Objective: Patients with psoriatic arthritis (PsA) in randomized controlled trials (RCTs) may not reflect patients with PsA in clinical practice. Our objective was to perform a metaanalysis comparing the characteristics of patients with PsA in RCTs of biologic disease-modifying antirheumatic drugs (bDMARDs) to patient profiles in a real-world study.
Methods: Data sources included (1) a scoping literature review of phase III RCTs of bDMARDs in PsA published between 2015 and 2020, and (2) an international observational study of patients with PsA starting a bDMARD enrolled between 2015 and 2018 (PsABio; ClinicalTrials.
Objectives: Warm autoimmune hemolytic anemia (wAIHA) is a rare autoantibody-mediated disorder, and first-line treatment primarily relies on corticosteroids. This study assessed overall survival (OS) and treatment patterns of wAIHA in Sweden.
Methods: Adults with ≥ 1 primary diagnosis code for wAIHA (or AIHA plus oral corticosteroids (OCS)/immunosuppressants as sensitivity analyses) between 2011 and 2022 were identified from five Swedish national registers and linked through each patient's unique identity number.
Ann Clin Transl Neurol
September 2024
Introduction: Two biologic therapies for psoriatic arthritis (PsA), guselkumab and ustekinumab, have demonstrated superior efficacy versus placebo in clinical trials. However, no head-to-head studies have been conducted comparing these two treatments for PsA. The objective was to indirectly compare guselkumab and ustekinumab on joint and skin efficacy up to week 52, using pooled individual patient-level data (IPD) from PsA trials.
View Article and Find Full Text PDFBackground: Myasthenia gravis (MG) is a rare autoimmune disease characterised by muscle weakness, and progression from ocular (oMG) to generalised (gMG) symptoms results in a substantial negative impact on quality of life (QoL). This systematic review aimed to provide an overview of the patient burden experienced by people living with gMG.
Methods: Electronic database searches (conducted March 2022), supplemented by interrogation of grey literature, were conducted to identify studies reporting patient burden outcomes in patients with gMG in Europe, the Middle East and Africa.
We present a case of a 59-year-old man who arrived to the emergency department with abdominal pain and bruising after coughing. Point of care ultrasound (POCUS) was used to make the diagnosis of rectus sheath hematoma (RSH). This diagnosis was made within minutes of arrival to the ED and subsequently confirmed on computed tomography (CT) of the abdomen.
View Article and Find Full Text PDFBackground: Nipple-sparing mastectomy (NSM) and immediate breast reconstruction have demonstrated positive aesthetic outcomes and high patient satisfaction. However, challenges arise when performing NSM on patients with large and ptotic breasts because of the higher risk of nipple-areola complex (NAC) necrosis. This study proposes a new technique: the three pedicle-based nipple-sparing skin-reducing mastectomy (TP-NSSRM), combined with direct-to-implant (DTI) breast reconstruction, aimed at reducing complications.
View Article and Find Full Text PDFBackground: To evaluate the real-world effect of the IL-12/23 inhibitor ustekinumab or of a tumour necrosis factor inhibitor (TNFi) on patient-reported outcomes (PRO) and their association with effectiveness endpoints in psoriatic arthritis (PsA) patients over 3 years.
Methods: In PsABio (NCT02627768), a prospective, observational study, patients with PsA that were prescribed first- to third-line ustekinumab or a TNFi, and remained on that drug for 3 years, were analysed for change in baseline in PROs (EuroQol-5 dimensions health state VAS [EQ-5D VAS], 12-item Psoriatic Arthritis Impact of Disease questionnaire [PsAID-12; range 0-10], Work Productivity and Activity Impairment for Psoriatic Arthritis questionnaire [WPAI; results expressed as a percentage for each domain]), and the association between PROs and WPAI with effectiveness endpoints, clinical disease activity index for psoriatic arthritis (cDAPSA), low disease activity (LDA)/remission, minimal disease activity (MDA) and very low disease activity (VLDA).
Results: In 437 patients (mean age 49.
Background: This post-hoc analysis of PsABio (NCT02627768) evaluated safety, effectiveness and treatment persistence in patients < 60 and ≥ 60 years of age receiving ustekinumab over 3 years.
Methods: Measures included adverse events (AE), clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA) including remission, Psoriatic Arthritis Impact of Disease-12 (PsAID-12), Minimal Disease Activity, dactylitis, nail/skin involvement and time to treatment stop. Data were analysed descriptively.
Objectives: Psoriatic arthritis (PsA) phenotypes are typically defined by their clinical components, which may not reflect patients' overlapping symptoms. This post hoc analysis aimed to identify hypothesis-free PsA phenotype clusters using machine learning to analyse data from the phase III DISCOVER-1/DISCOVER-2 clinical trials.
Methods: Pooled data from bio-naïve patients with active PsA receiving guselkumab 100 mg every 8/4 weeks were retrospectively analysed.
Objective: Investigate effects of gender on disease characteristics and treatment impact in patients with PsA.
Methods: PsABio is a non-interventional European study in patients with PsA starting a biological DMARD [bDMARD; ustekinumab or TNF inhibitor (TNFi)]. This post-hoc analysis compared persistence, disease activity, patient-reported outcomes and safety between male and female patients at baseline and 6 and 12 months of treatment.
Objectives: To evaluate real-world persistence and effectiveness of the IL-12/23 inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis over 3 years.
Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months.
Objectives: To compare real-world persistence, effectiveness and tolerability of ustekinumab versus TNF inhibitors (TNFi) in psoriatic arthritis (PsA).
Methods: One-year data from Italian subjects enrolled in the PsABio study (PsA patients receiving 1st- to 3rd-line treatment with ustekinumab or TNFi) were evaluated. Treatment persistence was analysed using Kaplan-Meier curves; hazard ratios (HR) of stopping treatment, and the corresponding 95% confidence intervals (CI), were computed through Cox regression models.
Objectives: To evaluate the efficacy of guselkumab for the treatment of active PsA utilizing composite indices.
Methods: Data were pooled from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies. In both studies, patients were randomized 1:1:1 to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then Q8W; or placebo Q4W with crossover to guselkumab 100 mg Q4W at week 24.
Introduction: In the European Union (EU), a Risk Management Plan (RMP) is submitted as part of the dossier for initial marketing authorization of a medicinal product or with an application involving a significant change to an existing marketing authorization. A comprehensive revision of the EU Guideline on Good Pharmacovigilance Practices (GVP) Module V-Risk Management Systems (Revision [Rev] 2), adopted in March 2017, provides a framework for developing more focused, actionable, and risk-proportionate RMPs. This paper describes the Janssen experience with the interpretation and application of GVP Module V (Rev 2) regarding the evaluation of safety concerns in an RMP.
View Article and Find Full Text PDFObjective: We evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).
Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months.
Objective: To evaluate efficacy and safety of guselkumab, an anti-interleukin-23p19-subunit antibody, in patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFi).
Methods: Adults with active PsA (≥3 swollen and ≥3 tender joints) who discontinued ≤2 TNFi due to IR (lack of efficacy or intolerance) were randomised (2:1) to subcutaneous guselkumab 100 mg or placebo at week 0, week 4, then every 8 weeks (Q8W) through week 44. Patients receiving placebo crossed over to guselkumab at week 24.
Objectives: To evaluate 6-month effectiveness of ustekinumab versus tumour necrosis factor inhibitor (TNFi), analysing predictors of low disease activity (LDA)/remission.
Methods: PsABio is a prospective, observational cohort study of patients with psoriatic arthritis (PsA) at 92 sites in eight European countries, who received first-line to third-line ustekinumab or a TNFi. Comparative achievement at 6 months of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) LDA/remission, and minimal disease activity (MDA)/very LDA using propensity score (PS)-adjusted multivariate logistic regression was assessed.
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View Article and Find Full Text PDFBackground: More than 300,0000 breast plastic surgery procedures are performed annually worldwide, of which more than 100,000 are reduction mammoplasties carried out in the United States. Although most patients tend to be satisfied with the immediate outcomes of this procedure, there is increasing concern among surgeons as well as patients with regard to breast sensibility and the postoperative recovery.The objectives of this study were to assess the variation in the sensibility in patients undergoing hypertrophic breast surgery by quantification of the impact of various variables and to evaluate its progression from before the surgery to between 3 and 6 months and 1 year postoperatively.
View Article and Find Full Text PDFJ Plast Reconstr Aesthet Surg
December 2019
Background: Breast sensitivity is a significant issue in preoperative consultation prior to reduction mammoplasty. Although a range of techniques is used, recovery of sensation is usually evaluated using the inferior pedicle. Our objective was to evaluate and compare the change in breast sensitivity using the superomedial versus the superior pedicle.
View Article and Find Full Text PDFBackground: The deep inferior epigastric artery perforator (DIEP) flap is considered the gold standard in autologous breast reconstruction. In bilateral cases, both flaps are often anastomosed to the internal mammary vessels on either side of the sternum. The authors propose a method in which both flaps are anastomosed to only the right side internal mammary artery and vein.
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