Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial.

Background: There is a need for efficacious therapies for patients with Crohn's disease that are better tolerated and more durable than available treatments. We aimed to evaluate the efficacy and safety of filgotinib, an oral Janus kinase 1 preferential inhibitor, for treating Crohn's disease.

Methods: This phase 3, double-blind, randomised, placebo-controlled trial was conducted in 371 centres in 39 countries.

Conclusions of clinical trials assessing monoclonal antibodies and sponsored by pharmaceutical industry: a meta-research study.

Objective: The objective of this study was to describe and critically appraise the conclusions of randomized clinical trials assessing monoclonal antibodies sponsored by the pharmaceutical industry.

Methods: This is a meta-research study on conclusions' characteristics of randomized clinical trials with monoclonal antibodies as interventions sponsored by the pharmaceutical industry.

Results: A total of 82 publications were considered.

Treat-to-Target Outcomes With Tapinarof Cream 1% in Phase 3 Trials for Plaque Psoriasis.

The National Psoriasis Foundation (NPF) treatment targets aim to achieve 1% or lower body surface area (BSA) affected after 3 months of treatment. European psoriasis treatment guidelines aim to achieve similar goals based on improvements in Psoriasis Area and Severity Index (PASI) scores. We performed pooled analyses of the PSOARING phase 3 program, which evaluated treat-to-target outcomes for patients treated with tapinarof cream 1% once daily (QD) for up to 52 weeks.

Ticagrelor vs Prasugrel for Acute Coronary Syndrome in Routine Care.

Importance: In patients with acute coronary syndrome (ACS) undergoing invasive treatment, ticagrelor and prasugrel are guideline-recommended P2Y12 receptor inhibitors. The ISAR-REACT5 randomized clinical trial demonstrated superiority for prasugrel, although concerns were raised about the generalizability of some underpowered subgroup analyses.

Objectives: To emulate a randomized clinical trial evaluating the safety and effectiveness of ticagrelor vs prasugrel under the conditions of routine care in individuals with ACS planned to undergo an invasive treatment strategy.

"I know this is on my chest, let's act": a qualitative study exploring self-management of acute COPD exacerbations with a sputum colour chart to reduce unnecessary antibiotic use.

Half of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are caused by bacterial infection, but self-management plans (SMPs) generally advocate use of antibiotics and steroids for all events. We report findings from a qualitative study exploring the acceptability of a sputum colour chart and SMP to guide patient use of antibiotics and steroids (commonly termed a 'rescue pack'). Qualitative interviews were conducted with healthcare professionals (HCPs) and patients from the Colour COPD trial - a randomised controlled trial of usual care (SMP alone) versus usual care plus sputum colour chart to manage AECOPD across England and sampled to promote maximum variation.

Pharmacogenetic-guided dosing for fluoropyrimidine (DPYD) and irinotecan (UGT1A1*28) chemotherapies for patients with cancer (PACIFIC-PGx): A multicenter clinical trial.

PACIFIC-PGx evaluated the feasibility of implementing pharmacogenetics (PGx) screening in Australia and the impact of DPYD/UGT1A1 genotype-guided dosing on severe fluoropyrimidine (FP) and irinotecan-related toxicities and hospitalizations, compared to historical controls. This prospective single arm trial enrolled patients starting FP/irinotecan for any cancer between 7 January 2021 and 25 February 2022 from four Australian hospitals (one metropolitan, three regional). During the accrual period, 462/487 (95%) consecutive patients screened for eligibility for DPYD and 50/109 (46%) for UGT1A1 were enrolled and genotyped (feasibility analysis), with 276/462 (60%) for DPYD and 30/50 (60%) for UGT1A1 received FP/irinotecan (safety analysis).

Triage test for all-oral drug-resistant tuberculosis (DR-TB) regimen: a phase IV study to assess effectiveness, feasibility, acceptability and cost-effectiveness of the Xpert MTB/XDR assay for rapid triage and treatment of DR-TB.

Introduction: The TriAD study will assess the Xpert MTB/XDR (Xpert XDR; Cepheid) assay to detect tuberculosis (TB) drug resistance in sputum testing positive for TB to rapidly triage and treat patients with a short all-oral treatment regimen.

Methods And Analysis: In this study, approximately 4800 Xpert MTB/RIF or Ultra MTB-positive patients (irrespective of rifampicin (RIF) resistance (RR) status) from several clinical sites across South Africa, Nigeria and Ethiopia will be enrolled over 18-24 months and followed-up for approximately 6 months post-TB treatment completion. Participants will be enrolled into one of two cohorts based on Xpert MTB/RIF and Xpert XDR results: () positive participants with RR in Cohort 1 (n=880) and positive RIF susceptible TB patients with isoniazid mono-resistance irrespective of presence of resistance to fluoroquinolones, second-line injectable drugs or ethionamide in Cohort 2 (n=400).

Performance of the EULAR Systemic sclerosis Impact of Disease (ScleroID) questionnaire as a patient-reported outcome measure for patients with diffuse systemic sclerosis.

Objective: Systemic sclerosis Impact of Disease (ScleroID) is the first comprehensive patient-reported outcome measure (PROM) specifically developed for systemic sclerosis (SSc). We investigated the performance of ScleroID in patients with diffuse cutaneous SSc (dcSSc), as a prerequisite for its use in randomised controlled trials (RCTs) testing potentially disease-modifying drugs.

Methods: All patients with dcSSc from the large, multicentric, ScleroID cohort were included.

Parents' experiences of early screening for cerebral palsy: A qualitative reflexive thematic analysis.

Aim: To explore parents' experiences of early screening for cerebral palsy (CP) in three Australian states.

Method: This is a qualitative description study using semi-structured interviews. Participants were parents of children who had CP (n = 5), or high risk of CP (n = 10), or no CP (n = 11) at 2 years, and had completed early screening for CP.

International Consensus Statement on Platelet Function and Genetic Testing in Percutaneous Coronary Intervention: 2024 Update.

Current evidence indicates that dual antiplatelet therapy with aspirin plus a P2Y inhibitor is essential for the prevention of thrombotic events after percutaneous coronary interventions. However, dual antiplatelet therapy is associated with increased bleeding which may outweigh the benefits. This has set the foundations for customizing antiplatelet treatments to the individual patient.

The 'golden fleece of embryology' eludes us once again: a recent RCT using artificial intelligence reveals again that blastocyst morphology remains the standard to beat.

Grading of blastocyst morphology is used routinely for embryo selection with good outcomes. A lot of effort has been placed in IVF to search for the prize of selecting the most viable embryo to transfer ('the golden fleece of embryology'). To improve on morphology alone, artificial intelligence (AI) has also become a tool of interest, with many retrospective studies being published with impressive prediction capabilities.

Effectiveness of a Novel Web-Based Intervention to Enhance Therapeutic Relationships and Treatment Outcomes in Adult Individual Psychotherapy: Randomized Controlled Trial and Analysis of Predictors of Dropouts.

Background: Routine process and outcome monitoring interventions added to psychotherapy are known to improve treatment outcomes, although they vary in format and effectiveness.

Objective: This study aimed to evaluate whether a therapist-independent, internet-based routine process monitoring and feedback system could significantly reduce psychological distress and enhance the quality of the therapeutic relationship compared with a treatment-as-usual control group among individuals already engaged in individual psychotherapy.

Methods: We randomized 475 participants into either the intervention group, which received access to an internet-based routine process monitoring and feedback system in addition to psychotherapy, or the control group, which received only psychotherapy.

Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials.

Importance: Safe and effective long-term treatments for moderate to severe plaque psoriasis are needed.

Objective: To evaluate the long-term safety and efficacy of deucravacitinib through 3 years (week 148) in the randomized POETYK PSO-1, PSO-2, and nonrandomized long-term extension (LTE) trials.

Design, Setting, And Participants: PSO-1/PSO-2 were global, 52-week, randomized, double-blinded phase 3 trials in patients with moderate to severe plaque psoriasis.

Preparing Nurses for CD20-CD3 Bispecific Antibody Treatment in Patients With Non-Hodgkin Lymphoma: A Scoping Review of Adverse Events and Management Strategies From Early Phase and Pivotal Trials.

Background: Bispecific T-cell engaging antibodies (BsAbs) are novel agents used to treat B-cell non-Hodgkin lymphoma (B-NHL); these agents demonstrate a different toxicity profile compared with standard chemoimmunotherapy.

Objective: To describe common adverse events (AEs) experienced by patients with B-NHL during BsAb treatment.

Methods: MEDLINE, EMCARE, and EMBASE were searched for relevant studies.

The Evolving Role of Neoadjuvant Radiation Therapy in Pancreatic Adenocarcinoma.

Background/objectives: Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest cancers. Surgical resection is the most reliable chance for cure, but high rates of positive margins and local failure persist. Neoadjuvant therapies (NAT), including chemotherapy and radiation therapy (RT), are being explored to improve surgical outcomes, particularly in borderline resectable (BRPC) and locally advanced pancreatic cancer (LAPC).

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial.

Background: Sphingosine-1-phosphate (S1P) is a signalling molecule that has an inhibitory role in atherosclerosis, inflammation, cell proliferation, and immunity. Cenerimod is a selective S1P receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving standard of care background therapy.

Neuropsychological Outcomes in 6-Year-Old Children of Women With Epilepsy: A Prospective Nonrandomized Clinical Trial.

Importance: Antiseizure medications (ASMs) are potential teratogens commonly prescribed for multiple indications. ASM fetal exposure can impair neurodevelopment. Folate improves pregnancy outcomes, but higher doses may pose risks.

Quality of life outcomes in patients participating in the CALGB 30610 trial (CALGB 70702): Alliance.

Background: CALGB 30610 trial demonstrated that once daily thoracic radiotherapy (TRT) was not superior compared to standard twice daily TRT, in patients with limited stage small cell lung cancer. Quality of life outcomes may help oncologists decide the best treatment approach.

Methods: A total of 417 patients on CALGB 30610 participated in the quality-of-life substudy (CALGB 70702), which included the FACT Trial Outcome Index-Lung Cancer (FACT-L TOI), FACT-Esophageal Cancer (FACT-E) Eating and Swallowing Indices, ECOG Acute Esophagitis Scale, Hospital Anxiety and Depression Scale (HADS), difficulty swallowing, EQ-5D, and treatment convenience assessment at baseline, 3, 5, 7, 12, 26, and 52 weeks after starting TRT.

Diagnosis and management of mantle cell lymphoma: a consensus practice statement from the Australasian Lymphoma Alliance.

Mantle cell lymphoma (MCL) is a clinically heterogeneous B-cell neoplasm with unique clinicopathological features, accounting for 5% of all non-Hodgkin lymphoma. Although for many chemoimmunotherapy can lead to durable remissions, those with poor baseline prognostic factors, namely blastoid morphology, TP53 aberrancy and Ki67 >30%, will have less durable responses to conventional therapies. With this in mind, clinical trials have focused on novel targeted therapies to improve outcomes.