A Web-Based Survey on Factors for Unvaccination and Adverse Reactions of SARS-CoV-2 Vaccines in Chinese Patients with Psoriasis.

PURPOSE: Vaccination is one of the most important strategy to prevent infections and control epidemics, but it also raises concerns about safety in patients receiving treatments. This study aimed to investigate the rate and factors for unvaccination, as well as adverse reactions and deterioration of disease after SARS-CoV-2 vaccination in psoriatic patients. METHODS: A web-based questionnaire survey on SARS-CoV-2 vaccination, adverse reactions, and self-reported change of disease condition after vaccination in patients with psoriasis was conducted. Demographic, clinical, and psychological data were collected. Multivariable logistic regression was used in the estimation of associations. RESULTS: A total of 788 psoriatic patients were investigated, and 68.9% reported SARS-CoV-2 vaccination. Younger age, use of interleukin-17 inhibitors, and symptoms of anxiety were associated with unvaccination. The incidence of overall adverse reactions after vaccination was 30.8%, and no severe adverse reaction was reported. The most common local and systemic adverse reactions were pain at the injection site and fatigue, respectively. Most patients reported no change in psoriasis after vaccination, while 16.6% and 4.4% reported slight and significant deteriorations of the disease, respectively. Nonadherence to treatment, symptoms of anxiety and depression, and perceived stress were associated with self-reported deterioration of psoriasis after vaccination. CONCLUSION: While a favorable safety profile of SARS-CoV-2 vaccines is observed, receiving biologic treatment is factor for unvaccination in patients with psoriasis. Deterioration of psoriasis reported by a small proportion of patients is partially attributable to mental and behavioral factors.

Safety and Efficacy of Ixekizumab and Antiviral Treatment for Patients with COVID-19: A structured summary of a study protocol for a Pilot Randomized Controlled Trial.

OBJECTIVES: A severe epidemic of COVID-19 has broken out in China and has become a major global public health event. We focus on the Acute Respiratory Distress Syndrome (ARDS)-like changes and overactivation of Th17 cells (these produce cytokines) in patients with COVID-19. We aim to explore the safety and efficacy of ixekizumab (an injectable drug for the treatment of autoimmune diseases) to prevent organ injury caused by the immune response to COVID-19. Ixekizumab is a human monoclonal antibody that binds to interleukin-17A and inhibits the release of pro-inflammatory cytokines and chemokines. TRIAL DESIGN: The experiment is divided into two stages. In the first stage, the open trial, 3 patients with COVID-19 are treated with ixekizumab, and the safety and efficacy are observed for 7 days. In the second stage, 40 patients with COVID-19 are randomly divided into two groups at 1:1 for 14 days. This is a two-center, open-label, randomized controlled pilot trial with 2-arm parallel group design (1:1 ratio). PARTICIPANTS: Patients with COVID-19 aged 18-75 with increased Interleukin (IL)-6 levels will be enrolled, but patients with severe infections requiring intensive care will be excluded. The trial will be undertaken in two centers. The first stage is carried out in Xiangya Hospital of Central South University, and the second stage is carried out simultaneously in the Third Xiangya Hospital of Central South University. INTERVENTION AND COMPARATOR: In the first stage, three subjects are given ixekizumab ("Taltz") (80 mg/ml, 160 mg as a single hypodermic injection) and antiviral therapy (α-interferon (administer 5 million U by aerosol inhalation twice daily), lopinavir/ritonavir (administer 100mg by mouth twice daily, for the course of therapy no more than 10 days), chloroquine (administer 500mg by mouth twice daily, for the course of therapy no more than 10 days), ribavirin (administer 500mg by intravenous injection two to three times a day, for the course of therapy no more than 10 days), or arbidol (administer 200mg by mouth three times a day, for the course of therapy no more than 10 days), but not more than 3 types). The treatment course of the first stage is 7 days. In the second stage, 40 randomized patients will receive the following treatments--Group 1: ixekizumab (80 mg/ml, 160 mg as a single hypodermic injection) with antiviral therapy (the same scheme as in the first stage); Group 2: antiviral therapy alone (the same scheme as in the first stage). The length of the second treatment course is 14 days. MAIN OUTCOMES: The primary outcome is a change in pulmonary CT severity score (an imaging tool for assessing COVID-19, which scores on the basis of all abnormal areas involved). Pulmonary CT severity score is assessed on the 7th day, 14th day, or at discharge. RANDOMISATION: In the second stage, 40 patients with COVID-19 are randomly divided into two groups at 1:1 for 14 days. The eLite random system of Nanjing Medical University is used for randomization. BLINDING (MASKING): The main efficacy indicator, the CT results, will be evaluated by the third-party blinded and independent research team. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): In the second stage, 40 patients with COVID-19 are randomly divided into two groups at 1:1 for 14 days. TRIAL STATUS: Trial registration number is ChiCTR2000030703 (version 1.7 as of March 19, 2020). The recruitment is ongoing, and the date recruitment was initiated in June 2020. The anticipated date of the end of data collection is June 2021. TRIAL REGISTRATION: The name of the trial register is the Chinese Clinical Trial Registry. The trial registration number is ChiCTR2000030703 ( http://www.chictr.org.cn/ ). The date of trial registration is 10 March 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Nonadherence to Treatment and Patient-Reported Outcomes of Psoriasis During the COVID-19 Epidemic: A Web-Based Survey.

PURPOSE: The COVID-19 epidemic has caused difficulties in continuous treatment for patients with chronic diseases and resulted in nonadherence to treatment and adverse health outcomes. This study aimed to investigate the associations of nonadherence to treatment with patient-reported outcomes of psoriasis during the COVID-2019 epidemic. METHODS: A cross-sectional study among Chinese patients with psoriasis was conducted through a web-based questionnaire survey during 25 Feb 2020 and 6 Mar 2020. Demographic and clinical data, nonadherence to treatment, and patient-reported outcomes were collected. The outcomes included deterioration of the disease condition, perceived stress, and symptoms of anxiety and depression. Logistic regression was used to investigate the associations. RESULTS: A total of 926 questionnaires were collected. A total of 634 (68.5%) reported nonadherence to treatment, and worse adherence was found among patients receiving systemic treatment (adjusted odds ratio [AOR]: 2.67; 95% CI: 1.40-5.10) and topical treatment (AOR: 4.51; 95% CI: 2.66-7.65) compared to biological treatment. Nonadherence to treatment (less than two weeks and more than two weeks) was significantly associated with deterioration of psoriasis (aOR: 2.83 to 5.25), perceived stress (AOR: 1.86 to 1.57), and symptoms of anxiety (AOR: 1.42 to 1.57) and depression (AORs: 1.78). Subgroup analysis by treatment showed consistent results in general. CONCLUSION: Nonadherence to treatment was associated with the aggravation of psoriasis conditions, perceived stress, and symptoms of anxiety and depression.