A real-world observational study of dupilumab treatment in adult patients with prurigo nodularis

Zhang, Zhixin; Li, Siyuan; Wang, Yang; Zhao, Jiahui

doi:10.1016/j.abd.2022.09.008

Zhixin Zhang

Critical literature review

data collection, analysis and interpretation

preparation and writing of the manuscript

statistical analysis

Department of Dermatology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Disease, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China

https://orcid.org/0000-0003-2979-6922

Siyuan Li

Critical literature review

data collection, analysis, and interpretation

Department of Dermatology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Disease, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China

https://orcid.org/0000-0003-1867-3855

Yang Wang

Critical literature review

effective participation in research orientation

management of studied cases

manuscript critical review

Department of Dermatology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Disease, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China

https://orcid.org/0000-0001-7805-2861

Jiahui Zhao ^*⁎ Corresponding author. E-mail: zzjh_2007@163.com (J. Zhao).

Critical literature review

data collection, analysis, and interpretation

effective participation in research orientation

management of studied cases

manuscript critical review

preparation and writing of the manuscript

study conception and planning

Department of Dermatology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, National Clinical Research Center for Skin and Immune Disease, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing, China

https://orcid.org/0000-0001-5359-3709

⁎ Corresponding author. E-mail: zzjh_2007@163.com (J. Zhao).

Conflicts of interest

None declared.

Figures (4)
Tables (3)

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Figure 1
Clinical response of prurigo nodularis to dupilumab treatment. (A) Multiple reddish brown, firm, and hyperkeratotic skin nodules were distributed extensively across the upper back at week 0 (baseline) prior to dupilumab treatment. (B) Prurigo nodules showed significant regression accompanied by post-inflammatory hyperpigmentation and the absence of erosion or excoriation by week 16 of treatment with dupilumab.

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Figure 2
Statistical analysis of prurigo nodularis clinical parameters. (A) Overall response of dupilumab treatment in 8 patients with prurigo nodularis by week 16 of the treatment. (B) Investigator’s Global Assessment (IGA) of the patients at week 0 and by week 16 of dupilumab treatment. Statistical significance was assessed by paired - tests, n = 8 patients; ****p < 0.001.

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Figure 3
Statistical analysis of prurigo nodularis severity ratings. Patient-reported outcomes of weekly average Numerical Rating Scale Itch Intensity (NRSI), Dermatology Life Quality Index (DLQI), and Hospital Anxiety and Depression Scale (HADS) at week 0 and by week 16 of dupilumab treatment. Statistical significance was assessed by paired t-tests, n = 8 patients; **p < 0.001, ***p < 0.0005, ****p < 0.001.

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Figure 4
Immunofluorescence staining of IL-17RA (green) in two patients’ lesional skin biopsy specimens before dupilumab initiation. (A) Immunofluorescence staining of IL-17RA in PN Patient 1 showing hyperkeratinization, irregular acanthosis, and hyper-granulosis. IL-17RA positive keratinocytes can be observed in parts of the stratum granulosum and the stratum spinosum. (B) Immunofluorescence staining of IL-17RA in PN Patient 2 showing hyperkeratinization, irregular acanthosis, and hypergranulosis. IL-17RA positive keratinocytes can be observed in large areas of the stratum granulosum and the stratum spinosum. (C) Immunofluorescence staining of IL-17RA in control specimen showing some IL-17RA positive keratinocytes in the stratum basale. Bar = 100 µm. IL-17RA- interleukin-17A receptor; PN- prurigo nodularis.

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Table 1
Baseline demographics and disease characteristics of patients with PN (n = 8).

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Table 2
The trend of WBC and AEC from week 0 to week 16 in 8 patients with prurigo nodularis treated with dupilumab.

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Table 3
The trend of serum total IgE (kU/L) from baseline to week 16 in 8 patients with prurigo nodularis treated with dupilumab.

Variables	Patients	Age, yrs	Sex	History of allergic disorders	Family history of allergic disorders	History of PN, years	Previous therapies	Clinical response to previous therapies	Current therapies	Other concurrent complications (comorbidity)	Adverse events
	1	73	F	N/A	N/A	3	Topical glucocorticoids, oral antihistamines, topical antibiotic ointment, tripterygium glycosides, thalidomide, traditional Chinese medicine	Ineffective	Dupilumab 300 mg qow, topical glucocorticoids, topical antibiotic ointment	N/A	N/A
	2	74	F	Allergic rhinitis, chronic urticaria	Eczema, allergic rhinitis, asthma, chronic urticaria, prurigo nodularis	20	Topical glucocorticoids, traditional Chinese medicine	Ineffective	Dupilumab 300 mg qow, traditional Chinese medicine	N/A	N/A
	3	53	M	N/A	N/A	2	Topical glucocorticoids, oral antihistamines, topical antibiotic ointments, tripterygium glycosides	Ineffective	Dupilumab 300 mg qow, topical glucocorticoids	N/A	N/A
	4	48	M	Asthma, allergic rhinitis, chronic urticaria	Eczema, allergic rhinitis, asthma, chronic urticaria, prurigo nodularis	10	Topical glucocorticoids, traditional Chinese medicine	Ineffective	Dupilumab 300 mg qow, traditional Chinese medicine	Hepatitis B	N/A
	5	76	F	N/A	N/A	2	Topical glucocorticoids, oral antihistamines, traditional Chinese medicine	Ineffective	Dupilumab 300 mg qow, topical glucocorticoids, oral antihistamines, traditional Chinese medicine	Diabetes, hypertension	N/A
	6	58	M	N/A	N/A	5	Topical glucocorticoids, oral antihistamines, azathioprine, thalidomide, glycyrrhizin, gabapentin	Ineffective	Dupilumab 300 mg qow, topical glucocorticoids, oral antihistamines	Hypertension	N/A
	7	66	F	N/A	Allergic rhinitis	1.5	Topical glucocorticoids, topical antibiotic ointments, oral antihistamines, traditional Chinese medicine	Ineffective	Dupilumab 300 mg qow, topical glucocorticoids, oral antihistamines, traditional Chinese medicine	Hypertension	N/A
	8	64	F	Asthma, allergic rhinitis	N/A	0.7	Topical glucocorticoids, traditional Chinese medicine	Ineffective	Dupilumab 300 mg qow, topical glucocorticoids, oral antihistamines, traditional Chinese medicine	Diabetes, hypertension	N/A
Value, n (%)	8	Mean ± standard deviation: 64 ± 10.3	Male: 3 (37.5); Female: 5 (62.5)	3 (37.5)	3 (37.5)	Mean ± standard deviation: 5.525 ± 6.6	N/A	Effective: 0 (0); Ineffective: 8 (100)	N/A	Hepatitis B: 1 (12.5); Diabetes: 2 (25.0); Hypertension: 4 (50.0)	0 (0)

	Patients’ WBC (cells*109/L)		Patients’ AEC (cells*109/L)
	Week 0	Week 16	Week 0	Week 16
Patient 1	5.66	4.13	0.28	0.15
Patient 2	6.78	7.16	0.64	0.46
Patient 3	5.8	7.62	0.2	0.13
Patient 4	4.78	6.72	0.17	0.14
Patient 5	5.89	5.26	0.17	0.14
Patient 6	5.75	5.61	0.12	0.31
Patient 7	8.72	10.95	0.5	0.16
Patient 8	6.46	7.36	0.4	0.43

	Patients’ serum total IgE (kU/L)
	Week 0	Week 16
Patient 1	196.0	180.0
Patient 2	1093.0	711.0
Patient 3	1438.0	1592.0
Patient 4	5000.0	1175.0
Patient 5	72.8	68.8
Patient 6	18.5	42.0
Patient 7	515.0	268.0
Patient 8	273.0	134.0

[1] ⁎ Corresponding author. E-mail: zzjh_2007@163.com (J. Zhao).

Brasil

Brasil

A real-world observational study of dupilumab treatment in adult patients with prurigo nodularis^✩ ✩ Study conducted at the Department of Dermatology and Venerology, Peking University First Hospital, Beijing, China.

Abstract

Background:

Objective:

Methods:

Results:

Study limitations:

Conclusions:

Brasil

Brasil

A real-world observational study of dupilumab treatment in adult patients with prurigo nodularis✩ ✩ Study conducted at the Department of Dermatology and Venerology, Peking University First Hospital, Beijing, China.

Abstract

Background:

Objective:

Methods:

Results:

Study limitations:

Conclusions:

A real-world observational study of dupilumab treatment in adult patients with prurigo nodularis^✩ ✩ Study conducted at the Department of Dermatology and Venerology, Peking University First Hospital, Beijing, China.