ABSTRACT
Objective: Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is approved for treating moderate-to-severe psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial (NCT03364309;registered December 6, 2017) evaluated the safety and efficacy of ixekizumab in Chinese patients with moderate-to-severe psoriasis. Method(s): 438 patients were randomized 2:2:1 to 80 mg ixekizumab every 2 weeks (IXE Q2W, n = 176), 80 mg ixekizumab every 4 weeks (IXE Q4W, n = 174), or placebo (n = 88). Efficacy was assessed by evaluating the static Physician's Global Assessment score of 0 or 1 (sPGA [0,1]) and Psoriasis Area and Severity Index (PASI) 75/90/100 responses, and nonresponder imputation was used for handling missing data. The safety profile was evaluated by assessing treatment emergent adverse events (AEs) and serious AEs. Result(s): At week 12, the sPGA (0,1) response rates were 3.4%, 79.9%, and 86.4% in the placebo, IXE Q4W, and IXE Q2W groups, respectively. The PASI 75/90/100 response rates were 8.0%/2.3%/0.0%, 87.4%/75.9%/29.3%, and 93.8%/82.4%/33.0% in the placebo, IXE Q4W, and IXE Q2W groups, respectively. Ixekizumab led to rapid PASI 50 responses, as early as week 1, whereas PASI 75 and sPGA (0,1) responses were observed from week 2. sPGA (0,1) and sPGA (0) responses were maintained through week 60 in a higher proportion of patients receiving IXE Q4W vs. placebo. The safety profile was consistent with previous studies of ixekizumab in psoriasis. Conclusion(s): Ixekizumab showed a rapid onset of action and high efficacy that was maintained through 60 weeks and was well tolerated with no unexpected AEs, in Chinese patients with moderate-to-severe plaque psoriasis. Copyright © 2022 International Journal of Dermatology and Venereology. All right reserved.
ABSTRACT
Objective To analyze the diagnosis and treatment data after the adjustment of various measures in the hospital fever clinic during the coronavirus disease 2019 (COVID-19) outbreak, so as to provide experience for the prevention and control of COVID-19 in non-epidemic areas. Methods We collected the diagnosis and treatment data from the fever clinic of Changhai Hospital of Naval Medical University (Second Military Medical University) in non-epidemic area from Dec. 21, 2019 to Feb. 22, 2020 and Jan. 1 to Mar. 5, 2019, and divided them into four groups: Group A (during the 2020 COVID-19 epidemic), from Jan. 22 to Feb. 22, 2020;group B (before the COVID-19 epidemic), from Dec. 21, 2019 to Jan. 21, 2020;group C (in the same period as group A in 2019), from Feb. 2 to Mar. 5, 2019;and group D (in the same period as group B in 2019), from Jan. 1 to Feb. 1, 2019. Year-on-year and month-on-month comparisons of the above data were conducted. Results The overall situation of the fever clinic around the Spring Festival in 2020 was similar to that of the same period in 2019. The year-on-year comparison results showed that during the COVID-19 epidemic, the number of daily patients in the fever clinic was significantly decreased ([114.3±62.9] cases vs [171.7±37.0] cases), the single consultation time of each physician was prolonged ([11.7±1.8] min vs [6.5±1.3] min), but the average waiting time of patients was decreased ([7.5±0.6] min vs [22.8±1.5] min) (all P<0.05). The month-on-month comparison results indicated that the number of daily patients in the fever clinic was significantly decreased during the COVID-19 epidemic ([114.3±62.9] cases vs [216.3±41.8] cases), the single consultation time of each physician was prolonged [( 11.7±1.8] min vs[ 5.6±0.8] min), but the average waiting time of patients was decreased ([7.5±0.6] min vs [23.3±3.2] min) (all P<0.05). The proportion of computed tomography (CT) examination during the 2020 COVID-19 epidemic was significantly higher than that in the same period of 2019 (7.9%[ 292/3 658] vs 3.7% [206/5 493]). Although the examination time was prolonged due to strengthened protective measures ([12.5±3.8] min vs [10.0±3.2] min) (P<0.05), the time for patients to have the CT examination report was significantly shortened ([10.6±2.5] min vs [58.4±9.6] min) (P<0.01). Conclusion During the COVID-19 epidemic, measures such as adjusting the relevant procedures of the fever clinic and equipping special CT machine in non-epidemic area can reduce the daily consultation time of physicians, improving the diagnosis and treatment efficiency and reducing cross infection.