Opioid use surrounding diagnosis and follow-up in patients with ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis: Results from US claims databases.

OBJECTIVE: To describe patients' use of opioids in the year preceding and year following new diagnosis of ankylosing spondylitis (AS), psoriatic arthritis (PsA), or rheumatoid arthritis (RA), compared with patients without the/se diseases. METHODS: This study used US IBM® MarketScan® Commercial Claims and Encounters (CCAE) and Medicaid data and included three cohorts, comprised of incident cases of AS, PsA, or RA (2010-2017). Three matched comparator patients (without the incident disease) were selected for each patient within the disease cohort. Opioid use and appropriate treatment exposure (as defined by US guideline recommendations) in the 12-month baseline and follow-up periods were evaluated using descriptive analyses. RESULTS: Prevalence of claims for opioids was higher for disease cohorts vs. comparators in CCAE; 36.4% of patients with AS, 29.5% with PsA, and 44.4% with RA did not have any claim for guideline-appropriate therapy in follow-up. Prevalence of claims for opioids was also higher for disease cohorts vs. comparators in Medicaid; 30.6% of patients with AS, 36.6% with PsA, and 65.4% with RA did not have any claim for guideline-appropriate therapy in follow-up. CONCLUSIONS: In patients with AS, PsA, or RA, there was high reliance on opioids at and around the time of diagnosis. Significant proportions of patients were not on appropriate treatment as defined by professional society post-diagnosis guidelines; this discordance between actual patient therapies and treatment recommendations may suggest a need for better awareness of appropriate pain management and treatment strategies in rheumatic diseases. Key Points • This study analysed opioid use among patients with ankylosing spondylitis (AS), psoriatic arthritis (PsA), or rheumatoid arthritis (RA), and adds to current knowledge by expanding beyond assessment of opioid use at diagnosis, to the year before and after diagnosis. • Opioid use was found to be highly prevalent in AS, PsA, and RA in the year prior to diagnosis and, interestingly, was still seen during the year after diagnosis. • Opioids are neither disease modifying, nor a targeted/recommended treatment for chronic autoimmune diseases. In addition to their association with significant economic costs, opioids are potentially hazardous and are not better than alternative treatments with superior safety profiles. • The reasons behind opioid prescribing patterns should be explored further to support movement to targeted therapies.

Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials.

BACKGROUND: Patients with psoriasis have increased risk of suicidal ideation and behavior (SIB) and depression. Bimekizumab, a biologic that inhibits interleukin (IL)-17A and IL-17F, received Food and Drug Administration approval in 2023 for moderate to severe plaque psoriasis, following 2021 European Medicines Agency approval. OBJECTIVE: To report SIB and depression in patients with moderate to severe psoriasis treated in bimekizumab clinical trials. METHODS: Mental health changes, including neuropsychiatric events, were actively monitored across 9 bimekizumab clinical trials in psoriasis phase 2/3 trials. The patient-reported electronic Columbia-Suicide Severity Rating Scale (measuring SIB) and Patient Health Questionnaire-9 (measuring depression) were administered, monitored by an independent Neuropsychiatric Adjudication Committee. RESULTS: Throughout 7166 patient-years (PY) of bimekizumab exposure, the adjudicated SIB rate was 0.13/100PY; SIB ranges for the general psoriasis population and patients receiving anti-IL-17A/anti-IL-23 therapies are 0.09 to 0.54/100PY and 0.09 to 0.19/100PY, respectively. At week 16, 92.9% vs 81.1% of bimekizumab- vs placebo-treated patients had no/minimal depression. Newonset positive electronic Columbia-Suicide Severity Rating Scale responses and mean Patient Health Questionnaire-9 scores were low for bimekizumab-treated patients. LIMITATIONS: Patient exclusion for significant/severe prespecified SIB/depression history. CONCLUSION: The long-term adjudicated SIB rate with bimekizumab was low and within ranges reported in the general psoriasis patient population and psoriasis patients treated with anti-IL-17A/anti-IL-23 biologics. Screening/monitoring questionnaires reported low SIB and depression levels.

Skin Clearance is Associated with Reduced Treatment Failure in Patients with Psoriasis: Real-World Evidence from the CorEvitas Psoriasis Registry.

INTRODUCTION: Complete and near-complete skin clearance have become achievable treatment goals for patients with psoriasis receiving systemic biologic therapies. However, there is limited real-world evidence regarding the impact of the degree of skin clearance on biologic treatment patterns among these patients. METHODS: This longitudinal cohort study assessed the relationship between degree of skin clearance following initiation of a systemic biologic therapy and treatment failure among patients from the CorEvitas Psoriasis Registry (April 2015-August 2021). Patients had Psoriasis Area and Severity Index (PASI) score > 5 at systemic biologic therapy initiation and ≥ 1 follow-up visit(s) within 15 months of initiation. Treatment failure (discontinuation due to poor response/adverse event; addition of non-biologic therapy) and degree of skin clearance (measured by PASI) were assessed following biologic initiation. Proportional hazards regression was used to estimate the association between PASI response level and treatment failure over follow-up. RESULTS: This study included 2701 patient initiations from 2516 unique patients with 3846 total visits over follow-up. Over half of the patient initiations (n = 1412; 52.3%) were among patients with PASI >10. Treatment failure occurred in 1.3% of visits at which PASI100 was achieved, while those achieving PASI90 - < 100 and PASI75 - < 90 had treatment failure rates of 3.4% and 3.5%, respectively. After adjustment for confounders, the risk of treatment failure was two to three times higher in the PASI90 - < 100 (hazard ratio [HR] = 2.61; 95% confidence interval [CI] 1.35, 5.02; p = 0.004) and PASI75 < 90 (HR = 2.97; CI 1.58, 5.58; p = 0.001) groups compared to the PASI100 group. The risk of treatment failure was more than 20 times higher in the < PASI75 group versus the PASI100 group (HR = 22.26; CI 13.32, 37.21; p < 0.001). CONCLUSIONS: The results suggest that patients are more likely to remain on a systemic biologic therapy if they achieve near-complete or complete skin clearance, supporting the continued need to target skin clearance as a treatment goal in psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02707341.

Many people with psoriasis are often treated with biologic medications that work to improve symptoms associated with psoriasis, including inflammation. These medications can lead to clear or almost-clear skin for many people. However, there is limited information available about how achieving this goal affects whether patients continue taking their biologic medication or add a new non-biologic medication. The data source for this study was a database of patients with psoriasis (the CorEvitas Psoriasis Registry) that records how clear patients' skin is and what medications they take. Over 1 year after starting a biologic medication, approximately 1 out of every 100 patients that achieved clear skin after taking a biologic medication stopped using that medication, and approximately 3 out of every 100 patients with almost-clear skin after taking a biologic medication stopped using that medication. Meanwhile, around 20 out of every 100 patients that did not have clear or almost-clear skin after taking a biologic medication stopped using that medication. Furthermore, patients who did not have clear or almost-clear skin after taking a biologic medication had more than 20 times greater risk of stopping their medication than those who did have clear or almost-clear skin after taking a biologic medication. These results suggest that patients are more likely to remain on their biologic medication if they experience clear or almost-clear skin after taking a biologic medication and that patients and their providers should aim for this goal when taking a biologic medication.

Nonradiographic axial spondyloarthritis: expanding the spectrum of an old disease: A narrative review.

ABSTRACT: Nonradiographic axial spondyloarthritis (nr-axSpA) represents a distinct phenotype within the spectrum of axial spondyloarthritis (axSpA), which is characterized by a range of clinical manifestations. Despite a high disease burden that is comparable to ankylosing spondylitis (also known as radiographic axSpA), there is an unmet need to recognize and effectively manage patients with active nr-axSpA.A targeted literature search was conducted in OVID (MEDLINE and Embase databases) to identify articles on nr-axSpA, including its definition, demographics, epidemiology, burden, diagnosis, clinical presentation, and treatment guidelines.The lack of adequate epidemiological data and incomplete understanding of nr-axSpA among rheumatologists and nonrheumatologists contributes to delayed referrals and diagnosis. This delay results in a substantial burden on patients, physically and psychologically, and the healthcare system. Targeted therapies, such as biologics, including inhibitors of tumor necrosis factor or interleukin-17A, have been approved and utilized for the management of nr-axSpA, and other novel therapeutics with different mechanisms of action are in development. Raising awareness among US internists regarding the prevalence of nr-axSpA, disease burden, clinical presentation, diagnostic tools, and available treatments is important for improved disease management.Future clinical investigations focusing on the development of markers that aid early diagnosis and predict treatment response may also improve the management of nr-axSpA. This review provides an overview of nr-axSpA with the aim of raising awareness of the disease among US internists, with an overarching goal to contribute toward the improved recognition and timely referral of these patients to rheumatologists for diagnosis and management.

Occurrence of Possible Rheumatologic Immune-Related Adverse Events (rh-irAEs) Associated with Immune Checkpoint Inhibitor (ICI) Therapy.

INTRODUCTION: Current epidemiologic literature of rheumatologic immune-related adverse events (rh-irAEs) consists of clinical trials, case reports, or smaller, single-center series. We evaluate the occurrence of rh-irAEs during immune checkpoint inhibitor (ICI) therapy from US commercial claims data. METHODS: Patients newly initiating ICI therapy in commercial claims data were eligible for inclusion. Rh-irAEs were defined using ≥ 1 International Classification of Diseases (ICD)-9 or ICD-10-Clinical Modification (CM) claims for selected events, ranging from joint pain and myalgia to ankylosing spondylitis and psoriasis. The percentage of patients experiencing rh-irAEs after ICI initiation was determined. RESULTS: A total of 5722 patients initiating an ICI between January 1, 2012, and June 30, 2018, were included; 201 patients (3.5%) had a history of rheumatic disease. Among the 5521 patients without a history of rheumatic disease, 29.6% experienced ≥ 1 rh-irAE in follow-up, decreasing to 22.6% when assessing events for which there was no diagnostic history. Limiting to claims for rh-irAE with a rheumatologist provider, the proportion of patients experiencing an event decreased to 0.9%. Among patients with a history of rheumatic disease, 71.6% experienced ≥ 1 rh-irAE. Limiting to events for which the patient did not have a history during baseline, 35.3% experienced an event. CONCLUSIONS: Occurrence of rh-irAEs during ICI use is higher in patients with pre-existing rheumatic disease compared to those with no pre-existing rheumatic disease. However, the most common events were not definitive rheumatic diseases but rather symptoms, such as pain in joints. Occurrence of events associated with a rheumatologist provider was substantially lower, suggesting that either patients are not referred to a rheumatologist or referral does not result in confirmation of the diagnosis by the rheumatologist.

The Annual Diagnostic Prevalence of Ankylosing Spondylitis and Axial Spondyloarthritis in the United States Using Medicare and MarketScan Databases.

OBJECTIVE: The objective of this study was to investigate the diagnostic prevalence of ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA) in the United States and examine treatment patterns for these diseases. METHODS: This retrospective observational cohort study drew from 2006-2014 data in the US Medicare Fee-for-Service and IBM MarketScan databases. AS and axSpA diagnoses were identified through International Classification of Diseases, Ninth Revision [ICD-9] codes. Diagnostic prevalence (per 10,000 patients) was calculated as patients with AS and axSpA with full insurance coverage in each calendar year divided by the total patients with full insurance coverage in the same year. Two diagnosis definitions were used: definition 1 (D1), one or more relevant ICD-9 codes from hospital claims or two or more relevant ICD-9 codes from outpatient claims; definition 2 (D2), one or more codes from hospital/outpatient claims. Primary analyses assessed annual AS and axSpA prevalence (D1); sensitivity analyses assessed annual (D2) and 2-year prevalence. Patterns in prevalence and treatment use were analyzed descriptively; no statistical tests were performed. RESULTS: An increase in AS prevalence (per 10,000 patients) was seen from 2006 to 2014 in primary analyses (Medicare: 2.12-3.60; MarketScan: 0.85-1.42) and sensitivity analyses. A similar trend occurred for axSpA (Medicare: 4.39-6.52; MarketScan: 1.33-2.21). For Medicare, the proportion of patients with AS (D1) using tumor necrosis factor α inhibitors (TNFis), conventional synthetic antirheumatic drugs (csARDs), nonsteroidal antiinflammatory drugs (NSAIDs), opioids, and glucocorticoids remained relatively stable; for MarketScan, TNFi-treated patients increased (51.7% to 65.7%) and NSAID-treated patients decreased (63.5% to 55.7%). CONCLUSION: AS and axSpA prevalence may have increased in the United States between 2006 and 2014. Reasons are unknown, but this may be due to increased disease awareness, among other factors.

Content validity of the ASQoL for use in a non-radiographic axial spondyloarthritis population: a qualitative study.

PURPOSE: The ankylosing spondylitis quality of life (ASQoL) instrument is widely used to assess health-related quality of life in patients with ankylosing spondylitis (AS). We assessed the relevance of the ASQoL items in patients with non-radiographic axial spondyloarthritis (nr-axSpA), a distinct subgroup within the axSpA disease spectrum. METHODS: This observational, cross-sectional, qualitative interview study recruited patients from clinic settings. Interviews from patients with axSpA who participated in a prior qualitative study were also used. Patients initially underwent a concept elicitation interview using open-ended questions to evaluate relevance of the concepts measured by the ASQoL. They then completed the ASQoL and underwent a cognitive interview to assess their understanding of the items, instructions and response options. Transcripts from patients who participated in the previous qualitative study (who did not complete the ASQoL or undergo cognitive interview) were evaluated to identify expressions of the concepts in the ASQoL. RESULTS: A total of 18 patients with nr-axSpA participated. The concept elicitation interview findings supported the relevance of the ASQoL items. Cognitive interviews determined that the ASQoL was easily understood; the 13 new patients chose a response for each item that matched their experience with nr-axSpA. Transcripts for the five previously interviewed patients confirmed the concepts presented in the ASQoL items were relevant and important to their experience of living with nr-axSpA. CONCLUSIONS: Our results represent an important first step in confirming the relevance of the concepts in the ASQoL to patients with nr-axSpA, supporting quantitative assessment of ASQoL validity in this population.

Barriers to treatment optimization and achievement of patients' goals: perspectives from people living with rheumatoid arthritis enrolled in the ArthritisPower registry.

BACKGROUND: Few studies have investigated patients' own treatment goals in rheumatoid arthritis (RA). The objective of this real-world, cross-sectional study of US patients with RA was to identify factors that patients believed influenced their physician's treatment decisions. Secondary objectives included reasons patients tolerated sub-optimal disease control and their perceived barriers to treatment optimization. METHODS: Eligible participants were enrolled in the ArthritisPower registry, ≥ 19 years, had physician-diagnosed RA, unchanged treatment within 3 months of baseline, prior/current disease-modifying antirheumatic drug treatment (DMARDs), and computer/smartphone access. In December 2017, participants completed Patient-Reported Outcomes Measurement Information System-Computerized Adaptive Tests (PROMIS-CAT) for pain interference, fatigue, sleep disturbance, and physical function. Routine Assessment of Patient Index Data 3 (RAPID3) provided disease activity scores (0-30). Participants completed an online survey on barriers to treatment optimization, including self-perception of disease compared to RAPID3/PROMIS scores. RESULTS: A total of 249 participants met inclusion criteria and completed the survey. Mean age (SD) was 52 (11) years, and the majority were female (92%) with high RAPID3 disease activity (175/249 [70%]; median score 18). The main reason participants did not change treatment was their physician's recommendation (66%; n = 32). Of participants with high RAPID3 disease activity, 66 (38%) were offered a treatment change; 19 (29%) of whom declined the change. Most participants who intensified treatment did so because their symptoms had remained severe or worsened (51%; n = 65); only 16 (25%) participants intensified because they had not reached a specified treatment goal. Among participants who self-reported their disease activity as "none/low" or "medium" (n = 202; 81% of cohort), most still had RAPID3 high disease activity (137/202 [68%]; score > 12). Most PROMIS scores showed moderate agreement with participants' self-assessment of health status, in contrast to RAPID3 (weighted kappa: 0.05 [95% CI - 0.01, 0.11]). CONCLUSIONS: Most participants trusted their rheumatologist's treatment decisions and prioritized their physician's treatment goals over their own. Patients should be encouraged to share their treatment goals/expectations with their rheumatologist, in line with the treat-to-target approach. RAPID3 may be inappropriate for setting patient-centric treatment goals given the poor agreement with self-reported disease activity; most PROMIS scores showed better alignment with patients' own assessments.

Opioid Use in Patients with Ankylosing Spondylitis Is Common in the United States: Outcomes of a Retrospective Cohort Study.

OBJECTIVE: To assess the prevalence of chronic opioid use in patients with ankylosing spondylitis (AS), and to compare the characteristics of patients with and without chronic opioid use. METHODS: This was a retrospective cohort study of patients with AS identified in the Truven Health MarketScan Research database between January 1, 2012, and March 31, 2017. Commercial and Medicaid claims data were examined using both specific (720.0 and M45.x) and broader (720.x and M45.x) International Classification of Diseases (ICD) coding definitions. Patients were aged ≥ 18 years on the date of first qualifying ICD code occurrence (the index date). Demographics and clinical characteristics were assessed in the 12-month period preceding the index date. The 12-month followup period was used to assess prevalence and characteristics of chronic opioid use. RESULTS: Chronic opioid use was common among patients with commercial claims (23.5% of ICD 720.0 patients; 27.3% of ICD 720.x patients), and especially those with Medicaid claims (57.1% and 76.7%, respectively). The proportion of patients with claims for anti-tumor necrosis factor therapies during followup was often low, and for Medicaid patients was lower among those with chronic opioid use (29.6% of ICD 720.0 patients; 2.3% of ICD 720.x patients) than those without (47.1% and 7.1%, respectively). Among chronic opioid users in all cohorts, the cumulative supply of opioids was typically high (≥ 270 days in the followup period); most opioids prescribed were Schedule II. CONCLUSION: Patients with AS receive opioids with disturbing frequency. The infrequent prescription of recommended therapies to these patients reflects a need to optimize treatment further through education of patients and healthcare professionals alike.