B or C infection |
HBsAg: Hepatitis B surface antigen, Anti-HBs: Hepatitis B surface antibody, Total anti-HBc: Total hepatitis B core antibody, Anti-HCV: Hepatitis C virus antibody.
ADVERSE EFFECTS AND CONTRAINDICATIONS
Acne is the most common treatment-emergent event associated with upadacitinib and is usually mild to moderate, with minimal impact on quality of life. JAK–STAT inhibition increases mTORC1 activity, sebaceous hyperactivity, follicular keratinization, and skews Th1/Th17 immune milieu, promoting follicular inflammation and dysbiosis.[43] Management is usually topical benzoyl peroxide, retinoids, and/or antibiotics; discontinuation is rarely necessary.[44] Class-wide boxed warnings apply to all JAK inhibitors, including upadacitinib, especially in the high-risk population. Among rheumatoid arthritis cohorts, upadacitinib has been associated with the highest incidence of hepatitis B virus reactivation, underscoring the need for more stringent pre-treatment screening and vigilant monitoring protocols.[45] Extremely rare events such as retinal detachment and diverticulitis have been reported, warranting clinician vigilance and prompt evaluation of new visual symptoms or acute abdominal pain in treated patients.[46] Tables 4 and 5 provide a summary of adverse effects and contraindications of upadacitinib therapy.[2,3]
| Cutaneous • Acne;Folliculitis • Pruritus; Urticaria • Rosacea General symptoms • Pyrexia; Flu-like syndrome; Fatigue • Peripheral edema • Headache, dizziness, insomnia Infections • Upper respiratory tract infection • Activation of latent TB • Reactivation of hepatitis B and C Musculoskeletal • Arthralgia; pain, tendinitis • Joint swelling Gastrointestinal • Nausea, gastritis, dyspepsia, vomiting, diarrhea, abdominal pain, • Gastrointestinal perforation |
Rare • Retinal detachment (in atopic dermatitis) Laboratory Hematological • Neutropenia • Lymphopenia • Anemia • Thrombocytosis Dyslipidemia • Increase in low-density lipoprotein, triglycerides, and total cholesterol • Decrease in high-density lipoprotein Others • Raised creatinine levels • Transaminitis and raised bilirubin level • Raised creatine phosphokinases |
Boxed warnings: Severe infections: Increased risk of severe bacterial, viral, and fungal infections; may be fatal. Higher incidence with a 30 mg dose, Mortality: Higher all-cause mortality, including sudden cardiovascular death, Major adverse cardiovascular events: Elevated risk of myocardial infarction, stroke, and cardiovascular death, Malignancies: Increased risk of cancers, including lymphoma and non-melanoma skin cancer; risk heightened in current or former smokers, Thrombosis: Deep venous thrombosis, pulmonary embolism, arterial thrombosis, TB: Tuberculosis.
| • History of hypersensitivity to upadacitinib • Pregnancy and breastfeeding • Children <12 years or <40 kg • Active local and/or systemic infections, including HIV, infective hepatitis, and active or latent tuberculosis • Hematologic thresholds • Hb <8g/dL • Absolute lymphocyte count <0.500 cells/mm3 • Absolute neutrophil count <1,000 cells/mm3 • Severe hepatic impairment: Child–Pugh C • Severe renal impairment: <15 mL/min/1.73 m2 Previous DVT and/or high risk for DVT without receiving anticoagulation |
HIV: Human immunodeficiency virus, Hb: Hemoglobin, DVT: Deep vein thrombosis, GFR: Glomerular filtration rate.
(High risk population: ≥1 of: aged 65 years or older, atherosclerotic cardiovascular disease, diabetes mellitus, hypertension, current smoking, HDL cholesterol <40 mg/dL, Body mass index ≥30 kg/m2, poor mobility on EQ-5D, or history of malignancy).
UPADACITINIB IN SPECIAL POPULATION
Upadacitinib is currently approved for the treatment of polyarticular juvenile idiopathic arthritis and psoriatic arthritis in patients aged 2 years and older. However, its labeling for AD is restricted to individuals aged 12 years and above. Real-world pediatric experience in vitiligo and alopecia areata is encouraging, though longer-term safety data remain limited.[47-49] Women of childbearing potential should use effective contraception (barrier or hormonal with ethinylestradiol/levonorgestrel) during treatment and for 4 weeks after the last dose.[50] Upadacitinib use is discouraged during pregnancy due to embryotoxicity in animal studies and is to be discontinued at least 1 month before conception. As upadacitinib is excreted in breast milk, breastfeeding should be avoided during therapy and for 4 days following the final dose. Nonclinical studies show no adverse effects on female or male fertility; real-world evidence reveals no safety signal yet.[51]
UPADACITINIB AND IMMUNIZATION
Live vaccines should be avoided during therapy. Inactivated or recombinant vaccines (COVID-19, influenza, pneumococcal) may be administered safely.[52] Immunizations should be updated before initiating therapy, ideally 4 weeks pre-initiation. Age- and risk-based pneumococcal vaccination (PCV15/PCV20 ± PPSV23) and recombinant zoster vaccine are recommended.[53]Hepatitis B vaccination should also be considered, especially in patients who are hepatitis B surface antigen (HBsAg)-negative and Hepatitis B core antibody (anti-HBc)-positive with low Hepatitis B surface antibody (anti-HBs) levels, to prevent HBV reactivation[54] (HBsAg; Anti-HBc, Anti-HBs)
CONCLUSION
Upadacitinib, a selective JAK1 inhibitor, has rapidly emerged as a pivotal therapeutic option for chronic inflammatory dermatologic conditions. Clinical data firmly establish its rapid and sustained efficacy in AD and demonstrate promising results in alopecia areata, vitiligo, PPP, and HS. Despite its benefits, prudent patient selection and close monitoring remain essential. Future research on upadacitinib must address long-term safety, comparative effectiveness versus biologics, pediatric weight-based dosing, and impact on growth/vaccine immunogenicity, risk-stratified protocols, and tapering feasibility to optimize therapeutic positioning.
Ethical approval:
Institutional Review Board approval is not required.
Declaration of patient consent:
Patient’s consent not required as there are no patients in this study.
Conflict 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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