Publications by authors named "LS Gold"

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes. Patients received Tapinarof or vehicle cream QD for 8 weeks.

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Background: Psoriasis is a chronic inflammatory skin disease often associated with obesity. Psoriasis therapies may be less effective in patients with obese. The purpose of this expert consensus panel is to evaluate the relationship between obesity and efficacy of psoriasis therapies, thereby optimizing patient care.

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  • The study investigates the effects of using gabapentin alongside opioids compared to tricyclic antidepressants (TCAs) or duloxetine with opioids in older adults with spine-related issues.
  • Researchers analyzed data from 134,266 Medicare beneficiaries, focusing on mortality rates and major medical complications from 2017 to 2019.
  • They found no significant difference in mortality between the two groups, but those on gabapentin and opioids had a slightly higher risk of major medical complications.
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  • Topical clindamycin phosphate/adapalene/benzoyl peroxide (CAB) gel is approved for treating acne in patients 12 and older, and post hoc analyses examined its effectiveness in younger patients with acne.
  • Data from two studies showed that CAB significantly improved treatment success and reduced acne lesions in adolescents compared to a vehicle gel, with 51.5% of treated adolescents achieving success versus 24.9% with the vehicle.
  • The CAB gel was generally well tolerated, with most adverse events being mild to moderate, and it was effective for younger children as well, with significant lesion reductions observed in all treated children.
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Importance: The Oral Rheumatoid Arthritis Trial Surveillance demonstrated an increased cancer risk among patients with rheumatoid arthritis (RA) taking tofacitinib compared with those taking tumor necrosis factor inhibitors (TNFis). Although international cohort studies have compared cancer outcomes between TNFis, non-TNFi drugs, and Janus kinase inhibitor (JAKis), their generalizability to US patients with RA is limited.

Objective: To assess the comparative safety of TNFis, non-TNFi drugs, and JAKis among US patients with RA (ie, the cancer risk associated with the use of these drugs among these patients).

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Background Context: Recent work indicates no increased mortality risk with concurrent gabapentin and opioid use when using an active comparator control design. However, concurrent gabapentin and opioid prescriptions have been associated with greater risk of respiratory depression in some studies.

Purpose: To compare the risk of respiratory events among Medicare enrollees with spine-related diagnoses treated with gabapentin + opioids vs those treated with tricyclic antidepressants (TCA) or duloxetine + opioids.

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  • Topical CAB gel, a combination of clindamycin phosphate, adapalene, and benzoyl peroxide, is the only approved treatment for moderate-to-severe acne using a triple formulation, showing superior results in clinical studies compared to individual components.
  • In two phase 3 studies, participants aged 9 and older were treated with CAB or a placebo, resulting in over 70% reduction in acne lesions for all CAB-treated cases by week 12, with most achieving clear skin or a notable reduction in severity.
  • Overall findings indicated CAB is effective and well-tolerated, emphasizing the need for patient education on adherence and managing expectations regarding side effects.
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  • Clindamycin phosphate/adapalene/benzoyl peroxide gel (CAB) is the only approved triple-combination treatment for acne, and a post hoc analysis evaluated its efficacy and safety based on sex.
  • In two phase 3 clinical studies, participants aged 9 and older with moderate-to-severe acne were treated with CAB or a placebo for 12 weeks, and outcomes were analyzed by sex regarding treatment success, lesion counts, quality of life, and side effects.
  • Results showed that CAB was significantly more effective than the vehicle for both sexes in reducing acne severity and improving quality of life, with no notable differences in safety or efficacy between male and female participants.
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  • Janus kinase inhibitors (JAKis) are new treatment options for various skin conditions but come with safety concerns due to a boxed warning.
  • The article explores how to use JAKis safely and effectively for dermatological issues.
  • It also outlines monitoring guidelines to ensure patient safety during treatment.
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  • The study aimed to understand the complexities behind starting systemic treatments in patients with moderate-to-severe atopic dermatitis (AD).
  • It analyzed data from the CorEvitas AD Registry, revealing that many patients who seemed to have severe AD were not prescribed systemic therapies despite high disease burden and poor quality of life.
  • Significant factors linked to the initiation of systemic treatments included disease severity, previous biologic use, and patient-reported symptoms, suggesting more research is needed to uncover why some severely affected patients remain untreated.
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Objectives: To compare 12-month spinal fusion surgery rates in the setting of low back pain among digital musculoskeletal (MSK) program participants versus a comparison cohort who only received usual care.

Study Design: Retrospective cohort study with propensity score matched comparison cohort using commercial medical claims data representing over 100 million commercially insured lives.

Methods: All study subjects experienced low back pain between January 2020 and December 2021.

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Objective: To determine the frequency of physical therapy (PT) services and potential disparities in receiving PT among Medicare fee-for-service beneficiaries with a history of spine pain who live in long-term care (LTC) settings.

Design: Secondary cross-sectional analysis of Medicare administrative data on beneficiaries with a history of spine pain from 2017-2019. We identified LTC residents using a validated algorithm, then identified and described PT episodes that occurred after the LTC index date.

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  • The study analyzes the effectiveness and safety of a new acne treatment gel (CAB) that combines clindamycin, adapalene, and benzoyl peroxide, focusing on both pediatric (<18 years) and adult populations.
  • In a phase 3 trial involving participants aged 9 and older, CAB was found to significantly improve acne symptoms more than the vehicle gel after 12 weeks of treatment, with success rates of 52.7% in pediatric and 45.9% in adult participants.
  • The results indicated that CAB led to greater reductions in both inflammatory and non-inflammatory acne lesions and improved quality of life while demonstrating acceptable safety and tolerability across all age groups.
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  • Oral isotretinoin is a key treatment for severe nodular acne, with newer formulations like lidose and micronized isotretinoin developed to improve effectiveness.
  • A group of expert dermatologists created five consensus statements on these novel formulations, focusing on their efficacy, tolerability, and side effects, all of which received strong agreement.
  • Micronized isotretinoin is noted for its increased bioavailability, potentially requiring lower doses and no need for cumulative dosing calculations, making it a flexible option in acne treatment.
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Importance: Given the negative impact of opioid use on population health, prescriptions for alternative pain-relieving medications, including gabapentin, have increased. Concurrent gabapentin and opioid prescriptions are commonly reported in retrospective studies of opioid-related overdose deaths.

Objective: To determine whether people who filled gabapentin and opioid prescriptions concurrently ('gabapentin + opioids') had greater mortality than those who filled an active control medication (tricyclic antidepressants [TCAs] or duloxetine) and opioids concurrently ('TCAs/duloxetine + opioids').

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Objectives: To compare 12-month total knee arthroplasty (TKA) and total hip arthroplasty (THA) rates for digital musculoskeletal (MSK) program members vs patients who received traditional care for knee or hip osteoarthritis (OA).

Study Design: Retrospective, longitudinal study with propensity score-matched comparison group that used commercial medical claims data representing more than 100 million commercially insured lives.

Methods: Study participants with hip OA (M16.

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  • - The study shows that a once-daily, three-in-one topical acne treatment (CAB gel) combining an antibiotic, antibacterial, and retinoid leads to faster and greater improvements in acne lesions compared to dual combinations or vehicle gel.
  • - In phase 2 and phase 3 trials, CAB gel users saw significant reductions in both inflammatory and noninflammatory acne lesions as early as week 4, with better results sustained over 12 weeks.
  • - By the end of the 12-week treatment, a higher percentage of participants using CAB gel achieved significant reductions in their acne compared to those using other combinations or placebo treatments.
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  • Rosacea is a common chronic skin condition in the USA that causes social and professional stigma, making effective management important for improving patients' quality of life.
  • Encapsulated benzoyl peroxide 5% (E-BPO 5%) is a new FDA-approved topical treatment that enhances therapeutic response and reduces skin irritation, though it isn't yet in clinical guidelines.
  • A review of various FDA-approved treatments, including E-BPO 5%, highlights its rapid efficacy, good tolerability, and potential long-term benefits for managing rosacea-related symptoms.
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  • Topical acne trials face challenges from high responses to placebo treatments and varied outcome measures, complicating treatment comparisons; number needed to treat (NNT) offers a straightforward way to evaluate effectiveness indirectly.
  • Among 13 acne treatments analyzed, the effectiveness varied significantly, with a triple-combination gel showing the highest treatment success rates, leading to favorable NNTs of 4 and 5.
  • The study concludes that using consistent outcome measures and similar patient demographics highlights triple-combination gel and adapalene/BPO gel as the most effective options based on NNT results.
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Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years or older with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported.

Methods: In the pivotal trials, patients with moderate-to-severe acne vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months.

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Background: Dornase alfa and hypertonic saline are mucoactive therapies that can improve respiratory symptoms in people with cystic fibrosis (CF). A recent randomized control trial showed that participants with well-preserved pulmonary function taking elexacaftor + tezacaftor + ivacaftor (ETI) who discontinued dornase alfa or hypertonic saline for 6 weeks had no clinically meaningful decline in lung function. This may prompt discussions with care providers regarding ongoing use of these medications.

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Objective: It remains unknown whether frailty status portends an increased risk of adverse outcomes in patients with rheumatoid arthritis (RA) initiating biologic or targeted-synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs). The objective of our study was to evaluate the association between frailty and serious infections in a younger population of patients (<65 years old) with RA who initiated b/tsDMARDs.

Methods: Using MarketScan data, we identified new users of tumor necrosis factor inhibitors (TNFi), non-TNFi biologic DMARDs, or Janus kinase inhibitors (JAKi) between 2008 and 2019 among those with RA.

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Previous studies indicate that hospital rather than home treatment of pulmonary exacerbations (PEx) in people with cystic fibrosis (CF) can improve outcomes. We evaluated characteristics of adult participants from the Standardized Treatment of Pulmonary Exacerbations (STOP2) trial with two separate comparisons: (1) those who were treated initially in hospital (N = 768) to those treated initially at home (N = 214) and (2) those treated only in hospital (N = 328) to those who were treated only at home or both at home and in hospital (N = 654). Participants who had Medicaid insurance, were treated for shorter duration, and traveled longer to reach treatment centers were more likely to have been treated initially in the hospital.

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Acne has psychosocial effects on patient's quality of life (QoL). This post hoc exploratory analysis of pooled phase 3 data assessed the impact of investigational IDP-126 gel (for moderate to severe acne) on the Acne-Specific Quality of Life Questionnaire (Acne-QoL; exploratory endpoint in the trials).  Methods: A post hoc exploratory analysis using pooled data (N=309; age ≥13 years) was conducted to assess if 1) changes from baseline to week 12 in Acne-QoL domain scores significantly differ by treatment; 2) differences were clinically meaningful, and 3) relative importance of acne severity as measured by the Evaluator's Global Severity Score (EGSS) or lesion counts explains the changes in QoL (Acne-QoL).

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Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented.  Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months.

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