Incidence of severe COVID-19 outcomes in psoriatic patients treated with systemic therapies during the pandemic: A Biobadaderm cohort analysis.

To the Editor: The use of systemic treatments in psoriatic patients during the pandemic has been the subject of extensive debate. In March 2020, we performed a specific study within the cohort of Biobadaderm Registry, a previously described national, multicenter, prospective cohort.

Our primary objective was to analyze the incidence of COVID-19 infections and severe outcomes in a cohort of psoriatic patients treated with systemic therapies and to compare it with that of the general population.

We reviewed all Biobadaderm patient records and contacted the patients when needed. We collected information about current comorbidities related to COVID-19 and COVID-19 outcomes in all active patients of the registry. We used the latest data updated on July 6, 2020.

We estimated the age and sex standardized incidence ratio (SIR) defined as the ratio of the observed cases to the expected number of cases according to the Spanish population. The main analysis examined hospitalization, intensive care unit (ICU) admissions, and death in polymerase chain reaction (PCR)-confirmed patients included in Biobadaderm compared with PCR-confirmed cases published by the Spanish Ministry of Health. Also 95% confidence intervals (CI) were calculated for each SIR to compare significance between the Spanish figures and those of Biobadaderm.

In our study, we found that of 2329 current active patients with systemic therapy, 73 patients (3.13%) had suffered from COVID-19, 13 patients (0.56%) required hospitalization, 1 patient (0.04%) needed ICU care, and 1 (0.04%) patient died. Patient characteristics are detailed in Table I . The profile of COVID-19 cases was similar to that of the population of origin (Biobadaderm) in age and sex, but with higher percentages of comorbidities like hypertension (27% vs 22%) or diabetes mellitus (16% vs 11%).

Table I

SARS-CoV-2 infection characteristics of patients treated with systemic therapies

Characteristics	SARS-CoV-2 infection
	Possible case,∗ n = 36 (%)	Probable case,† n = 16 (%)	PCR confirmed case,‡ n = 21 (%)	Hospitalized case, n = 13 (%)	ICU case, n = 1 (%)	Death case, n = 1 (%)	All cases, n = 73 (%)
Sex
Male	21 (58)	11 (69)	11 (52)	10 (77)	0 (0)	1 (100)	43 (59)
Female	15 (42)	5 (31)	10 (48)	3 (23)	1 (100)	0 (0)	30 (41)
Age (y), median (p25-p75)	51.3 (38.8-59.8)	49.9 (32.7-54.6)	54.8 (49.6-68.3)	54.8 (51.5-68.3)	51.2 (NA)	79.5 (NA)	51.8 (39.6-60.0)
Plaque psoriasis, yes	35 (97)	15 (94)	19 (90)	12 (92)	1 (100)	1 (100)	69 (95)
Psoriatic arthritis, yes	2 (6)	2 (13)	5 (24)	4 (31)	1 (100)	0 (0)	9 (12)
Treatment
Anti-TNF	6 (16)	5 (31)	2 (10)	1 (8)	0 (0)	0 (0)	13 (18)
Classic systemics treatments	3 (9)	2 (12)	4 (19)	2 (15)	0 (0)	0 (0)	9 (12)
Anti-IL-12/IL-23	9 (25)	4 (25)	3 (14)	4 (31)	0 (0)	0 (0)	16 (22)
Anti-IL17	6 (17)	5 (32)	2 (10)	1 (8)	0 (0)	0 (0)	13 (18)
Apremilast	6 (17)	0 (0)	6 (29)	2 (15)	0 (0)	1 (100)	12 (16)
Fumarates	1 (3)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (1)
Anti-IL-23p19	5 (14)	0 (0)	4 (19)	3 (23)	1 (100)	0 (0)	9 (12)
Changes in current treatment
No	29 (81)	12 (75)	20 (95)	12 (92)	1 (100)	1 (100)	61 (84)
Preventive minimization	3 (8)	2 (13)	0 (0)	0 (0)	0 (0)	0 (0)	5 (7)
Preventive suspension	4 (11)	2 (13)	1 (5)	1 (8)	0 (0)	0 (0)	7 (10)
Hypertension, yes	11 (31)	3 (19)	6 (29)	5 (38)	0 (0)	1 (100)	20 (27)
Diabetes mellitus, yes	7 (19)	2 (13)	3 (14)	5 (38)	0 (0)	0 (0)	12 (16)
Cardiovascular disease, yes	6 (17)	2 (13)	4 (19)	4 (31)	0 (0)	1 (100)	12 (16)
Respiratory tract disease, yes§	8 (22)	4 (25)	1 (5)	3 (23)	0 (0)	NA	13 (18)
ARA II or ACE treatments, yes	8 (22)	3 (19)	5 (24)	4 (31)	0 (0)	1 (100)	16 (22)
Relative hospitalized or death by COVID-19∗	3 (10)	2 (17)	2 (22)	5 (100)	1 (100)	NA	7 (14)
Time since first symptom, median (p25-p75)∗	20.5 (12-26)	23 (15-41)	18 (13.5-30)	23 (13-30)	30 (NA)	14 (NA)	20 (13-30)
COVID-19 outcome
Mild symptoms or asymptomatic	35 (97)	12 (75)	11 (52)	0 (0)	0 (0)	0 (0)	58 (79)
Hospitalization	1 (3)	4 (25)	8 (38)	13 (100)	0 (0)	0 (0)	13 (18)
ICU admission or similar	0 (0)	0 (0)	1 (5)	0 (0)	1 (100)	0 (0)	1 (1)
Death	0 (0)	0 (0)	1 (5)	0 (0)	0 (0)	1 (100)	1 (1)

ARA II, angiotensin II receptor antagonists; ACE, angiotensin-converting enzyme; IL, interleukin; TNF, tumor necrosis factor.

Possible case: febrile respiratory infection with compatible symptoms.

Probable case: clinical criteria with an epidemiological link or any person meeting the diagnostic criteria.

Confirmed case: laboratory confirmation of SARS-CoV-2, irrespective of clinical signs and symptoms.

Few missing data.

In our main analysis (Table II ), the SIR for COVID-19 infection, hospitalization, ICU care, and death were slightly higher in psoriatic patients treated with systemic therapies compared with the general population of Spain, but this was not significant: 1.58 (0.98-2.41), 1.55 (0.67-3.06), 1.78 (0.05-9.93), 1.38 (0.03-7.66), respectively.

Table II

Adjusted Cumulative Incidence and Standardized Incidence Ratio of psoriatic patients treated with systemic therapies and compared with equivalent definition in the general population of Spain

	Observed cases in Biobadaderm	Expected cases	Adjusted cumulative incidence 9 5CI% (per 100,000 patient-years)	SIR 95 CI%
All PCR-confirmed cases vs Spanish-confirmed cases	21	13.3	959.5 (593-1469)	1.58 (0.98-2.41)
PCR Hospitalized cases vs Spanish hospitalized cases	8	5.2	349.8 (149.4-692.6)	1.55 (0.67-3.06)
PCR ICU cases vs Spanish ICU cases	1	0.6	33.5 (0-192)	1.78 (0.05-9.93)
PCR death cases vs Spanish death cases	1	0.7	69.5 (0-398.3)	1.38 (0.03-7.66)

The results are consistent with the article published by Gisondi et al during the peak of the Italian pandemic that suggests that psoriatic patients receiving biologic treatments are not associated with worse outcomes.

Strengths of this study are that we analyzed a prospective cohort, we know the base population, and we can calculate the incidences. This study, therefore, avoids problems of other ongoing international registries based on case notifications, which do not have a well-defined base population and likely suffer from selection bias. Although the first data were reassuring at the start of the pandemic, some authors consider that it is necessary to confirm them using prospective studies of incidence with adequate denominators.

The limitations of this study include the lack of serologic or molecular confirmations for the diagnosis of COVID-19 of all possible cases, which is because in cases of mild courses of the disease, testing was often not done during the period of the study.

The findings of this prospective cohort study suggest that classic systemic or biologic treatments increase neither the susceptibility nor the severity of COVID-19.