INSURE: a pooled analysis of ixazomib-lenalidomide-dexamethasone for relapsed/refractory myeloma in routine practice.

Aim: We pooled data from three observational studies (INSIGHT MM, UVEA-IXA and REMIX) to investigate the real-world effectiveness of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory myeloma. Materials & methods: INSIGHT MM was a prospective study conducted in countries across Europe, Asia and North/Latin America while UVEA-IXA and REMIX were multicenter, retrospective/prospective studies conducted in Europe. Patients who had received IRd as ≥2nd line of therapy were analyzed. Primary outcomes were time-to-next treatment (TTNT) and progression-free survival (PFS). Results: Overall, 564 patients were included (median follow-up: 18.5 months). Median TTNT and PFS were 18.4 and 19.9 months; both outcomes were numerically longer for earlier versus later lines. Median treatment duration was 14.0 months. Overall response rate was 64.6%. No new safety concerns were noted. Conclusion: The effectiveness of IRd in routine practice appears similar to the efficacy observed in TOURMALINE-MM1. IRd benefit in earlier versus later lines was consistent with previous reports.

Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn's disease in Europe: a retrospective observational study.

BACKGROUND: Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn's disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland. METHODS: This retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups. RESULTS: Overall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0-98.0] and 95 [70.0-98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%). CONCLUSIONS: In this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD. TRIAL REGISTRATION: Not applicable.

Burden of illness in not adequately controlled chronic hypoparathyroidism: Findings from a 13-country patient and caregiver survey.

OBJECTIVE: To address knowledge gaps regarding burdens associated with not adequately controlled chronic hypoparathyroidism. DESIGN: Global patient and caregiver survey. STUDY POPULATIONS: Patients with chronic hypoparathyroidism not adequately controlled on conventional therapy and their caregivers. MEASUREMENTS: Health-related quality of life (HRQoL) and health status were evaluated using the 36-item Short Form version 2 (SF-36 v2.0) and Five-Level EuroQoL 5 Dimensions (EQ-5D-5L) instruments, respectively. Hypoparathyroidism-associated symptoms were assessed by a disease-specific Hypoparathyroidism Symptom Diary and caregiver burden via the Modified Caregiver Strain Index (MCSI). RESULTS: Data were obtained from 398 patients and 207 caregivers. Patients' self-rated hypoparathyroidism-related symptom severity was none (3%), mild (32%), moderate (53%) or severe (12%). Per the Hypoparathyroidism Symptom Diary, patients reported moderate, severe or very severe symptoms of physical fatigue (73%), muscle cramps (55%), heaviness in limbs (55%) and tingling (51%) over a 7-day recall period. Impacts (rated 'somewhat' or 'very much') were reported by 84% of patients for ability to exercise, 78% for sleep, 75% for ability to work and 63% for family relationships. Inverse relationships were observed between patient self-rated overall symptom severity and HRQoL and health status assessment scores-the greater the symptom severity, the lower the SF-36 and EQ-5D-5L scores. Caregiver burden increased with patient self-rated symptom severity: none, 1.7 MCSI; mild, 5.4 MCSI; moderate, 9.5 MCSI; and severe, 12.5 MCSI. CONCLUSION: Patients with not adequately controlled hypoparathyroidism reported substantial symptoms and impacts. Greater patient symptom severity was associated with decreased patient HRQoL and health status assessments and increased caregiver burden.

Attitudes of European physicians towards the use of long-acting injectable antipsychotics.

BACKGROUND: Prescription rates for long-acting injectable (LAI) antipsychotic formulations remain relatively low in Europe despite improved adherence over alternative oral antipsychotic treatments. This apparent under-prescription of LAI antipsychotics may have multiple contributing factors, including negative mental health practitioner attitudes towards the use of LAIs. METHODS: The Antipsychotic Long acTing injection in schizOphrenia (ALTO) non-interventional study (NIS), conducted across several European countries, utilised a questionnaire that was specifically designed to address physicians' attitudes and beliefs towards the treatment of schizophrenia with LAI antipsychotics. Exploratory principal component analysis (PCA) of feedback from the questionnaire aimed to identify and characterize the factors that best explained the physicians' attitudes towards prescription of LAIs. RESULTS: Overall, 136/234 solicited physicians returned fully completed questionnaires. Physicians' mean age was 48.5 years, with mean psychiatric experience of 20.0 years; 69.9% were male, 84.6% held a consultant position, and 91.9% had a clinical specialty in general adult care. Most physicians considered themselves to have a high level of clinical experience with LAI antipsychotics (77.2%), with an increased rate of LAI antipsychotics prescription over the last 5 years (59.6%). Although the majority of physicians (69.9%) declared feeling no difference in stress levels when offering LAI compared to oral antipsychotics, feelings of 'no/more stress' versus 'less stress' was found to influence prescription patterns. PCA identified six factors which collectively explained 66.1% of the variance in physician feedback. Multivariate analysis identified a positive correlation between physicians willing to accept usage of LAI antipsychotics and the positive attitude of colleagues (co-efficient 3.67; p = 0.016). CONCLUSIONS: The physician questionnaire in the ALTO study is the first to evaluate the attitudes around LAI antipsychotics across several European countries, on a larger scale. Findings from this study offer an important insight into how physician attitudes can influence the acceptance and usage of LAI antipsychotics to treat patients with schizophrenia.

Incidence of cardiovascular diseases and type-2-diabetes mellitus in patients with psychiatric disorders.

OBJECTIVE: To assess the incidence of cardiovascular diseases (CVD) and type-2-diabetes in patients with psychiatric disorders. METHODS: A population-based study was conducted using the Swedish national health registries. Patients were identified from the Electronic Medical Records (EMR) in 20 primary care centers and were categorized in four diagnosis cohorts according to their first psychiatric diagnosis: bipolar disorder, schizophrenia, major depressive disorder, or other mood disorder. A control cohort of patients with no psychiatric disorders followed in the same primary care centers was also identified. Incident CVD and type-2-diabetes were defined as the presence of a diagnosis of CVD or diabetes during the follow-up period in patients without prior event. RESULTS: The age and sex standardized incidence rate of CVD was 13.5 per 1000 patient-year in the patients with any psychiatric disorder versus 6.3 per 1000 patient-year in the controls. A similar trend was observed for incident diabetes (5.7 versus 3.4 per 1000 patient-year, respectively). The bipolar disorder and the schizophrenia cohorts showed the highest standardized incidence rates. CONCLUSION: Incidence of CVD and to a lesser extent type-2-diabetes was particularly high in patients with psychiatric disorders. This carries strong clinical implications for the prevention of CVD and type-2-diabetes in these patients.

Patient Preferences for Treatment Attributes in Inflammatory Bowel Disease: Results From a Large Survey Across Seven European Countries Using a Discrete Choice Experiment.

BACKGROUND: Inflammatory bowel disease requires long-term treatment; therefore, understanding patient preferences is important in aiding informed treatment decision making. This study explored patients' preferences for treatment attributes of available inflammatory bowel disease therapies. METHODS: Adult patients from 7 European countries who self-reported previous/current treatment for Crohn's disease (CD) or ulcerative colitis (UC) participated in an online survey via the Carenity platform. In a discrete choice experiment, the relative importance of treatment attributes for CD and UC was estimated using conditional logit models. Latent class analysis was conducted to estimate heterogeneous treatment preferences based on patient profiles. Patients' perspectives and preferences regarding their quality of life were assessed. RESULTS: Across 686 completed survey responses (CD, n = 360; UC, n = 326), the mean patient age was 48 and 50 years, respectively. Patients with CD ranked route of administration as the most important attribute (attribute importance: 32%), preferring subcutaneous over intravenous treatment (P < .001). Patients with UC ranked route of administration and frequency of serious adverse events as the most important attributes (attribute importance: 31% and 23%, respectively), preferring oral (P < .001) and subcutaneous (P < .001) over intravenous treatment and treatment that minimized the risk of serious adverse events (P < .001) or mild adverse events (P < .01). Latent class analyses confirmed the impact of patients' sociodemographic profile on their preferences. All patients prioritized general well-being, energy level, and daily activities as the most important aspects for improvement through treatment. CONCLUSIONS: Patient preferences for treatment attributes varied among patients with CD or UC, highlighting the importance of personalized care and shared decision making to maximize treatment benefits.

This study explored patients' preferences for treatment attributes in Crohn's disease or ulcerative colitis, such as subcutaneous/intravenous drug administration and adverse effects. Patients' preferences highlighted the importance of personalized care and shared decision making to maximize treatment benefits.

Real-world treatment patterns and outcomes for patients with multiple myeloma in Denmark, Finland and Sweden: An analysis using linked Nordic registries.

AIM: The Health outcomes and Understanding of MyelomA multi-National Study (HUMANS) was a large-scale, retrospective study conducted across Denmark, Finland and Sweden using linked data from national registries. We describe the characteristics, treatment patterns and clinical outcomes for patients with newly diagnosed multiple myeloma (NDMM) over 2010-2018. METHODS: Patients with NDMM who received MM-specific, first-line treatments, were categorised by treatment (autologous stem cell transplantation [ASCT] or a combination chemotherapy regimen based on bortezomib, lenalidomide or melphalan-prednisolone-thalidomide). RESULTS: 11,023 patients received treatment over 2010-2018. Time between diagnosis and treatment was shortest in Denmark (0.9 months), then Sweden (2.9 months) and Finland (4.6 months). Around one third of patients underwent ASCT. Lenalidomide-based regimens were prescribed to 23-28% of patients in Denmark and Finland, versus 12% in Sweden. Patients receiving lenalidomide had the longest wait for treatment, from 3.2 months (Denmark) to 12.1 months (Sweden). Treatment persistence was highest among patients receiving melphalan-prednisolone-thalidomide (7-8 months) in Finland and Sweden and lowest among those receiving bortezomib (3.5 months) in Finland. Overall survival (OS) was longest among patients with ASCT (7-10 years). Among patients receiving chemotherapy, OS (from diagnosis/treatment initiation), varied between cohorts. In a sensitivity analysis excluding patients with smouldering MM, OS decreased for all; for patients receiving bortezomib or lenalidomide, OS from diagnosis was 40-49 and 27-54 months, respectively. CONCLUSIONS: This population-based study of patients with NDMM receiving first-line MM-specific treatment, provides real-world data on treatment patterns and outcomes to complement data from randomised clinical trials.

Use Via Early Access to Ixazomib (UVEA-IXA) Study: Effectiveness and Safety of Ixazomib-based Therapy in Relapsed/Refractory Multiple Myeloma Outside of the Clinical Trial Setting.

BACKGROUND: In multiple myeloma (MM), improving our understanding of routine clinical practice and the effectiveness of agents outside of clinical trials is important. TOURMALINE-MM1 data resulted in approval of ixazomib for MM patients who have received ≥ 1 prior therapy. PATIENTS AND METHODS: UVEA-IXA comprised a retrospective chart review in the early access program, and a prospective 1-year follow-up period. Eligible patients had had a biochemical and/or symptomatic relapse after 1-3 prior lines of therapy; no anti-MM therapy for > 3 cycles at the start of ixazomib therapy; and an Eastern Cooperative Oncology Group performance score of 0-2. Lenalidomide- or proteasome inhibitor (PI)-refractory patients were ineligible. Primary endpoints were response and progression-free survival (PFS). RESULTS: Of 357 enrolled patients, 309 were evaluable; most patients received ixazomib alongside lenalidomide (98%) and dexamethasone (97%); 61% had received 2-3 prior lines of therapy. Median PFS was 15.6 months (95% confidence interval [CI]: 12.0-20.6) in all evaluable patients, and 19.6 (95% CI: 12.1-27.0) and 13.9 (95% CI: 10.1-18.1) months in patients who received 1 and ≥ 2 prior lines of therapy, respectively. The overall response rate was 67% in all evaluable patients, and 72% and 63%, respectively, in patients who received 1 and ≥ 2 prior lines of therapy. Median overall survival was 35.5 months. The ixazomib safety profile was consistent with previous reports. CONCLUSION: This study supports ixazomib-based therapy as an effective and tolerable treatment in the real-world. Outcomes were favorable in patients with 1 or ≥ 2 prior lines of therapy who were not lenalidomide- or PI-refractory.

Use of Linked Nordic Registries for Population Studies in Hematologic Cancers: The Case of Multiple Myeloma.

Purpose: Linked health-care registries and high coverage in Nordic countries lend themselves well to epidemiologic research. Given its relatively high incidence in Western Europe, complexity in diagnosis, and challenges in registration, multiple myeloma (MM) was selected to compare registries in Denmark, Finland, and Sweden. Patients and Methods: Data were obtained from four archetypal registries in each country (spanning January 2005-October 2018): National Patient Registry (NPR), Prescribed Drug Registry (PDR), Cancer Registry (CR), and Cause of Death Registry. Patients newly diagnosed with MM who received MM-specific treatment were included. PDR/NPR treatment records were used to assess incident NPR cases. The registration quality of MM-specific drugs in the PDR of each country was also evaluated. Results: In Denmark, only 6% of patients in the NPR were not registered in the CR; in Sweden, it was 16.9%. No systematic differences were identified that could explain this discrepancy. In Denmark, lenalidomide and bortezomib were registered in the NPR with high coverage, but less expensive drugs typically given in combination with bortezomib were not covered in any of the registries. In Finland and Sweden, bortezomib records were not identified in the PDR, but some were in the NPR; other drugs had good coverage in the PDR. Conclusions: The registries evaluated in this study can be used to identify the MM population; however, given the gaps in MM registration in the Finnish and Swedish CRs, Danish registries provide the most comprehensive datasets for research on treatment patterns for MM.

A Retrospective Chart Review of Treatment Patterns and Overall Survival among a Cohort of Patients with Relapsed/Refractory Mycosis Fungoides in France, Germany, Italy, Spain and the United Kingdom.

(1) Background: Most patients with mycosis fungoides (MF), a form of cutaneous T-cell lymphoma (CTCL), develop relapsed/refractory (R/R) disease following front-line systemic therapy. This report describes treatment patterns and outcomes from the subpopulation with R/R MF. (2) Methods: This observational, retrospective, cohort study analyzed patient records (1984-2016) from 27 clinical sites in Europe. Outcomes included treatments received, response to first-, second- and third-line treatment, overall survival (OS) and progression-free survival (PFS). (3) Results: Of 104 patients with MF, 100 received second-line and 61 received third-line therapy. The median (range) times from the start of first-line therapy to the first R/R MF and from the first to the second R/R MF were 11.2 (0.3-166.5) and 13.5 (0.0-174.6) months, respectively. Second-and third-line treatment options varied and comprised systemic therapies (85% and 79% of patients, respectively), radiotherapy (32% and 34%, respectively) and topical therapies (48% and 36%, respectively). The median (95% confidence interval [CI]) OS from the diagnosis of the first R/R MF was 11.5 (6.5-not reached [NR]) years and was higher with non-chemotherapy (NR) versus chemotherapy (6.5 years); the estimated median PFS (95% CI) from the time of the first R/R MF was 1.3 (1.0-2.1) years. (4) Conclusions: High rates of R/R disease were observed after second- and third-line treatments in this real-world cohort, with longer median OS in patients receiving non-chemotherapy treatment versus chemotherapy. Following the standard management of MF and using recently approved targeted therapies can help improve patient outcomes in advanced-stage MF.

First-line treatment of stage IIB to stage IV classical Hodgkin lymphoma in Italy, Israel, and Spain: Patient characteristics, treatment patterns, and clinical outcomes.

Classical Hodgkin lymphoma (cHL) is curable in 90% of cases, but advanced stage patients who do not respond well to first-line (1L) therapy have poorer outcomes. This retrospective study examines patient characteristics, treatment patterns, clinical outcomes, and safety management of 1L cHL therapies in common clinical practice in Italy (IT), Israel (IL), and Spain (SP). The overall sample (n = 256) included patients with stage IIb to IV cHL, of which 86.3% received ABVD as 1L therapy (n = 221). Clinical outcomes were similar for the overall population and ABVD subsample: complete response (CR) in 75% and 76.5%; 30-month (30-mo) survival (OS) of 92.5% and 93.6%; and 30-mo progression-free survival (PFS) of 70.7% and 72.6%. Thirty-month PFS was significantly lower for patients ≥ 60 years and/or with high (4-7) IPS. Treatment-induced pulmonary and cardiac toxicities, and febrile neutropenia occurred, respectively, in 10%, 2.3%, and 6.8% of ABVD-treated patients. Interim PET or PET-CT scans were performed after two cycles of 1L therapy (PET2) for 70.3% and 66.6% of the overall and ABVD cohorts, respectively. PET2 positive rates were nearly 30% (49/173), yet PET-adapted strategy of dose modification only occurred in a small fraction of patients.

Real-world treatment outcomes with brigatinib in patients with pretreated ALK+ metastatic non-small cell lung cancer.

BACKGROUND: The next-generation ALK inhibitor brigatinib is approved for use in patients with ALK inhibitor-naïve ALK-positive advanced NSCLC and in patients previously treated with crizotinib. A phase II trial showed that brigatinib is active in patients with ALK-positive metastatic NSCLC (mNSCLC) who had progressed on prior crizotinib (response rate 56 %, median PFS 16.7 months, median OS 34.1 months). We report final data from the UVEA-Brig study of brigatinib in ALK inhibitor-pretreated ALK-positive mNSCLC in clinical practice. METHODS: UVEA-Brig was a retrospective chart review of patients treated with brigatinib in Italy, Norway, Spain and the UK in an expanded access program. Adults with ALK-positive mNSCLC, including those with brain lesions, resistant to or intolerant of ≥1 prior ALK inhibitor and ECOG performance status ≤3 were eligible. Patients received brigatinib 180 mg once daily with a 7-day lead-in at 90 mg. The objectives were to describe patient characteristics, clinical disease presentation, treatment regimens used and clinical outcomes. RESULTS: Data for 104 patients (male: 43 %; median age: 53 [29-80] years; ECOG performance status 0/1/2/3: 41/41/10/5 %; brain/CNS metastases: 63 %) were analyzed. Patients had received a median of 2 (1-6) lines of systemic therapy prior to brigatinib (37.5 % received ≥3) and a median of 1 (1-5) lines of prior ALK inhibitor-containing therapy (crizotinib 83.6 %; ceritinib 50.0 %; alectinib 6.7 %; lorlatinib 4.8 %). At the time of analysis, 77 patients had discontinued brigatinib. Overall, the response rate was 39.8 %, median PFS was 11.3 (95 % CI:8.6-12.9) months and median OS was 23.3 (95 % CI: 16.0-NR) months. Four patients discontinued brigatinib treatment due to adverse events. 53 patients received systemic therapy after brigatinib, 42 with an ALK inhibitor (lorlatinib, n = 34). CONCLUSIONS: These real-world data indicate the activity and tolerability of brigatinib in patients with ALK-positive mNSCLC who were more heavily pretreated than patients included in clinical trials.

Effectiveness of brentuximab vedotin monotherapy in relapsed or refractory Hodgkin lymphoma: a systematic review and meta-analysis.

This systematic review and meta-analysis aimed to determine the effectiveness of brentuximab vedotin (BV) in relapsed/refractory classical Hodgkin lymphoma (R/R cHL) in the clinical practice setting using most recent results. A total of 32 observational studies reporting on treatment patterns, overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS), overall survival (OS), and adverse events were found. After four cycles, a random-effect model yielded pooled ORR and CR rates of 62.6% (95% confidence interval (CI): 56.0-68.9; I2 = 9.7%) and 32.9% (95% CI, 20.8-46.3, I2 = 64.8%), respectively. Regarding survival, 1-year, 2-year, and 5-year PFS ranged from 52.1% to 63.2%, 45.2% to 56.2%, and 31.9% to 33.0%, respectively. OS rates were 68.2-82.7%, 58.0-81.9%, and 58.0-62.0%, respectively. Most common adverse events were hematological toxicities (neutropenia: 13.3-23%, anemia: 8.8-39.0%, and thrombocytopenia: 4-4.6%), and grade ≥3 peripheral neuropathy (3.3-7.3%). This study supports the effectiveness and safety of BV in R/R cHL patients in the real-world setting.

Functional performance in patients with COPD: association with treatment regimen, GOLD group, lung function, and symptom burden in a cross-sectional study.

Background: Data suggesting that low physical activity levels are associated with increased mortality and exacerbations in patients with COPD have led to increasing interest in the role of physical activity in COPD. This study evaluated self-reported functional performance, a measure of physical activity impairment, according to current treatment regimen, lung function, symptoms, and Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 groups in a large sample of patients with COPD. Methods: This multicenter, cross-sectional, observational study (study identifier: D5970R00003) included patients with COPD (≥40 years) in the USA. A self-completion questionnaire captured demographics and patient-reported outcomes, including the Functional Performance Inventory-Short Form (FPI-SF). Diagnosis and treatment history (including spirometry results) were extracted from medical charts. Multiple linear regression was used to determine the relationship between FPI-SF and FEV1 % predicted, and FPI-SF and COPD assessment test (CAT) score. Results: Overall, 1,775 patients participated (classified as GOLD 2017 group A, 14.8%; B, 46.6%; C, 2.6%; D, 36.0%). Physical activity impairment affected patients across all treatment regimens and GOLD groups (mean FPI-SF total score: 2.1), with the greatest impairment within FPI-SF observed for domains requiring most physical exertion, "physical exercise" and "maintaining the household" (mean FPI-SF scores: 1.7 and 1.8, respectively). Patients receiving loose triple therapy and those in GOLD group D had the highest impairment (mean FPI-SF total scores: both 1.9), and the lowest FEV1 % predicted (55.5% and 54.7%, respectively). FPI-SF total score correlated with FEV1 % predicted and more strongly with CAT score (all P<0.05). Conclusion: The stronger correlation between FPI-SF and CAT scores compared to FPI-SF and FEV1 % predicted suggests that symptoms may have a greater impact on patients' functional performance than lung function. Further longitudinal studies are required to establish a correlation between the effect of treatment on symptoms, lung function, and physical activity.

Sunitinib Treatment Modification in First-Line Metastatic Renal Cell Carcinoma: Analysis of the STAR-TOR Registry.

BACKGROUND/AIM: Sunitinib is the current standard of care for first-line (1L) treatment of metastatic renal cell carcinoma (mRCC). Previous studies suggest that a modified treatment schedule may benefit patients. Our aim was to evaluate efficacy and safety regarding sunitinib treatment modification in 1L treatment of mRCC. MATERIALS AND METHODS: Data were drawn from STAR-TOR, a German real-world registry to evaluate outcomes of patients with mRCC who received 1L sunitinib. Patients were divided into two groups: subsequent treatment modification (SM) or remaining on standard dose/schedule (SS). Time on treatment (TT), progression-free survival (PFS), and overall survival (OS) were estimated. RESULTS: Overall, 297 patients were analyzed; 33% underwent treatment modification. Significant baseline differences between groups were observed; SM patients were older and had a more favourable Karnofsky performance status. SM patients achieved better outcomes than SS patients for median TT (15.1 versus 3.9 months; p<0.0001), PFS (15.1 versus 6.0; p<0.0001), and OS (38.1 versus 13.7; p<0.0001). Diarrhoea (34%/17%), fatigue (30%/11%), hand-foot syndrome (28%/10%), and stomatitis (20%/6%) were more frequently reported in SM versus SS; incidence was reduced following schedule/dose modification (except diarrhoea). CONCLUSION: In addition to AE mitigation, sunitinib treatment modification may help improve efficacy outcomes in mRCC by prolonging treatment duration.

Baseline results from the European non-interventional Antipsychotic Long acTing injection in schizOphrenia (ALTO) study.

BACKGROUND: The Antipsychotic Long-acTing injection in schizOphrenia (ALTO) study was a non-interventional study across several European countries examining prescription of long-acting injectable (LAI) antipsychotics to identify sociodemographic and clinical characteristics of patients receiving and physicians prescribing LAIs. ALTO was also the first large-scale study in Europe to report on the use of both first- or second-generation antipsychotic (FGA- or SGA-) LAIs. METHODS: Patients with schizophrenia receiving a FGA- or SGA-LAI were enrolled between June 2013 and July 2014 and categorized as incident or prevalent users. Assessments included measures of disease severity, functioning, insight, well-being, attitudes towards antipsychotics, and quality of life. RESULTS: For the 572 patients, disease severity was generally mild-to-moderate and the majority were unemployed and/or socially withdrawn. 331/572 were prevalent LAI antipsychotic users; of whom 209 were prescribed FGA-LAI. Paliperidone was the most commonly prescribed SGA-LAI (56% of incident users, 21% of prevalent users). 337/572 (58.9%) were considered at risk of non-adherence. Prevalent LAI users had a tendency towards better insight levels (PANSS G12 item). Incident FGA-LAI users had more severe disease, poorer global functioning, lower quality of life, higher rates of non-adherence, and were more likely to have physician-reported lack of insight. CONCLUSIONS: These results indicate a lower pattern of FGA-LAI usage, reserved by prescribers for seemingly more difficult-to-treat patients and those least likely to adhere to oral medication.

A Real-world Analysis of Treatment Patterns for Cholinesterase Inhibitors and Memantine among Newly-diagnosed Alzheimer's Disease Patients.

INTRODUCTION: Alzheimer's disease (AD) is the most common neurodegenerative form of dementia. Pharmacological therapies for symptomatic treatment, such as acetylcholinesterase inhibitors (AChEIs) and memantine, have been available in the USA since 2000. Over the past decade, few studies have analyzed real-world anti-dementia treatment patterns in the USA. This study evaluated monotherapy AChEIs and memantine treatment patterns among newly diagnosed AD patients. METHODS: A retrospective cohort study was conducted using Medicare data and the Minimum Data Set from 2008 to 2012. Patients aged 65-100 years with newly diagnosed AD (ICD-9 code: 331.0) and monotherapy AChEI or memantine treatment initiated after diagnosis were included. Descriptive treatment pattern analyses, including discontinuation and switch, were undertaken. Kaplan-Meier curves were developed to examine the treatment duration. RESULTS: A total of 9812 newly diagnosed AD patients were identified, with 56.7% (n = 5567) first receiving anti-dementia treatment after the initial AD diagnosis. Among patients initiating monotherapy AChEIs or memantine after AD diagnosis (N = 5200), 51.6% continued index treatment during the entire follow-up period (mean follow-up: 659.7 days) and 21.7% discontinued treatment. Of those who initiated monotherapy treatment with an AChEI, 11.1% received adjunct therapy with memantine. Among patients with ≥1 year of continuous treatment (mean follow-up: 834 days), 75.6% remained on the index drug, 10.2% discontinued during the remaining follow-up period, and 9.5% of the AD patients initiating AChEIs received adjunct memantine therapy during the remaining follow-up period. CONCLUSION: In the USA Medicare population, about 50% of the patients who initiated treatment with AChEI or memantine after diagnosis continued the index treatment, and more than 20% discontinued and were untreated afterwards over the observation period. AD patients initiating AChEIs or memantine were more likely to remain on their treatment if they were persistently treated for the first year.

Antidepressant monotherapy: A claims database analysis of treatment changes and treatment duration.

BACKGROUND: The basic principles of pharmacotherapy for depression are consistent among most US and western European guidelines. All recommend ≥6 months of antidepressant therapy and propose several alternatives in cases of inappropriate response. OBJECTIVES: The aims of this analysis were to describe antidepressant treatment changes and treatment duration in patients undergoing treatment for a new episode of depression and to identify risk factors for treatment changes and treatment discontinuation. METHODS: For this claims database analysis, adults and children treated with antidepressants for a new episode of depression in the time period from 2004 to 2006 were identified using the IMS LifeLink Health Plan Database. Treatment changes (defined as switches to an antidepressant or antipsychotic; combination with an antidepressant; or augmentation with lithium, an anticonvulsant, or an atypical antipsychotic) were described. Antidepressant treatment duration was assessed and described per treatment change. Risk factors for treatment change or discontinuation were identified using multivariate logistic regression (treatment change) or Cox regression (treatment duration). RESULTS: Of 134,287 patients identified using the database (mean [SD] age, 39.1 [14.9] years; 68.1% women), 31,123 (23.2%) had a treatment change, most commonly an antidepressant switch (12,735 [9.5%]) or combination (12,214 [9.1%]). Antipsychotics were introduced in <5% of patients. The median overall treatment duration (111 days) was shorter than that recommended in the guidelines (≥ 6 months). Index antidepressant class was significantly associated with treatment change (higher for tricyclic antidepressants [TCAs] [odds ratio (OR) = 1.59 (95% CI, 1.48-1.70)]; lower for selective serotonin reuptake inhibitors [OR = 0.87 (95% CI, 0.84-0.91)]) and duration (increased risk for early discontinuation for TCAs [hazard ratio (HR) = 1.36 (95% CI, 1.30-1.44)]; lower risk for late discontinuation for serotonin-norepinephrine reuptake inhibitors [HR = 0.81 (95% CI, 0.79-0.84)]). Indicators of depression severity or complexity (prescription by a mental health specialist, previous use of psychotropics, previous psychiatric hospitalization, and presence of psychosomatic comorbidities) were associated with a higher risk for treatment change and inconsistently associated with treatment duration. Two health plans were associated with increased risk for discontinuation (Medicaid, HR = 1.35 [95% CI, 1.28-1.42]; Medicare, HR = 1.38 [95% CI, 1.12-1.71]). Combination and augmentation strategies were associated with a lower risk for treatment discontinuation (combination, HR = 0.83 [95% CI, 0.81-0.86]; augmentation, HR = 0.75 [95% CI, 0.73-0.77]). Overall treatment duration was <30 days in 31,177 patients (26.2%) and >6 months in 54,502 (37.5%). CONCLUSIONS: In this claims database analysis, changes in antidepressant treatment involved 23.2% of patients. The median overall treatment duration was shorter than recommended by guidelines due to a quarter of patients having early treatment discontinuation.