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Introduction: Data assessing longer-term real-world effectiveness and treatment patterns with upadacitinib (UPA), a Janus kinase inhibitor, in rheumatoid arthritis (RA) are lacking. We assessed improvement in clinical and patient-reported outcomes and treatment patterns for up to 12 months among adult patients with RA initiating UPA. Methods: Data were collected from the CorEvitas® RA Registry (08/2019–04/2022). Eligible patients had moderate to severe RA (Clinical Disease Activity Index [CDAI] > 10) and follow-up visits at 6 or 12 months after UPA initiation. Outcomes were mean change from baseline, percentage achieving minimal clinically important differences (MCID) in clinical and patient-reported outcomes, and disease activity at follow-up. We evaluated clinical outcomes and therapy changes among patients with tumor necrosis factor inhibitor (TNFi) experience and among those receiving UPA as first-line therapy, as well as those receiving UPA as monotherapy versus as part of combination therapy. We further evaluated whether outcomes were similar among those that remained on therapy. Results: Patients treated with UPA (6-month cohort, N = 469; 12-month cohort, N = 263) had statistically significant improvements (p < 0.001) in mean CDAI, tender/swollen joint counts, pain, and fatigue at follow-up. At 12 months, 46.0% achieved MCID in CDAI and 40.0% achieved low disease activity/remission. Overall, 43.0% discontinued UPA at 12 months; of those receiving combination treatment (N = 90) with conventional therapies and UPA, 42.2% (N = 38) discontinued conventional therapy. Findings were similar in the 6-month cohort and among subgroups. Changes from baseline and proportions of patients achieving MCID or clinical outcomes tended to be numerically lower among patients with TNFi experience and numerically higher among those receiving UPA as first-line therapy. Conclusions: UPA initiation was associated with improvements in clinical and patient-reported outcomes, with meaningful clinical improvements regardless of prior TNFi experience, line of therapy, or concomitant use of conventional therapies. Further research is needed to better understand sustained response of UPA over longer treatment periods. [ABSTRACT FROM AUTHOR]

Introduction: The impact of upadacitinib on rheumatoid arthritis (RA) symptoms was evaluated during the first 12 weeks of treatment via patient-reported outcomes (PROs) using a mobile health application (app). Methods: Participating rheumatologists from the CorEvitas RA Registry (prospective, observational cohort) recruited patients with RA initiating upadacitinib treatment. A modified version of the ArthritisPower® app was used to collect PROs, including the Routine Assessment of Patient Index Data 3 (RAPID3), duration of morning joint stiffness, and the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue 7a Short Form at baseline and weeks 1–4, 8, and 12. RAPID3 responses over time were assessed using Kaplan–Meier estimation to determine the proportion of patients achieving disease activity improvement and minimal clinically important difference (MCID). Results were analyzed for all patients initiating upadacitinib and a subsample of TNF inhibitor (TNFi)-experienced patients with moderate to severe disease at baseline. Results: A total of 103 patients with RA initiating upadacitinib (62.1% TNFi-experienced) were included. At week 12, 53 patients (51.4%) completed the study and provided PRO data via the app. Among all patients, improvements in RAPID3, pain, morning stiffness, and fatigue were observed at week 1 and were maintained or further improved through week 12. At week 12, 37.5% of patients achieved RAPID3 low disease activity. Starting at week 1, improvements in RAPID3 disease activity category (19.4% of patients) and achievement of MCID (16.3%) were reported, with nearly 50% of patients achieving these outcomes by week 4 (RAPID3 category: 48.8%; MCID: 49.2%) and 60% by week 12 (RAPID3 category: 59.6%; MCID: 59.8%). TNFi-experienced patients generally reported similar outcomes. Patient-reported medication convenience and compliance were generally high. Conclusions: In this real-world cohort of patients with RA, treatment with upadacitinib was associated with early and significant improvement in RAPID3, pain, morning stiffness, and fatigue regardless of prior TNFi experience. Clinically meaningful improvement in RAPID3 patient-reported disease activity was observed as early as week 1, with continued improvement reported through week 12. [ABSTRACT FROM AUTHOR]

Background: There is limited evidence on the clinical and economic benefit of achieving disease control in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), thus we aimed to assess the impact of disease control on healthcare resource use (HCRU) and direct medical costs among US patients with PsA or AS over 1 year. Methods: Data were derived from the US OM1 PsA/AS registries (PsA: 1/2013–12/2020; AS: 01/2013–4/2021) and the Optum Insight Clinformatics® Data Mart to identify adult patients with PsA or AS. Two cohorts were created: with disease control and without disease control. Disease control was defined as modified Disease Activity Index for Psoriatic Arthritis (DAPSA28) ≤ 4 for PsA and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) < 4 for AS. Outcomes were all-cause inpatient, outpatient, and emergency department (ED) visits and associated costs over a 1-year follow-up period. Mean costs per person per year (PPPY) were assessed descriptively and adjusted odds ratios (aOR) with 95% confidence intervals (CI) were estimated for the likelihood of HCRU by logistic regression. Results: The study included 1235 PsA (with disease control: N = 217; without: N = 1018) and 581 AS patients (with disease control: N = 342; without: N = 239). Patients without disease control were more likely to have an inpatient (aOR [95% CI]; PsA: 3.0 [0.9, 10.1]; AS: 7.7 [2.3, 25.1]) or ED (PsA: 1.6 [0.6, 4.2]; AS: 3.5 [1.5, 8.3]) visit than those with disease control. Those without disease control, vs. those with disease control, had greater PPPY costs associated with inpatient (PsA: $1550 vs. $443), outpatient (PsA: $1789 vs. $1327; AS: $2498 vs. $2023), and ED (PsA: $114 vs. $57; AS: $316 vs. $50) visits. Conclusions: Findings from this study demonstrate lower disease activity among patients with PsA and AS is associated with less HCRU and lower costs over the following year. [ABSTRACT FROM AUTHOR]

Background: The use of medications not relieving symptoms or maximizing quality of life should be minimized following hospice enrollment.Objective: To evaluate the frequency of and predictive factors for continuation of medications with limited benefit after hospice admission among those admitted for cancer- and non-cancer-related causes.Design: Cohort study using the Surveillance, Epidemiology and End Results-Medicare linked database.Patients: Medicare Part D-enrolled beneficiaries 66 years and older who were admitted to and died under hospice care between January 1, 2008, and December 31, 2013 (N = 70,035).Main Measures: Patients were followed from hospice enrollment through death for Part D dispensing of limited benefit medications (LBMs) they had used in the 6 months prior to hospice admission, including anti-hyperlipidemics, anti-hypertensives, oral anti-diabetics, anti-platelets, anti-dementia medications, anti-osteoporotic medications, and proton pump inhibitors. The proportion of patients continuing an LBM after hospice admission was evaluated. Adjusted relative risks (RRs) were estimated for factors associated with LBM continuation.Key Results: Overall, 29.8% and 30.5% of patients admitted to hospice for a cancer- and non-cancer-related cause, respectively, continued at least one LBM after hospice admission. Anti-dementia medications were continued most frequently (29.3%) while anti-osteoporotic medications were continued least often (14.1%). Compared to home hospice, LBM continuation was greater in hospice patients residing in skilled nursing (RR 1.25, 95% CI 1.20-1.29), non-skilled nursing (RR 1.29, 95% CI 1.25-1.32), and assisted living facilities (RR 1.28, 95% CI 1.24-1.32). Patients with hospice stays ≥ 180 days were more likely to continue at least one LBM compared to those with stays of 1 week or less (RR 13.11, 95% CI 12.25-14.02).Conclusions: A substantial proportion of Medicare hospice beneficiaries continued to receive LBMs following hospice enrollment. Providers should evaluate the necessity of continuing non-palliative medications at the end of life through a careful, patient-centric consideration of their potential risks and benefits. [ABSTRACT FROM AUTHOR]

OBJECTIVE Sacubitril/valsartan (SAC/VAL) has been shown to reduce mortality and hospitalization in patients with heart failure with reduced ejection fraction (HFrEF) compared with enalapril but at a substantially higher cost. This study evaluates the cost-effectiveness of SAC/VAL versus enalapril in patients with HFrEF over a 5-year time horizon from the U.S. payer perspective. METHODS A cohort-based Markov model was developed to compare costs and quality-adjusted life years (QALYs) between SAC/VAL and enalapril in patients with HFrEF over a 5-year time horizon. Markov states included New York Heart Association (NYHA) class (II-IV) and death. Treatment discontinuation, HF-related hospitalizations, and NYHA class progression were modeled as transition states based on data from the PARADIGM trial. Other probabilities, costs, and utilities were obtained from published literature and public databases. RESULTS In the base case analysis, SAC/VAL cost more than enalapril ($81,943 vs $67,287) and was more effective (2.647 QALYs vs 2.546 QALYs), resulting in an incremental cost-effectiveness ratio of $143,891/QALY gained. At a willingness to pay (WTP) of $100,000/QALY, SAC/VAL was cost-effective up to a cost of $298/month. Results were most sensitive to SAC/VAL cost, SAC/VAL mortality benefit, and NYHA progression probability. SAC/VAL had a 10% and 52% probability of being costeffective at WTP thresholds of $100,000/QALY and $150,000/QALY, respectively. CONCLUSIONS SAC/VAL is associated with clinical benefit and may be cost-effective compared with the current standard of care over realistic treatment durations from the payer perspective. Results of this analysis can inform discussions on the value and position of SAC/VAL in the current market. [ABSTRACT FROM AUTHOR]

Objectives: To describe medications that older hospice beneficiaries receive through Medicare Part D and assess patterns in Part D use for individuals admitted to hospice for cancer and noncancer causes. Design: Descriptive cohort analysis using the Surveillance, Epidemiology and End Results (SEER)‐Medicare linked database. Setting: U.S. hospice programs Participants: Part D‐enrolled Medicare beneficiaries aged 66 and older who were admitted to hospice and died while under hospice care between January 1, 2008, and December 31, 2013 (N = 88,957). Measurements: We determined the 25 most commonly dispensed medications and the prevalence of at least 1 dispensing through Part D after hospice admission. The prevalence and temporal trends in receipt of opioid analgesics and several preventative medication classes are described. Results: More than half of individuals admitted to hospice for cancer (53.5%) and noncancer causes (52.9%) received at least 1 medication through Part D after hospice admission. The prevalence of receiving at least 1 Part D medication after admission was greatest in individuals admitted for debility or failure to thrive (63.5%) and dementia (61.5%) and lowest in those admitted for ischemic stroke (35.4%) and renal disease (36.0%). Beta‐blockers, angiotensin‐converting enzyme inhibitors, proton pump inhibitors, and statins were among the most common preventative drug classes received overall, although prevalence differed according to admission diagnosis. Nearly 1 in 6 individuals received opioids through Part D after admission, with prevalence steadily decreasing over the study period. Conclusion: Receipt of medications through Medicare Part D after hospice admission is common, particularly for preventative medications, and varies according to admission diagnosis. Further research aimed at better understanding individual‐, provider‐, and healthcare system–level contributors to nonpalliative medication use in the hospice population is warranted. [ABSTRACT FROM AUTHOR]

Background: As novel treatments for type II diabetes enter the market, there is a need to assess their long-term clinical and economic outcomes against currently available treatment alternatives. Objective compilation and evaluation of current pharmacoeconomic evidence can assist payers and decision makers in determining the appropriate place in therapy of a new medication. Objective: Our objective was to review the existing pharmacoeconomic literature evaluating the cost effectiveness and overall costs of treatment associated with liraglutide in type II diabetes. Data Sources: Medical literature indexed in MEDLINE, EMBASE, PsycINFO, CINAHL, and EconLit through 1 June 2014 was searched. Study Selection: Full-text, English-language cost-effectiveness, cost-utility, and other cost analyses in type II diabetes that compared liraglutide to one or more anti-diabetic agents were included. Initial screening was based on relevance of titles and abstracts followed by examination of the study methods of each remaining manuscript. Studies conducting original pharmacoeconomic analyses were chosen for inclusion. Study Appraisal Methods: Articles meeting the inclusion criteria were retrieved, and information on the study design and results was abstracted. Abstracted data elements were chosen and assessed based on the authors' experience as well as criteria set forth by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Health Economic Evaluation Publication Guidelines Task Force. Additionally, reported incremental cost-effectiveness ratios (ICERs) and selected sensitivity analysis results were converted to $US, year 2012 values, in order to facilitate comparison across studies. Results: A total of six cost studies and seven cost-utility studies were identified for inclusion. Across cost studies, liraglutide treatment resulted in costs ranging from a loss of $US2,730 (liraglutide 1.8 mg vs. sitagliptin; pharmacy costs only) over a 1-year time horizon to a savings of $US9,367 (liraglutide 1.8 mg vs. glimepiride; diabetes-related complication costs only) over a 30-year time horizon. Cost-utility analysis results reported base-case ICERs ranging from $US15,774 (vs. glimepiride) to $US40,128 (vs. rosiglitazone) per quality-adjusted life-year (QALY) ($US, year 2012) for liraglutide 1.2 mg and $US8,497 (vs. exenatide) to $US66,031 (vs. rosiglitazone)/QALY ($US, year 2012) for liraglutide 1.8 mg. Estimates were most sensitive to variations in time horizon and cardiovascular complication rates. Based on frequently cited, country-specific cost-utility thresholds, liraglutide was determined to have a probability of being cost effective of between 58 % (liraglutide 1.8 mg vs. sitagliptin) and 93 % (liraglutide 1.2 mg vs. glimepiride). Limitations: Weaknesses of included studies related primarily to study model inputs that assumed long-term morbidity and mortality benefits in favor of liraglutide based on improvements in clinical biomarkers observed in short-term clinical trials. The exclusion of drug acquisition costs in two identified cost studies as well as the assumed lifetime duration of treatment with liraglutide in several cost-utility studies were also identified as weaknesses. The authors' review was limited by the possibility of incomplete literature retrieval, unintended omission of relevant data elements, and comparison of costs and ICERs generated from healthcare systems from differing countries. Conclusions: The current literature presents liraglutide as a cost-effective adjunct treatment for type II diabetes that may also be associated with a reduction in diabetes-related complication costs; however, ICER values are largely dependent on assumptions regarding the benefits of long-term liraglutide treatment and the time horizon of the analysis. Real-world use may make liraglutide unattractive from a payer and policy-maker perspective. [ABSTRACT FROM AUTHOR]

Introduction: The Routine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported outcome tool recommended for the assessment of disease activity in patients with rheumatoid arthritis (RA) in clinical practice. This analysis evaluated the long-term effect of upadacitinib vs. comparators on RAPID3 scores in patients with RA in the phase 3 SELECT clinical trial program. Methods: This post hoc analysis included data from five randomized controlled trials (RCTs) in patients receiving upadacitinib 15 mg or 30 mg once daily (QD) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The proportions of patients reporting RAPID3 remission (scores ≤ 3) were assessed at week 60. Correlations between absolute scores for RAPID3 and Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and 28-joint Disease Activity Score with C-reactive protein (DAS28[CRP]) at week 60 were assessed using Spearman correlation coefficients. Results: A total of 3117 patients were included from the SELECT-NEXT, -BEYOND, -MONOTHERAPY, -COMPARE, and -EARLY trials. By week 60, 32–52% of methotrexate-naïve and csDMARD inadequate responder (IR) patients treated with either upadacitinib 15 mg QD or upadacitinib 30 mg QD reported RAPID3 scores consistent with remission. The proportions were slightly lower in the biologic DMARD-IR SELECT-BEYOND population (19–28%). RAPID3 scores highly correlated (Spearman correlation values ≥ 0.58) with CDAI, SDAI, and DAS28(CRP) scores through week 60 (all p < 0.001). Conclusions: Upadacitinib, as monotherapy or in combination with csDMARDs, was associated with patient-reported remission assessed by RAPID3 over 60 weeks across the SELECT RCTs in patients with RA. Trial registration: SELECT-BEYOND (NCT02706847); SELECT-NEXT (NCT02675426); SELECT-MONOTHERAPY (NCT02706951); SELECT-EARLY (NCT02706873); SELECT-COMPARE (NCT02629159). Plain Language Summary: Rheumatoid arthritis (RA) is a disease that causes inflammation of the joints. Doctors have several ways of assessing how bad a patient's disease is, and these often use a combination of signs and symptoms to develop a 'score'. One method is called RAPID3, which is a score based on an overall assessment of the disease by the patient, the level of pain, and the amount of physical disability. An advantage of RAPID3 is that it is quick and easy to use, and since it uses only patient-reported symptoms, it can be measured easily via telemedicine, without the need for an in-person consultation. In this study, we decided to look into the effect of upadacitinib, a drug used for the treatment of RA, on RAPID3 score in patients with RA. We also investigated whether RAPID3 correlates with other ways of measuring RA severity, including scores that use physician-measured factors such as number of affected joints, as this can help show whether RAPID3 is a valid and useful tool. We found that upadacitinib led to long-term improvements in RAPID3 score, and that results were the same in different studies and patient groups, including patients who had not responded well to other treatments. We also found that RAPID3 correlated well with other measures, i.e., improvements in RAPID3 happened in parallel with improvements in other scores. Overall, these results suggest that RAPID3 can be a useful tool in patients with RA. [ABSTRACT FROM AUTHOR]

Introduction: Despite recent advances in treatment for psoriatic arthritis (PsA), many patients experience inadequate response or intolerance to therapy, indicating that unmet treatment-related needs remain. To further characterize these unmet needs, we evaluated patients' experiences regarding the burden of PsA symptoms and disease impacts, and patients' preferences for treatment. Methods: Patients from ArthritisPower, a rheumatology research registry, completed a web-based survey. Object case best–worst scaling (BWS) was used to evaluate the relative burden of 11 PsA-related symptoms and the relative importance of improvement in nine PsA-related disease impacts. BWS data were analyzed using a random-parameters logit model. Patient demographics, preferences for mode and frequency of therapy, and preferences for methotrexate were analyzed descriptively. Results: Among the 332 participants, most were White (94%), female (80%), with mean age of 54 years (SD 11.4). In the BWS, joint pain was the most bothersome symptom, followed by other musculoskeletal pain and fatigue. The BWS for disease impacts found that improvements in the ability to perform physical activities were most important, followed by improvements in the ability to function independently, sleep quality, and the ability to perform daily activities. The most burdensome symptoms and desired disease impact improvements were similar in patients regardless of their experience with biologic disease-modifying antirheumatic drugs. The most preferred mode and frequency of treatment administration was oral, once-daily medication (preferred by 38% of respondents), and 74% prioritized therapies that significantly improved joint-related symptoms versus psoriasis-related symptoms. The majority of respondents (65%) preferred PsA treatment regimens that did not include methotrexate. Conclusions: Patients with PsA from a rheumatology registry found musculoskeletal pain symptoms to be the most bothersome and prioritized improvements to functional impacts of their disease. These findings can better inform development of new therapies and guide shared patient-provider treatment decision-making. [ABSTRACT FROM AUTHOR]

Pharmacogenomics has an important role in the evolution of personalized medicine, and its widespread uptake may ultimately depend on the interests and perspectives of key players in health care. Our aim was to summarize studies on stakeholder perspectives and attitudes toward pharmacogenomic testing. Thus, we conducted a review of original research studies that reported stakeholder views on pharmacogenomic testing using a structured approach in PubMed, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and EMBASE. A standardized data abstraction form was developed that included stakeholder group of interest-patients, general public, providers, and payers. Stakeholder views regarding barriers to pharmacogenetic implementation were organized into the following themes: ancillary information-related, clinical, economic, educational, ethical or legal, medical mistrust, and practicality. Of 34 studies that met our inclusion criteria, 37 perspectives were reported (15 on providers, 9 on the general public, 9 on patients, and 4 on payers). The most common topics that arose in studies of providers related to clinical usefulness of genetic data (n=11) and educational needs (n=11). Among the general public, the most common concerns were medical mistrust (n=5), insufficient education (n=5), and practicality (n=5). The most prevalent issues from the patient perspective were ethical or legal (n=6) and economic (n=5) issues. Among payers, leading issues were practicality (n=4) and clinical usefulness (n=3). There was overlap in the topics and concerns across stakeholder perspectives, including lack of knowledge about pharmacogenomic testing. Views on issues related to privacy, cost, and test result dissemination varied by stakeholder perspective. Limited research had been conducted in underrepresented groups. Efforts to address the issues raised by stakeholders may facilitate the implementation of pharmacogenomic testing into clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this work is to assess the effect of upadacitinib versus adalimumab and placebo on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with inadequate responses to ≥ 1 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR) in SELECT PsA-1. Methods: In this placebo- and active comparator, phase 3 randomized, controlled trial, patients received daily upadacitinib 15 or 30 mg, placebo, or adalimumab 40 mg every other week through 56 weeks. At week 24, placebo-assigned patients were rerandomized to upadacitinib 15 or 30 mg. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form 36 Health Survey (SF-36), EQ-5D-5L index score, Bath Ankylosing Spondylitis Disease Activity Index, morning stiffness, Self-Assessment of Psoriasis Symptoms, and Work Productivity and Activity Impairment. Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID), scores ≥ normative values, and sustained clinically meaningful responses were compared between treatment groups. Results: At weeks 12 and 24, upadacitinib treatment resulted in improvements from baseline versus placebo across all PROs as well as improvements versus adalimumab in HAQ-DI and SF-36 Physical Component Summary score (nominal p < 0.05). Improvements in PtGA, pain, and HAQ-DI were reported as early as week 2. At week 12, significantly (nominal p < 0.05) more upadacitinib- versus placebo-treated patients reported improvements ≥ MCID across all PROs including seven SF-36 domains. The proportions of upadacitinib-treated patients reporting clinically meaningful improvements at week 12 were similar to or greater than with adalimumab and sustained through week 56. Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab. Conclusions: Upadacitinib treatment provides rapid, sustained, and clinically meaningful improvements in PROs in non-bDMARD-IR patients with PsA. SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400. [ABSTRACT FROM AUTHOR]

Introduction: Psoriatic arthritis (PsA) has a major impact on health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), important components in the assessment of therapeutic efficacy. We evaluated the impact of upadacitinib on PROs in PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR). Methods: Patients enrolled in the phase 3 SELECT-PsA 2 randomized controlled trial (RCT) received 56 weeks of oral upadacitinib 15 mg QD, upadacitinib 30 mg QD, or placebo switched to either dose of upadacitinib at week 24. PROs included patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), health-related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores), fatigue (FACIT-F), psoriasis symptom severity (SAPS), and work productivity (WPAI). Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values, and maintenance of improvements were assessed. Results: At weeks 12 and 24, patients treated with either upadacitinib dose reported statistically and nominally significant improvements from baseline across all PROs versus placebo (p ≤ 0.05), except the WPAI absenteeism domain, which were maintained or further improved to week 56. A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56. Improvements ≥ MCID were reported as early as week 2 in PtGA, pain, and HAQ-DI. Conclusions: Upadacitinib provides rapid, clinically meaningful, and sustained improvements in PROs reported by bDMARD-IR PsA patients. SELECT-PsA 2 ClinicalTrials.gov number, NCT03104374. [ABSTRACT FROM AUTHOR]

Introduction: Upadacitinib is a Janus kinase inhibitor under investigation in patients with psoriatic arthritis (PsA). This study assessed the 56-week efficacy and safety of upadacitinib in patients with PsA and an inadequate response or intolerance to biologic therapy. Methods: In the phase 3 SELECT-PsA 2 study, patients were randomized to 56 weeks of blinded treatment with oral upadacitinib 15 or 30 mg once daily, or placebo switched to upadacitinib 15 or 30 mg once daily at week 24. Efficacy endpoints included the proportion of patients achieving 20/50/70% improvement in American College of Rheumatology criteria (ACR20/50/70), 75/90/100% improvement in Psoriasis Area and Severity Index (PASI75/90/100), and minimal disease activity. Safety was assessed throughout the study. Results: Of 641 patients who received ≥ 1 dose of study drug, 479 (74.7%) completed 56 weeks of treatment. Improvements in the proportion of patients achieving ACR20/50/70, PASI75/90/100, and minimal disease activity were maintained with both doses of upadacitinib through 56 weeks. Week 56 results for patients who switched from placebo to upadacitinib at week 24 were similar to those for patients originally randomized to the upadacitinib groups. The exposure-adjusted event rate for serious infections was 2.6 and 6.1 events/100 patient-years in the upadacitinib 15 and 30 mg groups, respectively. Herpes zoster occurred more frequently with upadacitinib 30 versus 15 mg; most cases were non-serious. Conclusion: In patients with PsA who had an inadequate response or intolerance to biologic therapy, the efficacy of upadacitinib was maintained over 56 weeks with no new significant safety signals observed. Trial registration: NCT03104374. [ABSTRACT FROM AUTHOR]

Background: The Janus kinase inhibitor upadacitinib is a potential treatment for psoriatic arthritis. The efficacy and safety of upadacitinib as compared with adalimumab, a tumor necrosis factor α inhibitor, in patients who have an inadequate response to nonbiologic disease-modifying antirheumatic drugs are unclear.Methods: In a 24-week, phase 3 trial, we randomly assigned patients in a 1:1:1:1 ratio to receive oral upadacitinib at a dose of 15 mg or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week). The primary end point was an American College of Rheumatology 20 (ACR20) response (≥20% decrease in the number of tender and swollen joints and ≥20% improvement in at least three of five other domains) at week 12 with upadacitinib as compared with placebo. Secondary end points included comparisons of upadacitinib with adalimumab.Results: A total of 1704 patients received an active drug or placebo. The percentage of patients who had an ACR20 response at week 12 was 70.6% with 15-mg upadacitinib, 78.5% with 30-mg upadacitinib, 36.2% with placebo (P<0.001 for both upadacitinib doses vs. placebo), and 65.0% with adalimumab. The difference between groups for 15-mg upadacitinib as compared with adalimumab was 5.6 percentage points (95% confidence interval [CI], -0.6 to 11.8) and for 30-mg upadacitinib as compared with adalimumab was 13.5 percentage points (95% CI, 7.5 to 19.4). Both upadacitinib doses were noninferior to adalimumab for the ACR20 response at week 12; the 30-mg dose but not the 15-mg dose was superior to adalimumab. The incidence of adverse events through week 24 was 66.9% with 15-mg upadacitinib, 72.3% with 30-mg upadacitinib, 59.6% with placebo, and 64.8% with adalimumab. There were serious infections in 1.2%, 2.6%, 0.9%, and 0.7% of the patients, respectively. Hepatic disorders occurred in 9.1% of patients in the 15-mg upadacitinib group and 12.3% in the 30-mg upadacitinib group, but grade 3 increases in aminotransferase levels occurred in 2% of patients or fewer in all groups.Conclusions: The percentage of patients with psoriatic arthritis who had an ACR20 response at week 12 was significantly higher with 15-mg or 30-mg upadacitinib than with placebo. The 30-mg dose but not the 15-mg dose was superior to adalimumab. Adverse events were more frequent with upadacitinib than with placebo. (Funded by AbbVie; SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400.). [ABSTRACT FROM AUTHOR]

A survey was issued to patients enrolled in the Medication Therapy Management Clinic (MTMC) at University of Illinois Hospital and Health Sciences (June 2011-January 2012) in order to assess satisfaction with pharmacy services provided by pharmacists. A 23-item survey was offered to 65 patients in the MTMC program before or after clinic visits. Since there is a paucity of data indicating the level of satisfaction with MTM services provided by pharmacists, this survey may contribute to the process of building a greater collaboration between the pharmacist and patient. Sixty-two of 65 patients completed the survey; satisfaction with MTMC pharmacists was demonstrated to be significantly positively correlated with overall satisfaction with the MTMC. Patient satisfaction is not significantly different according to age, gender, ethnicity, or number of disease states. Satisfaction with the pillbox service is not significantly different between younger and older patients. It was also noted that patients taking a greater number of medications had higher levels of satisfaction. Most patients indicated that they were satisfied with the MTMC pharmacists and services; further study linking patient satisfaction with MTM services to improved patient outcomes may allow our MTMC to serve as a model for other pharmacist-managed MTMCs serving similar patient populations. [ABSTRACT FROM AUTHOR]