TREMFYA – Occurrence of Dermatitis or Eczema

Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Data on the occurrence of dermatitis or eczema during treatment with TREMFYA are summarized below.^1-10
  • Multiple studies have reported eczema or dermatitis during treatment with TREMFYA, including isolated cases in prospective and retrospective cohorts, safety databases, and several case reports documenting new‑onset eczematous or nummular dermatitis shortly after initiating therapy.^1-6,7,9,10
  • Other reports have described eczema initially arising on secukinumab with subsequent recurrence or resolution upon switching to TREMFYA.⁸

CLINICAL DATA

Prospective Observational Studies

Al-Janabi et al (2024)¹ conducted a prospective cohort study using data from dermatology clinics in the United Kingdom and Ireland to explore the risk of paradoxical eczema by biologic class and to identify factors associated with paradoxical eczema in adults with plaque psoriasis (PsO).

Study Design/Methods

• This prospective cohort study included patients with ≥1 follow-up visits between September 2007 and December 2022 (data from the British Association of Dermatologists Biologics and Immunomodulators Register).
• Adults with plaque PsO were exposed to ≥1 of the following biologics: tumor necrosis factor (TNF) inhibitors (adalimumab, certolizumab pegol, etanercept, infliximab), interleukin (IL)‑17 inhibitors (bimekizumab, brodalumab, ixekizumab, secukinumab), IL‑12/23 inhibitors (ustekinumab), or IL‑23 inhibitors (guselkumab, risankizumab, tildrakizumab).

Results

• Among 56,553 drug exposures assessed, 24,997 exposures (median age, 46 years [interquartile range, 36-55 years]; 57% male) from 13,699 patients were included, representing a total exposure time of 81,441 patient-years. A total of 273 biologic exposures (1%) were associated with 265 paradoxical eczema events.
• Across 1149 exposures with TREMFYA, 3 cases of paradoxical eczema occurred, yielding an adjusted incidence rate of 0.37 (95% confidence interval [CI], 0.15-1.26) per 100,000 patient‑years.
• The hazard ratio for the risk of paradoxical eczema with the use of guselkumab was 0.28 (95% CI, 0.11-0.71; P-value, 0.008).

Zhuang et al (2021)² evaluated the short-term (16 weeks) effectiveness and safety of TREMFYA in patients with PsO under Chinese real-life conditions.

Study Design/Methods

• This Chinese, prospective, real-life study included adults with PsO from the Dermatology Hospital of Southern Medical University, Guangzhou, China, from April to September 2020.
• Safety assessments comprised adverse events (AEs), routine blood laboratory examinations (i.e., complete blood count, hepatic functions, etc.), physical examinations, and chest radiography.

Results

• A total of 45 patients with PsO were enrolled in the study.
• No severe AEs occurred during the follow-up period.
• AEs included 1 reported event of eczematous eruption (2.2%).

Retrospective Observational Studies

Fratton et al (2025)³ evaluated the long-term effectiveness and safety of TREMFYA in elderly patients.

Study Design/Methods

• This retrospective real-world study included elderly patients aged ≥65 years with chronic plaque PsO treated with TREMFYA 100 mg between June 2019 and June 2024.

Results

• Of the 66 patients included, 11 (16.7%) experienced a clinically significant treatment-emergent AE (TEAE) during the 104‑week follow‑up (TEAE rate: 11.9 events per 100 patient-years).
  • Of the 11 patients, 2 (3.1%) reported eczematous eruptions.
  • The TEAE rate for eczema was 2.2 events per 100 patient-years, with a mean onset at 3.0 weeks (±standard deviation, 1.4).

Fougerousse et al (2020)⁴ conducted a retrospective real-life multicenter study in France and Belgium evaluating the 16week tolerance and effectiveness of TREMFYA in the treatment of cutaneous PsO.

Study Design/Methods

• This retrospective study, conducted in France and Belgium, collected data including sociodemographic characteristics, PsO history (age of onset, clinical type, associated psoriatic arthritis, previous treatments), comorbidities, baseline PsO severity (Psoriasis Area and Severity Index [PASI], Physician’s Global Assessment, Dermatology Life Quality Index), as well as on tolerance.

Results

• Overall, 194 patients were included; data from 180 patients were analyzed (14 were excluded due to missing PASI at inclusion or at week 16).
• Side effects were reported in 15 patients.
  • One patient experienced eczema and heart palpitation and discontinued TREMFYA prior to week 16.

Xiang et al (2023)⁵ aimed to characterize the profile of AEs associated with TREMFYA from the Food and Drug Administration’s Adverse Event Reporting System database.

Study Design/Methods

• This retrospective pharmacovigilance study included reported AEs in which TREMFYA was identified as the primary suspect (PS) from the third quarter (Q3) of 2017 (when TREMFYA received marketing approval in the US) through Q3 2022.

Results

• There were 11,743 case reports with TREMFYA as the PS, comprising 39,030 AEs associated with TREMFYA. The number of reports with TREMFYA as the PS, secondary suspect, concomitant, and interacting was 24,312, 13,160, 1527, and 31, respectively.
• Three case reports are described in Table: Patients with Eczema Nummular.

Paolino et al (2022)⁶ evaluated a subpopulation of patients with atopic dermatitis (AD) and PsO who developed coexistence of both diseases under systemic and topical treatments.

Study Design/Methods

• This study reviewed clinical records from the San Raffaele Hospital dermatology unit in Milan, Italy, to identify patients who developed PsO after a previous diagnosis of AD, and patients who developed AD after a diagnosis of PsO.

Results

• Available data were collected for 12 patients who developed new AD and PsO.
• Eight patients (male, n=3; female, n=5) with a previous diagnosis of PsO subsequently developed AD with a mean time of onset of 71.5 months.
• Out of 8 patients, 1 patient was treated with TREMFYA. All new-onset cases of AD were treated with topical medications, except for 1 case treated with dupilumab.

Case Reports

Moreno-Davila et al (2025)⁷ reported a case of a man with plaque PsO who developed an eczematous reaction following treatment with TREMFYA.

• A 47‑year‑old man with a 4‑year history of plaque PsO presented for evaluation.
• The patient had previously received methotrexate (MTX), adalimumab, topical corticosteroids, and calcipotriol, but these therapies provided little clinical benefit.
• Treatment was switched to TREMFYA 100 mg administered at weeks 0 and 4, and then every 8 weeks.
• After 3 months of receiving TREMFYA, psoriatic plaques improved significantly, however, new pruritic eczematous lesions developed on the trunk and extremities.
• Dupilumab was initiated, but PsO worsened after 4 weeks, leading to the discontinuation of dupilumab and continuation of TREMFYA.
• Treatment with upadacitinib 15 mg once daily resulted in resolution of itch within 48 hours, with complete lesion clearance achieved by 3 months.
• After 10 months, the patient remained asymptomatic with complete disease control and no AEs with ongoing TREMFYA every 8 weeks and upadacitinib daily.

Miyagawa et al (2021)⁸ reported a case of a patient with pustular PsO who developed eczematous eruptions after treatment with secukinumab and in whom the eczematous eruptions recurred after he was switched to TREMFYA.

• The patient was a 75-year-old man with a 13-year history of pustular PsO who had initiated secukinumab 4 years earlier, achieving complete resolution of eruptions by week 12.
• After 5 months of secukinumab therapy, the patient developed itchy erythema on both ears that gradually spread. Although initially responsive to topical corticosteroids, eczema gradually became refractory.
• Examination revealed diffuse erythema involving both ears and the cheeks, hands, and back. Clinical and histopathological findings supported the diagnosis of nummular eczema.
• As the exacerbated skin lesions failed to improve with topical corticosteroids, secukinumab was discontinued at 30 months, and TREMFYA was initiated 1 month after the last dose of secukinumab.
• The eczematous lesions resolved completely following the initiation of TREMFYA.
• Three months after starting TREMFYA, the patient developed recurrent itchy erythema on both ears. Although topical corticosteroids initially improved the lesions, they were ineffective after 20 months.

Reyn et al (2019)⁹ reported a case of eczematous eruption after treatment with TREMFYA for PsO in a 47-year-old male.

• The patient with a history of PsO vulgaris was referred for assessment of exacerbating erythematosquamous plaques despite ongoing TREMFYA therapy.
• The patient had no family history of eczema, but reported childhood AD.
• Prior PsO treatments included topical steroids, phototherapy, MTX, cyclosporine, and apremilast. All treatments failed to achieve clearance except cyclosporine, which was discontinued due to side effects. Other medications (atorvastatin, desloratadine, levocetirizine, and lercanidipine) were given on a stable dose for over a year.
• TREMFYA was initiated 3 months before hospital consultation (first dose on September 27, 2018) and administered according to the label. Initially, there was a marked improvement, reaching PASI 100 by week 7, which sustained for several weeks.
• At week 10, erythematosquamous plaques developed with severe itching. No new topical or systemic treatments were introduced. As the symptoms progressively worsened and the lesions did not respond to topical steroids, he was referred on December 20, 2018, and the planned third dose (December 21, 2018) was withheld.
• The clinical, histologic, and laboratory findings supported a diagnosis of eczema with features of AD.

Truong et al (2019)¹⁰ reported a case of a 40-year-old man with a chronic history of refractory palmoplantar PsO who presented with new onset of well-demarcated oval erythematous asteatotic plaques on bilateral shins after starting TREMFYA therapy.

• The patient, with a remote history of childhood PsO and no family history of skin disease, first presented 9 years prior with generalized pustular eruptions, subungual pustules, nail dystrophy, and hyperkeratotic scaly plaques on the heel. Biopsies confirmed pustular and palmopustular PsO. Despite multiple treatments, including cyclosporine, topical and intralesional steroids, psoralen plus ultraviolet A, oral retinoids, and ustekinumab, only partial improvement was achieved, with persistent and painful pustular lesions on the fingertips and heels.
• Switch to TREMFYA resulted in a notable improvement. After 3 months, he developed new pruritic well‑demarcated erythematous asteatotic plaques on both shins. Biopsy of the left upper shin demonstrated chronic spongiotic dermatitis with psoriasiform epidermal hyperplasia, foci of spongiosis, hypergranulosis, parakeratosis, and perivascular lymphohistiocytic infiltrates consistent with nummular dermatitis.
• No changes in medication or medical history were identified at rash onset, and similar lesions had not been observed previously, indicating an unusual presentation of nummular dermatitis in a patient with recalcitrant palmoplantar PsO treated with TREMFYA.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^® and Derwent^® (and/or other resources, including internal/external databases) was conducted on 20 January 2026.