Publications by authors named "Marco DiBonaventura"

Patients with triple-class refractory (TCR) multiple myeloma (MM) have limited treatment options and poor prognoses. This high unmet need has prompted the development of new therapies allowing for improved outcomes for these patients. Recently, new targeted therapies for the treatment of patients with relapsed or refractory MM have been approved based on single-arm clinical trial results.

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Article Synopsis
  • Relapsed or refractory multiple myeloma (RRMM) significantly affects patients' health-related quality of life (QOL), causing both physical and emotional burdens.
  • An analysis of patient-reported outcomes (PROs) from the MagnetisMM-3 study on elranatamab showed early improvements in symptoms, such as reduced pain and better health outlooks for patients new to and those previously treated with BCMA therapy.
  • Approximately 40.2% of BCMA-naive and 52.6% of BCMA-exposed patients reported feeling 'a little better' or 'much better' by Cycle 1, Day 15, indicating that elranatamab not only offers clinical benefits but may also enhance
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Article Synopsis
  • - In the MagnetisMM-3 trial, the efficacy of elranatamab was compared to physician's choice treatment for patients with triple-class refractory multiple myeloma, showing promising results for the new therapy.
  • - Analysis of two oncology databases (COTA and Flatiron Health) revealed that patients treated with elranatamab had a higher objective response rate, longer progression-free survival, and better overall survival compared to those receiving standard physician-selected treatments.
  • - Elranatamab demonstrated significant benefits for BCMA-naive patients, suggesting it may be a more effective option compared to treatments commonly used in clinical practice.
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Background: Abrocitinib, an oral, once-daily Janus kinase 1-selective inhibitor, improved itch severity, sleep, and work productivity versus placebo in patients with moderate-to-severe atopic dermatitis.

Objective: The aim of this study was to investigate relationships among itch, sleep, and work productivity in the phase III JADE MONO-2 clinical trial.

Methods: A repeated-measures longitudinal model was used to examine relationships between itch (using the Peak Pruritus Numerical Rating Scale [PP-NRS] or Nighttime Itch Scale [NTIS]) and sleep disturbance/loss (using the Patient-Oriented Eczema Measure sleep item and SCORing AD Sleep Loss Visual Analog Scale) and, separately, between itch and work productivity (using the Work Productivity and Activity Impairment-Atopic Dermatitis Version 2.

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Background: Abrocitinib improved signs and symptoms of moderate-to-severe atopic dermatitis (AD) at 12 or 16 weeks in phase 3 studies with a manageable safety profile. Further understanding of the abrocitinib long-term efficacy and safety profile is important for its appropriate use in treating chronic AD.

Objective: To evaluate the abrocitinib efficacy up to 48 weeks and long-term safety in patients with moderate-to-severe AD.

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What Is This Summary About?: Atopic dermatitis (AD, also called atopic eczema) is a skin disease that that can affect a person for a long time and causes red or flaky skin that can be itchy and uncomfortable. Healthcare providers can prescribe medicated creams and ointments to reduce the visible signs and symptoms of AD, but these treatments are not always enough to keep it under control. A new medicine called abrocitinib is taken every day as a tablet.

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Background: Traditional systemic immunosuppressants and advanced therapies improve signs and symptoms of moderate-to-severe atopic dermatitis (AD). However, data are limited in severe and/or difficult-to-treat AD. In the phase 3 JADE COMPARE trial of patients with moderate-to-severe AD receiving background topical therapy, once-daily abrocitinib 200 mg and 100 mg showed significantly greater reductions in the symptoms of AD than placebo and significantly greater improvement in itch response (with abrocitinib 200 mg) than dupilumab at week 2.

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Objectives: To have confidence in one's interpretation of treatment effects assessed by comparing trial results to external controls, minimizing bias is a critical step. We sought to investigate different methods for causal inference in simulated data sets with measured and unmeasured confounders.

Methods: The simulated data included three types of outcomes (continuous, binary, and time-to-event), treatment assignment, two measured baseline confounders, and one unmeasured confounding factor.

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Background: Patients with ulcerative colitis (UC) often report impaired health-related quality of life (HRQoL). Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of UC. In addition to previous demonstrations of improved clinical measures (e.

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Background: Abrocitinib, an oral Janus kinase 1 inhibitor, provided significant itch relief by week 2 in patients with moderate-to-severe atopic dermatitis (AD) in the phase III JADE COMPARE trial.

Objectives: This post-hoc analysis of JADE COMPARE aimed to further characterize itch response and determined whether early itch relief could predict subsequent improvements in AD severity.

Methods: JADE COMPARE was a randomized, double-blind, double-dummy, placebo-controlled trial.

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Article Synopsis
  • Emerging treatments for moderate-to-severe atopic dermatitis (AD), like abrocitinib and dupilumab, are being studied for faster and more significant improvements compared to current therapies.* -
  • In the study, adults were randomly assigned to receive different treatments, and stringent efficacy measures showed that those taking abrocitinib (200 mg and 100 mg) experienced much better outcomes in various metrics than those on placebo.* -
  • The results indicated that a higher percentage of patients on abrocitinib achieved significant improvement in skin condition and quality of life compared to the placebo group, highlighting its effectiveness.*
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Background: Phase 3 trials have assessed efficacy of abrocitinib versus placebo in moderate-to-severe atopic dermatitis, a common immunoinflammatory skin disease. This study assessed the efficacy and safety of abrocitinib versus dupilumab.

Methods: This randomised, double-blind, double-dummy, active-controlled, parallel-treatment, phase 3 trial enrolled adults with moderate-to-severe atopic dermatitis who requir=ed systemic therapy or had inadequate response to topical medications.

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Introduction: Atopic dermatitis (AD) is associated with significant quality-of-life and economic burdens. Real-world evidence is needed to identify optimal treatment pathways for AD. Here we evaluate real-world effectiveness of systemic therapies for moderate-to-severe AD in the USA.

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Background: Abrocitinib, a once-daily, oral Janus kinase 1 selective inhibitor, was shown to be an effective treatment for moderate-to-severe atopic dermatitis in phase 2 b/3 monotherapy trials.

Methods: These analyses included data for Investigator's Global Assessment responder (clear [0] or almost clear [1] with ≥2-grade improvement) and nonresponder patients with moderate-to-severe atopic dermatitis who received abrocitinib (200 mg or 100 mg) or placebo in three abrocitinib monotherapy trials (phase 2 b, NCT02780167; two phase 3, NCT03349060/JADE MONO-1 and NCT03575871/JADE MONO-2). Outcomes measuring skin clearance, itch, and quality of life were evaluated.

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Background: Many patients with atopic dermatitis (AD) have a suboptimal response to systemic therapy.

Objective: This study assessed predictors of nonresponse to dupilumab in patients with AD.

Methods: Data (April 2017 through June 2019) for patients aged 12 years and above with AD (International Classification of Diseases-9/10-Clinical Modification: 691.

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Article Synopsis
  • The study aimed to understand how well Japanese patients with moderate to severe ulcerative colitis stick to their biologic treatments and how this affects their health care usage.
  • Data was collected from a database over a period of four years, examining both before and after patients started biologic therapy.
  • Results showed that adherence to the biologic adalimumab was higher than infliximab, but infliximab had better long-term persistence; persistent patients had fewer hospitalizations but more outpatient visits compared to nonpersistent ones.
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Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with intense and persistent pruritus.

Objectives: To examine associations between AD symptoms and health-related quality of life (HRQoL) in adults (aged ≥18 years) with moderate-to-severe AD.

Materials & Methods: Patient chart and survey data from physicians within Europe were derived from the Adelphi AD Disease Specific Programme (Q3 2019-Q2 2020).

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Background: Biologic therapies are often used in patients with ulcerative colitis (UC) who are nonresponsive to conventional treatments. However, nonresponse or loss of response to biologics often occurs, leading to dose escalation, combination therapy, and/or treatment switching. We investigated real-world treatment patterns of biologic therapies among patients with UC in the USA.

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Atopic dermatitis (AD, also called atopic eczema) is a long-term skin disease that causes intensely itchy, red skin. Healthcare providers can prescribe medicated creams and ointments to reduce the signs and symptoms of AD. However, these treatments are not always enough to provide relief.

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Background: The heterogeneous course of moderate-to-severe atopic dermatitis necessitates treatment flexibility.

Objective: We evaluated the maintenance of abrocitinib-induced response with continuous abrocitinib treatment, dose reduction or withdrawal, and response to treatment reintroduction following flare (JAK1 Atopic Dermatitis Efficacy and Safety [JADE] REGIMEN: National Clinical Trial 03627767).

Methods: Patients with moderate-to-severe atopic dermatitis responding to open-label abrocitinib 200 mg monotherapy for 12 weeks were randomly assigned in a 1:1:1 ratio to blinded abrocitinib (200 or 100 mg) or placebo for 40 weeks.

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Importance: Dupilumab subcutaneous injection is approved for treating moderate-to-severe atopic dermatitis (AD) in adolescents, but there has been too little research on an efficacious systemic oral treatment with a favorable benefit-risk profile for adolescents with moderate-to-severe AD.

Objective: To investigate the efficacy and safety of oral abrocitinib plus topical therapy in adolescents with moderate-to-severe AD.

Design, Setting, And Participants: The phase 3, randomized, double-blind, placebo-controlled study JADE TEEN was conducted in countries of the Asia-Pacific region, Europe, and North America in patients aged 12 to 17 years with moderate-to-severe AD and an inadequate response to 4 consecutive weeks or longer of topical medication or a need for systemic therapy for AD.

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Background: The expanding number of potential treatment options for atopic dermatitis (AD) highlights the need to better understand the treatment preferences of individuals with AD.

Objective: This study identified attributes that most greatly influenced treatment preferences of adults/adolescents/caregivers of children with mild/moderate/severe AD.

Methods: Adults (≥18 years), adolescents (12-17 years), and caregivers of children (2-11 years) with mild, moderate, or severe AD in the United States (US) and United Kingdom (UK) participated in semistructured interviews.

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Background: Itch, the most bothersome symptom in atopic dermatitis, is largely mediated by pruritogenic cytokines via Janus kinase 1 signaling in cutaneous sensory neurons.

Objectives: The aims of the study were to assess the magnitude and rapidity of itch relief with the Janus kinase 1 selective inhibitor abrocitinib and to evaluate the extent to which the effect of abrocitinib on itch relief is independent of overall disease improvement.

Methods: Pooled data from 1 phase 2b (NCT02780167) and 2 phase 3 (NCT03349060, NCT03575871) double-blind, randomized, placebo-controlled monotherapy trials in moderate to severe atopic dermatitis (N = 942) were analyzed.

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