Reasons for switching oral antipsychotic medications and related patterns of care and costs in patients with schizophrenia initiating monotherapy treatment: Claims-linked chart study.

BACKGROUND: Antipsychotic switching is frequent in schizophrenia and is associated with poor clinical outcomes, increased health care resource utilization (HCRU), and increased health care costs. Research describing the reasons for antipsychotic switching in patients with schizophrenia and the associated impacts on HCRU and costs is limited. OBJECTIVE: To explore the reasons for oral antipsychotic medication (OAM) switching and describe HCRU and costs associated with OAM switching, stratified by reasons for switching, in patients with commercial or Medicare Advantage insurance in the United States. METHODS: This retrospective observational study used medical and pharmacy claims from the Optum Research Database linked to patient medical chart data. Adults with a diagnosis of schizophrenia who initiated OAM monotherapy between January 1, 2015, and June 30, 2021, and switched from their initial OAM monotherapy to a second one were included. Reasons for OAM switching were recorded from medical charts abstracted between 4 months preceding and 2 months following the patient's switch date. HCRU and costs incurred up to 3 months before and 3 months after the OAM switch were stratified and compared by reasons for switching among individuals who switched OAM monotherapy. RESULTS: Among 134 patients with valid, abstracted charts, the 2 most common reasons for switching were lack of efficacy (57.5% of switches) and at least 1 tolerability issue (41.8%). Mutually exclusive categories of switching reasons included lack of efficacy and no tolerability issues (56/134; 41.8%), tolerability and no efficacy issues (35/134; 26.1%), lack of efficacy and tolerability issues (21/134; 15.7%), and other or unknown (22/134; 16.4%). All-cause and schizophrenia-related HCRU and costs in any health services category did not appear to differ across the reason-for-switching cohorts, with costs for inpatient stays accounting for greater than half of the total costs, regardless of switching reason. CONCLUSIONS: These findings provide insight on patient experiences that contribute to OAM switching, with nearly half of patients switching because of lack of efficacy, more than one-fourth because of tolerability issues, and an additional one-sixth for reasons of both efficacy and tolerability. Health care providers should address patients' expectations regarding OAM effectiveness, symptom resolution, and side effect tolerability at treatment initiation to minimize switching before the medication has reached peak effectiveness. Prescribing access to a broad selection of antipsychotics with different side effect profiles may help physicians better match treatment to individual patients, fostering greater acceptance of therapy, increased medication adherence, and better long-term outcomes.

Patterns of care and costs of switching oral antipsychotic medications in patients with schizophrenia initiating monotherapy treatment: A US claims analysis.

BACKGROUND: Antipsychotic medications are the mainstay of schizophrenia therapy but may need to be changed over the course of a patient's illness to achieve the desired therapeutic goals or minimize medication side effects. Investigations of real-world treatment patterns and economic consequences associated with antipsychotic changes, including switching, are limited. OBJECTIVE: To describe treatment patterns among patients with schizophrenia who initiated oral antipsychotic medication (OAM) monotherapy and assess switching-related health care resource utilization (HCRU) and costs in US Medicare Advantage and commercially insured patients. METHODS: Adults with at least 2 claims with a schizophrenia diagnosis who initiated (or reinitiated after ≥6 months) OAM monotherapy between January 1, 2015, and June 30, 2021, were identified in the Optum Research Database. A claims-based algorithm using timing of therapies and treatment gaps identified medication changes, specifically OAM monotherapy switches, among OAM initiators over a period of up to 7 years. Patients who switched from their initial OAM monotherapy to a second OAM monotherapy (initial OAM switchers) were matched based on clinical and demographic characteristics to OAM initiators who had not switched OAMs; switch-related HCRU and costs (incurred up to 3 months before and 3 months after the initial OAM switch) were compared between matched initial OAM switchers and nonswitchers. RESULTS: Among 6,425 OAM monotherapy initiators, 1,505 (23.4%) had at least 1 OAM monotherapy switch at any time during follow-up, with a mean (SD) time to first switch of 209 (333) days (median, 67 days), a rate of 0.65 switches per person-year of follow-up, and 56% of first switches occurring within 3 months of OAM initiation. Of all OAM initiators, 947 (14.7%) were initial OAM switchers. Compared with 865 matched nonswitchers, 865 initial OAM switchers had greater mean counts of all-cause medical visits and greater mean counts of schizophrenia-related emergency and inpatient visits and longer inpatient stays per patient per month. Mean (SD) total schizophrenia-related costs per patient per month were $1,252 ($2,602) for switchers compared with $402 ($2,027) for nonswitchers (P < 0.001). CONCLUSIONS: Changes to antipsychotic therapy in our sample of patients with schizophrenia were common, with nearly one-fourth switching OAMs, the majority within the first 3 months of therapy. Initial OAM switchers experienced greater HCRU and costs than nonswitchers. These findings highlight the importance of initiating OAM monotherapy that effectively maintains symptom control and minimizes tolerability issues, which would limit the need to switch OAMs and therefore prevent excess HCRU and treatment costs.

Symptom Burden and GOLD Classification in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone Propionate/Salmeterol Therapy.

Background: Long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) provide greater improvements in lung function and symptoms than inhaled corticosteroid (ICS)/LABA in patients with chronic obstructive pulmonary disease (COPD). This study evaluated symptom burden and Global Initiative for Obstructive Lung Disease (GOLD) categorization among patients who recently initiated umeclidinium/vilanterol (UMEC/VI; LAMA/LABA) or fluticasone propionate/salmeterol (FP/SAL; ICS/LABA) single-inhaler dual therapy. Methods: COPD-diagnosed Medicare Advantage enrollees aged ≥65 years were identified from the Optum Research Database (ORD). Eligible patients had ≥1 pharmacy claim for UMEC/VI or FP/SAL in the 6-month period before sample identification, with no evidence of triple therapy (ICS/LAMA/LABA), asthma, or lung cancer. Symptom burden was assessed via cross-sectional surveys using the COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scale. Patients were classified into GOLD categories using patient-reported symptoms and claims-based exacerbation history. Treatment groups were balanced on potential confounders using inverse probability of treatment weighting (IPTW). CAT and mMRC scores were analyzed with generalized linear regression models using IPTW propensity scores. Results: The final analytic sample included 789 respondents (UMEC/VI: N=392; FP/SAL: N=397). Approximately 66% patients were classified as GOLD B when assessing symptoms with CAT and mMRC together, or CAT alone; more patients were classified as GOLD A (~40%) than GOLD B (~36%) using mMRC alone. Proportions of patients in each GOLD group were similar between treatment cohorts. Post-IPTW multivariable modeling showed similar symptom burden between treatment groups. Conclusion: After controlling for baseline characteristics, symptom burden was similar between patients receiving UMEC/VI or FP/SAL. GOLD classification using mMRC produced more conservative results compared with CAT, potentially underestimating patient symptoms. Many patients receiving FP/SAL were classified as GOLD A or B, despite GOLD recommending non-ICS-containing therapy in these patients. These findings support the need for routine assessment of symptoms in patients with COPD.

The Identification and Cost of Acute Chronic Obstructive Pulmonary Disease Exacerbations in a United States Population Healthcare Claims Database.

Almost half of chronic obstructive pulmonary disease (COPD) exacerbations are estimated to be inaccurately reported by patients, inconsistently recorded in medical records, or not measured due to coding errors inherent to administrative claims. This retrospective observational study aimed to develop an algorithm capable of detecting acute COPD exacerbations (AECOPD) in healthcare claims and estimate costs associated with AECOPD over a 12-month period. Commercial and Medicare Advantage healthcare plan members (≥40 years old) with evidence of COPD were identified from US healthcare-claims database. To refine the algorithm detecting AECOPD in claims data, sensitivity and positive-predictive value calculations were performed to compare AECOPD identification in healthcare claims versus medical charts. Analyses were also performed to examine total exacerbation-related costs for events identified with the new claims algorithm plus events missed. The final algorithm had a sensitivity of 84.9%, with a positive-predictive value of 67.5%. Medical records were abstracted for 402 patients. In the overall sample of healthcare claims (n = 243,998), the algorithm detected ≥1 AECOPD event in 61.3% of patients. The mean cost per patient during an AECOPD episode, identified by the final algorithm, was USD 6,760 (n = 301), with an incremental average cost of USD 607 (n = 122) to 'unobserved' episodes (not reported in claims data) among the chart sample. After multivariate modeling, predicted yearly exacerbation costs translated to USD 1.12 billion per 100,000 patients (USD 12,000 per patient), with 35.76 million associated with unobserved exacerbations. While the final algorithm warrants further validation and study, these findings highlight unobserved AECOPD and their economic burden.

Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR).

AIMS: To characterize a US population of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) using CONTOR, a real-world longitudinal research platform that deterministically linked administrative claims data with patient-reported outcomes data among patients with these conditions. METHODS: Patients with IBS-C or CIC were identified using diagnosis and treatment codes from administrative claims. Potential respondents received a mailed survey followed by 12 monthly online follow-up surveys and 2 mailed diaries. Surveys collected symptom severity, treatment use, quality of life, productivity, and condition/treatment history. Comorbidities and healthcare costs/utilization were captured from claims data. Diaries collected symptoms, treatments, and clinical outcomes at baseline and 12 months. Data were linked to create a patient-centric research platform. RESULTS: Baseline surveys were returned by 2,052 respondents (16.8% response rate) and retention rates throughout the study were high (64.8%-70.8%). Most participants reported burdensome symptoms despite having complex treatment histories that included multiple treatments over many years. More than half (55.3%) were dissatisfied with their treatment regimen; however, a higher proportion of those treated with prescription medications were satisfied. LIMITATIONS: The study sample may have been biased by patients with difficult-to-treat symptoms as a result of prior authorization processes for IBS-C/CIC prescriptions. Results may not be generalizable to uninsured or older populations because all participants had commercial insurance coverage. CONCLUSIONS: By combining administrative claims and patient-reported data over time, CONTOR afforded a deeper understanding of the IBS-C/CIC patient experience than could be achieved with 1 data source alone; for example, participants self-reported burdensome symptoms and treatment dissatisfaction despite making few treatment changes, highlighting an opportunity to improve patient management. This patient-centric approach to understanding real-world experience and management of a chronic condition could be leveraged for other conditions in which the patient experience is not adequately captured by standardized data sources.

Observational vignette study to examine patient and healthcare provider perceived impact of asthma-related exacerbations in the US.

BACKGROUND: Little is known about how patients and healthcare providers (HCPs) perceive the impact of asthma-related exacerbations. This study examined the impact of asthma-related exacerbations on patients' lives from these different perspectives. METHODS: Web-based surveys were administered to a US sample of adult patients with asthma, and HCPs. Participants reviewed six vignettes describing two hypothetical patients with asthma (25-year-old/single/unemployed/no dependents; and 45-year-old/married/employed/two young children) experiencing mild, moderate, or severe exacerbations and rated the impact on eight measures: EuroQoL-5 Dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), sleep, household costs, and medical costs. The proportions reporting impact for each measure were calculated for each vignette; and patient responses were compared with HCP responses. RESULTS: 302 patients with asthma and 300 HCPs completed the survey. As exacerbation severity increased, a higher proportion of patients and HCPs reported impact of exacerbations on patients with asthma. Compared with HCPs, a greater proportion of patients reported problems with pain/discomfort related to mild and moderate exacerbations. Compared with patients, HCPs were more likely to indicate sleep impact, mobility problems, and financial burden across all exacerbation severity levels; self-care problems with moderate and severe exacerbations; and problems with usual activities and anxiety/depression for severe exacerbations. CONCLUSIONS: Understanding the distinctions between how patients and HCPs perceive the impact of exacerbations is important for optimizing patient care. HCPs may be less aware of patient's concerns about exacerbation-related pain/discomfort. Studies are needed to further understand patient-HCP interactions regarding asthma-related exacerbations.

The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study.

GOALS: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a focus on linaclotide. BACKGROUND: As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient expectations and inform clinical decision-making. MATERIALS AND METHODS: Data were derived from the Chronic Constipation and IBS-C Treatment and Outcomes Real-world Research Platform (CONTOR) study from 2 patient-reported 7-day daily BM diaries to create a dataset of 2922 diaries representing 26,524 BMs for 1806 participants. Binary variables were created for: medication(s) used in the past 24 hours and categorization of BMs as loose or watery stools (LoWS), hard or lumpy stools (HoLS), or intermediate (neither LoWS nor HoLS). The relationship between stool consistency, medication use, and BM satisfaction was analyzed using logistic regression with SEs corrected for repeated observations. RESULTS: BMs characterized as intermediate stools and LoWS were satisfactory more often (61.2% and 51.2%, respectively) than HoLS (19.4%). Participants who reported taking linaclotide rated a similar proportion of BMs as satisfactory when described as LoWS (65.6%) or intermediate (64.1%). Linaclotide use was associated with higher odds of BMs being reported as satisfactory compared with nonlinaclotide use (odds ratio: 1.23, P<0.05). CONCLUSIONS: Overall, CONTOR participants were more likely to report BMs classified as LoWS or intermediate as satisfactory, versus HoLS. Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide.

Classification of Patients with COPD on LAMA Monotherapy Using the GOLD Criteria: Analysis of a Claims-Linked Patient Survey Study.

INTRODUCTION: To address the burden of chronic obstructive pulmonary disease (COPD), the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends treatment according to classification of patients by symptom severity and exacerbation risk. This post hoc analysis of a previously reported claims-linked, cross-sectional survey [study 205862 (HO-16-16642)] classified patients with COPD receiving long-acting muscarinic antagonist (LAMA) monotherapy based on the GOLD 2017 categories. METHODS: Eligible patients who were ≥ 40 years of age, with ≥ 2 claims with International Classification of Diseases-10th Revision-Clinical Modification COPD diagnosis codes J40-J44 ≥ 30 days apart during the 12-month baseline period, and ≥ 2 claims for LAMA monotherapy in the 6 months prior to identification, were identified using claims data from the Optum Research Database. Patients completed a survey assessing modified Medical Research Council (mMRC) Dyspnea Scale and COPD Assessment Test (CAT) scores and demographics; clinical characteristics were assessed from claims and survey data, while exacerbation history was assessed from claims data. GOLD symptom severity classifications were low (groups A and C) for patients with low scores on both the CAT and mMRC scales (scores of < 10 and 0-1, respectively), and high (groups B and D) for patients with high scores on either scale (scores of ≥ 10 and 2-4, respectively). RESULTS: Of 433 patients included, 85.5% reported a CAT total score ≥ 10, and 45.5% reported mMRC grades 2-4. During the baseline period, 63.7% of patients had ≤ 1 moderate and 0 severe (hospitalized) exacerbations, and 36.3% had ≥ 1 severe or ≥ 2 moderate exacerbation(s). The proportions of patients with each GOLD classification were: A: 9.0%; B: 54.7%; C: 4.6%; D: 31.6%. CONCLUSIONS: In this population, over 85% of LAMA monotherapy users have symptoms and/or exacerbation risk that may necessitate therapy escalation according to 2017 GOLD guidelines. FUNDING: GlaxoSmithKline [study 205862 (HO-16-16642)].

Predictors of Symptom Burden in Patients with COPD on LAMA Monotherapy: Multivariable Analysis of a Claims-Linked Survey Study.

INTRODUCTION: Many patients with chronic obstructive pulmonary disease (COPD) prescribed long-acting muscarinic antagonist (LAMA) monotherapy remain symptomatic. This multivariable analysis of a previously reported claims-linked, cross-sectional survey assessed symptom burden measured by the COPD assessment test (CAT) in patients treated with LAMA monotherapy. METHODS: Eligible patients aged ≥ 40 years with COPD (≥ 2 International Classification of Diseases-10th Revision-Clinical Modification [ICD-10-CM] diagnosis codes ≥ 30 days apart during the 12-month baseline period) and ≥ 2 claims for LAMA monotherapy in the latter half of the baseline period were identified using claims data from the Optum Research Database. Patients completed a survey and 7-day daily diary; baseline clinical characteristics and resource utilization were assessed from claims data. Association between symptom burden and baseline characteristics was assessed using generalized linear regression modeling with normal distribution and identity link. RESULTS: Overall, 433 patients prescribed LAMA monotherapy with claims-linked survey and diary data were included in the analysis. Most patients (85.5%) had a mean CAT score ≥ 10; 39.0% had scores ≥ 21. Overall, the factors most related to a clinically meaningful increase in CAT score (≥ 2 points) were being diagnosed with COPD for > 5 years and being a current smoker (2.25 points, P = 0.003 and 2.22 points, P = 0.025, respectively). CONCLUSIONS: Results demonstrate that many patients with COPD receiving LAMA monotherapy remain symptomatic, especially those diagnosed > 5 years ago or those who continue to smoke. Use of patient-reported outcomes such as the CAT should be considered part of routine visits for patients with COPD. FUNDING: GlaxoSmithKline (GSK study number 205862 [HO-16-16642]).

Patient-Reported Burden of Illness in a Prevalent COPD Population Treated with Long-Acting Muscarinic Antagonist Monotherapy: A Claims-Linked Patient Survey Study.

INTRODUCTION: Symptom burden in inadequately controlled chronic obstructive pulmonary disease (COPD) considerably impacts quality of life, healthcare resource utilization (HCRU) and associated costs. This claims-linked cross-sectional survey study assessed symptom burden and HCRU among a prevalent population of COPD patients prescribed long-acting muscarinic antagonist (LAMA) monotherapy. METHODS: Patients were identified using claims data from the Optum Research Database. Eligible patients were aged ≥ 40 years with 12 months' continuous enrollment in a US health plan, ≥ 2 medical claims containing COPD diagnosis codes ≥ 30 days apart, and ≥ 2 claims for LAMA monotherapy in the latter half of the 12-month sample identification period. Patients were mailed a cross-sectional survey assessing patient-reported outcomes (PROs) [COPD assessment test (CAT) and modified medical research council dyspnea scale (mMRC)], clinical characteristics, smoking history, and demographics. Patients also completed the Exacerbations of Chronic Pulmonary Disease Tool (EXACT-PRO) daily diary for 7 days. HCRU was assessed from claims data. RESULTS: The study included 433 patients with a self-reported healthcare provider COPD diagnosis, and both claims-based and self-reported LAMA monotherapy treatment (mean age 71.0 years; 59.8% female). Most patients (85.5%) reported a high symptom burden (CAT score ≥ 10), 45.5% had high levels of dyspnea (mMRC grade ≥ 2), and 64.4% reported more severe daily symptoms by the EXACT-PRO. Most patients (71.6%) reported high scores on ≥ 2 PROs. More patients with high symptom burden had COPD-related emergency department visits than those with lower disease burden (27.6% vs 12.7%, P = 0.012). CONCLUSIONS: In conclusion, a large proportion of patients with COPD receiving LAMA monotherapy experienced a high symptom burden and may benefit from therapy escalation. Healthcare professionals can use validated PROs to help them assess symptom burden. FUNDING: GlaxoSmithKline (GSK study number: 205862).

Association Between Cognitive Function and Health Care Costs 3 Months and 6 Months After Initiating Antidepressant Medication for Depressive Disorders.

BACKGROUND: Major depressive disorder is one of the most common and disabling mental health disorders and is associated with substantial costs in terms of direct health care utilization and workplace productivity. Cognitive dysfunction, which alone substantially increases health care costs, is commonly associated with major depressive disorder. However, the health care costs of cognitive dysfunction in the context of depressive disorder are unknown. Recovery from mood symptoms is not always associated with resolution of cognitive dysfunction. Thus, cognitive dysfunction may contribute to health care burden even with successful antidepressant therapy.  OBJECTIVE: To compare health care utilization and costs for patients with a depressive disorder with and without cognitive dysfunction, at 3 and 6 months after initiation of antidepressant medication.  METHODS: This was an observational study, combining a cross-sectional patient survey, administered during a telephone interview, with health care claims data from a large, geographically diverse U.S. health plan. Included patients had at least 1 pharmacy claim for an antidepressant medication between August 1 and September 30, 2012, and no claim for any antidepressant during the 6 months prior to the index date. In addition to other criteria assessed in the claims data, patients confirmed a diagnosis of depression or major depressive disorder and the absence of any exclusionary neurological diagnoses possibly associated with cognitive impairment. Eligible patients were administered validated cognitive function assessments of verbal episodic memory (Hopkins Verbal Learning Test-Revised, Delayed and Total); attention (Digit Span Forward Maximum Sequence Length); working memory (Digit Span Backward Maximum Sequence Length); and executive function (D-KEFS-Letter Fluency Test). Based on comparison of scores with normative data, patients were assigned to cognitive dysfunction or cognitive normal cohorts. All-cause (all diagnoses) and depressive disorder-related health care utilization and costs (all from a payer perspective) were assessed 6 months prior (baseline) to antidepressant initiation and 3 months and 6 months after (follow-up) initiation of antidepressant medication. Health care utilization and costs included ambulatory (office and hospital outpatient), emergency room, inpatient hospital, pharmacy, other medical (e.g., laboratory and diagnostics), and total (all categories combined). All-cause and depressive disorder-related total costs during the 3- and 6-month follow-up periods were modeled with generalized linear modeling with gamma distribution and log link, while adjusting for potential confounders (age, race, gender, education, employment, and comorbidities). RESULTS: Of the 13,537 patients who were mailed an invitation, 824 (6%) were eligible and agreed to participate. Of these, 563 patients provided informed consent, completed the interview, maintained eligibility, and were included in the 3-month calculations. Among these, 255 (45%) were classified as having cognitive dysfunction. Mean patient age was 41.3 (± 12.5) years; 80% were female. Most patients were white and employed. More patients in the cognitive normal cohort were white (P less than 0.001) and employed full time (P = 0.029), had higher education attainment (P less than 0.001), and had fewer comorbidities (P = 0.007) than those in the cognitive dysfunction cohort. Over the first 3 months, patients with cognitive dysfunction had higher adjusted all-cause costs ($3,309 vs. $2,157, P = 0.002) and higher adjusted depressive disorder-related costs ($718 vs. $406, P less than 0.001) than patients without cognitive dysfunction. At 6 months, data from 4 patients were removed from the analysis because of exclusionary diagnoses. Over 6 months, patients with cognitive dysfunction had higher adjusted all-cause costs ($4,793) than patients without cognitive dysfunction ($3,683, P = 0.034). Over 6 months, depressive disorder-related costs did not significantly differ between patients with ($771) and without cognitive dysfunction ($594, P = 0.071). The main drivers of all-cause costs were office visits, outpatient hospital visits, and inpatient costs, and the main driver of depressive disorder-related costs was inpatient costs. CONCLUSIONS: Cognitive dysfunction was associated with higher adjusted all-cause and depressive disorder-related costs 3 months after initiation of an antidepressant medication. This difference persisted for all-cause costs through 6 months. Identification and treatment of cognitive dysfunction in patients with depressive disorder might reduce health care costs.

Health-related quality of life and treatment satisfaction in patients with gout: results from a cross-sectional study in a managed care setting.

BACKGROUND: Patient satisfaction with treatment directly impacts adherence to medication. OBJECTIVE: The objective was to assess and compare treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM), gout-specific health-related quality of life (HRQoL) with the Gout Impact Scale (GIS), and generic HRQoL with the SF-12v2(®) Health Survey (SF-12) in patients with gout in a real-world practice setting. METHODS: This cross-sectional mail survey included gout patients enrolled in a large commercial health plan in the US. Patients were ≥18 years with self-reported gout diagnosis, who filled ≥1 prescription for febuxostat during April 26, 2012 to July 26, 2012 and were not taking any other urate-lowering therapies. The survey included the TSQM version II (TSQM vII, score 0-100, higher scores indicate better satisfaction), GIS (score 0-100, higher scores indicate worse condition), and SF-12 (physical component summary and mental component summary). Patients were stratified by self-report of currently experiencing a gout attack or not to assess the discriminant ability of the questionnaires. RESULTS: A total of 257 patients were included in the analysis (mean age, 54.9 years; 87% male). Patients with current gout attack (n=29, 11%) had worse scores than those without gout attack on most instrument scales. Mean differences between current attack and no current attack for the TSQM domains were: -20.6, effectiveness; -10.6, side effects; -12.1, global satisfaction (all P<0.05); and -6.1, convenience (NS). For the GIS, mean differences were: 30.5, gout overall concern; 14.6, gout medication side effects; 22.7, unmet gout treatment needs; 11.5, gout concern during attack (all P<0.05); and 7.9, well-being during attack (NS). Mean difference in SF-12 was -6.6 for physical component summary (P<0.05) and -2.9 for mental component summary (NS). Correlations between several TSQM and GIS scales were moderate. CONCLUSION: The TSQM and GIS were complementary in evaluating the impact of gout flare on treatment satisfaction and HRQoL. Correlations between the two instruments supported the relationship between treatment satisfaction and HRQoL.

Patient-reported treatment satisfaction and choice of dosing frequency with biologic treatment for moderate to severe plaque psoriasis.

BACKGROUND: Moderate to severe plaque psoriasis has a serious effect on health-related quality of life. Patients treated with biologic medications place importance on satisfaction and treatment frequency options. We assessed patient-reported treatment satisfaction and dosing frequency choice with biologics. METHODS: We used a health care claims database to identify patients with moderate to severe plaque psoriasis. Participants completed the Treatment Satisfaction Questionnaire for Medication. Results were compared between patients experienced with biologics (adalimumab, etanercept, or ustekinumab) or not (cyclosporine or methotrexate). Participants were asked for their choices of dosing options of once every 1-2 weeks, 3-4 weeks, 1-2 months, or 2-3 months. Participants were also asked for their choices of dosing options of every 1, 2, 3, and so on up to every 12+ weeks. RESULTS: A total of 426 patients completed the survey (263 biologic-experienced and 163 biologic-naïve patients). Patient satisfaction with psoriasis treatment was significantly higher in the biologic-experienced cohort. The most frequently chosen option (38.8% of all participating patients) was every 2-3 months; 37.3% chose once every 1-2 weeks. Significant differences were found in the percentage of biologic-naïve patients choosing 2-3-month (49.7%) over 1-2-week (20.9%) dosing (P<0.001). Among biologic-experienced patients, the difference between the percentage of patients choosing the 2-3-month (35.7%) and 1-2-week (41.8%) options was not significant (P=0.264). The two most often week-specific intervals chosen by biologic-naïve patients were 12+ weeks (42.3%) and 4 weeks (15.6%). The biologic-experienced patients most often chose 12+ weeks (31.2%) and 1 week (25.9%). CONCLUSION: Patients using biologics reported satisfaction with their treatment, which may positively affect outcomes. Longer dosing intervals were chosen most frequently among all patients combined. Reports of patient satisfaction with prior treatments and choices regarding dosing frequency, among all other considerations, should be evaluated in determining an appropriate biologic medication for psoriasis.