SHORT COMMUNICATION

Real-world Experience of Abrocitinib on Difficult-to-treat Hand Eczema in Chinese Patients

Yiting LI^1#, Xi TAN^1#, Shu NIE¹, Xin TIAN^2,3*, and Zhouwei WU^1*

¹Department of Dermatology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Rd, Shanghai 200080, China, ²Institute of Dermatology, Guangzhou Medical University, Guangzhou, China, and ³Department of Dermatology, Guangzhou Institute of Dermatology, 56 Hengfu Rd, Guangzhou 510095, China. ^*E-mail: xinzisue@163.com; zhouwei.wu@shgh.cn
^#These authors contributed equally and should be considered as first authors.

 

 

INTRODUCTION

Chronic hand eczema (HE) is a distressing and pervasive dermatologic condition affecting approximately 10% of the global population, and effective treatment is challeng-ing (1). Severe itching, pain, and terrible appearance often result in decreased quality of life and a heavy psychosocial burden for patients (2,3). Conventional topical therapies for HE include emollients, topical corticosteroids, topical calcipotriol, and topical calcineurin inhibitors. Oral corticosteroids, alitretinoin, and immunosuppressants have been tried in difficult-to-treat patients, but the outcome is usually unsatisfactory and their long-term use was limited because of side effects (4). Recent literature showed that Janus kinase (JAK) inhibitors may be a potential treatment option for HE. Relevant clinical trials and case reports have shown the favourable efficacy and safety of delgocitinib, gusacitinib, baricitinib, and upadacitinib in treating HE (5–8). Abrocitinib is an oral selective JAK1 inhibitor recently approved for moderate-to-severe atopic dermatitis. It blocks IL-4, IL-13, IL-31, and IFN-γ pathways, which are involved in the pathogenesis of HE (9). However, the efficacy of abrocitinib on difficult-to-treat HE in real-world is limited (10, 11). Here, we reported the effectiveness and safety of abrocitinib on difficult-to-treat HE patients in daily practice.

MATERIALS AND METHODS

In this prospective, observational, single-centre cohort study, 12 adult patients with moderate-to-severe HE were enrolled from the Department of Dermatology of Shanghai General Hospital between March 2023 to May 2023. All patients met the diagnostic criteria for HE (12). According to medical history and patch test results, hand allergic and irritant contact dermatitis, hand psoriasis, and active hand infection were excluded. All these patients have failed at least 1 systemic treatment including corticosteroids, methotrexate, cyclosporine, and dupilumab. The study was conducted in accordance with the principles of the Declaration of Helsinki, and was approved by the Human Ethics Committee of Shanghai General Hospital (2023SQ293). Written informed consent was obtained from all patients.

All patients were administered abrocitinib 100 mg once daily for 16 weeks. All the patients had discontinued any systemic therapies for at least 3 months, and topical medications were also discontinued when abrocitinib treatment started. Patients were visited at the baseline, and weeks 2, 4, 8, 12, and 16.

The hand eczema severity index (HECSI) (13) and the 5-point Investigator’s Global Assessment (IGA) Scale (14) were used to assess the severity of HE by 2 independent dermatologists. Worst Itch Numeric Rating Scale (WI-NRS, 0 [no itch] to 10 [worst itch imaginable]) (15) was reported by the patient. The HECSI, WI-NRS, and IGA score were assessed at baseline, and weeks 2, 4, 8, 12, and 16. HECSI score improvement of ≥ 75% or ≥ 90% (HECSI-75, HECSI-90) was compared with baseline. Absolute cut-off scores were IGA ≤ 1 (clear or almost clear) and WI-NRS pruritus ≤ 4. Adverse events (AEs) were evaluated at each visit. Laboratory assessments including blood count, liver enzymes, and serum creatinine were performed at the baseline, and weeks 4 and 16.

IBM SPSS Statistics 26 (IBM Corp, Armonk, NY, USA) was used for statistical analysis. Changes in HECSI and WI-NRS scores from baseline to week 16 were compared with the Wilcoxon signed-rank test. A value of p < 0.05 was considered statistically significant. Figures were charted by GraphPad Prism 9 software (https://www.graphstats.net/graphpad-prism).

RESULTS

Patients and baseline characteristics. A total of 12 chronic HE patients (7 men and 5 women) were included. The mean age was 46.3 ± 14.1 years and the mean disease duration was 11.2 ± 7.3 years. According to the proposed classification of hand eczema, 9 patients had chronic recurrent vesicular hand eczema, and 3 patients had atopic hand eczema. Eight patients had comorbidities, the most common of which was allergic rhinitis (n = 6). All patients failed previous systemic treatment because of lack of response, intolerance, toxicity, or both lack of response and intolerance. Baseline characteristics and demographics are summarized in Table I.

Table I. Baseline characteristics and demographics of patients

Patient No.	Sex	Age (years)	Duration (years)	Subtype of HE	Comorbidities	Prior systemic therapy	Cause of discontinuation of prior therapy	Side effects of abro
1	Male	48	26	Recurrent vesicular HE		Prednisone, cyclosporine, dupilumab	Lack of response and intolerance
2	Male	52	10	Recurrent vesicular HE	AR, PN	Methotrexate	Lack of response	Blurred vision
3	Female	52	7	Recurrent vesicular HE		Methotrexate	Lack of response	Nausea, headache
4	Male	44	24	Atopic HE	AD, AR	Methylprednisolone, methotrexate, dupilumab	Intolerance	Headache, dizziness
5	Female	28	10	Recurrent vesicular HE	Asthma	Methylprednisolone, methotrexate	Toxicity
6	Male	43	8	Atopic HE	AD, AR	Cyclosporine	Intolerance	Nausea
7	Male	28	7	Recurrent vesicular HE	asthma	Methylprednisolone	Lack of response
8	Female	21	3	Atopic HE	AD, AR, asthma, food allergy, anxiety, depression	Methylprednisolone, cyclosporine, dupilumab	Lack of response and intolerance	Nausea, acne
9	Female	65	15	Recurrent vesicular HE		Methotrexate	Lack of response
10	Male	59	11	Recurrent vesicular HE	AR	Prednisone, methotrexate, dupilumab	Lack of response	Nausea
11	Male	59	3	Recurrent vesicular HE		Methotrexate	Intolerance
12	Female	60	10	Recurrent vesicular HE	AR	Dupilumab	Lack of response	Headache
Abro: abrocitinib; AD: atopic dermatitis; AR: allergic rhinitis; HE: hand eczema; PN: prurigo nodularis.

Effectiveness. Six patients reached HECSI-75 at week 4 and all patients reached HECSI-90 after 16 weeks of treatment. The median HECSI score declined significantly from 136.0 (90.3–172.5) at baseline to 3.0 (1.0–7.3, p < 0.01) at week 16. Meanwhile, the median WI-NRS score changed significantly from 8.5 (7.3–10) to 0 (0–1.0, p < 0.01). The WI-NRS scores of all patients were ≤ 2 and 8 patients achieved no itch (0) at week 16. In addition, 9 patients achieved an IGA score of 0/1 and improved by at least 2 scales at week 16. Changes in HECSI, WI-NRS, and IGA score from baseline to week 16 are shown in Fig. 1 a–c). Fig. 1d shows the representative clinical photographs of 3 patients.

Fig. 1. (a) Median Hand Eczema Severity Index (HECSI) score over time. (b) Median Worst Itch Numeric Rating Scale (WI-NRS) score over time. (c) Median Investigator’s Global Assessment (IGA) score over time. (d) Representative clinical photographs of 3 patients at baseline and Week 16.

Safety. During the 16-week treatment, 7/12 of the patients experienced AEs, with 3 patients reporting more than 1 AE. The most frequently reported AEs was nausea (n = 4). Other AEs included headache (n = 3), acne (n = 1), dizziness (n = 1), and blurred vision (n = 1). No abnormal laboratory results were observed. No serious AEs were reported and no patients discontinued abrocitinib treatment.

DISCUSSION

In the current study, we evaluated the efficacy and safety of abrocitinib on 9 recurrent vesicular and 3 atopic HE patients who had failed previous systemic therapies. The response was significant in all aspects assessed, suggesting abrocitinib could improve both atopic and recurrent vesicular HE.

The study of abrocitinib on HE was limited. Sitaru et al. (10) reported a case of refractory hand and foot eczema was successfully treated with abrocitinib. Kamphuis et al. (11) demonstrated that abrocitinib improved HE in patients with AD in which 13/17 of the patients achieved clear or almost clear and 60% of the patients achieved HECSI 90 at week 16. In our study, all patients reached HECSI 90 and 9/12 of the patients achieved an IGA score of 0/1 at week 16. In addition, most patients in their study were given abrocitinib 200 mg once a day, while all our patients were administrated 100 mg once daily. The effectiveness of abrocitinib seemed better in our patients although the evaluation might be not accurate because of the smaller sample size of our study. However, we supposed that the discrepancy might be because the weight of patients was usually less in Chinese patients than that of European people, and the 9/12 patients in our study had recurrent vesicular hand eczema while the subtypes of patients in their study were mixed, for example contact subtypes were included.

There were some limitations in this study. First, the sample size of this study was small. Second, only short-term outcome was evaluated; the long-term maintenance effect of abrocitinib on HE needs further investigation.

In conclusion, abrocitinib, and other JAK inhibitors, seems not only to treat atopic HE, but also has a remarkable therapeutic effect on recurrent vesicular HE, and even on refractory HE that fails other systemic treatments.

ACKNOWLEDGEMENTS

This study was supported by Innovative Research Team of High-level Local Universities in Shanghai (SHSMU-ZDCX20211002) and Science and Technology Program of Guangzhou (Grant No. 2023A03J0468).

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