An exploration of the domain specificity of maternal sensitivity among a diverse sample in the infancy period: Unique paths to child outcomes.

Maternal sensitivity during an observed mother-child clean-up task at 18 months and maternal sensitivity during an observed mother-child free-play task at 18 months were tested as independent predictors of child internalizing symptoms, externalizing symptoms, social competence, and language development at 24 months. Participants (n = 292 mothers) were recruited between 2015 and 2017, and were low-income (mean annual income = $19,136) and racially and ethnically diverse (43.8% Black; 44.2% Latinx). Maternal sensitivity during clean-up was a significant predictor of all social-emotional outcomes, and a unique predictor of child internalizing symptoms. Maternal sensitivity during free-play was a unique predictor of child language. Results suggest that context-specific subtypes of maternal sensitivity may differentially relate to early child outcomes.

Enhancing early language and literacy skills for racial/ethnic minority children with low incomes through a randomized clinical trial: The mediating role of cognitively stimulating parent-child interactions.

Parenting is a critical mediator of children's school readiness. In line with this theory of change, data from the randomized clinical trial of Smart Beginnings (tiered Video Interaction Project and Family Check-Up; N = 403, treatment arm n = 201) were used to examine treatment impacts on early language and literacy skills at child age 4 years (nLatinx = 168, nBlack = 198, nMale = 203), as well as indirect impacts through parental support of cognitive stimulation at child age 2 years. Although results did not reveal direct effects on children's early skills, there were significant indirect effects for early literacy (ß = .03, p = .05) and early language (ß = .04, p = .04) via improvements in parental cognitive stimulation. Implications for interventions targeting parenting to improve children's school readiness beginning at birth are discussed.

Integrating equifinality and multifinality into the of prevention programs in early childhood: The conceptual case for use of tiered models.

Introduced in the context of developmental psychopathology by Cicchetti and Rogosh in the Journal, the current paper incorporates the principles of equifinality and multifinality to support the use of tiered models to prevent the development of emerging child psychopathology and promote school readiness in early childhood. We use the principles of equifinality and multifinality to describe the limitations of applying one intervention model to address all children presenting with different types of risk for early problem behavior. We then describe the potential benefits of applying a tiered model for having impacts at the population level and two initial applications of this approach during early childhood. The first of these tiered models, Smart Beginnings, integrates the use of two evidenced-based preventive interventions, Video Interaction Project, a universal parenting program, and Family Check-Up, a selective parenting program. Building on the strengths of Smart Beginnings, the second trial, The Pittsburgh Study includes Video Interaction Project and Family Check-Up, and other more and less-intensive programs to address the spectrum of challenges facing parents of young children. Findings from these two projects are discussed with their implications for developing tiered models to support children's early development and mental health.

Promoting Cognitive Stimulation in Parents Across Infancy and Toddlerhood: A Randomized Clinical Trial.

OBJECTIVE: To test the impact of the fully integrated Smart Beginnings model on parental support of cognitive stimulation from 6 to 24 months across infancy and toddlerhood. STUDY DESIGN: This was a single-blind, 2-site randomized clinical trial of the Smart Beginnings intervention. Enrollment took place at birth in postpartum units of hospitals in New York City and Pittsburgh, Pennsylvania, with a consecutive sample of 403 mother-infant dyads. Smart Beginnings combines a Video Interaction Project-14-session universal primary prevention program delivered in the pediatric clinic at the time of well-child visits birth-36 months-with potential for Family Check-Up-3-4 sessions targeted secondary prevention home-visiting program. The principal outcome was parental support of cognitive stimulation assessed via parent survey and video-recorded observations of parent-child interactions. Ordinary least squares and mixed effects regressions were conducted. RESULTS: Families were mostly Black/African-American (50%) or Latinx (42%); all were Medicaid eligible (100%). Smart Beginnings significantly promoted cognitive stimulation during infancy and toddlerhood for most survey outcomes across time, including StimQ common total (effect size [ES] = 0.25, P = .01) and READ Quantity (ES = .19, P = .04) and Quality (ES = .30, P = .001). For the observations, the impact of Smart Beginnings varied by time, with significant impacts at 6 (ES = 0.37-.40, P < .001) and 24 (ES = 0.27-.30, P < .001) months, but not 18 months. CONCLUSIONS: Smart Beginnings positively promotes cognitive stimulation from infancy through toddlerhood using the integrated model. This study adds to the body of research showing preventive interventions in pediatric primary care and home visiting can support early relational health including parental support of cognitive stimulation. TRIAL REGISTRATION: NCT02459327.

Pre-pandemic support for shared reading buffers adverse parenting impacts: an RCT in Brazil.

BACKGROUND: To examine whether (1) a parent-child reading program (Universidade do Bebê [UBB]), conducted in Brazil pre-pandemic can support parenting and parent-child reading 6 months into the pandemic, (2) cognitive stimulation at pandemic onset mediates effects of UBB on these outcomes, and (3) UBB pre-pandemic buffers associations between COVID-19-related distress and parenting/parent-child reading 6 months into the pandemic. METHODS: 400 women, either pregnant or with children 0-24 months, were randomized to UBB (n = 200) or control groups. UBB consisted of monthly parent workshops focusing on parent-child reading and a book-lending library. Assessments pre-pandemic (June-2019) and at pandemic onset (April-2020) included cognitive stimulation. Assessments 6 months into the pandemic (October-2020) included COVID-19 exposure/impact/distress, as well as parenting and parent-child reading. RESULTS: 133 families (n = 69 UBB) contributed data 6 months into the pandemic. Participation in UBB pre-pandemic was associated with parent-child reading but not parenting 6 months into the pandemic. Indirect effects of UBB through cognitive stimulation at pandemic onset were observed for both outcomes. Increased COVID-19-related distress was significantly associated with reduced parenting/parent-child reading 6 months into the pandemic in the control group only. CONCLUSION: Promotion of cognitive stimulation pre-pandemic may have reduced risk for effects of the pandemic on parenting/parent-child reading. CLINICAL TRIAL REGISTRATION: The trial has been registered with the Brazilian Clinical Trials Registry RBR-29RZDH on 05/28/2018. IMPACT: This is the first study showing sustained impacts of a reading aloud intervention beginning in pregnancy and early infancy implemented pre-pandemic. Findings suggest that participation in a reading-aloud intervention buffered associations between COVID-19 distress and parenting/parent-child reading 6 months into the pandemic. Novel empirical evidence suggests that promotion of cognitive stimulation prior to the pandemic may buffer its impacts on parenting and parent-child book reading following onset in low- and middle-income countries. Findings provide important new support for implementation of parent-child reading aloud programs and likely have implications for early childhood development beyond the COVID-19 pandemic for disasters generally.

Maximizing the impact of reach out and read literacy promotion:anticipatory guidance and modeling.

BACKGROUND: Reach Out and Read (ROR) is a multi-component pediatric literacy promotion intervention. However, few studies link ROR components to outcomes. We examine associations between receipt of (1) multiple ROR components and (2) clinician modeling, a potential best practice, with enhanced home literacy environments (EHLEs) among Latino families. METHODS: We conducted secondary analyses of cross-sectional enrollment data from a randomized clinical trial at three urban community health centers between November 2020 and June 2023. Latino parents with infants 6-<9 months old were surveyed about ROR component receipt (children's book, anticipatory guidance, modeling) and EHLE (StimQ2- Infant Read Scale). We used mixed models with clinician as a random effect, adjusting for covariates. RESULTS: 440 Latino parent-infant dyads were included. With no components as the reference category, receipt of 1 component was not associated with EHLE. Receipt of 2 components (standardized beta = 0.27; 95%CI: 0.12-0.42) and 3 components (standardized beta = 0.33; 95% CI: 0.19-0.47) were associated with EHLE. In separate analyses, modeling was associated with EHLE (standardized beta = 0.16; 95%CI: 0.06-0.26). CONCLUSION: Findings support modeling as a core ROR component. Programs seeking to enhance equity by promoting EHLE should utilize such strategies as anticipatory guidance and clinician modeling in addition to book distribution. IMPACT: Reach Out and Read, a multi-component literacy promotion intervention, leverages primary care to promote equity in children's early language experiences. However, few studies link Reach Out and Read components to outcomes. Among Latino parent-infant dyads, we found that implementation of two and three components, compared to none, was associated with enhanced home literacy environments, following a dose response pattern. Parent report of clinician modeling was associated with enhanced home literacy environments. Literacy promotion programs seeking to enhance equity by promoting enhanced home literacy environments should utilize strategies in addition to book distribution, including anticipatory guidance and modeling, to maximize impact.

Supporting responsive parenting in real-world implementation: minimal effective dose of the Video Interaction Project.

BACKGROUND: The Video Interaction Project (VIP) is a healthcare-based intervention that provides real-time video-feedback of parent-child play and reading interactions to families with children aged 0 to 36 months. Although evidence from randomized controlled trials demonstrates improved early relational health, including responsive parenting, after three to five VIP visits, the minimal effective dose in real-world implementations is unknown. This study aimed to determine the minimal effective dose of VIP during a real-world implementation for changing responsive parenting behaviors. METHODS: We performed a longitudinal prospective study of 183 dyads at a public hospital pediatric clinic. Responsive parenting behaviors were assessed with an observational checklist utilized as part of standard VIP practice at baseline and two follow-up VIP visits. RESULTS: Multilevel models adjusted for baseline sociodemographics (child's sex and age, and maternal education) and time between visits showed that responsive parenting behaviors during parent-child reading and play significantly increased after a single VIP visit (Cohen's d = 0.52, p < 0.05) with additional impact following completion of a second visit (cumulative for 2 visits: d = 0.76, p < 0.05). CONCLUSIONS: A single VIP visit is associated with increased responsive parenting behaviors. Findings support offering VIP widely, regardless of capacity to ensure attendance at multiple visits. IMPACT: This is the first study showing the minimal effective dose of the Video Interaction Project (VIP) for increasing responsive parenting behaviors. Responsive parenting behaviors increased by over 22% following a single VIP visit, with a cumulative increase of 37% following the second visit compared to baseline. Findings have important implications for implementation and scalability of pediatric-based preventive programs that support early relational health through activities such as reading and play.

Impacts of a tiered intervention on child internalizing and externalizing behavior in the context of maternal depression.

Greater maternal depressive symptoms are consistently associated with higher levels of behavioral difficulties in children, emerging in early childhood and with long-lasting consequences for children's development. Interventions promoting early relational health have been shown to have benefits for children's behavior; however, these impacts are not always realized in the context of maternal depression. This study examined whether tiered programs could address this limitation by focusing on both parenting, through universal primary prevention, and psychosocial stressors and parent mental health, through tailored secondary prevention. Analysis of a randomized controlled trial (RCT) of the Smart Beginnings (SB) intervention was conducted to determine whether SB attenuated the association between maternal depression and early childhood internalizing and externalizing behaviors. Maternal depression significantly predicted both internalizing and externalizing behaviors in linear regression models. Further, there was a significant interaction between maternal depression and treatment group, such that among mothers with higher depressive symptoms, the SB treatment attenuated the magnitude of the association between depression and child behavior. Findings suggest that while parenting support is important for all families, it may be particularly critical for those with higher levels of depression and underscores the need to consider multidimensional family processes in both research and clinical practice.

Phase IIb randomized CONTROL study demonstrates a novel topical isotretinoin formulation, TMB-001, is safe and effective in participants with either recessive X-linked or autosomal recessive lamellar congenital ichthyosis.

BACKGROUND: In two severe congenital ichthyosis subtypes, autosomal recessive lamellar ichthyosis (ARCI-LI) and X-linked recessive ichthyosis (XLRI), cutaneous manifestations include widespread scaling. Approved topical treatment options are limited to emollients and keratolytics. AIM: This analysis from the randomized phase IIb CONTROL study assessed whether the efficacy and safety of TMB-001, a novel topical isotretinoin ointment formulation, differed between ARCI-LI and XLRI subtypes. METHODS: Participants ≥ 9 years with genetically confirmed XLRI or ARCI-LI and ≥ 2 (of 4) Visual Index for Ichthyosis Severity (VIIS) assessment areas with ≥ 3 scaling score were randomized 1 : 1 : 1 to TMB-001 0.05%/TMB-001 0.1%/vehicle, twice daily for 12 weeks. The proportion of participants with ≥ 50% reduction vs. baseline in VIIS scaling (VIIS 50; primary endpoint) and ≥ 2-grade reduction in Investigator's Global Assessment (IGA)-scaling score vs. baseline (key secondary endpoint) were evaluated. Adverse events (AEs) were monitored. RESULTS: Among enrolled participants (TMB-001 0.05%, n = 11; 0.1%, n = 10; and vehicle, n = 12), 52% had ARCI-LI and 48% XLRI subtypes. Mean age was 33.6 and 35.4 years for participants with ARCI-LI and XLRI, respectively. Overall, 33%, 50% and 17% of participants with ARCI-LI and 100%, 33% and 75% of participants with XLRI achieved VIIS 50 in the TMB-001 0.05%, TMB-001 0.1% and vehicle groups, respectively (nominal P = 0.24 for 0.05% vs. vehicle, intent-to-treat population). Improvement of ≥ 2-grade IGA score was observed in 33%, 50% and 0% of participants with ARCI-LI and 83%, 33% and 25% of participants with XLRI in the TMB-001 0.05%, TMB-001 0.1% and vehicle groups, respectively (nominal P = 0.03 for 0.05% vs. vehicle, intention-to-treat population). Most AEs were application-site reactions. CONCLUSION: Regardless of congenital ichthyosis subtype, TMB-001 demonstrated greater proportions of participants achieving VIIS 50 and ≥ 2-grade IGA improvement vs. vehicle.

Characteristics and outcomes for participants with congenital ichthyosis who responded to treatment with the topical isotretinoin formulation TMB-001: results from the Phase IIb CONTROL study.

BACKGROUND: Emollients and keratolytics are frequently used to manage symptoms of congenital ichthyosis (CI). Systemic retinoid treatment is complicated by teratogenicity and dose-limiting adverse effects. OBJECTIVES: This analysis from the randomized Phase IIb CONTROL study investigated the characteristics of participants who responded to treatment with TMB-001, a novel topical isotretinoin ointment formulation. METHODS: Participants ≥ 9 years of age with genetically confirmed CI and ≥ 2 (out of 4) Visual Index for Ichthyosis Severity (VIIS) assessment areas with ≥ 3 scaling score were randomized 1 : 1 : 1 to TMB-001 0.05%, TMB-001 0.1% or vehicle, twice daily for 12 weeks. Efficacy endpoints included the proportion of participants with ≥ 50% reduction in VIIS-scaling (VIIS-50) compared with baseline and ≥ 2-grade reduction in Investigator's Global Assessment (IGA)-scaling score compared with baseline. Changes in body surface area (BSA) involvement, Dermatology Life Quality Index (DLQI) scores and Itch-Numeric Rating Scale (I-NRS) scores were assessed. RESULTS: Among the 33 participants (11 randomized to TMB-001 0.05%, 10 to TMB-001 0.1% and 12 to vehicle), median age was 29 years (range 9-80), and most were male (64%) and White (79%). Baseline demographics were generally similar among participants who did or did not achieve TMB-001 treatment success. Participants who had lower mean BSA involvement and higher DLQI and I-NRS scores at baseline were more likely to achieve VIIS-50. Similarly, higher baseline DLQI and I-NRS scores were associated with IGA response; BSA involvement was similar for IGA responders vs. nonresponders. CONCLUSIONS: Higher DLQI and I-NRS scores at baseline were associated with participants achieving treatment success by VIIS-50 and IGA response. Lower BSA involvement was associated with VIIS-50 success.

Tiered Universal and Targeted Early Childhood Interventions: Enhancing Attendance Across Families with Varying Needs.

This study examined whether a two-tiered parenting program, which provides universal primary prevention along with targeted secondary prevention only for families with increased needs, would have mutually beneficial impacts on attendance across two program components. A secondary analysis of the Smart Beginnings (SB) randomized controlled trial was conducted. SB takes place from birth to age 3 and combines universal delivery of the Video Interaction Project (VIP) with targeted delivery of the Family Check-Up (FCU) for families identified as having increased risks following yearly screening. The current study analyzed whether attendance in VIP in the first six months was associated with FCU attendance for eligible families at six months, and whether FCU attendance at six and 18 months was associated with subsequent VIP attendance. Analyses included logistic and mixed-effects Poisson regression, as well as group-based trajectory analysis. VIP attendance predicted later FCU attendance (AOR = 5.43, p < .01), and FCU attendance predicted later VIP attendance (IRR = 1.35, p < .01) and a high-stable VIP attendance trajectory (AOR=14.98, p < .01). Findings provide strong support for the ability of tiered models to engage parents, to promote effective and efficient service delivery to reduce disparities in school readiness, and their potential to overcome common barriers to attendance and scaling by addressing the heterogeneity of risk among low-income families.

Collateral benefits from a school-readiness intervention on breastfeeding: A cross-domain impact evaluation.

This study evaluated the collateral, or unanticipated, impacts of Smart Beginnings (SB), a two-site, tiered intervention designed to promote responsive parenting and school readiness, on breastfeeding intensity in a low-income sample. Impact analyses for the SB intervention were conducted using an intent-to-treat design leveraging a two-arm random assignment structure. Mothers assigned to the SB intervention group were more than three times more likely to give breastmilk as the only milk source at infant age 6 months than mothers assigned to the control group at one site, an effect not evident at the other study site. As development and growth are the two most salient domains of child health, understanding how interventions impact subsequent parenting practices across both domains is critical to address long-term economic and racial/ethnic disparities. Implications of the findings are discussed for improving the efficacy of interventions based on paediatric primary care.

Effects of maternal trauma and associated psychopathology on atypical maternal behavior and infant social withdrawal six months postpartum.

Maternal psychopathology given a history of maltreatment and domestic violence exposure increases the risk for child psychopathology. Infant social withdrawal is one warning sign of adverse developmental outcomes including child anxiety and depression. It remains unclear how maternal trauma-related psychopathology might affect infant social withdrawal six-months postpartum. METHODS: One-hundred ninety-five women and their six-month-old infants were studied in an at-risk community sample. Maternal trauma history, posttraumatic stress (PTSD) and major depressive (MDD) disorders were assessed. Maternal and infant behaviors were coded from videotaped interactions. RESULTS: Maternal trauma was correlated with atypical maternal behavior (AMB) and infant social withdrawal (p ≤ .001). PTSD and MDD, and comorbid PTSD/MDD predicted increased AMB (p ≤ .001) but only maternal MDD was predictive of infant social withdrawal (p ≤ .001). Effects of maternal MDD on infant withdrawal were mediated by AMB. CONCLUSIONS: At six-months postpartum, maternal MDD was associated with infant withdrawal. AMB is an important target for early intervention.

Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study.

OBJECTIVES: To evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA). METHODS: In this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs). RESULTS: 391/500 patients screened were randomised and treated. At W24, 71.4%-79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p<0.01). Patients receiving tildrakizumab versus placebo generally achieved higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein <3.2, minimal disease activity and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52. Improvement in dactylitis and enthesitis was not observed; results were mixed for other outcomes. Responses in patients switched to tildrakizumab 200 mg at W24 were consistent with treatment from baseline. TEAEs and serious TEAEs occurred in 64.5% and 3.3%, respectively, of all patients through W52 and were comparable among treatment arms. CONCLUSIONS: Tildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692.

Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: Long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2).

BACKGROUND: Data for the effect of metabolic syndrome (MetS) on the efficacy and safety of biologic agents for psoriasis treatment are limited. OBJECTIVE: To evaluate long-term tildrakizumab efficacy, drug survival, and safety in patients with psoriasis by baseline MetS status. METHODS: Post hoc analyses of up to 3 years of efficacy data and 5 years of safety data from the phase 3, double-blind, randomized controlled reSURFACE 1 and 2 trial (NCT01722331 and NCT01729754) base and extension studies were conducted for patients receiving continuous tildrakizumab 100 or 200 mg. RESULTS: Of 338 (n = 124/214 in reSURFACE 1/2) and 307 (n = 147/160 in reSURFACE 1/2) patients continuously receiving tildrakizumab 100 and 200 mg, respectively, throughout the studies, 26/44 (21%/21%) and 34/30 (23%/19%) met MetS criteria. Proportions of patients who achieved a 75% improvement in the Psoriasis Area and Severity Index (PASI) in reSURFACE 1/2 were generally comparable among those with versus without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148. Results were similar for responders with 90% and 100% improvement in the PASI. Tildrakizumab's safety profile did not vary by MetS status. LIMITATIONS: Small sample size and post hoc analysis limit interpretation. CONCLUSION: Long-term tildrakizumab efficacy and safety were comparable between patients with and without MetS.

Breastfeeding and Responsive Parenting as Predictors of Infant Weight Change in the First Year.

OBJECTIVE: To test breastfeeding duration and responsive parenting as independent predictors of infant weight change from birth to 12 months, and to test the moderating effect of a tiered parenting intervention on relations between breastfeeding and responsive parenting in relation to infant weight change. METHODS: Mother-infant dyads (N = 403) were participants in the ongoing Smart Beginnings (SB) randomized controlled trial testing the impact of the tiered SB parenting model that incorporates two evidence-based interventions: Video Interaction Project (VIP) and Family Check-Up (FCU). The sample was low income and predominantly Black and Latinx. Responsive parenting variables (maternal sensitivity and intrusiveness) came from coded observations of mother-infant interactions when infants were 6 months. Continuous weight-for-age (WFA) z-score change and infant rapid weight gain (RWG) from 0 to 12 months were both assessed. RESULTS: Longer breastfeeding duration was significantly associated with less WFA z-score change. The relationship between breastfeeding duration and WFA z-score change was significant only for infants in the intervention group. Intrusive parenting behaviors were also associated with greater WFA z-score change after accounting for breastfeeding duration. CONCLUSIONS: This study is one of the first to test both breastfeeding and parenting in relation to infant weight gain in the first year. Findings may have implications for family-focused child obesity prevention programs.

Father involvement in infancy predicts behavior and response to chronic stress in middle childhood in a low-income Latinx sample.

Fathers' involvement in early childhood is important for children's physical, emotional, and cognitive development, particularly in low-income families. However, little is known about the longitudinal relations between early father involvement and children's later physiological responses to chronic stress and behaviors impacted by stress in the context of poverty. These issues are particularly important among Latinx immigrant families who face significant psychosocial and poverty-related risk. In the current study, we examined the relationship between father involvement in infancy and physiological chronic stress in the middle childhood period, as measured through hair cortisol concentration (HCC), and several behavioral measures (attention problems, working memory) in a Latinx immigrant sample with low income. Father involvement in infancy predicted children's later HCC, and working memory in second to third grade. Father involvement also moderated the effect of HCC on working memory, such that increased HCC predicted better working memory when fathers were not involved. These findings suggest that the fathers' involvement in infancy has lasting impacts on health and behavior and that associations between physiological and behavioral measures of stress may be moderated by differences in early father involvement.

Real-world biologic and apremilast treatment patterns in patients with psoriasis and psoriatic arthritis.

PURPOSE: Real-world treatment patterns among psoriasis patients with and without psoriatic arthritis (PsA) newly initiating treatment with a biologic or apremilast were assessed. PATIENTS AND METHODS: MarketScan claims data from adults with psoriasis and ?1 new prescription for secukinumab, adalimumab, ustekinumab, etanercept, or apremilast from January 1, 2015, to August 31, 2018, were assessed for adherence, switching, and combination therapy by index medication and PsA diagnosis. RESULTS: At treatment initiation, 22.0%-45.7% of patients had PsA. Over 24 months, discontinuation rates were high (34.4%-54.6%) overall and higher in patients with versus without PsA (all P<0.05 except secukinumab). Adherence was poor (16.8%-34.8%); switching and combination therapy were common. CONCLUSION: Treatment patterns varied, with better outcomes in PsA patients receiving anti-tumor necrosis factor versus anti-IL17/IL12/23 agents.

Real-world biologic and apremilast treatment patterns and healthcare costs in moderate-to-severe plaque psoriasis.

Plaque psoriasis is a chronic disease requiring long-term therapy. However, long-term real-world treatment patterns and costs are not well characterized. This study examined treatment patterns and healthcare costs among patients newly initiating a biologic or apremilast for moderate-to-severe plaque psoriasis. Included patients had ?1 prescription for secukinumab, ixekizumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018, no prior use of the index medication, and continuous enrolment 12 months pre-index and 24 months post-index. Treatment adherence, non-persistence, discontinuation, switching, use of combination therapy, and re-initiation were assessed at 12, 18, and 24 -months post-index. In addition, total and psoriasis-related healthcare costs were evaluated at 24 months. A total of 7,773 patients with 24-month follow-up were included. Overall, adherence was low (21.3%-33.5%) and non-persistence was high (58.4%-86.5%) over 24 months. Discontinuation (38.4%-51.3%), switching (29.7%-52.6%), combination therapy (27.6%-42.9%), and re-initiation of the index medication (19.3%-44.5%) were common. Healthcare costs were high and mostly contributed by psoriasis treatment. Therefore, maintaining disease control on long-term therapy is still challenging for many patients.

The Effect of Tildrakizumab on Cardiometabolic Risk Factors in Psoriasis by Metabolic Syndrome Status: Post Hoc Analysis of Two Phase 3 Trials (ReSURFACE 1 and ReSURFACE 2).

Background: Metabolic syndrome (MetS) is the most prevalent comorbidity in psoriasis and increases the risk of cardiovascular disease, diabetes, and mortality. Assessment of impacts of biologic therapies on cardiometabolic risk factors are relatively limited. This study evaluated the effect of tildrakizumab on cardiometabolic risk factors in patients with moderate to severe plaque psoriasis and stratified by MetS status. Methods: In this post hoc analysis of reSURFACE 1/2, tildrakizumab 100 and 200 mg were continuously administered to patients with moderate to severe plaque psoriasis at weeks 0 and 4, and every 12 weeks thereafter. Mean and mean percent changes from baseline were assessed for fasting serum glucose, low/high-density lipoprotein-cholesterol, total cholesterol, triglyceride levels, body weight, and blood pressure at week 64/52 for reSURFACE 1 and 2, respectively, in patients with and without MetS. Results: A total of 369 patients in reSURFACE 1 and 2 received continuous tildrakizumab 100 mg and 330 received tildrakizumab 200 mg; 21.4% and 20.3% in reSURFACE 1 and 2, respectively, had MetS. At week 64/52, mean changes in cardiometabolic risk factors from baseline did not significantly differ regardless of MetS status. Numerically larger mean decreases in fasting glucose, triglycerides, and systolic blood pressure following tildrakizumab 100 mg and in systolic and diastolic blood pressure following tildrakizumab 200 mg were observed in patients with MetS relative to those without MetS. Conclusions: Changes in cardiometabolic disease risk factors following tildrakizumab treatment were limited. Risk factors were not increased in patients with MetS vs without MetS. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5337.