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.
View Article and Find Full Text PDFBackground: 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.
View Article and Find Full Text PDFImportance: 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).
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.
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.
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.
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').
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.
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.
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.
View Article and Find Full Text PDFObjective: 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.
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.
View Article and Find Full Text PDFAcne 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).
View Article and Find Full Text PDFBackground: 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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