Management of psoriasis and risk and severity of COVID-19 infection in systemic, biologic and topical treatment for psoriasis during the COVID-19 pandemic: an epidemiological cohort study

Psoriasis is a chronic inflammatory skin disease which affects approximately 2%
of the population. In recent years an increasing amount of patients are being
treated for psoriasis with biological immunosuppressive agents such as
anti-TNF-alpha, anti IL12/23, Anti-IL17 and recently anti-IL23 antibodies as
opposed to treatment with conventional systemic immunosuppressive agents such
as methotrexate, ciclosporin and fumaric acid. Currently, it is still unknown
whether treatment with these immunosuppressive medications have to be stopped
or continued during the Covid-19 pandemic.

Recently a couple of studies and case reports described Covid-19 incidence in
dermatology, especially psoriasis patients treated with biologicals, and
indicated few hospitalizations1,2,3. However, the patients included in these
studies were only patients that were admitted to the hospital and tested for
Covid-19 infections because of their symptoms. Another Italian study contacted
all their psoriasis patients in their outpatient service, but also here, only a
few patients were actually tested.4 As only hospitalized psoriasis patients
were tested, it is still unclear the use of these immunosuppressive agents
influenced the infection rate or the severity of Covid-19 disease in psoriasis
patients. A recent study on seroprevalence of COVID-19 in a small biological
treated psoriasis cohort without controls seems to suggest that the use if
these medications is not associated with severe covid-19 infection.
Evidence on the actual infection rate, proven bij PCR or serological tests, is
scant and therefore the observation of just a few severe infections in this
group might also be explained by a lower infection rate due to different
behavior of psoriasis patients compared to the healthy population. It was
recently reported that psoriasis patients showed more risk-mitigating behavior,
which may lower the risk of being infected in this group5. It is therefore not
clear whether the use of immunosuppressive drugs for psoriasis results in an
increase in Covid-19 infections and/or more severe course compared to the
non-systemic treated psoriasis patients. An increase in infection-rate and
severity could relate to the immunosuppressive effects of systemic
anti-psoriatic therapies, like methotrexate or biologics.

In patients using systemic immunosuppressive therapies, a decrease in disease
severity is also a possibility due to the suppression of parts of the cytokine
storm associated with Covid-19 infections6,7. Several cytokines have been found
to play a role in this storm: IL-6, IL-10, IL12 and TNF. And the use of
anti-TNF alpha and other biologics and immunosuppressive drugs have been
suggested as possible treatments for severe Covid-19 infections.
At this moment there is clinical support of therapeutical effect of IL-6
inhibitor tocilizumab12,13, and in several cases of anti-TNF-alpha:
etanercept14 and infliximab15 in people suffering from Covid-19 infection. For
anti-IL-17 biologicals it*s not clear, some suggest it could be used as a
treatment for Covid-1916, but there are also some case reports with patients
who had severe Covid-19 disease while treated with anti-IL-17 biologicals.
Without an effective treatment, and current state of viral mutations with new
emerging Covid-19 strain it will be very important to know whether patients on
immunosuppressive medications are at increased risk of getting Covid-19 and
whether they are more prone to severe Covid-19 infections or whether biologics
can even have a protective effect by e.g. suppressing the cytokine storm
implicated in Covid-19 infections. However, this requires insight in the actual
seroprevalence of COVID-infections and information on the number of severe
infections in this group. Due to this lack of knowledge, psoriasis patients
have not been advised uniformly how to manage their psoriasis and their
anti-psoriatic treatment. Patients have therefore sometimes even stopped their
treatment (with or without their doctors consent) due to concerns of increased
susceptibility for serious Covid-19 infections. This could potentially result
in an increased psoriasis disease activity and worsened quality of life.

Evaluate the point-prevalence, relative risk and severity of COVID-19
infections in psoriasis patients treated with immunosuppressive biologicals or
conventional systemic immunosuppressive therapies as compared to topical
treatments.
Furthermore, we would like to evaluate the management of these psoriasis
patients during the recent pandemic. How did hospitals inform these patients on
how to use their immunosuppressive medication in these times (continue or
discontinue)? Did patient perform self-quarantine or not? Did patients
experience an increase in psoriatic disease activity? How did hospitals stay in
contact with these patients (outclinic visits, phone calls, teleconsultations
(Apps/chat/video consultations). How was this change in care perceived by the
patients? Are there lessons to be learned for the next wave(s) of the pandemic
or for psoriasis care in general? andemic

epidemiological cohort study

Burden: patient has to make time to answer the one time questionnaire and go to
a local blood withdrawal lab to give 10 ml blood., the blood withdrawal can
sometimes be combined with other planned bloodwork
Risk: common blood withdrawal risks
Benefit: knowledge of having had (sub)clinical COVID-19 infection.