Disease burden and predictors associated with non-response to antihistamine-based therapy in chronic spontaneous urticaria.

Background: H1-antihistamines (H1AH) are the first-line treatment for chronic spontaneous urticaria (CSU), but 50% of patients have inadequate disease control at standard doses. Objective: To assess the comorbidity burden and healthcare resource utilization (HRU) associated with non-response to H1AH-based treatments; to identify predictors of non-response. Methods: Optum® de-identified Electronic Health Record dataset (2007-2020) was used to identify adult patients with CSU who initiated a H1AH, alone or in combination with other oral non-biologics (index treatment). Based on twelve-month treatment patterns observed after index treatment initiation, patients were categorized as responders (continued index treatment or had only 1 next H1AH treatment without corticosteroids) or non-responders (continued corticosteroids or had 2 or more treatment switches). Patient characteristics and HRU were assessed in the 12 months before (baseline) and ≥12 months after (follow-up) index treatment initiation. Baseline predictors associated with non-response were identified using machine learning. Results: There were 17 062 patients who met inclusion criteria, and 14824 (86.9%) were classified as non-responders. A higher proportion of non-responders had records of CSU-related symptoms, comorbidities, polypharmacy, and certain laboratory tests than responders at baseline. A higher proportion of non-responders than responders visited an allergist or dermatologist during follow-up (59.5% vs 53.0%). Non-responders had a larger increase in hospitalizations (15.7% vs -2.4%) than responders during follow-up vs baseline. Predictors of non-response included index and baseline treatment classes, types of specialists seen, chronic pulmonary disease, depression, and female sex. Conclusion: A large proportion of CSU patients treated with H1AH-based therapies had uncontrolled disease, contributing to increased HRU and patient burden. Non-responders had more comorbidities and HRU at baseline and follow-up, with steep increases in follow-up hospitalizations relative to baseline, highlighting an urgent need for early disease control.

Prevalence of Musculoskeletal Symptoms in Patients with Psoriasis and Predictors Associated with the Development of Psoriatic Arthritis: Retrospective Analysis of a US Claims Database.

INTRODUCTION: Psoriasis (PsO) is associated with the development of psoriatic arthritis (PsA). Patients with PsO often experience pre-PsA musculoskeletal (MSK) symptoms, leading to potential structural damage and substantial disease burden with impact on function. The objective of this study is to describe prevalence rates and evidence of MSK symptoms, including incidence of comorbid PsA diagnosis, in patients newly diagnosed with PsO and identify factors associated with PsA diagnosis. METHODS: This retrospective analysis included administrative claims from the Optum Research Database for adult patients with a new PsO diagnosis between January 2008 and February 2019. Eligible patients had ≥ 2 claims for PsO on unique dates, were aged ≥ 18 years at the date of the first claim with a diagnosis of PsO (index date), and had continuous enrollment with medical and pharmacy coverage for 12 months before (baseline period) and ≥ 12 months following the index date. Primary outcomes were incidence of comorbid PsA diagnosis, prevalence of MSK symptoms other than PsA, and evidence of MSK symptoms collected at baseline and assessed in 12-month intervals through 60 months. RESULTS: Of the 116,203 patients with newly diagnosed PsO, 110,118 were without baseline comorbid PsA. High prevalence rates of MSK symptoms among patients with only PsO were seen at baseline (47.1%), 12 months (48.2%), and 60 months (82.1%). Patient age, baseline MSK symptoms, and baseline MSK symptom-related healthcare utilization were associated with increased hazard of a PsA diagnosis. CONCLUSION: Increased prevalence rates of MSK symptoms and burden are experienced by patients newly diagnosed with PsO through 60 months of follow-up. Several baseline factors were associated with increased risk of PsA diagnosis.

A Study to Look at Symptoms of Muscles, Joints, and Bones in Patients with Psoriasis and Whether They Can Predict a Diagnosis of Psoriatic ArthritisPsoriasis is an inflammatory skin disease that results in areas of significant itchiness, pain, and scaling, and ultimately decreases patient quality of life. Psoriasis affects approximately 2­4% of the general US population and 1.3­2.2% of the UK population. Some patients with psoriasis may experience musculoskeletal symptoms and may go on to develop psoriatic arthritis. The goal of this study was to determine the frequency of patients with psoriasis who experienced complaints of musculoskeletal pain prior to and/or following their psoriasis diagnosis, and whether these were associated with further probability of developing psoriatic arthritis.Using a large US-based database with data from approximately 115,000 patients with newly diagnosed psoriasis, we determined the percentage of newly diagnosed psoriasis patients with existing musculoskeletal pain complaints within 12 months of their initial diagnosis. We found that 47% of newly diagnosed patients had previous musculoskeletal pain complaints, with joint pain, back pain, and overall fatigue representing the most common forms. Notably, psoriasis patients with previous joint pain were approximately 50% more likely to develop psoriatic arthritis compared with patients with no previous joint pain. Furthermore, patients with previous other forms of arthritis were nearly twice as likely to develop psoriatic arthritis.This study provides additional support that existing musculoskeletal pain in patients with newly diagnosed psoriasis may predict the potential future onset of psoriatic arthritis. These findings will help guide primary care physicians, dermatologists, and rheumatologists in understanding the importance of earlier detection of psoriatic arthritis to provide more appropriate care.

Perspectives on nonmedical switching and the COVID-19 pandemic: a narrative review.

OBJECTIVES: Nonmedical switching (NMS) is a change in a patient's treatment regimen for reasons other than lack of efficacy, intolerance, adverse effects, or poor adherence. We describe the impact of NMS on patients, health care workers, and health systems, focusing on NMS to in-class biologic alternatives in US patients with chronic, immune-mediated rheumatic and dermatologic conditions. Additionally, we evaluate the ways in which the COVID-19 pandemic may exacerbate the physical, psychological, and economic impacts of NMS. STUDY DESIGN: Narrative review. METHODS: We performed a search of MEDLINE's PubMed database from October 2015 to October 2020, with a repeat search in October 2021. Search terms included relevant keywords pertaining to NMS, biologics, and disease areas. Results were supplemented by a search of key congress abstracts from 2015 to 2021 and a targeted internet search. RESULTS: NMS increases medication abandonment, errors, and adverse effects, and it can lead to longer patient visits, increased follow-up visits, additional laboratory tests and procedures, and greater overall health care resource utilization (HCRU). The increased HCRU associated with NMS increases patients' financial burden due to additional co-pays and out-of-pocket costs. CONCLUSIONS: The decision to switch treatments should result from shared decision-making between health care providers (HCPs) and patients to achieve the best clinical outcomes and optimal HCRU. The issues related to NMS may be compounded by the financial and psychosocial stress on HCPs and patients created by the COVID-19 pandemic. HCPs should advocate for continuous patient treatment and be familiar with continuity of care legislation, appeals processes, and manufacturer assistance programs.

Impact of secukinumab on patient-reported outcomes in biologic-naive patients with psoriasis in a US real-world setting.

OBJECTIVE: To describe real-world baseline characteristics and patient-reported outcomes (PROs) at 6-month and 12-month follow-up visits among patients with psoriasis who initiated and maintained secukinumab, stratified by prior exposure to biologics. METHODS: This real-world study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry who initiated and maintained secukinumab through 6-month and/or 12-month follow-up. Demographics, clinical characteristics, and PROs were collected. PROs included Dermatology Life Quality Index (DLQI); itch, skin pain, fatigue, and EuroQol visual analog scales; and Work Productivity and Activity Impairment. Mean (SD) differences between baseline and follow-up visits were calculated for all outcomes. RESULTS: Overall, 652 patients had a 6-month follow-up visit, 460 (70.6%) were biologic experienced and 192 (29.4%) were biologic naive. Biologic-experienced and biologic-naive patients reported mean (SD) improvements in all PROs measured at 6-month follow-up. Similar improvements were seen among patients with a 12-month follow-up visit (n = 390) and both 6-month and 12-month follow-up visits (n = 326). CONCLUSIONS: Biologic-experienced and biologic-naive patients with psoriasis who initiated and maintained secukinumab treatment reported improvements in PROs at 6-month and/or 12-month follow-up visits. These findings suggest that secukinumab is a potential biologic for psoriasis at any point along the patient treatment journey.

Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting.

INTRODUCTION: Real-world evidence has demonstrated the effectiveness of secukinumab in the treatment of psoriasis; however, limited data are available on patient profiles of US secukinumab initiators over time and clinical outcomes in biologic-naive patients. This study describes clinical characteristics of secukinumab initiators by year, and the clinical outcomes in patients after 6- and/or 12-month follow-up visits, stratified by prior biologic use. METHODS: This observational study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry. Analyses were conducted in two patient cohorts: (1) all secukinumab initiators, stratified by year, and (2) those who initiated and maintained secukinumab through a 6- and/or 12-month follow-up visit. For all secukinumab initiators, patient characteristics at initiation were described per calendar year; in initiators with follow-up visits, mean (SD) differences in percentage affected body surface area (BSA), five-point Investigator's Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI) scores between baseline and follow-up visits were calculated. Analyses were conducted separately for biologic-naive and biologic-experienced patients. RESULTS: Between 2015 and 2020, the proportion of secukinumab initiators in the registry who were biologic-naive increased each year from 12.5% to 49.7%. Overall, 1518 patients initiated secukinumab at or after enrollment; 980 (64.6%) were biologic experienced, and 538 (35.4%) were biologic naive. At 6 months, biologic-experienced and biologic-naive patients reported mean (SD) decreases in BSA (-9.3 [14.5] versus -11.7 [16.6]), IGA (-1.4 [1.3] versus -1.7 [1.4]), and PASI (-5.2 [6.6] versus -6.7 [7.8]). The proportion of patients with an IGA score of clear/almost clear (0/1) increased over fivefold, irrespective of biologic experience. At 12 months, similar improvements were seen. CONCLUSIONS: The proportion of biologic-naive secukinumab initiators increased over time. Biologic-naive patients demonstrated similar improvements in clinical outcomes compared with biologic-experienced patients, suggesting that secukinumab may be considered as a first-line therapy for psoriasis.

Incidence and prevalence of psoriatic arthritis in patients with psoriasis stratified by psoriasis disease severity: Retrospective analysis of an electronic health records database in the United States.

BACKGROUND: Among patients in the United States with psoriasis (PsO), limited data exist on the incidence and prevalence of psoriatic arthritis (PsA) based on disease severity. OBJECTIVE: To assess the incidence, prevalence, and predictors of PsA among patients with PsO stratified by PsO severity using treatment type. METHODS: Incidence of PsA per 100 PsO patient-years (PY) and prevalence were assessed using the Optum electronic health records database. Incidence was assessed from PsO diagnosis and 1 year after PsO diagnosis overall and stratified by mutually exclusive treatment classes as a severity surrogate. RESULTS: The overall incidence of PsA was 2.9 (95% CI, 2.9-3.0) events per 100 PY. The incidence (95% CI) by severity surrogate was 2.1 (2.1-2.1), 9.9 (9.5-10.4), and 17.6 (16.9-18.3) events per 100 PY for patients with mild, moderate, and severe PsO as determined by receiving nonsystemics, nonbiologic systemic therapy, and biologics, respectively. When excluding patients diagnosed with PsA 1 year after PsO diagnosis, overall incidence was lower (1.7 [95% CI, 1.6-1.7] events per 100 PY), with similar trends for treatment-severity surrogates. LIMITATIONS: Results may not be generalizable to a wider population. CONCLUSION: The risk of developing PsA increased with disease severity and was highest in patients with the most severe PsO.

Real-World Satisfaction with Secukinumab in Clearing the Skin of Patients with Plaque Psoriasis through 24 Months of Follow-Up: Results from US Dermatology Electronic Medical Records.

INTRODUCTION: Information on the long-term treatment satisfaction with secukinumab for patients with plaque psoriasis in real-world settings is limited. The objective of this study was to describe real-world treatment satisfaction in patients with plaque psoriasis who initiated secukinumab using data from an electronic medical records-based dermatology database. METHODS: Patients aged ≥ 18 years with plaque psoriasis in Modernizing Medicine Data Services' affiliate's database who received secukinumab 3/1/2018-1/21/2020 were included. Satisfaction with the treatment's effectiveness in clearing the skin of psoriasis was evaluated using a 5-point Likert scale during the 12-month baseline period and at 6-, 12-, 18-, and 24-month postindex visits for the overall population and at 6-, 12-, and 18-month postindex visits for subgroups stratified by prior biologic and systemic therapy use. Additionally, satisfaction levels were assessed among patients who were unsatisfied with treatment at baseline. RESULTS: Overall, 82.3% agreed that secukinumab was effective in clearing their skin at 6 months, which was maintained through 12 (81.7%), 18 (83.3%), and 24 months (81.4%). Similar results were observed in biologic-experienced/naive and systemic-experienced/naive patients. Overall mean (SD) treatment satisfaction improved from 2.49 (1.36) at baseline to 1.77 (1.06) at 6 months, with similar improvements in satisfaction scores reported at each follow-up period up through 24 months. Of the patients who were not satisfied at baseline, 77.9% reported being satisfied with their treatment at 6 months, which continued through 12 (74.4%), 18 (82.8%), and 24 months (71.4%). Patients receiving secukinumab experienced meaningful changes in percent affected body surface area and Physician Global Assessment scores that were sustained through 24 months, regardless of prior treatment experience. CONCLUSIONS: These real-world findings highlight the high level of sustained satisfaction with secukinumab treatment for improving and maintaining skin clearance in patients with moderate-to-severe disease, regardless of prior treatment experience.

Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab.

INTRODUCTION: Patients with psoriasis (PsO) experience impaired health-related quality of life due to physical and psychosocial burdens. The objective of this study was to assess the correlation between change in Psoriasis Area and Severity Index (PASI) score and selected Dermatology Life Quality Index (DLQI) domain scores in patients with moderate-to-severe PsO and those with PsO and comorbid psoriatic arthritis (PsA). METHODS: This post hoc analysis of four phase 3 clinical trials included patients with moderate-to-severe PsO randomized to secukinumab 150/300 mg, etanercept, or placebo. Pairwise latent growth models were applied to assess the longitudinal correlation between change in PASI scores and changes in three DLQI domain scores (daily activities, leisure activities, and symptoms/feelings). The initial (baseline to week 12) and sustained (week > 12 to week 52) treatment exposures were analysed by population type (total, PsO only, and PsO with comorbid PsA) and treatment arm (secukinumab, etanercept, or placebo). RESULTS: Among the total population (N = 2401), PASI change was positively correlated with change in each assessed DLQI domain; correlations were weak to moderate over the initial treatment exposure period (ß range, 0.20-0.29; all P < 0.001) and moderate to strong over the sustained exposure period (ß range, 0.63-0.69; all P < 0.001). Similar trends were observed regardless of the presence of comorbid PsA. These relationships were confirmed among patients treated with secukinumab, etanercept, or placebo. CONCLUSIONS: Improvements in PASI scores were directly moderately related to improvements in DLQI domain scores from initiation of treatment and extended over time, regardless of presence of comorbid PsA or treatment received. CLINICAL TRIAL REGISTRATION: ERASURE (NCT01365455), FIXTURE (NCT01358578), FEATURE (NCT01555125), and JUNCTURE (NCT01636687).

Comparison of infection-related hospitalization risk and costs in tumor necrosis factor inhibitor-experienced patients with rheumatoid arthritis (RA) treated with abatacept or other targeted disease-modifying anti-rheumatic drugs (tDMARDs).

Background: Evidence on the cost and risk of infection-related hospitalizations associated with targeted disease-modifying anti-rheumatic drugs (tDMARDs) in patients with RA previously treated with a tumor necrosis factor inhibitor (TNFi) is limited. This study compared the risk and cost of infection-related hospitalizations in commercially insured TNFi-experienced RA patients receiving abatacept, TNFi, or another non-TNFi.Methods: A retrospective observational study was conducted using 2 large insurance claims databases (1 January 2009-30 June 2017). Adult TNFi-experienced RA patients initiating a subsequent tDMARD (initiation date of tDMARD = index date) with 12 months of continuous enrollment pre-index date, and who had ≥1 inpatient or ≥2 outpatient medical RA claims on 2 different dates were included. Abatacept was compared to TNFis (adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab) and other non-TNFis (tocilizumab, rituximab, and tofacitinib). Cox proportional hazards models estimated the adjusted risk for infection-related hospitalization; costs were calculated on a per-member-per-month (PMPM) and per-patient-per-month (PPPM) basis using generalized linear models.Results: More patients in the abatacept cohort had an infection-related hospitalization at baseline (4.5%) vs TNFis (2.0%, p < .0001) and other non-TNFis (3.6%, p = .2619). However, during follow-up abatacept patients had fewer infection-related hospitalizations (abatacept: 2.8%, TNFi: 3.7% and other non-TNFis: 5.2%; p < .05). Regression results indicated that compared to patients on abatacept, patients receiving a TNFi [HR: 1.6 (95% CI: 1.1, 2.2)] and other non-TNFis [HR: 1.9 (95% CI: 1.3, 2.8)] had a significantly higher risk of infection-related hospitalization. Abatacept PMPM costs were lowest ($0.25 vs $0.39 and $0.43 for TNFi and other non-TNFi respectively). Mean PPPM (95% CI) cost in the follow-up was lower for abatacept compared to TNFi ($73 vs. $115; p = .042), and other non-TNFi ($73 vs. $125; p = .039).Conclusions: There were significantly lower infection-related hospitalizations and associated costs in TNF-experienced RA patients treated with abatacept than TNFis and other non-TNFis.

Factors affecting the adoption and use of gene expression profiling by oncologists in clinical practice.

AIM: In this study, we evaluated the association between oncologists' perceptions of and attitudes toward one frequently used gene expression profiling assays, the Oncotype DX® and oncologists' intention to use this assay in making treatment recommendations for breast cancer patients. METHODS: A nationally representative sample of breast cancer oncologists was surveyed using an adapted technology acceptance model. RESULTS: The survey response rate was 44.1%. The test characteristics `validity of the test' (p = 0.006) and 'use of Oncotype DX by fellow oncologists' (p = 0.0068) were significantly associated with use of the assay by oncologists. Oncologists' intention to use Oncotype DX increased consistently with their perceptions about its usefulness (ß = 0.222). Insurance status of the patients was also significantly associated with physicians' use of Oncotype DX (p = 0.008). CONCLUSION: We report a novel application of an adapted technology acceptance model to understand the adoption of gene expression profiling by oncologists who treat breast cancer patients in making treatment recommendations.