Background: Effective, well-tolerated oral psoriasis treatments are needed.
Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis.
Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16.
Results: At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < .0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast.
Limitations: One-year duration, limited racial diversity.
Conclusion: Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.
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http://dx.doi.org/10.1016/j.jaad.2022.07.002 | DOI Listing |
Hernia
January 2025
Department of Surgery, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1259, New York, NY, 10029, USA.
Purpose: While surgeons agree that perioperative field blocks should be performed for open inguinal hernia surgery, there lacks consensus in the minimally invasive context. Prior small-scale randomized trials study pain scores only up to 24 h postoperatively. Thus, we sought to investigate the analgesic benefits of a bupivacaine transversus abdominis plane (TAP) block in the first 4 postoperative days.
View Article and Find Full Text PDFNutrients
December 2024
Sección de Gastroenterología y Nutrición Infantil, Hospital Regional Universitario de Málaga, 29010 Málaga, Spain.
: Hydrolysed rice formula (HRF) is tolerated by >90% of children with cow's milk protein allergy (CMPA). However, concerns have been raised about potential suboptimal growth in infants fed HRF compared to those fed an extensively hydrolysed milk protein formula (eHF). : To compare growth, safety and tolerance acquisition in infants with CMPA when fed HRF versus eHF.
View Article and Find Full Text PDFGut
December 2024
Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Madrid, Spain
Background And Objectives: Primary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it.
Secondary Objectives: to evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse.
Design: Prospective, quadruple-blind, multicentre, randomised, controlled trial.
Am J Reprod Immunol
January 2025
Placental Analytics, LLC, New Rochelle, New York, USA.
Problem: Hashimoto's disease is the commonest autoimmune disease of pregnancy. The presence of Anti-Thyroid antibodies (ATAs) alone [subclinical hypothyroidism] has also been shown to have adverse pregnancy effects. These can result in failure to conceive, recurrent miscarriages, anemia, preeclampsia, and abruption.
View Article and Find Full Text PDFJ Cancer Res Ther
December 2024
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China.
Background: Patients with transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) have limited treatment options and poor outcomes.
Methods: This phase III study (NCT04236141) evaluated the efficacy and safety of polatuzumab vedotin plus bendamustine and rituximab (Pola+BR) versus BR in Chinese patients with transplant-ineligible R/R DLBCL to support regulatory submission in China. Patients were randomized 2:1 to receive Pola+BR or placebo+BR.
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