Background: We evaluated the disease and patient characteristics, treatment, and MET testing patterns, predictive biomarkers and survival outcomes in patients with MET-dysregulated metastatic non-small-cell lung cancer (NSCLC) in a real-world setting.
Patients And Methods: This was a multinational, retrospective, noninterventional chart review study. Data from medical records of patients with advanced/metastatic EGFR wild-type, MET-dysregulated NSCLC (December 2017-September 2018) were abstracted into electronic data collection forms.
Background: Despite the high prevalence of brain metastases (BM) secondary to non-small-cell lung cancer (NSCLC) (NSCLC/BM), patients' experiences (symptoms and impacts) are not fully understood. This study sought to understand the patient experience with NSCLC/BM and identify a patient-reported outcome (PRO) measure fit to capture the most important NSCLC/BM symptoms and impacts.
Methods: A targeted literature review was completed; the National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy-Brain Symptom Index, 24-item version (NFBrSI-24) was identified as a relevant measure that assessed the core symptoms and impacts associated with NSCLC/BM.
Introduction: Capmatinib, a MET inhibitor, showed substantial antitumour activity with manageable side effects in patients with MET exon 14 (METex14)-mutated advanced non-small cell lung cancer (aNSCLC) in the GEOMETRY mono-1 study. We report patient-reported outcomes (PROs) from this study.
Methods: Enrolled treatment-naïve (1L) or pre-treated (2L) patients with aNSCLC with a METex14-skipping mutation received 400 mg capmatinib twice daily during 21-day treatment cycles.
Background: The phase 3 FUTURE 5 trial (NCT02404350) showed the clinical and radiographical efficacy of secukinumab in patients with psoriatic arthritis. This analysis aimed to assess the effect of secukinumab on patient-reported outcomes (PROs).
Methods: FUTURE 5 was a phase 3, multicentre, parallel-group randomised trial in which patients who were 18 years old or older, met the classification criteria for psoriatic arthritis at screening, and had symptoms of moderate-to-severe psoriatic arthritis for at least 6 months were randomly assigned to receive secukinumab 300 mg, 150 mg, 150 mg no loading dose (NL), or placebo weekly from baseline to week 4 and every 4 weeks thereafter.
Background: Biologic psoriasis treatments are differentiated by efficacy, side effects, and other attributes.
Objective: Determine attributes of biologic psoriasis treatments that drive patients' treatment choices.
Methods: Respondents (USA: = 300; Germany: = 300) with moderate-to-severe psoriasis completed a discrete-choice-experiment survey, choosing between hypothetical treatments characterized by attributes with varying levels: chance of clear skin after 1 year, number of first-year treatments, first-year risks of mild-to-moderate injection site reaction (ISR) and serious infection, and years of proven efficacy/safety.
Objective: To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in the MEASURE 1 study (up to 3 years) and the MEASURE 2 study (up to 2 years).
Methods: Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous) and MEASURE 2 (150 mg subcutaneous). Patients were naive to treatment with anti-tumor necrosis factor (anti-TNF-naive) therapy or had an inadequate response/intolerance to anti-TNF therapy (anti-TNF-IR).
Background: Psoriasis Area and Severity Index (PASI) response rates have been the benchmark for evaluating treatment efficacy in trials involving moderate-to-severe psoriasis.
Objective: To understand how dermatologists assess biologics and which trade-off rules they apply when planning psoriasis treatment.
Methods: Two online surveys of 130 and 129 US dermatologists (surveys 1 and 2, respectively) were conducted with use of direct and indirect elicitation via discrete choice experiment.
Introduction: Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated superior efficacy to ustekinumab in the phase 3b CLEAR study of moderate to severe plaque psoriasis. Here, we report 16-week results from CLARITY, a second head-to-head trial comparing secukinumab with ustekinumab.
Methods: In the phase 3b CLARITY study, patients were randomized 1:1 to receive subcutaneous secukinumab 300 mg or ustekinumab per label.
Aim: To evaluate the cost-effectiveness of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, compared to other clinically used biologics (adalimumab, infliximab, and ustekinumab) in Japan for the treatment of moderate-to-severe psoriasis from the healthcare system (total costs) and patient co-payment (using different frequencies of drug purchase) perspectives.
Methods: A decision-tree (first year)/Markov model (subsequent years), with an annual cycle, was developed. The model adopted a 5-year time horizon.
There is limited evidence regarding biologics dosing patterns and its costs among psoriasis patients in the United Kingdom (UK). This retrospective study assessed biologics dose increase beyond labelled dose and associated UK pharmacy costs in moderate to severe psoriasis patients. Adult psoriasis patients on biologic prescription for ≥12 continuous months between January 2010 and March 2015 with their diagnosis recorded in the UK Hospital Treatment Insights Database within one month of such prescription were included.
View Article and Find Full Text PDFIntroduction: Data regarding disease burden and quality of life (QoL) for patients with psoriasis from Russia are limited. The objective of this study was to describe the demographic and clinical characteristics, comorbidities, and treatment patterns of systemic therapy eligible psoriasis patients in Russia in order to assess the impact of psoriasis on the QoL and work productivity of the patients and to evaluate patient/dermatologist concordance on disease severity, signs/symptoms, and satisfaction with psoriasis treatment.
Methods: Data were collected by the Growth from Knowledge Disease Atlas global real-world evidence programme from nine countries.
Background: Psoriasis is associated with a high economic burden to society. New psoriasis systemic treatments offer the potential for improved skin clearance. Whether a higher degree of clearing translates into economic benefit through decreased work impairment has not been fully determined.
View Article and Find Full Text PDFBackground: Psoriasis causes work productivity impairment that increases with disease severity. Whether differential treatment efficacy translates into differential indirect cost savings is unknown.
Objective: To assess work hours lost and indirect costs associated with secukinumab versus ustekinumab and etanercept in the United Kingdom (UK).
J Eur Acad Dermatol Venereol
December 2018
Background: Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin 17A, has demonstrated strong and sustained efficacy in adults with moderate to severe psoriasis in clinical trials.
Objective: This analysis compared the cost per responder of secukinumab as first biologic treatment of moderate to severe psoriasis, with adalimumab, infliximab, etanercept and ustekinumab in Germany.
Methods: A 52-week decision-tree model was developed.
J Eur Acad Dermatol Venereol
September 2018
Background: Psoriasis is a chronic immune-mediated inflammatory disease, which often requires lifelong treatment. A strong partnership between the patient and healthcare practitioners should help to achieve effective treatment outcomes.
Objective: To assess concordance of views between patients with psoriasis and their treating dermatologists relative to psoriasis severity, presence of symptoms and satisfaction with disease control achieved.
Background: The appearance and lifelong, chronic nature of psoriasis result in considerable burden to patients, such as sleep impairment, depressive symptoms, negative self-esteem and reduced work productivity.
Objectives: To examine direct and indirect (mediated) effects of secukinumab vs. ustekinumab on quality of life, work productivity and activity impairment based on psoriasis severity and symptoms.
Background: Psoriasis is a chronic, immune-mediated disease, characterized by symptoms that include itching and skin pain and is often associated with comorbidities. Patients have a substantial detriment to quality of life (QoL) and work productivity with associated cost burden.
Objectives: To investigate the incremental burden of comorbidities, itch and affected body areas among systemic eligible patients with psoriasis, using a multinational survey of dermatologists and their patients with psoriasis.
Background: Secukinumab has demonstrated greater sustained skin clearance than ustekinumab through week 52, greater improvement in symptoms and health-related quality of life, and comparable safety profile.
Objective: To assess the impact of secukinumab versus that of ustekinumab on complete relief from psoriasis-related symptoms, time to response in terms of health-related quality of life, and cumulative benefit among patients with moderate-to-severe plaque psoriasis.
Methods: Psoriasis-related pain, itching, and scaling and the Dermatology Life Quality Index (DLQI) score were compared between treatments on the basis of time to complete relief of symptoms and time to DLQI response in the CLEAR trial.
Background: Psoriasis can greatly impact patients' lives by influencing clothing worn as well as by impairing sexual functioning. Secukinumab, a human monoclonal antibody selectively neutralizing interleukin-17A, has demonstrated good efficacy and safety in the treatment of moderate-to-severe psoriasis and psoriatic arthritis with a rapid onset of action and sustained response.
Objective: This analysis using the CLEAR study, a phase 3b double-blind study comparing the efficacy and safety of secukinumab vs.
Background: Secukinumab has demonstrated significant efficacy with a good safety profile through 1 year in plaque psoriasis. Given the chronic nature of this disease, long-term follow-up is needed to evaluate psoriasis therapies fully.
Objectives: To determine the long-term (3-year) efficacy and safety of secukinumab in moderate-to-severe psoriasis.
Background: Psoriasis is a multifactorial, inflammatory, skin disease associated with various comorbidities. The cost of those comorbidities is not well characterized. The present study assesses the incremental burden of comorbidities on healthcare resource utilization, direct costs and indirect costs associated with short-term disabilities among patients with psoriasis in the United States.
View Article and Find Full Text PDFBackground: Moderate-to-severe psoriasis is associated with reduced health-related quality of life (HRQoL). Individuals with psoriasis are at increased risk for other medical conditions, but little information quantifies the incremental burden of psoriasis-associated comorbidity among European adults, and data have generally been limited to clinical samples.
Objective: To quantify the incremental burden of cardiovascular comorbidity and psoriatic arthritis among adults with moderate-to-severe psoriasis in the general population of France, Germany, Italy, Spain and the United Kingdom (EU5).
Background: The emergence of new biological therapies showing high and sustained level of Psoriasis Area and Severity Index (PASI) 90 response has provided the possibility of both greater skin clearance and increased quality of life (QOL).
Objective: To evaluate the association of greater response in skin clearance with improvements in skin-related QOL up to 52 weeks.
Methods: Subjects achieving various levels of skin clearance (PASI 90-100 or PASI 75-89) and Dermatology Life Quality Index (DLQI) (0/1) response were compared using ERASURE and FIXTURE trial data.