Patient-reported outcomes in urticarial vasculitis treated with omalizumab: case report

Abstract

Background: Despite the current knowledge of UV, there is a lack of consensus among diagnostic criteria and management. In general, antihistamine therapy is regularly used for the symptomatic management of pruritus but does not control inflammation or alter the course of the disease. Monoclonal antibodies such as omalizumab (anti-IgE) have been proposed as a potential treatment for urticarial vasculitis. A few studies have reported the benefits of omalizumab in patient-reported outcome measures (PROMs). Herein we describe a female patient with urticarial vasculitis who was treated with omalizumab. We discuss the response to treatment and possible implications of PROMs in guiding the management of the disease.

Case presentation: We describe the case of a 57-year-old woman with a diagnosis of urticarial vasculitis. Due to lack of response to first-line treatment and the severity of the disease, treatment with omalizumab was initiated. Omalizumab 150 mg was administered every four weeks for three months. Second-generation antihistamines were used as needed. Both CU-Q2oL and UAS 7 improved. After three-month therapy with omalizumab, disease severity improved from moderate severity (UAS7 = 19) to well controlled (UAS7 = 6). However, 5 months after the last administration of omalizumab, the patient complained of worsening symptoms and active disease with quality of life impairment. A single dose of omalizumab (150 mg) was prescribed with corticosteroids. Thereafter, the patient presented a disease activity and quality of life with a fluctuating pattern that was controlled with additional doses of omalizumab.

Conclusion: In chronic urticaria, patient-reported outcome measures (PROMs) are important for assessing disease status and the impact of symptoms on patients' lives. However, to our knowledge, there is no validated tool to measure such outcomes in UV patients. Although UAS7 and CU-Q2oL were not designed for UV assessment, they might be useful in the clinical setting as objective measures to determine treatment efficacy. However, some domains in the CU-Q2oL questionnaires do not correlate well with UAS7, which might serve as a relative indication to continue treatment despite disease severity improvement. Based on our observations, we believe omalizumab 150 mg might be a feasible therapeutic alternative when first-line treatment is unsuccessful.

Keywords: Omalizumab; Patient-reported outcomes; Urticarial vasculitis.

Fig. 1

Urticarial vasculitis lesions on lateral portion of right thigh. Clinical characteristics of lesions included generalized burning sensation of the skin, with plaques persisting for more than 24 h and leaving faint residual hyperpigmentation of the skin (highlighted by the arrow)

Fig. 2

Histopathology of urticarial vasculitis lesions showing leukocytoclastic vasculitis with perivascular infiltrates and neutrophil predominance

Fig. 3

UAS7, CU-Q2oL and UCT scores over time. Data are expressed as scores in Y axis, while time is expressed in a monthly scale on X axis. (A) UAS7, CU-Q2oL and UCT scores during treatment with Omalizumab. For CU-Q2oL, each of the six domains are represented separately (functioning, sleep, itching/embarrassment, mental status, swelling/eating and limits looks). Omalizumab doses received are depicted as purple circles. (B) UAS7 scores during follow-up after treatment with Omalizumab. UAS7, Urticaria Activity Score 7; CU-Q2oL, Chronic Urticaria Quality of Life; UCT, Urticaria Control Test

Fig. 4

CU-Q2oL domains’ scores as a function of UAS7 scores. Each CU-Q2oL domain value in Y axis is expressed as a function of UAS7 on X axis, as depicted on each upper right box. All correlations were statistically significant, except for swelling/eating and limits looks. Continuous line represents the linear regression line of best fit, whilst dashed lines are confidence intervals (95%). UAS7, Urticaria Activity Score 7; CU-Q2oL, Chronic Urticaria Quality of Life; R² linear, coefficient of determination