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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

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TREMFYA – Use in Patients with Acrodermatitis Continua of Hallopeau

Last Updated: 01/04/2025

Summary

The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
Data summarizing the use of TREMFYA in patients with acrodermatitis continua of Hallopeau (ACH) from a retrospective study, case series, and case reports are provided below.¹^-⁷

CLINICAL DATA

Retrospective Study

Kromer et al (2020)¹ reported results from a multicenter study that assessed patient and disease characteristics, regimens, and outcomes of patients with ACH from medical chart reviews between January 2005 and May 2019.

Study Design/Methods

Diagnosis of ACH was based on European consensus statement on pustular psoriasis phenotypes.
Patients were excluded if they had generalized pustular psoriasis (GPP) as their primary manifestation of pustular psoriasis and had concomitant acral involvement or pustulosis of palms and/or soles (PPP) without involvement of the nail apparatus.
- Patients with ACH who developed GPP were included only if ACH was the predominant disease.
Final response to treatment at the end of treatment course (if discontinued) or at last observation (if not discontinued) were recorded as excellent, partial, or non-response in patient medical records and/or photographs.
- Excellent response was determined by phrases such as “complete” or “marked response,” “remission,” “dramatic improvement,” and “near” or “complete clearance.”
- Partial response was determined by phrases such as “some improvement”.
- Non-response was determined if there were exacerbations or if response was not clearly stated and if treatment was discontinued due to ineffectiveness.

Results

A total of 39 patients with ACH were included in the study and 2 patients were receiving TREMFYA at the standard maintenance psoriasis dose. Of the 2 patients treated with TREMFYA, 1 patient also received acitretin.
Both patients treated with TREMFYA reported partial response as their first response and excellent response as their final response.
The mean treatment duration of TREMFYA was 10 months.
No adverse events or discontinuation due to adverse events, remission, or ineffectiveness were reported for patients treated with TREMFYA.

Case Series

Langer et al (2021)² presented a case series of 3 patients with ACH who received TREMFYA treatment.

Case	ACH Case Series Details
Patient 1	A 60-year-old female had a 2-year history of ACH on both hands and feet with comorbidities of PsO and history of breast cancer. Patient did not respond to previous therapies including acitretin, secukinumab, and ixekizumab. The patient was initiated on TREMFYA (baseline PPGA^a 2) and after 5 months of treatment, showed improvement in skin lesions. TREMFYA response was maintained for an additional 10 months of treatment (at last follow-up, PPGA^a 1). No adverse events occurred during treatment.
Patient 2^b	A 61-year-old male had a 6-year history of ACH on both hands and feet with comorbidities of PsO, PsA, diabetes mellitus type 2, hyperlipoproteinemia, hyperuricemia, hepatic steatosis, and previous alcohol abuse. Patient did not respond to previous therapies including prednisolone, cyclosporine, acitretin, etanercept, infliximab, methotrexate, apremilast, ustekinumab, secukinumab, ixekizumab, and anakinra. The patient was initiated on TREMFYA after anakinra treatment (baseline PPGA^a 3) and after 4 months of treatment, significant improvement was observed. Response was maintained over the following 19 months (at last follow-up, PPGA^a 1). No adverse events occurred during treatment.
Patient 3^{b, c}	A 71-year-old female had a 28-year history of ACH on both hands and one foot with comorbidities of hypertension, asthma, hypothyroidism, and panic disorder. Previous therapies included acitretin, methotrexate, fumaric acid esters, cyclosporine, etanercept, ustekinumab, apremilast, and secukinumab. Due to refractory acitretin response, TREMFYA was added (baseline PPGA^a 2). Improvement was observed and acitretin was discontinued 3 months later. TREMFYA response was maintained for the following 2 years (PPGA^a1). No adverse events occurred during treatment.
Abbreviations: ACH, acrodermatitis continua of Hallopeau; PPGA, Palmoplantar Pustulosis Physician Global Assessment; PsA, psoriatic arthritis; PsO, psoriasis.^aPPGA was evaluated according to description in medical records and photographic evidence on a 5-point scale (0-4).^bPatients 2 and 3 were previously reported in Kromer et al.^cPatient 3 was given TREMFYA in an off-label setting, while patients 1 and 2 had an indication for plaque PsO and were treated with TREMFYA 100 mg subcutaneous at weeks 0, 4, and every 8 weeks thereafter.

Case Reports

Publication	ACH Case Reports
Al-Khawaga et al (2021)³	A 23-year-old female presented with ACH symptoms: marked erythema, edema, slight scaling, crusting, nail dystrophy, and pain (score of 8 out of 10) involving all fingernails and toenails. Dermatologic examination confirmed ACH diagnosis, showing severe erythematosquamous, psoriasiform, pustular eruption surrounded by a hyperemic area of terminal phalanges of all digits. X-rays of the hands and feet, bacterial Gram staining, and genetic testing related to ACH-associated IL36RN and AP1S3 candidate genes were all negative. Previous treatments included oral methotrexate 25 mg weekly, topical clobetasol dipropionate, and oral prednisolone. The patient was treated with TREMFYA SC based on plaque psoriasis dosing. At week 12, patient showed 90% improvement with no adverse events, relapse, or need for additional treatment. At week 12, the patient reported being 4 weeks pregnant. TREMFYA was discontinued and certolizumab treatment was initiated. At the 18-month follow-up, the patient reported giving birth without complications. Follow-up visits showed sustained improvement, no signs of active disease, and only discrete residual erythema. Patient was switched back to TREMFYA, which showed excellent response and marked decreased psoriasis-associated cytokine levels.
Buononato et al (2022)⁴	A 50-year-old male presented with a 10-year history of ACH: pustules, erythema, and desquamation of the first finger of left hand (DLQI 26) with involvement of the nail and distal interphalangeal joints. Previous treatments included acitretin, topical clobetasol, and subcutaneous methotrexate. The patient was initiated on TREMFYA 100 mg SC at weeks 0, 4 and every 8 weeks thereafter. At week 12, patient showed improvement with skin lesions, partial response for joint stiffness, and mild improvement in nail involvement. After 24 weeks of treatment, the patient continued improvement of skin lesions, presenting with mild disease; complete resolution of joint involvement; and improvement of nail involvement (DLQI 7). The patient sustained therapeutic response over 13 months of TREMFYA treatment.
Yamamoto et al (2023)⁵	A 52-year-old female was diagnosed with ACH about 20 years ago. Patient had erythematous plaques with nail deformities, which were refractory to topical corticosteroids, ultraviolet therapy, and cyclosporine. The erythematous plaques and pustules spread to the trunk, lower extremities, and the sole of the foot. The patient was diagnosed with GPP based on histological findings and initiated on etretinate and cyclosporine. Nail deformities on the fingers and pustules on the sole of the foot were refractory to etretinate and cyclosporine. Apremilast replaced cyclosporine treatment, which showed partial response. Etretinate and apremilast were discontinued and TREMFYA was initiated. Patient had improvement in nail deformities after 12 months of treatment. Patient continued with treatment on TREMFYA for more than 2 years without relapse or any adverse events.
Zheng et al (2023)⁶	A 61-year-old male presented with ACH clinical features including: recurrent episodes of redness, swelling, and purulent discharge on all fingers and toes with nail degeneration. The patient was diagnosed with eczema after the soles of the patient’s feet showed erythema, pustules, and crusting. Onychodystrophy showed pustules in his nailbeds and soles of his feet and the patient reported the maximum score on a 10-point pain visual analog scale. Prior to treatment, clinical evaluation and laboratory tests confirmed moderate enthesitis with effusion, nail dystrophy (disappearance of the anatomical space between cuticle and lunula), and a CRP level of 1.3 mg/L and an ESR of 17 mm/h. Patient’s past medical history included: local antibiotics, antifungals, oral itraconazole, local steroids and oral antihistamines. The patient was treated with TREMFYA 100 mg at weeks 0, 4, and then every 8 weeks. The patient showed a reduction of discomfort and pain after 4 weeks with improvement in the skin and nails lesions after 6 weeks. An additional echographic examination showed a reduction of the size of the dystrophic nail and reappearance of the anatomical space between the cuticle and nail lunula. The patient’s nail lesions showed almost complete resolution after 76 weeks of TREMFYA treatment.
Wang et al (2024)⁷	A 31-year-old male patient presented with a 1 year history of recurrent erythema, pustules, and desquamation on the left thumbnail and perinail, with negative results from mycologic examination. The patient was diagnosed with ACH, had no chronic medical history, and no significant abnormalities in liver and kidney function or auto-antibody screening. The patient had previously been treated with long-term oral acitretin, but the rash did not completely subside. A combination therapy with low-dose methylprednisolone helped to improve his condition, but there was rapid recurrence after drug withdrawal. The patient was administered ixekizumab 80 mg SC every 4 weeks repeated 3 times, but the rash worsened. At week 14, local microdose injections of TREMFYA were started. The microdose treatment involved a 0.1 mL (1 mg) SC injection into the normal skin near the left thumbnail every 2 weeks for a total of 4 times, and skin lesions gradually improved. The fourth and final injection was administered at week 22, and the lesions were resolved at week 40. The patient did not experience any adverse events during treatment, except for brief, tolerable pain during administration of the SC injection.
Abbreviations: ACH, acrodermatitis continua of Hallopeau; CRP, C-reactive protein; DLQI, Dermatology Life Quality Index; ESR, erythrocyte sedimentation rate; GPP, generalized pustular psoriasis; IL, interleukin; SC, subcutaneous.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and Derwent^® (and/or other resources, including internal/external databases) was conducted on 17 June 2024.

References

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1	Kromer C, Loewe E, Schaarschmidt ML, et al. Treatment of acrodermatitis continua of Hallopeau: A case series of 39 patients. J Dermatology. 2020;47(9):989-997.
2	Langer N, Wilsmann‐Theis D, Kromer C, et al. Successful therapy of acrodermatitis continua of Hallopeau with IL‐23 blockers – two new cases. Jddg J Der Deutschen Dermatologischen Gesellschaft. 2021;19(10):1504-1507.
3	Al-Khawaga S, Krishnankutty R, Sher G, et al. Treatment and molecular profiling of acrodermatitis continua of Hallopeau during pregnancy using targeted therapy. JAAD Case Rep. 2021;16:164-167.
4	Buononato D, Licata G, Gambardella A, et al. A case of acrodermatitis continua of Hallopeau successfully treated with guselkumab. Dermatol Ther. 2022;35(7):e15514.
5	Yamamoto H, Kamiya K, Okada H, et al. A case of acrodermatitis continua of Hallopeau evolving into generalized pustular psoriasis successfully treated with guselkumab. Int J Dermatol. 2022;62(2):269-270.
6	Zheng J, Zhang Y, Ding Y, et al. Treatment of acrodermatitis continua of Hallopeau with guselkumab in a patient without IL36RN mutations: A case report and a literature review. Ann Case Rep. 2022;7:1017.
7	Wang Y, Zhou C, Hou Y, et al. Local injection of micro‐dose guselkumab for acrodermatitis continua of Hallopeau after failure of systemic ixekizumab treatment. Int J Dermatol. 2024;63(4):547-548.