RESUMO
BACKGROUND: Psoriasis is a common autoimmune dermatologic condition which has a pronounced negative impact on patient quality of life and disease burden. Currently, there are a number of treatments available for psoriasis, with differences in efficacy, mechanism of action, mode of administration, adverse effects, and tolerability. However, a reliable, validated patient-reported instrument to address patient expectations and of psoriasis treatment has not been developed. This project was undertaken with the aim of developing a fit-for-purpose self-reported instrument to inform patient expectations and preferences of psoriasis treatments. METHODS: Two studies, both utilizing qualitative and quantitative methods, were conducted in patients within the entire spectrum of psoriasis severity. In Study 1, a group concept mapping (GCM) exercise was conducted with dermatologists and moderate-to-severe psoriasis patients to identify concepts important in the treatment of psoriasis. In Study 2, a preliminary Treatment Acceptability Questionnaire (TAQ) was developed using GCM-derived concepts from Studies 1 and 2, followed by cognitive debriefing (CD) telephone interviews of the preliminary TAQ. In Study 2, another GCM exercise was conducted with mild and newly diagnosed psoriasis patients. Psychometric analyses were performed on the TAQ to evaluate validity and reliability. RESULTS: The Study 1 GCM exercise generated 43 concepts from moderate-to-severe psoriasis patients (n = 20) and dermatologists (n = 10). In Study 2, 37 GCM concepts were generated from mild and newly diagnosed psoriasis patients (n = 20). From the 2 GCM exercises, 28 concepts were selected to form the preliminary TAQ; CD interviews indicated strong understanding and relevance of TAQ items among patients with disease ranging from mild to severe. The final TAQ consisted of 20 items; psychometric analysis demonstrated strong validity and reliability of the TAQ. CONCLUSIONS: The TAQ is a novel psychometrically validated patient-reported instrument to inform healthcare providers of patients' expectations of and preferences for treatment of their psoriasis and can help in shared decision making between patients and physicians.
Assuntos
Psoríase , Qualidade de Vida , Humanos , Reprodutibilidade dos Testes , Inquéritos e Questionários , Autorrelato , Psicometria , Psoríase/tratamento farmacológicoRESUMO
Aim: To estimate treatment patterns and healthcare costs among triple-class exposed relapsed and refractory multiple myeloma (RRMM) patients. Materials & methods: Eligible patients had ≥1 line of therapy (LOT) each of proteasome inhibitors, immunomodulatory drugs and daratumumab in December 2015-September 2018 and received a new LOT. Results: A total of 154 patients were included with a median follow-up of 6.2 months. Median time from diagnosis to new LOT was 41.0 months. Kaplan-Meier estimate of median time to therapy discontinuation was 4.2 months. Mean per-patient, per-month MM-related costs were USD 35,657. Most frequently observed regimens were lenalidomide or pomalidomide + daratumumab (18.2%), lenalidomide or pomalidomide + proteasome inhibitors (15.6%) and lenalidomide or pomalidomide monotherapy (11.0%). Conclusion: Triple-class exposed RRMM patients receive heterogeneous treatments for a short duration with high healthcare resource utilization and costs.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Inibidores de Proteassoma/uso terapêutico , Idoso , Anticorpos Monoclonais/uso terapêutico , Resistencia a Medicamentos Antineoplásicos , Feminino , Humanos , Estimativa de Kaplan-Meier , Lenalidomida/uso terapêutico , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/patologia , Recidiva Local de Neoplasia/epidemiologia , Intervalo Livre de Progressão , Estudos Retrospectivos , Talidomida/análogos & derivados , Talidomida/uso terapêutico , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Long-term data from patients with tuberous sclerosis complex (TSC)-associated renal angiomyolipoma (angiomyolipoma) are limited. STUDY DESIGN: Retrospective observational study. SETTING & PARTICIPANTS: Adult patients with TSC treated at the University Medical Center Utrecht (the Netherlands) from January 1990 through April 2012. PREDICTORS: Patient age and angiomyolipoma stage, based on computed tomography lesion count, size, and impact on renal anatomy, with higher stage representing higher angiomyolipoma burden. Patients in stages 3 or higher were considered at high risk for hemorrhage and candidates for selective arterial embolization. OUTCOMES: Kidney-related outcomes included hypertension, anemia, decreased kidney function, dialysis, kidney transplantation, nephrectomy, kidney-related blood transfusions, and mortality. Observed mortality was compared to the Dutch National Bureau of Statistics using standardized mortality ratio. RESULTS: Median follow-up was 15.8 years, of which staging was available for 5.4 years. Of 351 patients with TSC, 244 (69.5%) had confirmed angiomyolipoma; 144 (59.0%) reached stage 3 or higher. Age and angiomyolipoma stage were positively correlated: median age in the none-detected stage was 36.8 years, increasing to 43.6 years for stage 6. Embolization was performed in 117 patients; 57 had 2 or more embolization procedures. Higher stage was associated with hypertension, anemia, decreased kidney function, and transfusion. Hypertension, anemia, and decreased kidney function were more common in patients who underwent selective arterial embolization. 7 patients required dialysis, 7 received a kidney transplant, and 16 underwent nephrectomy. 29 deaths were recorded, most commonly related to renal complications (n=9[31%]). Mortality was significantly higher in the study cohort versus the general population (standardized mortality ratio, 4.8; 95% CI, 3.4-6.9). LIMITATIONS: Duration of follow-up with staging was too short to observe stage progression in most patients. CONCLUSIONS: Despite the use of preventive selective arterial embolization, patients with TSC exhibit clinically significant kidney disease and excess mortality, largely because of kidney-related complications.
Assuntos
Angiomiolipoma/mortalidade , Angiomiolipoma/terapia , Neoplasias Renais/mortalidade , Neoplasias Renais/terapia , Esclerose Tuberosa/mortalidade , Esclerose Tuberosa/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Angiomiolipoma/diagnóstico por imagem , Estudos de Coortes , Embolização Terapêutica/métodos , Embolização Terapêutica/mortalidade , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Neoplasias Renais/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Países Baixos , Distribuição de Poisson , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Fatores de Tempo , Tomografia Computadorizada por Raios X/métodos , Resultado do Tratamento , Esclerose Tuberosa/diagnóstico por imagem , Adulto JovemRESUMO
AIMS: The study objectives were to 1) characterize the cost drivers of patients with Helicobacter pylori (HP) and 2) estimate HP-related cost savings following lab-confirmed HP eradication with US guideline-recommended treatment compared to failed eradication. METHODS: We identified adults newly diagnosed with HP between 1/1/2016-12/31/2019 in the Veradigm Electronic Health Record Database linked to claims data (earliest HP diagnosis = index date). For the overall costs analysis, we required patients to have data available for ≥12 months before and after the index date. Then, we used multivariable modeling to assess the marginal effects of comorbidities on all cause-healthcare costs in the 12 months following HP diagnosis. For the eradication savings analysis, we identified patients with ≥1 HP eradication regimen, a subsequent HP lab test result, and ≥1 year of data after the test result. Then we used multivariable modeling to estimate HP-related cost while adjusting for eradication status, demographics, post-testing HP-related clinical variables, and the interactions between eradication status and each HP-related clinical variable. RESULTS: The overall cost analysis included 60,593 patients with HP (mean age 54.2 years, 65.5% female). Mean (SD) 12-month unadjusted all-cause costs were $23,693 ($78,089). Rare comorbidities demonstrated the highest marginal effect. The marginal effects of gastric cancer and PUD were $15,705 and $7,323, respectively. In the eradication savings analysis, 1,835 (80.0%) of the 2295 patients had lab test-confirmed HP eradication. Compared to failed eradication, there were significant one-year cost savings among patients with successful HP eradication and select conditions: $1,770 for PUD, $518 for atrophic gastritis, $494 for functional dyspepsia, and $352 for gastritis. CONCLUSIONS: The healthcare costs of patients with HP are partially confounded by their burden of high-cost comorbidities. In the subset of patients with available results, confirmed vs. failed eradication of HP was associated with short-term cost offsets among those with specific to HP-related sequelae.
Helicobacter pylori (HP) is a common infection. We aimed to better understand healthcare costs for people infected with HP. Specifically, we were interested in 1) investigating whether complications from HP were causing high costs. 2) whether successful eradication of HP would lead to lower healthcare costs. We captured data on adults diagnosed with HP between 2016 and 2019. The data used in this study came from medical records and insurance bills. In the first part of the study, we found that patients with HP often have other health issues, and these other health issues were driving high healthcare costs. The majority of cost savings associated with HP eradication accrue from the prevention of potential complications of long-term infection, such as peptic ulcer disease and, rarely, gastric cancer.
Assuntos
Antiulcerosos , Infecções por Helicobacter , Helicobacter pylori , Adulto , Humanos , Feminino , Estados Unidos , Pessoa de Meia-Idade , Masculino , Infecções por Helicobacter/tratamento farmacológico , Infecções por Helicobacter/diagnóstico , Antiulcerosos/uso terapêutico , Custos de Cuidados de Saúde , Antibacterianos/uso terapêuticoRESUMO
INTRODUCTION: Erosive esophagitis (EE) is a severe form of gastroesophageal reflux disease commonly treated with proton pump inhibitors (PPIs). The aim of this retrospective, observational cohort study was to describe the characteristics and healthcare burden of patients with EE. METHODS: We identified adults in the USA with an EE diagnosis between January 1, 2016 and February 28, 2019 in a linked dataset containing electronic health records (EHR) from the Veradigm Network EHR and claims data from Komodo Health. Patients were required to have 1 year of baseline data and 3 years of follow-up data. Patients were stratified by the number of PPI lines of therapy (LOT) during the 4-year study period. We descriptively captured patient characteristics and treatment patterns, along with all-cause and EE-related healthcare utilization and costs. RESULTS: Among the 158,347 qualifying adults with EE, 71,958 (45.4%) had 1 PPI LOT, 14,985 (9.5%) had 2 LOTs, 15,129 (9.6%) had 3+ LOTs, and 56,275 (35.5%) did not fill a PPI prescription. Omeprazole and pantoprazole comprised more than 70% of any LOT, with patients commonly switching between the two. Mean (standard deviation) annualized all-cause and EE-related healthcare costs in the follow-up period were $16,853 ($70,507) and $523 ($3659), respectively. Both all-cause and EE-related healthcare costs increased with LOTs. CONCLUSIONS: Patients with EE are commonly treated with prescription PPIs; however, 19.0% of patients cycled through multiple PPIs. Higher PPI use was associated with a higher comorbidity burden and higher healthcare costs compared to 0 PPI use.
Assuntos
Registros Eletrônicos de Saúde , Esofagite , Adulto , Humanos , Estados Unidos , Estudos Retrospectivos , Revisão da Utilização de Seguros , Inibidores da Bomba de Prótons/uso terapêutico , Esofagite/tratamento farmacológicoRESUMO
Approximately 36% of the United States (US) population is infected with Helicobacter pylori (HP), a known major risk factor for peptic ulcer disease and gastric cancer. HP eradication reduces the rate of complications; however, the benefits are undermined by rising rates of HP eradication treatment failure. This real-world observational cohort analysis aims to describe HP diagnostic and treatment patterns among insured patients in the US. Using diagnoses, lab results, and treatment patterns, we identified adults (18+) with new diagnoses of HP in the Veradigm Health Insights EHR Database linked to Komodo claims data (1/1/2016-12/31/2019). Patients were required to have ≥ 12 months of data pre-/post-index. We captured patient characteristics, HP-related diagnostic testing, and the use of US guideline-recommended HP eradication regimens. HP eradication rates following first-line eradication treatment were measured among patients with available lab results. Overall, 31.8% of the 60,593 included patients did not receive guideline-recommended treatment. Among the 68.2% (41,340) with first-line treatment, 80.2% received clarithromycin-based triple therapy, and 6.6% received bismuth quadruple therapy. Of the 4569 patients with a repeated course of eradication therapy, 53.4% received the same regimen as their first-line, the majority (90.7%) of whom received two rounds of clarithromycin-based triple therapy. Among the 2455 patients with results of HP non-serology testing following first-line treatment, the 180-day eradication rate was 80.2% overall, with differences based on treatments and demographics. This study highlights gaps between guideline-recommended HP management and real-world patterns, underscoring the need to improve HP testing, treatment, and follow-up practices.
Assuntos
Infecções por Helicobacter , Helicobacter pylori , Adulto , Humanos , Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/tratamento farmacológico , Infecções por Helicobacter/epidemiologia , Claritromicina/uso terapêutico , Antibacterianos/uso terapêutico , Amoxicilina/uso terapêutico , Omeprazol/uso terapêutico , Quimioterapia Combinada , Inibidores da Bomba de Prótons/uso terapêuticoRESUMO
Background: Japanese guidelines recommend triple therapy with vonoprazan or a proton pump inhibitor (PPI) in combination with antibiotics to treat Helicobacter pylori (H. pylori) infection. While studies have shown improved eradication rates and reduced costs with vonoprazan versus PPIs, there is little data describing healthcare resource use (HCRU) and treatment patterns. Objectives: To compare patients treated with a vonoprazan-based or PPI-based regimen for H. pylori infection in Japan in terms of their characteristics, HCRU, healthcare costs, clinical outcomes, and treatment patterns. Design: Retrospective matched cohort. Methods: We used data from the Japan Medical Data Center claims database (July 2014-January 2020) to identify adult patients with H. pylori infection and a first observed use of vonoprazan or a PPI in 2015 or later (index date). Patients prescribed a vonoprazan-based or a PPI-based regimen were matched 1:1 using propensity score matching. HCRU, healthcare costs, diagnostic tests, a proxy for H. pylori eradication (i.e. no triple therapy with amoxicillin in combination with metronidazole or clarithromycin >30 days after the index date), and second-line treatment were described during the 12-month follow-up period. Results: Among 25,389 matched pairs, vonoprazan-treated patients had fewer all-cause and H. pylori-related inpatient stays and outpatient visits than PPI-treated patients, resulting in lower all-cause healthcare costs [185,378 Japanese yen (JPY) versus 230,876 JPY, p < 0.001]. Over 80% of patients received a post-treatment test for H. pylori. Fewer vonoprazan-treated than PPI-treated patients subsequently received an additional triple regimen for H. pylori infection (7.1% versus 20.0%, p < 0.001) or a prescription for vonoprazan or a PPI as monotherapy (12.4% versus 26.4%, p < 0.001) between 31 days and 12 months after the index date. Conclusion: Patients with H. pylori infection who were treated with vonoprazan-based therapy had lower rates of subsequent H. pylori treatment, lower overall and H. pylori-related HCRU, and lower healthcare costs than patients treated with PPI-based therapy.
RESUMO
Background: Helicobacter pylori eradication rates achieved with clarithromycin-based triple therapies are declining due to antibiotic resistance, but data regarding temporal changes in efficacy with these eradication therapies are scarce. Objective: To evaluate the efficacy of clarithromycin-based triple eradication regimens over time. Design: A comprehensive literature review and time-trend analysis. Data sources and methods: Bibliographies of recently published systematic literature reviews were searched and supplemented with a targeted literature review conducted using Medline and Embase databases and ProQuest from conception to May 2021. Studies reporting H. pylori eradication rates of clarithromycin-based triple therapies were included and temporal trends were estimated using a random-effects model. Results: Eradication rates for triple therapies containing proton pump inhibitors (PPIs), clarithromycin, and amoxicillin showed a significant decline over the past 23 years (p = 0.0315). However, this decline was not significant when eradication rates achieved with vonoprazan-based triple therapy were included (p = 0.3910). Conclusion: Vonoprazan-based triple therapy partially mitigated the decline in eradication rates seen with PPI-based triple therapy, likely due to more powerful acid suppression of vonoprazan.
RESUMO
INTRODUCTION: Helicobacter pylori (Hp) is causal in benign and malignant gastrointestinal diseases. Accordingly, current guidelines recommend Hp eradication in patients with active infection. Unfortunately, treatment failure is common, exposing patients to complications associated with persistent Hp infection and consequences of repeated treatment, including promotion of antibiotic resistance. In the United States (US), data regarding eradication rates with available therapies are limited. Moreover, the clinical and economic burden of eradication treatment failure have not been thoroughly described. AREAS COVERED: We aimed to characterize Hp eradication rates and the clinical consequences and associated costs of persistent Hp infection among US adults. We conducted focused literature reviews using initial searches in Embase, MEDLINE, and Cochrane Database of Systematic Reviews via Ovid followed by manual searches to identify relevant publications. EXPERT OPINION: Hp eradication rates were suboptimal, with most studies reporting rates ≤80% with clarithromycin-based triple therapy and bismuth quadruple therapy. There was direct evidence supporting numerous benefits of successful Hp eradication, including decreased risk of recurrent or complicated peptic disease and non-cardia gastric cancer. Cost benefits of eradication were related to mitigation of conditions associated with persistent Hp infection, (e.g. complicated peptic ulcer disease, and gastric cancer) which altogether exceed US$5.3 billion.
Assuntos
Infecções por Helicobacter , Helicobacter pylori , Neoplasias Gástricas , Adulto , Amoxicilina , Antibacterianos/efeitos adversos , Bismuto/efeitos adversos , Claritromicina/uso terapêutico , Quimioterapia Combinada , Infecções por Helicobacter/complicações , Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/tratamento farmacológico , Humanos , Inibidores da Bomba de Prótons/efeitos adversos , Neoplasias Gástricas/tratamento farmacológico , Revisões Sistemáticas como Assunto , Falha de TratamentoRESUMO
INTRODUCTION: Erosive esophagitis (EE) occurs when refluxate from the stomach causes T-lymphocyte infiltration of the esophageal mucosa, resulting in mucosal breaks. Currently, therapy with proton-pump inhibitors (PPIs) is the standard treatment for EE in the United States, but few comprehensive reviews exist on the efficacy of PPIs in US populations. Here, we present the most contemporary, thorough analysis of PPI efficacy rates, and identify and characterize patient subgroups at risk for poor healing outcomes. AREAS COVERED: We searched the literature to identify studies reporting rates of endoscopic healing and maintained healing of EE with PPI therapies in the US and found a paucity of recent evidence and real-world evidence. Twenty-two studies from 2009 and earlier were included in the final dataset. EXPERT OPINION: Rates of EE healing with PPIs were highest after 8 weeks of treatment, with over 80% of patients in most treatment arms demonstrating endoscopic healing, compared to lower efficacy (<80%) at 4 weeks. Rates of maintained healing with PPIs at 6 and 12 months were mostly lower than 80%, although the data were limited. Symptomatic patients and those with severe EE were less likely to achieve healing. Obese patients experienced similar healing rates as non-obese patients.
Assuntos
Esôfago de Barrett , Esofagite , Úlcera Péptica , Trato Gastrointestinal Superior , Humanos , Estados Unidos/epidemiologia , Esofagite/diagnóstico , Esofagite/tratamento farmacológico , Esofagite/complicações , Inibidores da Bomba de Prótons/efeitos adversos , Esôfago de Barrett/etiologiaRESUMO
OBJECTIVE: Management of erosive oesophagitis (EE) remains suboptimal, with many patients experiencing incomplete healing, ongoing symptoms, and relapse despite proton pump inhibitor (PPI) treatment. The Study of Acid-Related Disorders investigated patient burden of individuals with EE in a real-world setting. DESIGN: US gastroenterologists (GIs) or family physicians (FPs)/general practitioners (GPs) treating patients with EE completed a physician survey and enrolled up to four patients with EE for a patient survey, with prespecified data extracted from medical records. RESULTS: 102 GIs and 149 FPs/GPs completed the survey; data were available for 73 patients (mean age at diagnosis, 45.4 years). Omeprazole was healthcare professional (HCP)-preferred first-line treatment (60.8% GIs; 56.4% FPs/GPs), and pantoprazole preferred second line (29.4% and 32.9%, respectively). Price and insurance coverage (both 55.5% HCPs) and familiarity (47.9%) key drivers for omeprazole; insurance coverage (52.0%), price (50.0%), familiarity (48.0%), initial symptom relief (46.0%), and safety (44.0%) key drivers for pantoprazole. Only 49.3% patients took medication as instructed all the time; 56.8% independently increased medication frequency some of the time. Despite treatment, 57.5% patients experienced heartburn and 30.1% regurgitation; heartburn was the most bothersome symptom. 58.9% patients believed that their symptoms could be better controlled; only 28.3% HCPs were very satisfied with current treatment options. 83.6% patients wanted long-lasting treatment options. Fast symptom relief for patients was a top priority for 66.1% HCPs, while 56.6% would welcome alternatives to PPIs. CONCLUSION: This real-world multicentre study highlights the need for new, rapidly acting treatments in EE that reduce symptom burden, offer durable healing and provide symptom control.
Assuntos
Antiulcerosos , Esofagite , Refluxo Gastroesofágico , Úlcera Péptica , Médicos , 2-Piridinilmetilsulfinilbenzimidazóis/uso terapêutico , Antiulcerosos/efeitos adversos , Benzimidazóis/efeitos adversos , Esofagite/induzido quimicamente , Esofagite/tratamento farmacológico , Esofagite/epidemiologia , Refluxo Gastroesofágico/tratamento farmacológico , Refluxo Gastroesofágico/epidemiologia , Azia/induzido quimicamente , Azia/tratamento farmacológico , Humanos , Omeprazol/uso terapêutico , Pantoprazol/uso terapêutico , Úlcera Péptica/induzido quimicamente , Úlcera Péptica/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêuticoRESUMO
Background and Aims: Helicobacter pylori eradication rates have declined as antibiotic resistance rates have increased. In addition, adherence to treatment guidelines is suboptimal. It is therefore important that contemporary, real-world evidence of diagnostic and treatment patterns is explored and compared with evidence-based guidelines. The Study of Acid-Related Disorders investigated unmet needs among patients with H pylori infection and past or current dyspepsia. Methods: Gastroenterologists (GIs) and family physicians (FPs) or general practitioners (GPs) treating patients with H pylori infection and past or current dyspepsia completed a physician survey and invited patients to complete a patient survey; data were also extracted from the medical records of enrolled patients. Results: Two hundred fifty-one physicians and 77 patients were enrolled. A total of 19.5% of patients were diagnosed by serology, whereas the urea breath test was used by 6.5% of GIs and 50.0% of FPs or GPs. A total of 68.6% of GIs and 79.8% of FPs or GPs selected clarithromycin, amoxicillin, and proton pump inhibitor triple therapy as their ideal first-line treatment. Physicians reported that 52.9% of patients experienced dyspepsia daily. A total of 46.8% of patients believed that complete resolution of dyspepsia would indicate effective treatment. As their treatment goal, 69.3% of physicians selected improvement in overall symptoms, whereas 92.2% of patients specified improvement in dyspepsia. Only 28.7% of physicians were satisfied with current treatment options. A total of 59.7% of patients took all of their prescribed medicine(s). A total of 59.7% of patients would prefer to take fewer pills; 45.5% would prefer convenience packs. Conclusion: This study reveals a lack of adherence to current H pylori guidelines for diagnosis, testing, and treatment. New treatment options that are more efficacious and simpler for patients to adhere to are needed.
RESUMO
Background and Aims: Effective acid suppression is a crucial component of Helicobacter pylori (H. pylori) eradication regimens. Approved treatments include dual, triple, and quadruple therapies composed of certain antibiotics in combination with proton pump inhibitors (PPIs). Vonoprazan, a potassium-competitive acid blocker, provides more potent and durable acid suppression than PPIs. We compared the efficacy of vonoprazan-based therapies vs approved standard regimens using new evidence from the phase 3 pHalconHP trial in North America and Europe. Methods: Studies reporting first-line H. pylori eradication rates from empiric treatment with Food and Drug Administration-approved therapies and vonoprazan-containing therapies were identified via bibliographic searches of systematic literature reviews and a subsequent MEDLINE/Embase search using index terms for H. pylori and eradication. Randomized controlled trials comparing 2 or more relevant comparators were included in Bayesian network meta-analyses for grouped and distinct therapies. Results: Twenty-three distinct regimens from 42 trials including 12,773 patients were identified. Vonoprazan-based triple therapy showed the highest relative efficacy (odds ratio: 2.73, 95% credible interval 2.11, 3.54) and 72.1% probability of being the best. North American, Western, and global scenarios were largely consistent. Vonoprazan-based therapies demonstrated higher odds of H. pylori eradication than each PPI-based triple therapy. Furthermore, vonoprazan-based triple therapy was superior to bismuth subcitrate quadruple therapy (odds ratio: 1.60, 95% credible interval: 1.07, 2.38). Conclusion: Vonoprazan-based eradication regimens represent novel treatments for H. pylori infection on a global scale, offering efficacy that, in this analysis, is superior to PPI-based triple therapy and comparable or better than bismuth quadruple therapy.
RESUMO
Aim: Real-world treatment data for psoriatic arthritis are limited. We evaluated switch rates, adherence, and costs for patients initiating apremilast versus tumor necrosis factor inhibitor (TNFi) and interleukin inhibitor (ILi) among biologic-naive psoriatic arthritis patients. Materials & methods: This retrospective analysis used IBM MarketScan claims data to assess treatment switches, adherence and costs. Results: Twelve-month switch rates were significantly lower for apremilast versus TNFi (15.5% vs 26.6%; p < 0.0001) and similar to ILi (15.5% vs 14.0%; p = 0.71). Apremilast initiators had lower total costs versus TNFi and ILi (US$39,854 vs US$57,243 and US$65,687; p < 0.05) and adherence was slightly lower versus TNFi and higher versus ILi. Conclusion: Biologic-naive apremilast initiators had lower switch rates versus TNFi initiators and lower total costs versus TNFi or ILi initiators.
Assuntos
Artrite Psoriásica , Produtos Biológicos , Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Humanos , Estudos Retrospectivos , Talidomida/análogos & derivados , Talidomida/uso terapêuticoRESUMO
OBJECTIVES: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US. METHODS: DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls. RESULTS: A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p < 0.001). CONCLUSIONS: Employed DMT users in the US incurred incremental increased indirect burden ($2007 in absenteeism, $2040 in short-term disability, and $244 in long-term disability) compared with matched controls. Despite evidence of delays in treatment initiation, oral DMT users had evidence of reduced work loss compared with injectable users, suggesting that open access to all treatment options may reduce the indirect burden of MS. Additional research into the impact of route of administration on the burden of long-term disability among MS patients is needed.
RESUMO
BACKGROUND: Although confirmed disability progression (CDP) is a common outcome in multiple sclerosis (MS) clinical trials, its predictive value for long-term outcomes is uncertain. OBJECTIVE: To investigate whether CDP at month 24 predicts subsequent disability accumulation in MS. METHODS: The Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women's Hospital includes participants with relapsing-remitting MS or clinically isolated syndrome with Expanded Disability Status Scale (EDSS) scores ≤5 (N = 1214). CDP was assessed as a predictor of time to EDSS score 6 (EDSS 6) and to secondary progressive MS (SPMS) using a Cox proportional hazards model; adjusted models included additional clinical/participant characteristics. Models were compared using Akaike's An Information Criterion. RESULTS: CDP was directionally associated with faster time to EDSS 6 in univariate analysis (HR = 1.61 [95% CI: 0.83, 3.13]). After adjusting for month 24 EDSS, CDP was directionally associated with slower time to EDSS 6 (adjusted HR = 0.65 [0.32, 1.28]). Models including CDP had worse fit statistics than those using EDSS scores without CDP. When models included clinical and magnetic resonance imaging measures, T2 lesion volume improved fit statistics. Results were similar for time to SPMS. CONCLUSIONS: CDP was less predictive of time to subsequent events than other MS clinical features.
RESUMO
This retrospective study estimated postinfusion health care resource utilization (HCRU) by site of care among 303 patients with relapsed/refractory large B-cell lymphoma who received third- or later-line treatment with lisocabtagene maraleucel (liso-cel) in the TRANSCEND NHL 001 and OUTREACH trials. Inpatients (n = 256) had higher rates of hospitalization versus outpatients (n = 47; >99% vs 62%), by definition, and higher rates of tocilizumab use for cytokine release syndrome and/or neurological events (22% vs 9%). Rates of intensive care unit admission, corticosteroid use, vasopressor use, hemodialysis, and intubation were generally low and similar between groups. Median (range) total hospital length of stay was 15 (0-88) days (inpatients) and 4 (0-77) days (outpatients). Over 6 months, estimated mean postinfusion cost of care was $89,535 (inpatients) and $36,702 (outpatients). Most costs were incurred in the first month post infusion (inpatients, $50,369 [56%]; outpatients, $19,837 [54%]). Lower overall HCRU was observed with outpatient postinfusion monitoring.
Assuntos
Imunoterapia Adotiva , Linfoma Difuso de Grandes Células B , Hospitalização , Humanos , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Pacientes Ambulatoriais , Estudos RetrospectivosRESUMO
Chimeric antigen receptor (CAR) T-cell therapies have demonstrated high response rates in patients with relapsed/refractory large B-cell lymphoma (LBCL); however, these therapies are associated with 2 CAR T cell-specific potentially severe adverse events (AEs): cytokine release syndrome (CRS) and neurological events (NEs). This study estimated the management costs associated with CRS/NEs among patients with relapsed/refractory LBCL using data from the pivotal TRANSCEND NHL 001 trial of lisocabtagene maraleucel, an investigational CD19-directed defined composition CAR T-cell product with a 4-1BB costimulation domain administered at equal target doses of CD8+ and CD4+ CAR+ T cells. This retrospective analysis of patients from TRANSCEND with prospectively identified CRS and/or NE episodes examined relevant trial-observed health care resource utilization (HCRU) associated with toxicity management based on the severity of the event from the health care system perspective. Cost estimates for this analysis were taken from publicly available databases and published literature. Of 268 treated patients as of April 2019, 127 (47.4%) experienced all-grade CRS and/or NEs, which were predominantly grade ≤2 (77.2%). Median total AE management costs ranged from $1930 (grade 1 NE) to $177 343 (concurrent grade ≥3 CRS and NE). Key drivers of cost were facility expenses, including intensive care unit and other inpatient hospitalization lengths of stay. HCRU and costs were significantly greater among patients with grade ≥3 AEs (22.8%). Therefore, CAR T-cell therapies with a low incidence of severe CRS/NEs will likely reduce HCRU and costs associated with managing patients receiving CAR T-cell therapy. This clinical trial was registered at www.clinicaltrials.gov as #NCT02631044.
Assuntos
Síndrome da Liberação de Citocina , Linfoma Difuso de Grandes Células B , Antígenos CD19 , Humanos , Imunoterapia Adotiva , Estudos RetrospectivosRESUMO
Objective: Information on treatment costs for psoriatic arthritis (PsA) can be valuable for payers and providers who make treatment and formulary decisions. This study compared real-world treatment patterns and healthcare costs among biologic-naive patients with PsA initiating apremilast or biologics.Methods: A retrospective cohort study was conducted using the Optum Clinformatics™ claims database. The study included biologic-naive patients with PsA who initiated treatment with apremilast or a biologic between 1 January 2014, and 31 December 2015. Propensity score matching was used to adjust for selection bias. Treatment persistence/adherence and all-cause healthcare costs were evaluated. Cost differences were determined using Wilcoxon rank-sum tests.Results: In all, 125 biologic-naive patients initiating treatment with apremilast were matched to 245 biologic-naive patients initiating treatment with a biologic. Twelve-month treatment persistence was similar for apremilast vs. biologic users (43.2 vs. 36.7%; p = .2277). While persistent on treatment for up to 12 months, total healthcare costs (from all utilizations) were significantly lower among apremilast vs. biologic users ($28,130 vs. $37,093; p < .0001). Likewise, per-patient per-month costs while persistent on treatment were significantly lower among apremilast vs. biologic users whether they switched treatments ($2,455 vs. $3,497; p = .0103), remained persistent on treatment ($2,434 vs. $3,521; p < .0001), or discontinued but did not switch treatments ($2,178 vs. $2,696; p = .0082).Conclusions: Apremilast patients had significantly lower healthcare costs than biologic patients, even when they switched to a biologic, during the 12-month post-index period. These results may be useful to payers and providers seeking to optimize PsA care while reducing healthcare costs.
Assuntos
Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Talidomida/análogos & derivados , Adulto , Idoso , Estudos de Coortes , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Talidomida/administração & dosagemRESUMO
Aim: Treatment switching and healthcare costs were compared among biologic-naive psoriasis patients initiating apremilast or biologics with ≥12 months pre-/post-index continuous enrollment in Optum Clinformatics™ Data Mart. Methods: After propensity score matching, switch rates (new therapy post-index) and days between index and switch were assessed. Total and per-patient per-month costs by service type were assessed. Results: Apremilast initiators (n = 533) were matched and compared with biologic initiators (n = 955). Twelve-month cumulative switch rates and days to switch were similar. Apremilast initiators had significantly lower total healthcare costs than biologic initiators; apremilast switchers and nonswitchers had significantly lower per-patient per-month costs than biologic switchers and nonswitchers, driven mainly by reduced outpatient pharmacy costs. Conclusion: Apremilast initiators had lower healthcare costs even with treatment switching.