Publications by authors named "Dalia Wajsbrot"

Article Synopsis
  • The ALLEGRO study assessed the effectiveness and safety of ritlecitinib, a treatment for alopecia areata (AA), focusing on patient-reported hair loss outcomes.
  • Patients aged 12 and older with significant scalp hair loss participated in a 48-week trial comparing different dosages of ritlecitinib to a placebo.
  • Results showed that 5-36% of ritlecitinib patients reported improved hair loss after 24 weeks, which correlated with positive changes in emotional symptoms and activity limitations, indicating the treatment's beneficial effects.
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Article Synopsis
  • This study investigates the effectiveness and safety of ritlecitinib, a treatment for alopecia areata (AA), over 48 weeks in patients with varying responses by Week 24.
  • Results showed that over 85% of patients who had good responses at Week 24 maintained their improvement, while some nonresponders also began to show better results by Week 48.
  • The study had a small sample size, but it concludes that ritlecitinib can lead to sustained hair regrowth in many patients with AA.
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Article Synopsis
  • A post-hoc analysis of the ALLEGRO study assessed the effects of ritlecitinib, an oral JAK inhibitor, in treating patients aged 12 and older with alopecia totalis (AT) and alopecia universalis (AU) over 48 weeks.
  • Out of 718 patients, those treated with ritlecitinib showed significantly higher hair regrowth response rates compared to the placebo group, improving from week 24 to week 48.
  • Ritlecitinib was well tolerated, demonstrating clinical efficacy and an acceptable safety profile for patients with both AT and AU.
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Article Synopsis
  • A subgroup analysis of the ALLEGRO trial tested ritlecitinib, a medication for alopecia areata (hair loss), in adolescents aged 12-17 to assess its effectiveness and safety.
  • In the study, adolescents with over 50% scalp hair loss received different doses of ritlecitinib or a placebo for 24 weeks, followed by a 24-week extension where some switched to ritlecitinib.
  • Results showed significant hair regrowth in those taking ritlecitinib, with 25%-50% achieving substantial improvement after 48 weeks, while common side effects included headache and acne, but there were no serious safety concerns.
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Article Synopsis
  • The ALLEGRO-2b/3 clinical trial tested the effectiveness and safety of ritlecitinib, a daily pill for treating alopecia areata (AA), an autoimmune disease leading to hair loss.
  • The study involved adults and adolescents, with participants taking ritlecitinib showing significantly more hair regrowth compared to a placebo after 24 weeks, with improvements observed on the scalp, eyebrows, and eyelashes.
  • Ritlecitinib was found to be an effective and well-tolerated treatment for 48 weeks, with side effects being similar in both ritlecitinib and placebo groups, mostly mild to moderate.
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Article Synopsis
  • Alopecia areata causes non-scarring hair loss on the scalp and body, and this study explored the effectiveness and safety of ritlecitinib, an oral medication that inhibits certain kinases, in treating this condition.* -
  • The research was a randomized, double-blind trial across 118 sites in 18 countries, enrolling patients aged 12 and older with significant scalp hair loss, who were assigned to receive either ritlecitinib or a placebo for 24 weeks.* -
  • A total of 718 patients participated, with a majority being female (62%) and White (68%), while 104 patients discontinued treatment during the trial due to various reasons, including adverse events.*
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Pediatric drug development has many unique challenges, one of which is the evaluation of growth and development changes in children that are expected and are not due to the study intervention. Children grow and mature at different pace. The potential impact of the drug could vary with the developmental age of the participants receiving the treatment.

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Introduction: This exploratory analysis assessed efficacy and safety outcomes in patients with Gram-negative bacteremia treated with ceftazidime-avibactam or comparator across five phase 3, randomized, controlled, multi-center trials in adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)/pyelonephritis, hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP).

Methods: In each trial, RECLAIM and RECLAIM 3 (cIAI; NCT01499290/NCT01726023), REPRISE (cIAI/cUTI; NCT01644643), RECAPTURE (cUTI; NCT01595438/NCT01599806), and REPROVE (HAP/VAP; NCT01808092), patients were randomized 1:1 to intravenous ceftazidime-avibactam (plus metronidazole for those with cIAI) or comparators (carbapenems in > 97% patients) for 5-21 days. Efficacy assessments included clinical and microbiological responses at the test-of-cure visit in the pooled Gram-negative extended microbiologically evaluable (GNeME) population (bacteremia subset).

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Purpose/background: Heterogeneity has been documented in trajectories of symptom change during antidepressant treatment for major depressive disorder (MDD). It is unclear whether distinct trajectories of change exist for functioning during antidepressant treatment.

Methods/procedures: This analysis explored distinct trajectories of functioning in MDD and tested whether they corresponded to trajectories of symptom change.

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Objective: To identify clusters of patients with major depressive disorder (MDD) based on the baseline 17-item Hamilton Rating Scale for Depression (HAM-D) items and to evaluate the efficacy of venlafaxine extended release (VEN) vs placebo, and the potential effect of dose on efficacy, in each cluster.

Methods: Cluster analysis was performed to identify clusters based on standardized HAM-D item scores of individual patient data at baseline from 9 double-blind, placebo-controlled studies of VEN for MDD. Change from baseline in HAM-D total score was analyzed using a mixed-effects model for repeated measures for each cluster; response and remission rates at week 8 were analyzed using logistic regression.

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Background: Major depressive disorder is characterized by the presence of at least five of nine specific symptoms that contribute to clinically significant functional impairment. This analysis examined the effect of desvenlafaxine (50 or 100 mg) versus placebo on symptom cluster scores and the association between early improvement in symptom clusters and symptomatic or functional remission at week 8.

Methods: Using data from nine double-blind, placebo-controlled studies of desvenlafaxine for the treatment of major depressive disorder (=4317), the effect of desvenlafaxine 50 or 100 mg versus placebo on scores for symptom clusters based on 17-item Hamilton Rating Scale for Depression items was assessed using analysis of covariance.

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Background: Ceftazidime-avibactam is effective and well tolerated in adults with complicated urinary tract infection (cUTI), but has not been evaluated in children with cUTI.

Methods: This single-blind, multicenter, active-controlled, phase 2 study (NCT02497781) randomized children ≥3 months to <18 years with cUTI (3:1) to receive intravenous (IV) ceftazidime-avibactam or cefepime for ≥72 hours, with subsequent optional oral switch. Total treatment duration was 7-14 days.

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Background: Ceftazidime-avibactam plus metronidazole is effective in the treatment of complicated intra-abdominal infection (cIAI) in adults. This single-blind, randomized, multicenter, phase 2 study (NCT02475733) evaluated the safety, efficacy and pharmacokinetics of ceftazidime-avibactam plus metronidazole in children with cIAI.

Methods: Hospitalized children (≥3 months to <18 years) with cIAI were randomized 3:1 to receive intravenous ceftazidime-avibactam plus metronidazole, or meropenem, for a minimum of 72 hours (9 doses), with optional switch to oral therapy thereafter for a total treatment duration of 7-15 days.

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Objective: The value of early functional improvement at week 2 for predicting subsequent functional outcomes at week 8 was assessed in a pooled analysis of patients with major depressive disorder (MDD) treated with desvenlafaxine (50 or 100 mg/d) or placebo.

Methods: Data were pooled from eight double-blind, placebo-controlled studies of desvenlafaxine 50 mg/d or 100 mg/d for the treatment of MDD. Optimal week-2 improvement thresholds in Sheehan Disability Scale (SDS) score, which best predicted week-8 treatment success, were determined using receiver operating characteristic (ROC) analysis.

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Effects of baseline anxiety on the efficacy of venlafaxine extended release versus placebo were examined in a post hoc pooled subgroup analysis of 1573 patients enrolled in eight short-term studies of major depressive disorder. Anxiety subgroups were defined based on baseline 17-item Hamilton Rating Scale for Depression Item 10 score <3 (low) versus ≥3 (high). Change from baseline to final visit in Montgomery-Åsberg Depression Rating Scale total score and Montgomery-Åsberg Depression Rating Scale response and remission rates were analyzed.

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Background Evidence suggests that patients with higher blood pressure variability ( BPV ) have a higher risk for stroke, but any link between BPV and stroke recurrence is unknown among those who had a stroke or transient ischemic attack ( TIA ). Methods and Results Data for patients with a history of stroke or TIA at enrollment were extracted from the ASCOT (Anglo Scandinavian Cardiac Outcomes Trial) and the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). BPV was defined as the within-subject standard deviation or coefficient of variation of systolic blood pressure across visits from 12 weeks poststroke or TIA onward.

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Objective: Two similarly designed extension studies evaluated the long-term safety and tolerability of desvenlafaxine for the treatment of children and adolescents with major depressive disorder (MDD). Efficacy was evaluated as a secondary objective.

Methods: Both 6-month, open-label, flexible-dose extension studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies.

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Objective: To examine methylphenidate extended-release chewable tablets (MPH ERCT) dose patterns, attention-deficit/hyperactivity disorder (ADHD) symptom scores, and safety during the 6-week, open-label (OL) dose-optimization period of a phase 3, laboratory classroom study.

Methods: Boys and girls (6-12 years) diagnosed with ADHD were enrolled. MPH ERCT was initiated at 20 mg/day; participants were titrated in 10-20 mg/day increments weekly based on efficacy and tolerability (maximum dose, 60 mg/day).

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Objectives: To evaluate the short-term efficacy and safety of desvenlafaxine (25-50 mg/d) compared with placebo in children and adolescents with major depressive disorder (MDD).

Methods: Outpatient children (7-11 years) and adolescents (12-17 years) who met DSM-IV-TR criteria for MDD and had screening and baseline Children's Depression Rating Scale-Revised (CDRS-R) total scores >40 were randomly assigned to 8-week treatment with placebo, desvenlafaxine (25, 35, or 50 mg/d based on baseline weight), or fluoxetine (20 mg/d). The primary efficacy endpoint was change from baseline in CDRS-R total score at week 8, analyzed using a mixed-effects model for repeated measures.

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Objective: To evaluate the short-term efficacy and safety of desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder (MDD).

Methods: Outpatient children (7-11 years) and adolescents (12-17 years) who met DSM-IV-TR criteria for MDD and had screening and baseline Children's Depression Rating Scale-Revised (CDRS-R) total scores >40 were randomly assigned to 8 weeks of treatment with placebo, low exposure desvenlafaxine (20, 30, or 35 mg/day based on baseline weight), or higher exposure desvenlafaxine (25, 35, or 50 mg/day based on baseline weight). The primary efficacy endpoint was change from baseline in CDRS-R total score at week 8, analyzed using a mixed-effects model for repeated measures.

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Purpose/background: This post hoc analysis examined the time point at which clinically significant improvement in major depressive disorder (MDD) symptoms occurs with desvenlafaxine versus placebo.

Methods: Data were pooled from 9 short-term, double-blind, placebo-controlled studies in adults with MDD randomly assigned to desvenlafaxine 50 mg/d, 100 mg/d, or placebo. A mixed-effects model for repeated-measures analysis of change from baseline score was used to determine the time point at which desvenlafaxine treatment groups separated from placebo on the 17-item Hamilton Rating Scale for Depression and psychosocial outcomes.

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Nine randomized, double-blind, placebo-controlled studies of major depressive disorder were pooled to evaluate the effects of desvenlafaxine 50- and 100-mg/d on energy and lassitude in adults with major depressive disorder ( n=4279). Changes from baseline to endpoint in 17-item Hamilton Rating Scale for Depression (HAM-D) Work and Activities, Retardation, and Somatic Symptoms General items, HAM-D psychomotor retardation factor, and Montgomery-Åsberg Depression Rating Scale Lassitude item were analyzed with a mixed model for repeated measures analysis of variance. Associations between residual energy measures and functional impairment, based on the Sheehan Disability Scale, were modeled using stepwise multiple linear regression.

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Objective: To evaluate the short-term efficacy of venlafaxine extended release (ER) 75-225 mg/day compared with placebo for treating major depressive disorder (MDD) and to examine associations between baseline characteristics and efficacy outcomes in MDD patients treated with venlafaxine ER 75-225 mg/day.

Research Design And Methods: This meta-analysis included published and unpublished short-term, double-blind, placebo-controlled, Wyeth/Pfizer sponsored studies of venlafaxine ER at doses up to 225 mg/day in adults with MDD.

Clinical Trial Registration: All trials were conducted before trial registration became mandatory.

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The long-term cardiovascular (CV) effects of calcium channel blockers, with special focus on amlodipine, were compared with other classes of antihypertensive medications in high-risk hypertensive patient subgroups. A systematic literature review and meta-analysis was undertaken of 38 unique randomized, active-controlled, parallel-group trials comparing amlodipine/calcium channel blockers with diuretics, β-blockers, α-blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers, with ≥6-month follow-up, and which had included assessment of blood pressure (BP) and CV events [all-cause death, CV death, myocardial infarction (MI), stroke, congestive heart failure (CHF), or major CV events (MACE: MI, CHF, stroke, and CV death)], in hypertensive patients (baseline systolic/diastolic BP ≥140/≥90 mm Hg) with either concomitant diabetes and/or renal dysfunction. In hypertensive patients with diabetes, no difference was found for amlodipine versus comparators with respect to all-cause death, CV death, MACE, and MI; a decrease in stroke risk, and an increase in CHF risk, was seen.

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