SARS-CoV-2 serology in patients on biological therapy or apremilast for psoriasis: a study of 93 patients in the Italian red zone.

Editor

Lombardy, Italy was one of the most heavily impacted areas in the world during the height of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‐CoV‐2) pandemic, quickly becoming the epicentre within Italy. There have been 845 898 cases reported to date 19 July 2021 within Lombardy, accounting for ~20% of the cases overall in Italy. During the height of the pandemic, concern was raised over the use of biologics for psoriasis as they necessitate some degree of immunomodulation.

Herein, we wish to report our real‐world experience with psoriatic patients treated with biological drugs or apremilast during the SARS‐CoV‐2 pandemic at the tertiary level Dermatological Clinic at the IRCCS Policlinico San Matteo Foundation, Pavia, Italy. We conducted serological analysis for SARS‐CoV‐2 seroprevalence levels in relation to patient specific variables (including type of systemic treatment, sex, age, place of work, number of family members). We analysed present comorbidities as a factor for SARS‐CoV‐2 seroprevalence rates. Finally, we used the serological data to determine the usefulness of an over‐the‐phone questionnaire for SARS‐CoV‐2 positivity performed by Brazzelli et al. on the same cohort of psoriatic patients.

All patients were over the age of 18, and under systemic therapy with biological drugs or apremilast for psoriasis. Serological data was collected from 93 psoriatic patients (n = 93) during a period from June 2020 to May 2021 using enzyme linked immunosorbent assay for SARS‐CoV‐2 related antibodies. Patient history was retrieved from medical records. The statistical analysis of the data was performed using Stata (Version 1.4). The study protocol was approved by the IRCCS Policlinico San Matteo Foundation, Pavia, Italy (Protocol number: 38152/2020).

The parameters and variables analysed in the study are summarised in Table 1. Patients were organised into four functional groups according to the fundamental molecular target of the drug: Anti‐TNF‐α (Etanercept, Infliximab, Adalimumab), Anti‐IL‐12/23 (Ustekinumab, Guselkumab), Anti‐IL‐17 (Secukinumab, Ixekizumab), or Anti‐PDE4 (Apremilast).

Table 1

Variables and Parameters Analysed for Psoriatic Patients undergoing therapy with biological drugs or apremilast

Parameter	Patients (n = 93)	Serology (IgG Spike)
		Positive	Negative
Sex
Male	70	10	60
Female	23	2	21
Age
Mean	54 ± 12.4
<60	61	7	54
>60	32	5	27
Type of systemic therapy
Anti‐TNF‐a	43	9	34
Anti‐IL‐17	24	3	21
Anti‐IL‐12/23	17	0	17
Anti‐PDE4	9	0	9
Place of Work
Retired / work from home	41	5	36
Community / Public work	37	5	32
Office work	15	2	13
Number of family members
1	13	0	13
2	32	5	27
3	27	2	25
4 or more	21	5	16

In our sample cohort of 93 patients, 12 were found to have SARS‐CoV‐2 positivity according to anti‐Spike protein IgG levels, corresponding to an incidence rate of 13%. None of the 12 positive patients had a severe infection or required hospitalisation due to SARS‐CoV‐2 infection.

In terms of patient‐specific variables, sex, age, place of work, number of family members, and type of systemic therapy did not seem to significantly alter the likelihood of having a positive SARS‐CoV‐2 serology. The most commonly used type of systemic therapy was Anti‐TNF‐α (43% of patients) which also accounted for 9/12 (75%) positive patients.

Between the comorbidities analysed (Table 2), only a history of cardiovascular disease was associated with a statistically significant increase in SARS‐CoV‐2 seroprevalence [Odds Ratio (OR) 5.07 P‐value = 0.045 (95% CI 1.03–24.8)].

Table 2

Comorbidities and increased risk factor of incidence rate (IR) for positive SARS‐CoV‐2 Serology

COMORBIDITY†	Number of patients (% of overall)	Positive cases	IR increase factor	95% confidence interval	P‐value
Hypertension	33 (35%)	6	2.00	0.59–6.80	0.266
Obesity	18 (19%)	3	1.47	0.35–6.08	0.598
Dyslipidemia	12 (13%)	1	0.58	0.07–4.93	0.617
Diabetes	10 (11%)	0	1.00	–	–
Cardiovascular disease	8 (8.6%)	3	5.07	1.03–24.80	0.045
COPD	4 (4.3%)	0	1.00	–	–
Chronic kidney disease	2 (2.2%)	1	7.27	0.42–125.80	0.171

Note that cerebrovascular disease and neoplastic disease were also screened for but omitted as 0 of 93 patients had either comorbidity.

Statistical analysis between serological data and over‐the‐phone questionnaires performed by Brazzelli et al. showed a strong association [OR 9.60 P‐Value = 0.001 (95% CI 2.43–37.9)] between questionnaire positivity and serological positivity.

In conclusion, we found an incidence rate of 13%, within the range from the literature for Italy (7.7% –19.7% ). The use of biological drugs and apremilast for psoriasis does not seem to increase severity of the disease or susceptibility to SARS‐CoV‐2 infections, similar to findings from the literature. , Data from our sample cohort suggests that patients with cardiovascular disease may be at an increased risk of contracting SARS‐CoV‐2. Finally, over‐the‐phone questionnaires for SARS‐CoV‐2 positivity are a potentially useful diagnostic tool during the heights of pandemics where in‐person meetings may not be possible.

Conflict of interest

The authors have no conflicts of interest to declare.

Funding source

None.