key: cord-0842424-szlnog0q authors: Yalici‐Armagan, Basak; Tabak, Gulsun Hazan; Dogan‐Gunaydin, Sibel; Gulseren, Duygu; Akdogan, Neslihan; Atakan, Nilgun title: Treatment of psoriasis with biologics in the early COVID‐19 pandemic: A study examining patient attitudes toward the treatment and disease course date: 2021-08-08 journal: J Cosmet Dermatol DOI: 10.1111/jocd.14381 sha: 55e0c9d4535cc284c8879499c427ef93e808fd70 doc_id: 842424 cord_uid: szlnog0q BACKGROUND: Since March 2020, the coronavirus disease 2019 (COVID‐19) pandemic has been ongoing all around the world with a wide range of clinical course including asymptomatic cases to severe and fatal respiratory tract disease. Patients on immunosuppressive treatments were predicted to be more susceptible to COVID‐19. AIMS: It was aimed to assess treatment continuity, the course of psoriasis and the course and clinical features of COVID‐19 in patients treated with biological agents for psoriasis at the early initial period of COVID‐19 pandemic. PATIENTS/METHODS: Patients treated with biological agents for psoriasis at our institute were contacted by phone between 1 and 10 July 2020 and fulfilled a questionnaire about their continuity to psoriasis treatments, clinical course of psoriasis, and any suspicion/diagnosis of COVID‐19. RESULTS: A total of 106 patients, 41 females and 65 males, were enrolled. Mean age of the patients was 46.1 ± 12.1 years (range: 19–77). Median duration of psoriasis was 18 years (min–max: 1 month–51 years). Twenty‐four patients (22.6%) were using tumor necrosis alpha inhibitors (ETA:1, IFX:19, ADA:4), whereas 82 patients (77.4%) were using interleukin (IL) 12/23 or IL‐17 inhibitors (UST:48, SECU:30, IXE:4). Seventy‐six patients (71.7%) continued the treatment, whereas 30 patients (28.3%) interrupted the treatment voluntarily. Twenty out of 30 patients (66.6%) who interrupted the treatment had an exacerbation of psoriasis. None of the patients were diagnosed with COVID‐19 in the study period. CONCLUSION: Patients with psoriasis who received biological therapy continued their treatment at a high rate during the early period of the COVID‐19 pandemic. No COVID‐19 diagnosis was made among patients whether they continued or discontinued treatment. Recurrence and exacerbation of psoriasis in a significant proportion of patients who interrupted treatment and absence of COVID‐19 diagnosis in each group support the importance and safety of continuity of biological treatments for psoriasis in COVID‐19 era. COVID-19 is a viral respiratory tract infection caused by a new coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 1 The disease, which emerged in Wuhan, China at the end of 2019, spread around the world in a short time and the World Health Organization (WHO) declared the COVID-19 pandemic in March 2020. 2 The disease has a fairly wide clinical spectrum, including asymptomatic infection, mild upper respiratory disease, respiratory failure from severe viral pneumonia, hyperinflammatory syndrome, and even death. 3, 4 The presence of conditions such as advanced age, male gender, smoking, obesity, hypertension, diabetes mellitus, cardiovascular diseases, cerebrovascular diseases, chronic obstructive pulmonary disease (COPD), malignancy, and HIV infection are indicated as risk factors for severe disease. 3, 5, 6 Psoriasis is a chronic and systemic inflammatory disease that affects approximately 2-3% of the general population. 7 Management of psoriasis is a complicated process; since it has been frequently associated with systemic inflammatory comorbidities including arthritis, metabolic syndrome, cardiovascular diseases, diabetes mellitus, obesity, and inflammatory bowel disease. 8, 9 Biological immunomodulatory agents targeting the inhibition of cytokines such as tumor necrosis factor alpha (TNFα), interleukin (IL) 17, IL 12/23, and IL 23 are also used successfully in selected moderate-to-severe psoriasis. 10 Although biological agents do not have cumulative organspecific toxicities, they are known to predispose various infections, especially upper respiratory tract infections just as older conventional agents including methotrexate (MTX) and cyclosporine. 11 Therefore, COVID-19 pandemic has raised significant concern on severe psoriasis management due to presence of common inflammatory comorbidities as well as the immunosuppressive and immunomodulatory agents used in its treatment. Lack of clinical evidence and outcome reports especially during the initial period of the pandemic led both physicians and patients to experience the dilemma of potentially fatal SARS-CoV-2 infection risk to psoriasis exacerbation and/or secondary ineffectiveness to treatment which may occur as a result of interruption of treatment. In the light of observational studies during the pandemic period, discontinuation/withdrawal or dose reduction of biological agents is not recommended in the management of patients with psoriasis unless a COVID-19 documentation is made. 12 In this study, it was aimed to assess treatment continuity, the course of psoriasis and the course and clinical features of COVID-19 in patients treated with biological agents for psoriasis at the early initial period of COVID-19 pandemic. Patients treated with biological agents for psoriasis at our institute were contacted by phone between 1 and 10 July 2020 and fulfilled a questionnaire about their continuity to psoriasis treatments, clinical course of psoriasis, and any suspicion/diagnosis of COVID-19. Statistical analyses were performed using the SPSS software version 22 . The variables were investigated using visual (histograms, probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk test) to determine whether or not they are normally distributed. Descriptive analyzes were presented using means and standard deviation for normally distributed variables, and median and interquartile range (IQR) for non-parametric variables. Categorical variables were summarized as frequencies and percentages. The chi-square test was used to compare the exacerbation ratio of psoriasis between the groups that discontinued and continued treatment. A p-value of less than 0.05 was considered to show statistically significant results. All procedures were performed in accordance with the ethical principles of the Helsinki Declaration. After having received a complete description of the study, patients provided recorded verbal consent. A total of 106 patients, 41 females (38.6%) and 65 males (61.3%), were included in the study. The mean age of the patients was 46.1 ± 12.1 were receiving MTX treatment in addition to biological therapy. Nine patients (8.4%) stated that they did not comply with the recommendations for protection from COVID-19 because of their The COVID-19 pandemic caused by the new SARS-CoV-2 virus has led to numerous infections and deaths worldwide. 13 Patients on immunosuppressive therapies are generally more prone to infections. In a meta-analysis of 62 studies involving 319.025 patients using conventional disease-modifying agents (csDMARDs), biologics or targeted synthetic DMARDs (b/tsDMARDs); prevalence of COVID-19 was found to be increased in patients with autoimmune diseases. Risk and severity of COVID-19 were increased with glucocorticoids, csDMARDs and b/tsDMARDs-csDMARDs combination therapy whereas the risk of severe COVID-19 reduced with b/tsDMARDs monotherapy and particularly with anti-TNF therapy. 14 Currently, biological and non-biological systemic treatments of psoriasis are accepted to not pose an increased risk of SARS-CoV-2 infection and /or an increased risk of hospitalization and death compared to the normal population. [15] [16] [17] Moreover, rate of hospitalization due to COVID-19 in psoriasis patients receiving biological therapy was lower than those receiving conventional systemic therapies. 18 Thus, even when there was not enough evidence in the earlier period of the pandemic, the majority of patients who informed by phone calls decided to continue to the treatment and did not experience an increased COVID-19 rate compared to those who stopped treatment. The risk-mitigating behaviors of patients with psoriasis who use biological agents are reported to be greater than those who use non-biological systemic therapy and those who do not use systemic therapy. 18, 19 In a study including 1626 patients with psoriasis by Mahil et al., compliance with social or individual isolation measures was reported as 72% in patients with psoriasis using biological agents, and 63% in patients using non-biological systemic therapy and not using systemic therapy. 18 In the same study, the rate of those who did not comply with general virus protection measures was reported as 0.4% in patients with psoriasis using biological agents whereas 0.8% using non-biological systemic therapy and 0.9% in patients not using systemic therapy. In our study, 8 .4% (N = 9) of our patients stated that they could not comply TA B L E 1 Demographic characteristics, treatment continuation, and disease activation status of patients Psoriasis is a common chronic and systemic inflammatory disease with both physical and psychosocial burden. 21, 22 It has been shown that the quality of life in psoriasis patients is affected as much as other principal chronic diseases such as cancer and diabetes including physical and psychological evaluations. 10 Indeed, this is reflected in patients' risk tolerance behavior for better treatment responses. 23 In the study by Fairchild et al., including 927 patients with psoriasis; it was reported that 72% of the patients were willing to accept the higher risks of infection-related mortality associated with treatment in order to completely remove the plaques covering only 1% of the body. 24 In another study of Mahil SK et al, the rate of discontinuation of treatment due to pandemic was reported as 17% in patients with psoriasis using biological agents, and 20% in patients using non-biological systemic agents. 18 In a study from Turkey, 61% of 133 patients with psoriasis and receiving biological therapy were reported to continue to their treatment. 25 Similarly, in our study, approximately 72% of the patients who received biological therapy for psoriasis continued to the treatment at the initial period of the COVID-19 pandemic which represents the most uncertain period in terms of biological treatment risks. This suggests that psoriasis is an important disease for patients to take some risks including a fatal infection. In addition, we believe that being easily accessible by all our patients and being informed with self-sacrifice contributes to the treatment compliance of our patients in this period. The treatment duration is predicted to be long-term due to the chronic repetitive nature of psoriasis. Although research on discontinuation or dose reduction of biological therapies after disease remission continues, the optimal duration of use for biological therapies is currently not specified. 26 In real-life data, discontinuation of biological therapies is often reported to be due to ineffectiveness or loss of efficacy over time. 27 In addition, low-dose and intermittent use of biological therapies are not recommended because of the risk of secondary ineffectiveness due to the development of neutralizing antibodies. 28 We declare that there is no conflict of interest of all authors in this work. Basak Yalici-Armagan, Sibel Dogan Gunaydın, Duygu Gulseren, Neslihan Akdogan, Nilgun Atakan contributed to the study conception, design and critically revision of the manuscript. Gulsun-Hazan Tabak acquired the patient data and Basak Yalici-Armagan drafted the manuscript; she is the study guarantor. The study was approved by Hacettepe University Non-interventional Clinical Researches Ethics Board (06/23/2020 -GO 20/612) and Turkish Ministry of Health (06/12/2020 -2020-06-08T15_36_57). Basak Yalici-Armagan https://orcid.org/0000-0001-9745-1331 Gulsun Hazan Tabak https://orcid.org/0000-0003-1553-5190 Duygu Gulseren https://orcid.org/0000-0003-1602-726X Neslihan Akdogan https://orcid.org/0000-0002-1137-5399 World Health Organization. Novel Coronavirus (2019-nCoV) SITUATION REPORT-1 World Health Organization. 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