The impact of biologic treatment in psoriasis patients on COVID-19 infection: A single-center retrospective study

doi:10.21203/rs.3.rs-3208100/v1

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The impact of biologic treatment in psoriasis patients on COVID-19 infection: A single-center retrospective study

https://doi.org/10.21203/rs.3.rs-3208100/v1

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Previous studies of whether biologics place psoriasis patients at more severe SARS-CoV-2 infection risk and disease course remains unclear.This single-center retrospective clinical study included patients with psoriasis from December 2022 to April 2023 to compare the rate of COVID-19 infection, duration, and risk of hospitalization and death in patients treated with to without biologics,and to compare the effect of COVID-19 on the course of psoriasis. General information, underlying diseases, disease information of psoriasis and covid-19 infection were recorded. SPSS 28.0 was used for statistical analysis of the data. Among the 260 included patients with psoriasis, 73.85% were treated with biologics. 67.31% of patients were infected with COVID-19.The mean duration of symptoms was 7.57±4.75 days. No patients were counted as requiring oxygenation or hospitalization for SARS-CoV-2 infection. No deaths were recorded during the observation period.The amount of patients with fever was lower in patients treated with biologics(81.20%) compared to those without one(97.62%). Differences in the distribution of other COVID-19-specific signs and symptoms were not statistically significant(P＜0.05). Binary logistic regression suggested that increased prevalence was not associated with the use of biologics after adjustment for potential confounders (OR=0.672,P=0.198). 38.86% of patients had exacerbation of psoriatic lesions after infection with SARS-CoV-2, with a statistically significant difference between those with and without biologics. Exacerbation was more common in the form of a new rash. The finding suggests biologics in patients with psoriasis does not increase the risk of SARS-CoV-2 infection or worsen the course of COVID-19. In terms of exacerbation of psoriatic lesions by SARS-CoV-2 infections, the number of worsening disease courses treated with biologics was lower compared to conventional treatments.

psoriasis

COVID-19

biologics

anti-IL-17

anti-IL-23

Coronavirus disease (COVID-19) is a highly infectious respiratory infection caused by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)[1].COVID-19 may also involve skin and has altered the course of many skin diseases since the early 2020 epidemic[2].Psoriasis is a chronic immune-mediated inflammatory skin disease for which biologics are effective treatments[3].Previous studies have shown that biologics increase the risk of respiratory infections[4].However, several recent studies have shown that severe COVID-19 may increased levels of cytokines including interleukin-17(IL-17).IL-17 inhibitors directly block the IL-17 pathway and therefore may be a new option for the treatment of COVID-19[5].Findings on the risk of SARS-CoV-2 infection and the course of COVID-19 in psoriasis patients treated with biologics and non-biologics are not entirely consistent.Whether biologics increase the risk of acquiring COVID-19 or worsen disease in those who are infected[6].

Therefore, we used a retrospective study to compare the rate of COVID-19 infection, duration of disease, and risk of hospitalization and death in patients with psoriasis treated with biologics versus non-biologics.The effect of COVID-19 on the course of psoriasis in both groups was compared to explore treatment decisions for patients with psoriasis who received biologics during COVID-19.

This is a single-center retrospective clinical study.Patients with psoriasis who attended the outpatient clinic of the Department of Dermatology at China-Japan Friendship Hospital were followed up by questionnaire from December 2022 to April 2023.General information (age, sex, body mass index, history of smoking and alcohol), underlying disease, psoriasis characteristics (type of psoriasis, duration of disease, treatment, disease progression) were recorded for patients who gave verbal consent, and treatment therapy for psoriasis was divided into biologics and non-biologics therapy (including untreated, topical medications, oral methotrexate, etc.) according to the medications used up to 4 weeks before the onset of COVID-19.

If a patient is infected with SARS-CoV-2, the method of diagnosis, clinical symptoms, duration of illness, treatment, outcome, hospitalization associated with covid − 19, death, and impact on psoriasis will be recorded.The severity of COVID-19 was classified into four categories according to the Guidelines for the Diagnosis and Treatment of New Coronavirus Pneumonia[7]:(1) mild type: no complaints to mild clinical symptoms without any chest CT involvement; (2) moderate type: patients with fever and signs of respiratory infections with chest CT scan involvement; (3) severe type: any of these criteria: (a) a respiratory distress, respiratory rate > = 30/min; (b) finger oxygen saturation < = 93% in resting condition; (c) arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) < = 300, (4) critical type: any of these criteria: respiratory failure, needing Intensive Care Unit (ICU) admission, shock.

Statistical analysis was performed using SPSS 28.0 software.Continuous variables were first tested for normality.Data conforming to a normal distribution were expressed as mean mean ± standard deviation (x ± s) and the independent samples t-test was used for comparison.Non-normally distributed data were expressed as median of interquartile range (IQR) and analyzed using Wilcoxon rank sum test.Categorical variables expressed as numbers and percentages were compared using the chi-square test.Fisher's exact test was used when the conditions of the chi-square test were not met. p < 0.05 was considered statistically significant.We further performed a binary logistic regression analysis to assess the relationship between biologics and prevalence by adjusting for the participants' general information and underlying disease.

3.1 Demographic and clinical characteristics of psoriasis patients

A total of 260 psoriasis patients were included.The patient characteristics including general information were summarized in Table 1.The mean age was 42.82 ± 13.34 years, with a male predominance (63.85%).The majority of patients had a psoriatic disease type of common psoriasis (92.69%) with a disease duration of 13.67 ± 10.37 years.At the onset of COVID-19 most patients had complete or almost complete clearance of psoriatic lesions while some patients had a few lesions present.The most common comorbidities were overweight or obesity (58.08%) followed by afatty liver (26.15%), hypertension (15.77%), and diabetes mellitus (11.54%).Gender, age, weight, height, BMI, smoking rate, alcohol use rate, type of psoriasis, and underlying disease in this period were not significantly different among the two groups (P > 0.05).Psoriasis was more severe in the non-biologics group than in the biologics group.Most patients (73.85%) were being treated with biologics, including 92.71% with interleukin-17 inhibitors (64.58% with secukizumab and 28.16% with echizumab) and 20.83% with interleukin-23 inhibitors.

Table 1

Clinical characteristics of psoriasis patients
	All patients	Biologics group	Non-biologics group	P-value
Number of patients	n = 260	n = 192	n = 68
Gender Male(n;%) Female(n;%)	166;63.85% 94;36.15%	127;66.15% 65;33.85%	39;57.35% 29;42.65%	0.195
Age (years) (mean ± SD)	42.82 ± 13.338	43.43 ± 12.736	41.10 ± 14.874	0.217
Types of psoriasis
Unusual(n;%)	241;92.69%	179;93.23%	62;91.18%	0.774
Pustular(n;%)	10;3.85%	7;3.65%	3;4.41%	1.000
Arthritic(n;%)	23;8.85%	19;9.90%	4;5.88%	0.317
Erysipelas(n;%)	6;2.31%	3;1.56%	3;4.41%	0.382
The course of psoriasis	13.67 ± 10.37	13.91 ± 10.68	13.71 ± 9.10	0.917
Current severity of psoriasis
Complete removal(n;%)	47;18.08%	45;23.44%	2;2.94%	＜0.001
Almost completely cleared (n;%)	96;36.92%	83;43.23%	13;19.12%
Mild(n;%)	77;29.62%	51;26.56%	26;38.24%
Moderate(n;%)	32;12.31%	10;5.21%	22;32.35%
Severe(n;%)	8;3.08%	3;1.56%	5;7.35%
Length of treatment (months)		13.66 ± 11.10
Discontinued during COVID-19(n;%)	71;27.31%	47;24.48%	24;35.29%	0.085
Type of biologics used
IL-23 inhibitor(n;%)		40;20.83%	-
IL-17 inhibitor(n;%)		178;92.71%	-
BMI	25.64 ± 5.48	25.72 ± 5.66	25.42 ± 4.96	0.700
Underlying Diseases
None(n;%)	130;50%	105;54.69%	25;36.76%	0.011
Overweight/obese(BMI ≥ 24)(n;%)	151;58.08%	116;60.42%	35;51.47%	0.199
Fatty liver(n;%)	68;26.15%	55;28.65%	13;19.12%	0.124
High blood pressure(n;%)	41;15.77%	35;18.23%	6;8.82%	0.067
Diabetes(n;%)	30;11.54%	27;14.06%	3;4.41%	0.032
Hyperlipidemia	22;8.46%	18;9.38%	4;5.88%	0.374
Chronic respiratory diseases (n;%)	20;7.69%	17;8.85%	3;4.41%	0.237
Cardiovascular disease(n;%)	16;6.15%	12;6.25%	4;5.88%	1.000
Hyperuricemia / Gout(n;%)	14;5.38%	12;6.25%	2;2.94%	0.299
Anxiety and depression(n;%)	9;3.46%	5;2.60%	4;5.88%	0.376
Chronic liver disease(n;%)	4;1.54%	4;2.08%	0;0%	0.531
Chronic kidney disease(n;%)	1;0.38%	1;0.52%	0;0%	1.000
Tumor(n;%)	0;0%	0;0%	0;0%	-
Smoking(n;%)				0.968
Never smoked(n;%)	134;51.54%	99;51.56%	35;5.15%
Have quit smoking(n;%)	36;13.85%	26;13.54%	10;14.71%
Smoking(n;%)	90;34.61%	67;34.90%	23;33.82%
Drinking(n;%)	96;36.92%	70;36.46%	26;38.24%	0.794

3.2 Effect of biological agents on COVID-19 infection status

A total of 175 patients (67.31%) were infected with COVID-19, with a mean age of 41.54 ± 11.96 years.The most common symptoms of COVID-19 infection were fever (85.14%), cough (69.14%) and sore throat (51.43%), with a mean duration of symptoms of 7.57 ± 4.75 days.No patients were counted as requiring oxygenation or hospitalization for COVID-19 infections, and no deaths were recorded during the observation period.The data showed that compared to patients treated with non-biologics(97.620%),fewer patients treated with biologics(81.20%) had fever,an important symptom of COVID-19 infection(P＜0.05). The differences in the infection,distribution of COVID-19-specific signs and other symptoms were not statistically significant (P༞0.05).

For COVID-19 diagnosis, 122 patients reported positive COVID-19 antigen, 31 patients reported positive nucleic acid tests, 30 patients reported the presence of COVID-19 signs and symptoms in their relatives.The information were summarized in Table 2

Table 2

Covid-19 infection in psoriasis patients
	All patients	Biologics group	Non-biologics group	P-value
Biologics group	260	192	68
COVID-19 infection (n;%)	175;67.31%	133;69.17%	42;61.76%	0.257
Disease Classification
mild type(n;%)	172;98.29%	130;97.74%	42;100.00%	1.000
moderate type(n;%)	3;1.71%	3;2.26%	0;0%
severe type(n;%)	0;0%	0;0%	0;0%
critical type(n;%)	0;0%	0;0%	0;0%
Inpatient treatment (n;%)	0;0%	0;0%	0;0%	-
Death(n;%)	0;0%	0;0%	0;0%	-
Symptoms of COVID-19 infection
No symptoms(n;%)	6;3.43%	5;3.76%	1;2.38%	1.000
Fever(n;%)	149;85.14%	108;81.20%	41;97.62%	0.009
fatigue(n;%)	87;49.71%	64;48.12%	2354.76;%	0.453
Cough(n;%)	121;69.14%	94;70.68%	27;64.29%	0.434
Breathing difficulties (n;%)	19;10.86%	13;9.77%	6;14.29%	0.593
Headaches(n;%)	55;31.42%	40;30.08%	15;35.71%	0.493
Sore Throat(n;%)	90;51.43%	66;49.62%	24;57.14%	0.395
Muscle Soreness(n;%)	77;44.00%	60;45.11%	17;40.48%	0.598
Joint pain(n;%)	45;25.71%	33;24.81%	12;28.57%	0.627
Diarrhea(n;%)	26;14.86%	18;13.53%	8;19.05%	0.381
Nausea/vomiting (n;%)	18;10.29%	12;9.02%	6;14.29%	0.493
Duration of symptoms	7.567 ± 4.752	7.535 ± 4.266	7.667 ± 6.075	0.876

3.3 Factors influencing the prevalence and severity of COVID-19 in psoriasis patients

To account for potential confounders from a range of identified risk factors for neocoronary pneumonia, we developed a binary logistic regression model after univariate analysis to exclude irrelevant variables (Table 3).The increased prevalence was not associated with the use of biologics(P＜0.05).Still, in interpreting the results, we should consider several possible sources of bias.

Table 3

Binary logistic regression model of COVID-19 infection rate
	P-value	OR	95%CI
Biologics	0.198	0.672	0.367,1.230
Age	0.066	1.554	0.999, 1.046
Smoking	0.144	1.022	0.900, 2.685
Diabetes	0.914	1.049	0.438, 2.510
High blood pressure	0.746	1.139	0.517, 2.509
Cardiovascular disease	0.924	0.959	0.404, 2.276
Chronic liver disease	0.3564	0.746	0.396, 1.405
Chronic respiratory diseases	0.415	1.504	0.564, 4.011

3.4 Effect of covid-19 infection on psoriasis condition

Table 4 shows the effect of covid-19 infection on the condition of psoriasis. 38.86% of the patients had exacerbation of psoriatic lesions after infection with COVID-19.The difference between the use of biologics(32.33%of the patients) and non-use of biologics(59.52%of the patients) was statistically significant.

In the patients with exacerbation, the most frequent clinical form was Emerging skin lesions(70.59%of the patients).

Table 4

Effect of covid-19 on the condition of psoriasis
	All patients	Biologics group	Non-biologics group	P-value
Number of patients	175	133	42
Changes in psoriatic lesions after the infection
exacerbated(n;%)	68;38.86%	43;32.33%	25;59.52%	0.002
Not exacerbated(n;%)	107;61.14%	90;67.67%	17;40.48%	0.002
exacerbated form
Emerging skin lesions (n;%)	48;70.59%	30;69.77%	18;72.00%	0.846
Increased itching (n;%)	23;33.82%	13;30.23%	10;40.00%	0.412
Increased flaking(n;%)	20;29.41%	12;27.91%	8;32.00%	0.721

The results of our study showed that psoriasis patients treated with biologics neither had a higher risk of COVID-19 infection nor a more severe course of disease compared to patients not using biologics.But they had fewer fever after COVID-19 infection.And no patients were observed to be hospitalized or die from COVID-19 infections.This finding remains consistent when considering a range of confounding clinical features.Moreover,the risk of COVID-19 infection may be lower in the psoriasis treated with biologics(OR = 0.672),though it was not statistically significant(P = 0.198).Compared to those treated with biologics, the results of our study were a more pronounced exacerbation of infection with COVID-19 psoriasis in patients treated with non-biologics.

Immune pathways associated with the pathogenesis of psoriasis and the drugs used to treat psoriasis may have a differential impact on the clinical course of COVID-19.The IL-23/Th17 axis has a central role in the pathogenesis of psoriasis, while plasmacytoid DCs are involved via IL‐36 signalling and type I interferon activation[8].In the initial phase of COVID-19, when early host type I IFN-mediated inhibition of viral replication is essential, immune dysregulation in psoriasis may be beneficial while immunosuppressive drugs may be detrimental[9].However, biologics are more targeted to inhibit an inflammatory factor and less involved in the components of the viral immune response mentioned earlier[10].Trials also suggested that the use of biologics (TNF-α, IL-17 and IL-23 inhibitors) in psoriasis is not associated with increased rates of viral infections such as influenza compared to placebo[11].Some studies have found that the use of IL-17 inhibitors in patients with psoriasis does not increase the risk of SARS-CoV-2 infection or worsen the course of neocoronary pneumonia compared to the use of non-biologics[12].One study analyzed skin tissue from psoriasis patients before and after treatment with IL-17 monoclonal antibodies and found decreased expression of ACE2 (a receptor necessary for cells infected with COVID-19) in patient lesions, suggesting that IL-17 antibodies may reduce the risk of COVID-19 by reducing cells that interact with SARS-CoV-2.The results of this study suggest that IL-17 monotherapy does not increase the risk of COVID-19 infection, but rather controls inflammation while downregulating ACE2 and thereby decreasing the risk of infection[13].

The second phase of the COVID-19 cytokine storm includes TNF, IL-1b, IL-6, IL-8, IFN-g, and IL-17.This is when the host immune response is excessive and can lead to acute respiratory distress syndrome (ARDS), multi-organ failure, and death[14].Some authors speculate that the inhibitory effect of biologics on inflammatory factors in patients with severe COVID-19 may attenuate the inflammatory factor storm caused by SARS-CoV-2.So the symptoms are reduced and the course of the disease is shortened[12][15].

The results of this study suggest that SARS-CoV-2 may exacerbate psoriasis and that this was more pronounced in patients not treated with biologics.The reasons for this analysis may be multifaceted. (1) Several studies have shown that IL-17 levels in peripheral blood are elevated in patients with COVID-19[16].Due to the key role of inflammation in the pathogenesis of psoriasis, the excessive inflammatory state induced by COVID-19 may also exacerbate psoriasis.Biologics may target cytokine levels and resist the increased levels of inflammatory factors caused by COVID-19.(2) Currently, drugs used to treat the COVID-19 include various antiviral drugs, antipyretic and analgesic drugs, immunotherapy and vaccines[17].Although the effects of these treatments on psoriasis and their mechanism of action need to be further explored, their effects on psoriasis cannot be ruled out. (3) With regard to social factors, COVID-19 pandemic prevented many psoriasis patients from being seen in a timely manner, resulting in the worsening of pre-existing psoriasis cases and the failure to diagnose new cases.Emotional stress is another factor that can become a factor in the development and worsening of psoriasis[18].

Unnecessary discontinuation of medication in case of infection with COVID-19 may lead to exacerbation of psoriasis, and loss of response on reintroduction of treatment, even leading to the formation of antibodies to the discontinued biologic agent[19].This may lead to worsening of psoriasis, increased disease burden, adverse effects on quality of life, and increased healthcare costs.Therefore, prophylactic withdrawal should be avoided.

Limitations of this study are (1) Although some patients presenting with COVID-19 symptoms were not specifically tested during this study, the peak in symptoms in December 2022 strongly suggests all participants were experiencing the omicron peak to some degree.This finding is virtually consistent with the epidemiology of the COVID-19 outbreak in China. (2) The small sample size, the lack of COVID-19-related hospitalizations and deaths observed in this report, and the relatively short follow-up period prevented the identification of risk factors for adverse COVID-19 outcomes.It is expected that a larger collection of cases will address this issue. (3) As biologic therapy is mainly targeted at patients with moderate to severe psoriasis, our findings may not be applicable to patients with mild psoriasis.

Our study suggests that the use of biologics in patients with psoriasis does not increase the risk of SARS-CoV-2 infection or worsen the course of COVID-19.

In terms of exacerbation of psoriatic lesions by COVID-19 infections, the number of disease courses worsened by treatment with biologics was lower compared to conventional treatment.This study provides evidence for treatment decisions for psoriasis patients receiving biologics during the COVID-19 pandemic.

Additional patients need to be included and more rigorous controlled clinical trials conducted to demonstrate the efficacy and safety of biologics in treating COVID-19 in the psoriasis population.

Compliance with ethical standards

Conflict of interest: The authors declare that they have no conflict of interest.

Ethical approval: The questionnaire and methodology for this study was approved by the Human Research Ethics committee of China-Japan Friendship Hospital(Ethics approval number:2022-KY-24).

Informed consent: Informed consent was obtained from all individual participants included in the study.

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No competing interests reported.

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The impact of biologic treatment in psoriasis patients on COVID-19 infection: A single-center retrospective study

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Abstract

1 Introduction

2 Methods

3 Results

3.1 Demographic and clinical characteristics of psoriasis patients

3.2 Effect of biological agents on COVID-19 infection status

3.3 Factors influencing the prevalence and severity of COVID-19 in psoriasis patients

3.4 Effect of covid-19 infection on psoriasis condition

4 Discussion

5 Conclusion

Declarations

References

Additional Declarations

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